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Cancer Patients Aid Association, has won a seven-year legal battle against Swiss drugmaker Novartis' attempt to patent anti-leukemia drug Glivec. The Supreme Court on Monday rejected Novartis' efforts to patent anti-leukemia drug Glivec (beta crystal form of imatinib mesylate) in India. CPAA fought relentlessly from 2006 to keep prices of this cancer drug in check in the country.

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Top Articles:

Big pharma's uncertain future in India | Sushmi Dey | New Delhi April 16, 2013
The Judgment In Novartis v. India: What The Supreme Court Of India Said | Intellectual Property Watch | Inside Views | 4 April 2013
India: pariah or pathbreaker of pharma world? | Apr 8, 2013 | DNA
Injecting purpose into pharma R&D | The Hindu | Business Line | 4 April 2013
Novartis Loses Historic India Patent Case On Cancer Drug Glivec: Asian Scientist | 5 April 2013
Judgment will ensure no ever-greening of patents: Y K Sapru | Business Standard | April 3, 2013
Brian Druker, who invented the drug's molecule, says it would benefit patients in the short term | Business Standard | April 3, 2013
Novartis: India rejects patent plea for cancer drug Glivec | 1 April 2013, BBC Business News
Cheap drugs triumph as India justices reject patent: International Herald Tribune Asia | 2 Apr 2013
Low-Cost Drugs in Poor Nations Get a Lift in Indian Court: The New York Times | 1 April 2013
Ex- J&J India head led fight against patent: Economic Times | 2 April 2013
Cancer drug down to 8K from 1.2L ? Mumbai Mirror | 2nd April 2013
Supreme Court rules for cheap cancer drug: TNN | Apr 1, 2013
SC rejects Novartis' patent plea for cancer drug Glivec: The Hindu | 1 April 2013
Novartis loses landmark India patent case on Glivec: Reuters Mumbai / New Delhi | 2 April 2013
Novartis order may force pharma MNCs to change: ET Bureau | 2 April 2013
Costly disease for poor country: TNN | 2 Apr 2013
Supreme Court’s decision on Section 3(d) historic: Anand Grover: Times of India, Mumbai | 2nd April 2013
PATENT WAR: Drug price negotiation may be way forward: TNN | 2nd April 2013
Good news for Indian pharma, consumers: Learning with the times: Times of India | 2nd April 2013
The Judgement will change the cancer scene in India: Mid-Day | 2nd April 2013
Landmark judgment: No SC cure for Novartis patent pain: DNA | April 2, 2013
Key cancer drug will stay cheap after patent ruling: Hindustan Times (Mumbai) | 2 Apr 2013
Novartis verdict a boon for health care in India: Doctors, Hindustan Times Mumbai | April 02, 2013
Novartis ruling opens doors for Indian pharma firms... | Hindustan Times (Mumbai) | 2 Apr 2013
SC’s Glivec ruling setback to foreign pharma firms | April 2 2013
Voices on the Verdict: Times of India, Mumbai | Tuesday 2nd April 2013

 


 


Big pharma's uncertain future in India
Sushmi Dey | New Delhi April 16, 2013


Multinationals are worried about the country's patent regime, but India is too big a market to be ignored

India's drive towards compulsory licensing, increasing patent challenges and denial of patent protection to anti-cancer drug Glivec have not gone down well with multinational drug makers who are grumbling that India has become a difficult market for them to operate, bring newer drugs and make investments in research. Their contention is patents are inadequately protected in India, which not just discourages research and development but also makes it a low-priority market for innovator companies.

While earlier this year, the Intellectual Property Appellate Board upheld the compulsory licence granted to Natco for manufacturing the generic version of Bayer's Nexavar, the Supreme Court denied patent protection to Novartis beginning of this month for Glivec. This is not all. The government is also considering a proposal to invoke compulsory licences for three more patented drugs, while another drug maker, BDR Pharma, has approached the Patent Controller seeking a compulsory licence for US-based Bristol-Myers Squibb's anti-cancer drug Sprycel. BDR Pharma has offered to sell the cancer medicine at a price 95 per cent cheaper than that of the multinational. The latest is the legal battle between Merck Sharp & Dohme and Mumbai-based Glenmark. Merck has challenged Glenmark in the Delhi High Court alleging patent violation of its anti-diabetes drugs Januvia and Janumet.

The increasing number of conflicts in the intellectual property space has led to some multinationals warning India that they may divert investments to other markets or at least start acting "cautious" in their approach. Novartis has repeatedly said that if intellectual property is not adequately protected in India then it will be "cautious" while making investments in innovation here. Merck has also indicated that patent protection is essential for attracting investments from companies in research and development. "Strong intellectual property protection is essential for growing India's innovative capacity and economic growth. As an innovative pharmaceutical company, protection of our intellectual property is vital to ensure that we continue to assume the tremendous monetary risks associated with the discovery of innovative medicines," it had said after challenging Glenmark in the Delhi High Court recently.

Making a case for patent
Kewal Handa, former managing director of Pfizer India and currently promoter-director of Salus Lifecare, says the apex court's judgement against Novartis and various patent challenges against Roche, Bayer and other multinationals could be a huge setback to the innovation and research ecosystem of India. "We would be perceived by the world as a country that doesn't recognise, respect and reward research and innovation," Handa says. "This one judgement may have also larger consequences on global investments, particularly in the area of manufacturing, clinical research and BPO."

However, market analysts opine that all multinationals may not be as much impacted or discouraged by the latest moves. According to Nitin Agarwal of IDFC Securities, companies such as GlaxoSmithKline, Pfizer and Sanofi are seen to be less impacted as they already have a presence in India and have established their products. They have also made substantial gains from their patented products here. "So, their strategy and businesses may not be impacted much due to the latest developments or mood," he says.

Industry estimates show that multinationals have established their key brands over the years across therapies. Not all of these products are patented. In fact, the share of patented products is not more than 2 per cent of the total market, including those pushed by them through their own retail and access programmes. Foreign players such as Abbott, GlaxoSmithKline, Novartis and Pfizer account for five of the top-10 brands in the Indian market. According to a study conducted by IDFC Securities, Abbott's anti-diabetic drug Human Mixtard, which was launched in 1992 and currently occupies the top-slot of best-selling brands, garnered revenue of around Rs 219 crore last year. Similarly, Pfizer's cough medication Corex, launched a year later in 1993, clocked annual sales of Rs 215 crore in 2011. Even older brands like Voveran and Revital clocked significant sales. While Voveran earned Rs 194 crore for Novartis, Revital contributed Rs 182 crore towards Ranbaxy's sales last year. Abbott, which leads the top-300 list, now has 28 brands in that bracket aided by its acquisition of Piramal Healthcare's domestic formulations business.

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The Judgment In Novartis v. India: What The Supreme Court Of India Said
Intellectual Property Watch | Inside Views | 4 April 2013 @ 4:33 pm

By Frederick M. Abbott

As part of a series of amendments to the India Patents Act that took effect on January 1, 2005, the Parliament of India adopted Section 3(d). This statutory provision has been in force for more than seven years. A challenge brought by Novartis to the constitutionality of the provision and to its compatibility with the WTO TRIPS Agreement (World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights) was rejected by the High Court at Madras in 2007. That judgment was not appealed. On 1 April 2013, the Supreme Court of India rendered judgment [pdf] on an appeal by Novartis against rejection by the India Patent Office of a product patent application for a specific compound, the beta crystalline form of imatinib mesylate. Imatinib mesylate is used to treat chronic myeloid leukemia and is marketed by Novartis as “Glivec” or “Gleevec”. Affirming the rejection, the Supreme Court confirmed that the beta crystalline form of imatinib mesylate failed the test of Section 3(d). The Court clarified that efficacy as contemplated under Section 3(d) is therapeutic efficacy.

This judgment has attracted worldwide press coverage. It has received severe criticism from a number of originator pharmaceutical companies, including Novartis, and from the US Chamber of Commerce, to the effect the judgment of the Indian Supreme Court has dealt a harsh blow against the future of innovation, particularly in India. It is somewhat difficult to know why this decision interpreting Section 3(d) should come as a major surprise to anyone. Perhaps more important, it is difficult to understand what it is about the Supreme Court judgment that might so offend the sensibility of patent lawyers or government policymakers. The judgment is well-crafted, with close attention to the facts presented, and appears to take a balanced view of the matters brought before the Court. What did the Supreme Court of India say?

The case involves a substantial number of fairly complex technical issues, including some fairly complex legal issues. Without intending an injustice to that complexity, the main points made by the Court are these:

 

  1. The express terms of the Patents Act as amended in 2005 reflect the considered judgment and will of the Indian Parliament as found in the legislative record. Section 3(d) was proposed by the Government with the stated purpose of addressing concerns raised by members of Parliament that the introduction of pharmaceutical product patent protection would substantially inhibit the availability of medicines for the population of India and developing countries more generally. Parliament sought to limit practices that might result in the grant of patents for insubstantial technological contributions. Parliament adopted in the Section 3(d) amendment, including the explanation, a requirement that patents for new forms of known substances should only be granted on the showing of a significant enhancement in known efficacy.

  2. International legal rules accepted by India, in particular the WTO TRIPS Agreement, provide sufficient leeway or flexibility in the adoption of patenting standards to allow the approach adopted by the Indian Parliament.

  3. The facts of this case involve certain transitional arrangements between the former pre-2005 Indian patent system which did not allow patents for pharmaceutical products, and the post-2005 regime under which such patents are permitted. For patent applications filed (with priority date) before 1 January 1995, a patent could not be secured in India for a pharmaceutical product. From 1995 to 2005, pharmaceutical product patent applications could be filed and held in a “mailbox”. A patent could be granted and become effective after 1 January 2005, based on a “mailbox application”.

  4. In 1992, Novartis filed an initial patent application in the United States covering the drug “imatinib”, which patent application also covered pharmaceutically acceptable salts. It was subsequently granted a patent. Novartis applied for and received US Food and Drug Administration (FDA) approval for the marketing of a salt form of that drug called “imatinib mesylate”. The drug was placed on the market in that form in 2001.

  5. In 1997, Novartis filed a patent application for a specific variation of the imatinib mesylate salt, the “beta crystalline” form. An examiner in the United States rejected this patent application, but the examiner was overruled by a Patent Office appeal board because the new crystalline form of the mesylate salt of imatinib involved a sufficient “manipulative step” under US patent law. The patent was granted for the United States.

  6. In 1998, Novartis filed an application in India for this beta crystalline form. The application did not disclose any improvement in efficacy. However, when India adopted section 3(d) in 2005, Novartis undertook some studies to meet the statutory requirement to show enhanced efficacy.

  7. The first issue before the Supreme Court was whether the mesylate salt form of imatinib had been disclosed, and was therefore publicly known, prior to 1997. On the basis of the documents, the Supreme Court found that it was. The mesylate salt was the form in which the drug was marketed. To satisfy the requirement of “enhanced efficacy” in section 3(d), comparison of the beta crystalline form had to be made with the already known mesylate salt. In light of this, the Indian Supreme Court found the efficacy studies reported by Novartis very odd. Novartis alleged that the beta crystalline form showed a 30% increase in “bioavailability” (based on tests in rats). But this 30% increase in bioavailability was not in comparison to the known and previously marketed mesylate salt form of the drug, which would ordinarily be soluble, but rather in comparison to the “free base” form of the imatinib drug that was not marketed because it was not soluble. So, Novartis did not compare its “new” form of salt to its “old” marketed form of salt, but rather to what it knew would be a much less bioavailable form. There was no evidence in the record as to how the new salt compared to the old salt even in terms of bioavailability.

  8. The Supreme Court interpreted the meaning of “efficacy” in Section 3(d). It said that the new form of a drug must demonstrate an improvement in its therapeutic effect or curative property as compared to the old form in order to secure a patent. Novartis offered evidence that the beta crystalline form differed regarding certain properties relating to production and storage (e.g., heat stability). The Court held that these properties may be important from storage point of view, but would not be relevant to showing “enhanced therapeutic efficacy”.

  9. As previously noted, Novartis also presented evidence regarding increased “bioavailability”. The Court observed that “bioavailability” measures the level at which the drug is made available in the human body. The level of bioavailability may or may not have an influence on the therapeutic or curative effect of the drug. In this case, the Court held that such effect was not demonstrated.

  10. The Court discussed at some length the meaning of therapeutic efficacy in respect to pharmaceutical products, and observed that there are different possible meanings. The definition may be limited only to action resulting in a curative effect, or it might be more broadly extended to cover improved safety or reduced toxicity. The Court decided to leave open what is the appropriate definition of enhanced (therapeutic) efficacy – the narrower or broader interpretation – because it did not need to reach that question in this case. Novartis had provided no evidence that the beta crystalline form of imatinib improved the therapeutic effect of the drug. There was nothing to measure. The Court did not say that a change in bioavailability may never result in enhanced efficacy. It said that the patent applicant needed to demonstrate that there was a resulting enhancement in efficacy.

  11. At the very end of the decision, in requiring Novartis to pay the costs of the challengers, the Court said that it appeared that Novartis was in fact marketing an older form of the drug and not the beta crystalline version, and that it appeared that Novartis may have been trying to use a patent in India to cover a drug that it was not actually selling. It suggested that this showed Novartis “in rather poor light”.

    The Supreme Court affirmed that India has adopted a standard of pharmaceutical patenting that is stricter than that followed by the US or the EU. For India, a patent applicant must not only show that a new form of known compound is different than an old form, but that the modification will result in an improvement in the treatment of the patient. There is in fact nothing new about such a standard. This was the approach followed by the US Patent Office up until a case decided by the Court of Appeals for the Federal Circuit, In re Brana, in 1995. Today, the Patent Office and Federal Circuit will approve patents for very minor modifications, supporting the practice known as “evergreening”. This is a very expensive proposition for US consumers because it allows the manufacturers to market and sell higher-priced patent-protected versions of their popular drugs.

    The Federal Circuit rationalizes this practice, saying that allowing patenting without demonstration of significant therapeutic effect encourages the development of new compounds, therefore encouraging innovation. But, this is just a theory about the best time along a continuum for granting a patent. It may well be that granting patents after researchers have demonstrated that drugs will accomplish something significant in terms of curative effect will encourage researchers to concentrate on achieving desirable end results, rather than winning marketing games. The race will not be won by the first person who creates a new compound, but the first person who creates a new compound and shows that it is therapeutically significant.

    The Indian Parliament, supported by the Supreme Court, has decided that Indian consumers should only pay for expensive patented products when those products represent a genuine advance over older versions. It is important to note what the Supreme Court did not say. It did not say that a new form of known compound may never be patented. It did not say that improving the bioavailability characteristics of the drug may never result in enhanced efficacy. It left open the question whether enhanced efficacy refers narrowly to curative effect, or more broadly to improved safety profile and reduced toxicity.

    From a patent law standpoint, it is rather difficult to discern what about the Supreme Court’s decision strikes the US Chamber of Commerce, Pfizer or Novartis as some great threat to innovation or the long-term welfare of patients. It may put a damper on the profits of Pfizer or Novartis as they are less able to extend the life of patents by minor modifications that result in patients and public health systems paying more for drugs. But, one should be very careful of confusing the interests of the shareholders of Pfizer and Novartis with the interest of patients in the United States, Europe, India or Kenya. One might also be skeptical of claims from the industry that it will withdraw from the Indian market. Where there are profits to be made, the industry will be participating.

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India: pariah or pathbreaker of pharma world? | Monday, Apr 8, 2013, 10:00 IST | DNA
Patralekha Chatterjee


This was not the 3D of movies, games and computer graphics. But it gripped the national imagination. The Supreme Court ruling last week dismissing Swiss drug major Novartis AG’s bid for a patent for its cancer drug Glivec hinged on the interpretation of Section 3(d) of India’s patent law which defines what are not “inventions” under Indian law, and therefore not patentable.

It was an epic finale to a tortuous seven year-old legal battle that pitted Novartis against the Indian government, the country’s leading generic drug makers and the Cancer Patients Aid Association.

The reactions to the verdict have been totally predictable. Health activists and patients’ groups worldwide are delirious with happiness. No surprises there — India’s generic drug industry makes cheaper versions of life-saving medicines that cater to the entire developing world.

Novartis is unhappy, as is Big Pharma and its advocates.

Over the past few days, a stream of analyses has parsed the Court’s verdict , especially in relation to Section 3(d) of the patent law which states that inventions that are a mere “discovery” of a “new form” of a “known substance” and do not result in increased efficacy of that substance are not patentable.

The Glivec case hinged on this provision, introduced by the Indian Parliament in the country’s patent law in 2005 as a public interest safeguard to prevent patenting of new forms of known substances unless they exhibit enhanced efficacy.

This case triggered so much interest across the world because it touched upon one of the central challenges of our times — how to balance incentives for innovation with interests of public health and access to medicine.

Most people in this country pay for medical treatment out of their pocket and, therefore, anything that promotes cheap drugs is a big deal. Glivec enjoys patent protection in 40 countries. Novartis says most of those who are prescribed Glivec in India get the medicine free of charge from Novartis’ patient assistance programme. This may be true. But the fact of the matter is that a month’s dosage of Glivec, the branded drug, costs over a lakh. The generic version in India costs less than Rs10,000. I reckon most people in this country are taking the generic medicine.

The striking feature of the Glivec saga has been the use of war imagery to tell the tale — Western pharmaceutical firms are perceived to have received a “blow” and Indian generic drug makers are portrayed as the “victors”.

But to see it as a morality play is to miss the larger point. There will be differences of opinion between lawyers. But Novartis lost the case because it could not convince the Supreme Court judges that there was enough scientific evidence to demonstrate that it was different enough and more therapeutically effective than an earlier patent relating to Glivec. There is nothing to suggest that the Indian judiciary is biased against innovators, or that in the future, other multinational or local pharma companies applying for a patent in India will necessarily be disappointed.

The future is likely to be a shade of grey, rather than black and white. Generic drug makers may appear to have triumphed this time, and with other recent judicial verdicts in the country. But there are challenges ahead. Big Pharma has to also go in for a reality check. Affordability is a big issue, and not just in India. Unless there is differential pricing, it won’t be smooth-sailing.

Big Pharma honchos predict dire consequences for India — no new life-saving drugs, no future as a research and development hub, and so on. Despite the sound and fury, I don’t’ think it is quite Apocalypse now.

Will India be a reduced to a pariah or will it continue to be seen as a path-breaker of the pharma world? Those who have been watching the Glivec saga from afar say that it is necessary to sift the rhetoric from the reality. With pharmaceutical profits decreasing in the developed world, pharma MNCs are increasingly looking to the developing world to expand profits. Everyone is banking on the emerging markets. Despite India’s slowing economic growth, the country’s pharma industry remains attractive. A 2011 report by the Confederation of Indian Industry and Pricewaterhouse Coopers says that the Indian pharma industry today is the third largest market globally in terms of volume and the 14th largest market by value. It is likely to be a $74 billion market by 2020.

Secondly, India is not the only country with public health safeguards in its patent regime. Many other developing countries have put in place such provisions into their patent law. For example, Argentina and Phillipines have something similar to India’s Section 3(d) in their patent legislation.

Or take compulsory licensing (CL), another public interest safeguard allowed by the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

India has been slammed for using it. But Indonesia, Thailand, Brazil, Malaysia, Zambia, Cameroon, Ecuador, and now even China are joining the ranks of those using CL.

Public health safeguards is a good thing. However, India should brace itself for political pressure from developed countries, home of pharma MNCs, in the coming days. One increasingly disturbing aspect of free trade agreements (FTAs), for example, is the inclusion of investor-state provisions that essentially allow companies — usually multinationals — to challenge the policies of signatory governments directly. US drug giant Eli Lilly & Co. is demanding $100 million in compensation for Canadian court decisions that stripped the company of its patent for a drug used to treat attention-deficit disorder. With India planning or negotiating a raft of free trade deals in the coming days, these are some of the issues to keep in mind.

The author is a Delhi-based writer.

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Injecting purpose into pharma R&D
P.T. JYOTHI DATTA | The Hindu | Business Line | 4 April 2013


The Glivec ruling is a watershed, but we also need to spur local research and ensure access through insurance.

Some of the attention on the legal battle involving Novartis’ blood cancer drug Glivec can be explained by the David-versus-Goliath nature of the fight. In India, it was the Cancer Patients’ Aid Association that stood with those legally opposing multinational drug-major Novartis’ claim for a patent on Glivec. And at the Novartis headquarters in Basel, a shareholder spoke up for Indian patients at the Swiss company’s annual shareholders’ meeting.

But when the dust settles and the breathless commentary on the Supreme Court’s landmark judgment wanes, it would be time to introspect and face some disconcerting realities on why patients in the country bear the brunt of mounting medical bills. And reality is — an unhealthy mix of abysmal healthcare spends by the Government, patchy health-insurance coverage and the absence of an environment that sparks bright minds to research products to tackle diseases of the local population.

Earlier this week, when the Supreme Court dismissed Novartis’ plea on Glivec, it did not just put a lid on a seven-year long, high-profile case. The watershed judgement stood for innovation, as defined by the Indian Patents Act, and its touchstone to measure efficacy — the law’s Section 3 (d).

After technically evaluating the merits of the patent claim, the Court had ruled that imatinib mesylate (sold under the Glivec brandname) did not show an inventive step or improved efficacy (from its already known version) to merit patent protection. In fact, there are a handful of drugs locked in patent battles, at various stages of progress across the country (see table compiled by Gopakumar Nair Associates). Last year, the Patent Controller took the unprecedented step of issuing the country’s first compulsory licence to drug-maker Natco, allowing it to make its less expensive version of Bayer’s advanced kidney cancer drug Nexavar, on the payment of a 7 per cent royalty. The decision was seen to be in the interest of public health.

But patent battles are a moment in time in the country’s changing landscape of protecting intellectual property — the data and knowledge generated while undertaking research. India amended its Patents Act (1970) to respect product patents in 2005. And this made the environment difficult for companies that reverse-engineered new products to make similar versions.

With this crutch being removed came a new concern — who would shoulder the responsibility of treating diseases in the country? Would it be the domestic industry, still getting its act together on research; the multinationals and their high-priced innovative products; the slow-moving public sector institutions; or the low-spending Government?
 

No social security net

Unfortunately, while the Courts step in to protect the interest of the patient, the Government and industry fall short in their efforts. The Government’s spending on healthcare is a shameful 1 per cent odd of GDP. Not a patch on other developed nations that spend over 10 per cent.

Health insurance continues to be patchy and riddled with mistrust between insurance companies (wary of false claims) and patients, who feel companies are tight-fisted when it comes to reimbursing their legitimate medical bills.

The country is not even close to bringing in a social security net, where people pay when they are young and earning, to get a State cover when they are older.

Doctors treating cancer patients acknowledge, in private conversations, the situation that patients find themselves in — something that’s lost in the present jingoism over medicine prices.

If Glivec is beyond reach at Rs 1 lakh a month, even the reduced price of Rs 10,000 per month is steep, as a life-long expense for salaried people, says a doctor.

While the patent-life of the drug may be debated, what is not in question is that it is improves the quality of life for a patient — from the earlier five years to about 17 years now, he points out.

Tempering jubilation over the Glivec ruling with realism, the doctor wryly says if there is no original research, there would be no medicine to be copied. This is not to say that medicine prices should not be affordable. But the Government has to step in and support massive healthcare programmes, even as it facilitates an environment to encourage research.

It needs to bring in a transparent procurement system to buy drugs at subsidised cost and give it free to patients. Companies would be willing to participate in Government programmes if they were transparent, did not have an L-1 fixation (where the drug with the lowest price is chosen, even if it is not the most effective one) and did not threaten to blow up into the next big scam in the country — is the measured observation in some medical circles.

Step up research


A section of the scientific community is also uneasy about the state of affairs in research. Unlike overseas, there isn’t a system where research from government institutions and labs gets picked up and commercialised by industry. Whether this is because innovative work does not come out of labs here, or because industry is not supportive, is something that needs to be figured out.

But research is a shot in the dark, a pathway fraught with risk. And some of the biggest names in the domestic pharma space have sold out entirely, because they lacked their predecessor’s vision to power ahead .

All the more reason for research alliances between local companies, government labs and foreign companies — to push for new drugs to be brought into India, and at reasonable prices.

Companies and policymakers will have to figure out better ways to fund healthcare innovation, and not make patients pay a huge price for falling sick. In the last 60 years, the country has built its rock-solid base of generic drug makers. They have played, and will continue to play a key role in providing inexpensive drugs in India and across the world. But there is huge opportunity to be tapped — from scientific capabilities to the scope of traditional knowledge available in the country.

As the doctor says, it is in the interest of local researchers and companies to get out of the “photo-copier” mindset and take that leap into meaningful research to bring out affordable medicine.

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Novartis Loses Historic India Patent Case On Cancer Drug Glivec | Asian Scientist | Sanjay Kumar | 5 April 2013

After a seven year protracted battle, the Supreme Court of India has rejected a patent application by Swiss pharma giant Novartis for an updated version of its blockbuster drug.

AsianScientist (Apr. 5, 2013) – After a seven year protracted battle in various courts, the Supreme Court of India finally rejected a patent application by Swiss pharma giant Novartis earlier this week (April 1) for an updated version of the anti cancer drug Glivec (imatinib mesylate).

This case is seen as one of the highest profile cases in India – keenly watched by the international pharmaceutical industry and health activists alike – with wide ranging implications for not only India but also other developing countries. Glivec is used for treating chronic myeloid leukemia (CML) and some other forms of cancers.

The Indian Supreme Court held that the new version of the drug differed slightly from the older known version but not substantially enough to categorize it as a novel product, and hence denied a patent to Novartis. The controversy revolves around the interpretation of a provision of the Indian Patents Act called Section 3(d), which disallows patenting of new forms of already known molecules. This provision prevents the ‘evergreening’ of patents by interested entities who slightly tweak patented molecules and seek a fresh patent beyond the normal duration of 20 years, thus posing a long-term challenge to the availability of affordable and cheap medicines to patients, especially in developing countries.

Pharma multinationals have been accused by non-profit health groups of earning large profits through patented medicines. While Novartis sells Glivec at Rs.120,000 (US$2,400) per monthly dose, its Indian generic equivalents cost only Rs. 8,000-12,000 (US$160-$240) for a monthly dose.

In 1998, Novartis had applied for a product patent on the beta crystalline form of imatinib mesylate, the original molecule having been discovered in early 1990s and patented by Novartis in the United States and other developed countries in 1993.

In 2006, the Chennai Patent Office rejected Novartis’ new application on grounds of lack of novelty and increased efficacy over the already known substance. Novartis filed an appeal against the rejection of its patent application and also challenged the constitutional validity of Section 3(d) in the Chennai High Court. In 2009, the Intellectual Property Appelate Board rejected Novartis’ appeal against Section 3(d) and Novartis approached the Supreme Court in 2009 which rejected its plea this week.

The Supreme Court judgment is widely seen as a setback for the multinational pharmaceutical lobby which may have been looking forward to protecting its turf by the ‘evergreening’ of existing patents. Quite clearly, its reverberations will be felt in various other cases – many already in various stages of litigation in Indian courts – involving Indian generic manufacturers and competing multinational companies.

On the heels of the Novartis judgment, Merck, Sharp & Dohme (MSD) has taken Mumbai based Glenmark Pharmaceuticals to the Delhi High Court alleging infringement of its patent for its anti diabetes blockbuster drugs, Januvia and Janumet. Glenmark is marketing its Zita and Zita-Met drugs as branded generics which are priced 30 percent cheaper than Merck’s products.


Novartis says court decision discourages drug innovation

Novartis described the primary concern of the case as one of India’s growing non-recognition of intellectual property rights that sustain research and development for innovative medicines. It dubbed the judgment as one that discourages innovative drug discovery essential to advancing medical science for patients.

“We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs,” said Ranjit Shahani, Vice-Chairman and Managing Director, Novartis India Limited. “This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options,” he added.

But the patients groups have been ecstatic over the judgment. Y K Sapru of Cancer Patients Aid Association (CPAA), which fought Novartis in court, said, “We are very happy that the apex court has recognized the right of patients to access affordable medicines over profits of big pharmaceutical companies through patents.”

International medical humanitarian organization Medecins Sans Frontieres (MSF) or Doctors Without Borders described the judgment as a major victory for patients’ access to affordable medicines in developing world.

“This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India and for treatment providers like the MSF,” said Dr. Unni Karunakara, MSF’s International President.

“By refusing patent monopolies on minor changes to known molecules, this judgment will facilitate early entry of generic medicines into the market for other medicines and diseases too,” says Anand Grover, director of Lawyer’s Collective who represented the CPAA. “The impact will be felt not only in India but across the developing world,” he added.

The Indian Drug Manufacturers Association (IDMA), an apex body of indigenous (non-multinational) drug manufacturing companies, has also, quite understandably, welcomed the Supreme Court judgment. The Indian drug industry ranks third largest in volume (10 percent) and 14th (1.5 percent) in value globally. It tops the world in exporting generic medicines, valued at US$11 billion annually. This number is expected to cross US$16 billion by 2013-14, according to the IDMA.

In 2011, global generic drug spending was estimated to be US$267 billion, and is expected to rise to $400-430 billion by 2015, nearly 70 percent of which will be outside developed countries.

Drugs with an estimated combined annual sales of US$150 billion are slated to go off-patent by 2015. Backed by the recent Supreme Court judgment, Indian firms are expected to rake in profits with the patent expiration of blockbuster drugs looming in the horizon.

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Judgment will ensure no ever-greening of patents: Y K Sapru | Interview with Founder chairman of Cancer Patients Aid Association | Business Standard | Sushmi Dey April 3, 2013

Y K SapruThough the legal battle over Glivec's patentability may be over for now, Y K Sapru, the man spearheading the fight against Swiss multinational Novartis, isn't resting. Sapru, founder chairman of Cancer Patients Aid Association, or CPAA (which moved the Supreme Court to keep the prices of the cancer drug low), tells Sushmi Dey what the judgment means to cancer patients. Edited excerpts:

What does a judgment in CPAA's favour mean for patients across the country?
The Supreme Court's judgment on the Glivec case is a landmark one. This may form the basis for decisions in all patent disputes in the future. The judgment is crucial because it would ensure there is no ever-greening of patents and Section 3(d) can be used to ensure incremental innovation would not be accepted for drug patents in the future, too. As far as Glivec is concerned, there is no immediate benefit for patients, because a lower-priced version of the drug is already available. Still, it is a major victory because if we would have lost the battle, patients would have had to pay Rs 1,25,000 for a month's therapy, against the current Rs 6,000-8,000.

What is CPAA's next objective? Are you planning to take the struggle forward and fight more such cases?
Now, we are planning a two-pronged attack. First, pick up expensive patented products and get their patents cancelled. Second, convince the government to allow compulsory licences for such products to allow competition in the market. This would bring down prices for patients. We have already started working on one such drug - Herceptine, used for the treatment of breast cancer. While the patented drug costs Rs 1,50,000 for a single course, a generic version can be made available at a much lower price.

How many patients would benefit from the generic version of Glivec?
In India, about 2,00,000 people suffer from chronic myloid leukaemia and about 30,000 are added every year. With prices of the drug remaining low, all these people would benefit.

Novartis has claimed it provides the drug free of charge to most patients. Since your organisation works for cancer patients, what is your view on the issue?
Novartis is giving Glivec free to only to selected patients and that, too, through doctors chosen by Novartis. Besides, patients have to take this drug throughout their lives; under its assistance programme, Novartis is giving doses for only one to two months.

Moreover, the availability of generics would ensure more people have access to the treatment through their lives.

Earlier, you worked with Johnson & Johnson. What motivated you to take up this cause?
I was with Johnson & Johnson till 1999. I founded Cancer Patients Aid Association about 43 years ago, when I was still working with the company. This is because I found cancer patients across the globe weren't able to afford medicines. I realised people were not dying because of unavailability of treatment, but because the medicines weren't affordable. That motivated me to take up the cause and fight for it.

There is a view provisions such as compulsory licence and Section 3(d) may hit the introduction of new drugs in India. Don't you think that would be a bigger threat to patients with unmet medical needs?
That is not true. Even now, there is no research taking place in India. Not a single drug is discovered here. There are generics available all over the world and research happens everywhere. Even for generics, companies are required to prove their efficacy.

What challenges did you face during your seven-year-long Glivec battle with Novartis?
I have faced a lot of pressure, both direct and indirect, to withdraw the case. I have also faced various charges. But the fact is for cancer patients, it is a fight between life and death. If medicines are made affordable, patients across the globe can be treated properly and unaffordability would be a thing of the past.

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Brian Druker, who invented the drug's molecule, says it would benefit patients in the short term
The man behind Glivec hails verdict | Reghu Balakrishnan | Mumbai April 03, 2013

Even though Novartis and other multinational corporations (MNCs) are upset with the Indian Supreme Court’s decision to reject Novartis’ patent claim on Glivec, the key man behind the popular cancer drug has welcomed the verdict, saying it would benefit patients.

Brian Druker, director, Knight Cancer Institute at Oregon Health and Sciences University, is the man who invented the molecule — imatinib, the precursor to Gleevec (Glivec) — as a promising anti-cancer compound in 1990s. “This patent decision clearly makes more affordable drugs available immediately and this is good for patients in the short term,” Druker said in an email response to Business Standard.

“I have consistently spoken out about what I view as the high price of drugs, but if we too severely restrict the price of medications, we may lose the ability to invest in new drugs,” he added.

In 2007, Druker reportedly said the price at which Novartis was selling imatinib around the world had caused him considerable discomfort. “Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified, given the vital investments made by the public sector over decades that make the discovery of these medicines possible,” said Druker. His statement is widely used by pharma non-government organisations across India to challenge the claims of MNCs.

Druker’s effort to find a new drug for chronic myeloid leukemia (CML) was started in late 1980s, when he joined hands with industry scientists at Ciba-Geigy (now Novartis Pharmaceuticals). In 1993, he moved to Oregon Health Sciences University in Portland and continued his efforts. Imatinib was approved by the US Food and Drug Administration in May 2001 for use in CML.

“The issue is, when does a country move from needing assistance to make drugs affordable, to being able to contribute more to drug discovery and innovation,” said Druker.

At present, India is at the receiving end after MNCs flayed the government’s decision to allow compulsory licence for patented cancer drugs, which remain unaffordable to Indian patients. Recently, the Indian patent office issued a compulsory licence to Natco Pharma to manufacture the generic version of Nexavar, cancer drug owned by Bayer. Natco plans to sell the drug at Rs 8,880 for a pack of 120 tablets / month, compared to Bayer’s price of Rs 2.8 lakh.

“Whether patients will be adequately monitored is another issue and for the long-term. Whether this patent decision damages the drug discovery cycle remains to be seen,” said Druker.

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Novartis: India rejects patent plea for cancer drug Glivec | 1 April 2013, BBC Business News

India's Supreme Court has rejected a plea by Novartis to patent an updated version of its cancer drug, Glivec.

The Swiss drugmaker had been denied a patent by Indian authorities on the grounds that the new version was only slightly different from the old. The decision means generic drugmakers can continue to sell copies of the drug at a lower price in India, one of the fastest growing pharmaceutical markets.

Novartis said the decision "discourages future innovation in India".

"This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options," said Ranjit Shahani, vice-chairman and managing director of Novartis India.

Glivec, which is used to treat chronic myeloid leukaemia and other cancers, costs about $2,600 (£1,710) a month. The generic equivalent is currently available in India for just $175.

There were concerns that, if granted, a patent could threaten access to cheap generic versions of life-saving drugs in poorer countries. "This will go a long way in providing affordable medicine for the poor," said Anand Grover, a lawyer representing Cancer Patients Aid Association, adding that he was "ecstatic with the ruling".

Long battle

Novartis applied for a patent in 2006 for its new version of the drug, arguing that it was easier to absorb and therefore qualified for a fresh patent.

However, the Indian patent authority rejected the application based on a law aimed at preventing companies from getting fresh patents by making only minor changes to existing drugs, a practice known as "evergreening". Officials also turned down a subsequent appeal by the company three years later.

On Monday, India's Supreme court rejected the firm's appeal to get patent protection for the drug.

The AFP news agency quoted the court as saying that the updated drug "did not satisfy the test of novelty or inventiveness" as required by the law.
Setting a precedent?

Patents usually protect the companies for 20 years of exclusive sales. After that, it is open to other firms who can make cheaper copies of the original drug. Once the protection expires, the first company to challenge the patent gets an exclusive right to sell the copy for 180 days. After 180 days, more companies can sell the generic versions, potentially resulting in a further price drop. It is estimated that drugs with combined annual sales of $150bn will go off-patent by 2015.

India's generic drug makers are among the biggest in the world and many expect them to benefit from these patents expiring in the coming years. However, there have been concerns that if firms are granted patents for updated versions of their drugs, it may not only deny access to cheaper medicines to poor people, but also hurt the makers of generic drugs. Pratibha Singh, a lawyer for the Indian generic drug manufacturer Cipla, said the ruling had set a precedent that would prevent international pharmaceutical companies from obtaining fresh patents in India on updated versions of existing drugs. "Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug,'' she said.

Shares of Novartis India fell almost 5% on the Bombay Stock Exchange, while stocks of generic drugmakers such as Cipla and Natco rose after the judgement.

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 Ruling allows production of generic version of cancer pills to continue
International Herald Tribune Asia BY GARDINER HARRIS | 2 Apr 2013

The Indian Supreme Court rejected a Swiss drug maker’s patent application for a major cancer drug Monday in a landmark ruling that will allow poor patients continued access to many of the world’s best drugs, at least for a while. The ruling allows Indian makers of generic drugs to continue making copycat versions of the Novartis drug Gleevec — spelled Glivec in some markets, like Europe — which can have a seemingly miraculous effect on some forms of leukemia.

But the ruling’s effect will be felt well beyond the limited number of patients in India who need Gleevec, because it will help maintain India’s role as the world’s most important provider of inexpensive medicines, which is critical in the global fight against HIV/AIDS and other diseases. Gleevec can cost as much as $70,000 per year, while Indian generic versions cost about $2,500 year. ‘‘The judgment in the Novartis case is a victory for patients both in India and around the world,’’ Dr. Yusuf K. Hamied, chairman of Cipla, an Indian generic drug giant, wrote in an e-mail. ‘‘India, being the pharmacy capital of the world, can continue to produce affordable, high-quality medicines without the threat of patents for minor modifications of known medicines.’’

In a televised interview, Ranjit Shahani, vice chairman of Novartis’s Indian subsidiary, said that India would suffer as a result of the ruling because companies like Novartis would invest less money in research there. ‘‘We will continue with our investments in India, even though cautiously,’’ he said. ‘‘We hope that the ecosystem for intellectual property in the country improves.’’

The ruling is a landmark in one of the most important economic battles of the 21st century, in which rich nations that increasingly rely on the creation of ideabased products like computer programs and medicines try to compel mostly poor countries that make physical things like clothing and toys to pay for their ideas.

While the goods made by poor countries cannot easily be shared or stolen, the ideas that power the economies of rich countries can be. So rich countries have insisted that poor countries give some of the world’s most profitable companies government-sanctioned monopolies for what the rich nations see as innovative ideas. But a few of these poorer countries — particularly India, Brazil and China — have begun to question the price they must pay for these idea-based products and whether paying such prices does them any good.

On Monday, the Indian Supreme Court ruled that the patent that Novartis sought for Gleevec did not represent a novel invention. In many ways, this ruling is something of a historic anomaly. India’s 2005 patent law allowed for drug patents on medicines discovered after 1995. In 1993, Novartis patented a version of Gleevec that it later abandoned in development, but the Indian judges ruled that the early and later versions were not different enough for the later one to merit a separate patent.

Leena Menghaney, a patient advocate at Medecins Sans Frontieres, said the ruling Monday was a reprieve from more expensive medicines, but only for a while.

‘‘The great thing about this ruling is that we don’t have to worry about the drugs we’re currently using,’’ Ms. Menghaney said. ‘‘But the million-dollar question is what is going to happen for new drugs that have not yet come out.’’

But Anand Grover, a lawyer who argued the case on behalf of the Cancer Patients Aid Association of India, said that the ruling confirmed that the country had a very high bar for approving patents on medicines. He noted that the majority of patented drugs in the United States won patents for fairly minimal discoveries — like a new form of drug delivery or for certain manufacturing techniques.

In a classic example, Nexium, a heartburn pill by AstraZeneca that was long one of the world’s biggest-selling drugs, is almost identical to Prilosec. But both medicines managed to win patent protection in the United States, something that would not happen in India under the new ruling, Mr. Grover said.

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Low-Cost Drugs in Poor Nations Get a Lift in Indian Court | By GARDINER HARRIS and KATIE THOMAS
April 1, 2013 , The New York Times

NEW DELHI — People in developing countries worldwide will continue to have access to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at least for a while.

Production of the generic drugs in India, the world’s biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court.

The debate over global drug pricing is one of the most contentious issues between developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines.

Specifically, the decision allows Indian makers of generic drugs to continue making copycat versions of the drug Gleevec, which is made by Novartis. It is spelled Glivec in Europe and elsewhere. The drug provides such effective treatment for some forms of leukemia that the Food and Drug Administration approved the medicine in the United States in 2001 in record time. The ruling will also help India maintain its role as the world’s most important provider of inexpensive medicines, which is critical in the global fight against deadly diseases. Gleevec, for example, can cost as much as $70,000 a year, while Indian generic versions cost about $2,500 a year.

The ruling comes at a challenging time for the pharmaceutical industry, which is increasingly looking to emerging markets to compensate for lackluster drug sales in the United States and Europe. At the same time, it is facing other challenges to its patent protections in countries like Argentina, the Philippines, Thailand and Brazil.

“I think other countries will now be looking at India and saying, ‘Well, hold on a minute — India stuck to its guns,’ ” said Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge, a group based in New York that works on patent cases to foster access to drugs.

 In trade agreements — including one being negotiated between the United States and countries in the Pacific Rim — the drug industry has lobbied for stricter patent restrictions that would more closely resemble protections in the United States.

Gleevec is widely recognized as one of the most important medical discoveries in decades. In a televised interview, Ranjit Shahani, vice chairman of the Indian subsidiary of Novartis, said that companies like Novartis would invest less money in research in India as a result of the ruling. “We hope that the ecosystem for intellectual property in the country improves,” he said.

 India exports about $10 billion worth of generic medicine every year. India and China together produce more than 80 percent of the active ingredients of all drugs used in the United States.

 In Monday’s decision, India’s Supreme Court ruled that the patent that Novartis sought for Gleevec did not represent a true invention. The ruling is something of an anomaly. Passed under international pressure, India’s 2005 patent law for the first time allowed for patents on medicines, but only for drugs discovered after 1995. In 1993, Novartis patented a version of Gleevec that it later abandoned in development, but the Indian judges ruled that the early and later versions were not different enough for the later one to merit a separate patent.

Leena Menghaney, a patient advocate at Doctors Without Borders, said that the ruling was a reprieve from more expensive medicines, but only for a while. “The great thing about this ruling is that we don’t have to worry about the drugs we’re currently using,” Ms. Menghaney said. “But the million-dollar question is what is going to happen for new drugs that have not yet come out.” Others decried the ruling, saying it was further evidence that India does not respect the intellectual property rights of pharmaceutical companies. Last year, India granted what is known as a compulsory license to a generic drug manufacturer to begin making copies of Bayer’s cancer drug Nexavar, and revoked Pfizer’s patent for another cancer drug, Sutent. Both companies have appealed the decisions.

“It really is in our view another example of what I would characterize as a deteriorating innovation environment in India,” said Chip Davis, the executive vice president of advocacy at the Pharmaceutical Research and Manufacturers of America, the industry trade group. “The Indian government and the Indian courts have come down on the side that doesn’t recognize the value of innovation and the value of strong intellectual property, which we believe is essential.”

 Anand Grover, a lawyer who argued the case on behalf of Cancer Patients Aid Association in India, said the ruling confirmed that India had a very high bar for approving patents on medicines. “What is happening in the United States is that a lot of money is being wasted on new forms of old drugs,” Mr. Grover said. Because of Monday’s ruling, “that will not happen in India.”

In the United States, companies can get a new patent for a drug by altering its formula or changing its dosage. The companies contend that even minor improvements in medicines — changing a pill dosage to once a day instead of twice a day — can have a significant impact on patient wellness. But critics say a majority of drug patents given in the United States are for tiny changes that often provide patients few meaningful benefits but allow drug companies to continue charging high prices for years beyond the original patent life.

They point to AstraZeneca, for example, which extended for years its franchise around the huge-selling heartburn pill Prilosec by slightly altering the chemical structure and renaming the medicine Nexium. Amgen has won so many patents on its expensive erythropoietin-stimulating drugs that the company has maintained exclusive sales rights for 24 years, double the usual period. A result of this practice is that the United States pays the highest drug prices in the world, prices that only a tiny fraction could afford in India, where more than two-thirds of the population lives on less than $2 a day.

While advocates for the pharmaceutical industry argue that fairly liberal rules on patents spur innovation, a growing number of countries are questioning why they should pay high prices for new drugs. Argentina and the Philippines have passed laws similar to the one enacted in India, placing strict limits on patents. And Brazil and Thailand have been issuing compulsory licenses for AIDS drugs for years under multilateral agreements that allow such actions on public health grounds.

As the economies of emerging markets grow, the countries’ refusal to pay higher premiums for newer drugs could significantly reduce the money needed for innovation. The drug industry makes more than a third of its sales in the United States, a dependence that many in the industry fear is unsustainable, especially since sales of prescription drugs actually dropped in the United States in 2012, according to the research firm IMS Health. Sales in emerging markets like Brazil and China are expected to account for 30 percent of global pharmaceutical spending by 2016, up from 20 percent in 2011, according to IMS Health.

The United States government has become increasingly insistent in recent years that other countries adopt far more stringent patent protection rules, with the result that poorer patients often lose access to cheap generic copies of medicines when their governments undertake trade agreements with the United States. Washington is currently negotiating the terms of a new Pacific Rim trade agreement, called the Trans-Pacific Partnership, which might be completed later this year. The pharmaceutical industry has lobbied the United States to require other countries to enforce tougher patent restrictions, although the details are still being worked out.

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Ex-J&J India head led fight against patent | 2 Apr, 2013, 04.00AM IST, Soma Das

NEW DELHI: Cancer Patients Aid Association, which has won a seven-year legal battle against Swiss drugmaker Novartis' attempt to patent anti-leukemia drug Glivec, is ironically headed by a former country head of a multi-national medical products company. The Supreme Court on Monday rejected Novartis' efforts to patent anti-leukemia drug Glivec (beta crystal form of imatinib mesylate) in India. YK Sapru-headed Cancer Patients Aid Association (CPAA), which fought relentlessly from 2006 to keep prices of this cancer drug in check in the country, has its provenience in a little girl's fight against leukemia.

Moved by three-year-old Jaya Jhabbar's struggle with the life-threatening medical condition, Sapru, a pharma professional who retired as president of Johnson & Johnson's India operations in 1999, decided to fund her treatment by chipping in with a few friends. Jaya survived. She now lives in Gwalior and has three children. The lady's triumph over leukemia was a fitting reward for Sapru who, armed with a typewriter and Rs500 in funds, went on to start CPAA in 1970 with his journalist wife Rekha.

A year later, and with some more helping hands, the organisation started cancer screening clinics and awareness programmes in the country. It now helps cancer patients with counselling, diet, rehabilitation and follow-ups with doctors. CPAA now has centres in several places including Mumbai, Chennai, Delhi and Pune.

 "In our initial days, we realised that the medical fraternity focused only on the tumour while managing cancer. But the turmoil that accompanies cancer takes a toll in many ways," Sapru told ET. "We started by helping with whatever we could—counselling, money, accommodation, transportation and employment-—while the treatment was on, and education for children." In 1994, CPAA entered into a partnership with New India Assurance Co to offer cancer insurance policy.

 "Today we have over 12,000 policy holders," Sapru said. CPAA has proactively intervened in a series of cases being fought by big pharma and generic drugmakers in Indian courts. Besides the Glivec case, it has also intervened to make a case for cheaper drugs in the Bayer Corp-Cipla battle over the kidney cancer drug Sorefenib Tosylate.

 "We will continue to intervene in such cases in the interest of patients. We have already initiated an intervention in case of Herceptin, sent our reservation to the patent office," Sapru said. Herceptin (Trastuzumab) is a breast cancer drug marketed by Roche. Interestingly, even while dealing with a grim subject like cancer, CPAA has found time and the resources to be creative.

 In early 2000, CPAA and its agency O&M won a series of awards at the Cannes Lions International Festival of Creativity for the campaigns they created, mostly urging people to quit smoking. Almost from its inception, CPAA has roped in actors to promote its cause. Raj Kapoor, Shashi Kapoor, Amitabh Bachchan, Aishwarya Rai and Vivek Oberoi are among many that have provided star power.

 "A small seed we planted decades ago has grown into big tree with many branches. I want every state to adopt CPAA's core movement and would love to help many more organisations to grow like ours," Sapru said.

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Cancer drug down to 8K from 1.2L? Yes, says SC | Top court rejects patent bid by Swiss drug giant Norvatis, paving way for cheap generic drugs | 2nd April 2013 Mumbai Mirror

NEW DELHI In a landmark ruling, the Supreme Court on Monday rejected a patent bid by Swiss drug giant Novartis for a cancer drug, thus paving the way for access to cheap generic drugs and affordable healthcare.

Novartis fought a seven-year legal battle to gain patent protection for an updated version of its blockbuster cancer drug Glivec, arguing that the compound was a significant improvement because it is more easily absorbed by the body.

 But in a ruling that went to the heart of patent law in India, known as the ‘pharmacy to the world’, the apex court said the compound ‘did not satisfy the test of or inventiveness’ required by Indian legislation.

Indian patent laws restrict pharmaceutical companies from seeking fresh patents for making only small modifications – an industry practice known as ‘evergreening’ – and the ruling enables generic drug makers to continue copying Glivec.

 “The ruling has come as a big relief,” Leena Menghaney, a lawyer with medical charity Medecins Sans Frontieres (MSF), said outside the courtroom. “It will save a lot of lives – not only in India but across the developing world.”  “The ruling doesn't mean no patents will be granted in India, but the abusive practice of seeking many patents for one drug will be curbed,” she added. MSF says Glivec – often hailed as a “silver bullet” for its breakthrough in treating a deadly form of leukaemia – costs over Rs 1.2 lakh a month in its branded form while the generic version is available in India for around Rs 8,000.

 Novartis, which reported net profit of $9.6 billion in 2012 on sales of $56.7 billion, condemned the judgment, saying in a statement it “discourages innovative drug discovery essential to advancing medical science for patients”.

“This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options,” said Ranjit Shahani, managing director of Novartis India.

The Supreme Court upheld the view of India's Intellectual Property Appellate Board, which refused to grant Novartis protection in 2009 on the grounds that the amended form of Glivec was not vastly different from the earlier version.

 The Madras High Court had also rejected Novartis’s arguments in 2007.

Lawyer Anand Grover, representing the Cancer Patients Aid Association in the case,said he was ‘ecstatic’, adding that the ruling will ‘go a long way in providing affordable medicine for the poor’.

Pratibha Singh, a lawyer acting on behalf of generics drug giant Cipla, said the judgment ‘makes it clear you cannot patent a drug by just making some minor modifications – the key Section 3(d) of the patent law has been upheld by the court’. Global drug makers say India's generics industry reduces commercial incentives to produce cutting-edge medicines and Novartis has warned it might stop introducing new drugs in India.

At the same time, the market is difficult to ignore and is set to touch $74 billion in sales by 2020 from $11 billionin2011,accordingtoindustryestimates.

THE CASE

In 1997, Novartis filed a patent application to have exclusive rights to manufacture Glivec and to restrain Indian firms from making generic variants. It claimed that the drug was more stable and more soluble. While the Patent Controller in Chennai denied Novartis a patent, the case reached finally reached the SC in 2009.

THE RULING

Abench of justices Aftab Alam and Ranjana Prakash Desai refused to give credence to Novartis’s claim that 'Imatinib Mesylate', a substance used in the cancer drug, is a new product and the outcome of an invention. The court held that a repetitive patent was not permissible.

GLOBAL SIGNIFICANCE

The apex court judgment can pave the way for access to cheaper drugs as a one-month dose of Glivec costs around Rs 1.2 lakh. Generic drugs manufactured by Indian companies, will cost around Rs 8,000 per month. If Indian law allowed global drug firms to extend the lifespan of patents by making minor changes to medicines, it would have adversely affected the country’s $26-billion generic drug industry, which supplies much of the cheap medicine used in the developing world.

ADVANTAGE GENERIC

Nearly 10 years ago, Mumbai-based Cipla began selling generic anti-retro viral drugs (to suppress HIV virus) at one tenth of the price MNCs charged. The firm took advantage of Indian laws that allowed local companies to make such drugs as long as they used a process that differed from the original patented process. Cipla sold the medicne to international aid agency MSF at $350 per patient a year, which was between $10,000 and 15,000 in the market, on the condition that they gave it to patients for free.

GLIVEC ISSUE, IN THE EYES OF NOVARTIS, SC AND OTHERS

We certainly do not wish the law of patent in this country to develop on the lines where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers

    – JUSTICES AFTAB ALAM, RANJANA DESAI, SC

Patents will continue to be granted by India, but definitely the abusive practice of getting many patents on one drug will be stopped

    – LEENA MENGHANEY, MSF

This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options. Novartis will introduce products in India, but will not invest in R&D. Novartis India will also continue to invest here, but with caution

    – RANJIT SHAHANI, MD, NOVARTIS INDIANDIA

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Supreme Court rules for cheap cancer drug | Subodh Varma, TNN | Apr 1, 2013, 11.57PM IST

NEW DELHI: The Supreme Court on Monday rejected pharma giant Novartis AG's plea to preserve its patent over a life-saving cancer drug, Glivec, drawing a huge sigh of relief from thousands of patients in India and in dozens of developing countries as the fear of an almost 15-fold escalation of drug costs receded. It is the biggest setback for multinational pharma companies, which have been denied patent protection for a series of life-saving drugs in recent years.

Invented in 1991, Glivec is a miracle cure for a type of blood cancer called chronic myeloid leukemia (CML). In this form of cancer, certain bone marrow cells go rogue and produce excessive white blood cells, causing mild fatigue and hip pain initially, but slipping into an out-of-control crisis of zooming platelet and white cell counts. It used to be fatal, but with Glivec, the survival rate is over 95%. Imanitib, the active component, is on the National Essential Drugs List in India.

India has an estimated 3 lakh CML patients, with 20,000 added every year. Glivec is sold by Novartis for about Rs 1.2 lakh per month. Indian manufacturers sell the same drug at a monthly cost of Rs 8,000. This was the reason why Novartis launched a seven-year-long legal battle to protect its patent on the drug.

Novartis, which reported a net profit of $9.6 billion in 2012 on sales of $57 billion, criticized the judgment. In a statement Ranjit Shahani, vice chairman and managing director, Novartis India said, "This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."

When the drug was first commercially sold in 2001, India was moving over from the old patent regime to a new one after signing the international trade and patent related agreements in 1995. The new patent law came into force in 2005. Novartis could not get a patent on Glivec as it dated from an earlier time when a different patent law prevailed. It tried but the patent tribunal rejected the claim in 2006.

After going through various appeals, Novartis ended up in the apex court pleading that a crucial section 3 (d) of the new patent law was not applicable to Glivec. This section says that just discovering a new form of a substance is not enough to grant a patent, if it does not enhance its "known efficacy".

Novartis was arguing that a new "beta crystalline" form of Glivec is more effective and hence qualifies as a new invention, and hence should get patent protection.

The Supreme Court, in a 112-page analysis of all the claims and counter- arguments disagreed. It said that the beta crystalline form was nothing new. It has always existed in the original amorphous form.

The landmark judgement means that Indian companies like Natco and Cipla can continue making and selling Glivec, not only for India but to most third world countries.

Monday's Supreme Court judgment dims hopes for some other pharma giants fighting legal battles on patents. Pfizer's cancer drug Sutent and Roche's hepatitis C treatment Pegasys and Merck & Co's asthma treatment aerosol suspension formulation lost their patented status in India last year, decisions the companies are fighting to have reversed.

Many pharma giants are concentrating their legal fire-power on India because it is an $11 billion a year market growing at 13-14 percent annually. Equally important is that India has emerged as the 'pharmacy of the world" selling over $26 billion worth of cheap generic (non-patent) drugs to most of the poor and still developing countries. It is estimated that about 80% of the HIV/AIDS patients in the developing world are surviving because of cheap Indian drugs.

Chronic Myeloid Leukemia

CML is a type of blood cancer. It affects mostly adults in their 40s and 50s. The disease tends to progress more slowly than acute forms of blood cancer. The incidence of CML in India is 4-5 cases per 100,000 population. It constitutes 10% of all cancers Treatment includes targeted therapy and bone marrow transplant. Targeted therapy involves the administration of oral drugs and is given for at least five years. Some patients may need it for a lifetime though.

  • Cost of Glivec used for targeted therapy in CML patients: 1 lakh per month (approx)
  • Cost of its generic versions : 8,000 -10 ,000 per month
  • No. of cancer centres in India: 450 approx (half are in the private sector)

 

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SC rejects Novartis' patent plea for cancer drug Glivec | The Hindu, 1 April 2013

Swiss pharma major Novartis AG on Monday lost a seven-year long legal battle for getting its blood cancer drug Glivec patented in India and to restrain Indian companies from manufacturing generic drugs, with the Supreme Court rejecting the multinational company’s plea.

A bench of justices Aftab Alam and Ranjana Prakash Desai dismissed the claim of the Swiss firm for getting exclusive rights for manufacturing the cancer drug on the ground that a new substance has been used in the medicine.The judgment, which was keenly watched by pharma companies across the world, will clear hurdles coming in the way for the manufacture of generic drugs in India for cancer patients.

While a one-month dose of Glivec costs around Rs. 1.2 lakh, generic drugs, manufactured by Indian companies, for the same period are priced at Rs. 8,000. Advocate Pratibha Singh, appearing for Indian drug firms Ranbaxy and Cipla which had opposed Novartis’ plea, said that the judgment is a victory for Indian companies as they can now manufacture cheaper drugs so long as there is no patent over a medicine. “Patents will now be granted only for genuine inventions and not on repetitive inventions. The Supreme Court said there was no new invention in the Novartis’ drug,” she said. She also said there should be no fear that foreign firms would be affected with Monday’s verdict since as long as they have genuine inventions, patents will be given to them.

In its judgement, the apex court also held that ‘imatinib mesylate’ used in Glivec is a known substance and Novartis can’t claim patent over the drug for using this chemical. Novartis had approached the apex court in 2009 against the order of Chennai-based Intellectual Property Appellate Board (IPAB), which had rejected its claim for patent. The multinational company (MNC) had applied for patent in 2006. Novartis’ claim was opposed by Indian pharma companies, which are manufacturing generic drugs, as well as by health aid activists in the apex court. They had claimed that the MNC is not entitled for patent and it is indulging in “ever-greening” of patent by simply changing the composition of the ingredients of the drug.

Ever-greening of patent right is a strategy allegedly adopted by the innovators having patent rights over products to renew them by bringing in some minor changes such as adding new mixtures or formulations. It is done when their patent is about to expire.

A patent on the new form would have given Novartis a 20-year monopoly on the drug. Earlier, the Comptroller General of Patent and Design had denied patent to Glivec on several grounds including its alleged failure to meet stipulations under sections 3(d) and 3(b) of the Indian Patent Law.

Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy while Section 3(b) bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products. During the arguments earlier, Novartis had tried to dispel the impression that its drug would be beyond reach of poor cancer patients due to its high cost.

“The purpose is not to make money from the poor. This is not the purpose, but am I not entitled for patent for our drug? We are fighting the case on principle,” senior advocate Gopal Subramanium, appearing for the company, had said.

He had submitted that there should be no cause of concern that the poor would not get treatment and had claimed that 85 per cent of such patients are treated free under its scheme.

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Novartis loses landmark India patent case on Glivec By Kaustubh Kulkarni and Suchitra Mohanty | MUMBAI/NEW DELHI | Tue Apr 2, 2013 1:43am IST

(Reuters) - The Supreme Court dismissed Swiss drugmaker Novartis AG's (NOVN.VX) attempt to win patent protection for its cancer drug Glivec, a blow to Western pharmaceutical firms targeting India to drive sales and a victory for local makers of cheap generics.

The decision sets a benchmark for intellectual property cases in India, where many patented drugs are unaffordable for most of its 1.2 billion people, and does not bode well for foreign firms engaged in ongoing disputes in India, including Pfizer Inc (PFE.N) and Roche Holding AG (ROG.VX), analysts said. It cements the role of local companies as big suppliers of inexpensive generics to India's rapidly growing $13 billion-a-year drugs market and also across the developing world.

Among the chief beneficiaries of Monday's Supreme Court ruling will be India's Cipla Ltd (CIPL.NS) and Natco Pharma Ltd (NATP.NS), which already sell generic Glivec in India at around one-tenth of the price of the branded drug. "The multinational companies will have to find new ways of doing business in India," said Deepak Malik, healthcare analyst at brokerage Emkay Global, suggesting they may consider licensing agreements with local firms to offer cheap versions of branded drugs like Glivec.

Ranjit Shahani, managing director of Novartis India Ltd (NOIN.BO), the firm's locally listed unit, said it would be cautious about investing in India, especially over introducing new drugs, and seek patent protection before launching any new products. It will continue to refrain from research and development activities there. "The intellectual property ecosystem in India is not very encouraging," Shahani told reporters in Mumbai after the ruling.

Healthcare activists have asked the government to make medicines cheaper in a country where many patented drugs are too costly for most people, 40 percent of whom earn less than $1.25 a day, and where patented drugs account for under 10 percent of total drug sales. "This appears to be the best outcome for patients in developing countries as fewer patents will be granted on existing medicines," said Leena Menghaney, Medecins Sans Frontieres' Access Campaign manager for India.

Over 16,000 patients in India use Glivec and the vast majority of those get it free of charge, Novartis says. By contrast, generic Glivec is used by more than 300,000 patients, according to industry reports.

The U.S. industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, said the decision reflected a deteriorating environment for innovation in India. "Protecting intellectual property is fundamental to the discovery of new medicines," the group said in a statement. "To solve the real health challenges of India's patients, it is critically important that India promote a policy environment that supports continued research and development of new medicines."

U.S. pharmaceutical industry analysts said the ruling was in line with lower court decisions and therefore largely expected. "For other firms, rulings like this, and just the overall environment in India for branded drugs, make it less appealing. However, you are talking about a major geography," said Morningstar analyst Damien Conover.

The Supreme Court's decision comes after a legal battle that began when Novartis was denied a patent for Glivec in 2006. Novartis had argued it was entitled to a patent for the amended version of Glivec because the original patented compound was never suitable for making into a pill. Developing the final chemically stable form took years of extra work and it was this effort that marked the real breakthrough in developing Glivec as a life-saving cancer medicine, the Swiss company said.

Glivec is used to treat certain forms of leukemia and gastrointestinal cancer, as well as some other rare tumors.

Shares in Novartis' Indian unit ended 1.8 percent lower after falling as much as 6.8 percent after the verdict. Natco Pharma stock ended 5.4 percent higher after earlier gaining nearly 11 percent and Cipla gained 1.3 percent, beating the benchmark index .BSESN which ticked up 0.15 percent.

India's domestic drugs market is the 14th-largest globally, but with annual growth of 13 to 14 percent and the world's second-biggest population, international pharmaceutical firms say India has massive potential at a time when traditional developed markets have slowed down.

The ruling may dampen enthusiasm from foreign pharmaceutical firms in the short term, said S. Majumdar, head of law firm S. Majumdar & Co based in the eastern city of Kolkata. "They will have to get used to it and learn to live with the law," he said.

Pfizer's cancer drug Sutent and Roche's hepatitis C treatment Pegasys lost their patented status in India last year, decisions the companies are fighting to have reversed. The Supreme Court's latest ruling will make it tougher for them to win back patent protection.

"Henceforth, multinational pharma companies are likely to want that their patents are first recognized in India before launch of a patented product," said Ameet Hariani, managing partner at Mumbai-based law firm Hariani & Co. India has refused protection for Glivec on the grounds that it is not a new medicine, but an amended version of a known compound. By contrast, the newer form of Glivec has been patented in nearly 40 countries including the United States, Russia and China.

Indian law bans firms from extending patents on their products by making slight changes to a compound, a practice known as "evergreening". The Supreme Court said Glivec does not satisfy a patent's "novelty" requirement, Pravin Anand, lawyer for Novartis, told reporters. Novartis can file a review petition within 90 days. Indian Trade Minister Anand Sharma called the ruling "a historic judgment" that reaffirmed legal provisions mandating the need for substantial innovation before new patents are issued on medicines.

(Additional reporting by Ben Hirschler in LONDON and Susan Kelly in CHICAGO; Editing by Daniel Magnowski, Matthew Tostevin and Richard Chang)

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Novartis order may force pharma MNCs to change | 2 Apr, 2013, 04.00AM IST, ET Bureau

MUMBAI/NEW DELHI: Foreign pharma companies could be forced to overhaul their strategy for the Indian market by striking more local deals and cutting sky-high drug prices after the Supreme Court slammed the door on Swiss giant Novartis' attempts to gain a patent for its blood cancer-busting drug Glivec. But the ruling, welcomed by activists campaigning for affordable drugs and local generic companies, threatened to reinforce a narrative that India was hostile to foreign investors.

The Supreme Court on Monday denied patent protection to Glivec, saying it is an example of "incremental innovation" under Section 3(d) of the Indian Patents Act and thus not liable for protection. The court said the company failed to satisfy criteria stipulated in the Act such as research data clarifying the increased "therapeutic efficacy" of the innovation.

The ruling ends Novartis' attempts to secure a patent for the drug and continues to keep the price of anti-blood cancer drugs low in the country. Patients would have otherwise been forced to pay 1.20 lakh for a month's dosage if the court case had gone in favour of Novartis. Generic variants of Glivec cost 8,000 per month.

Novartis shares crashed 6.8% on Monday before ending down 1.81% at 587.95. Novartis responded to the ruling by decrying India's patent protection laws, adding it would invest cautiously in India and R&D investment would not happen. "The atmosphere for IP in India is not good. We have been boxed in from all sides. Novartis is committed to India, but there won't be any investment in R&D," said Ranjit Shahani, chairman of Novartis India. The multinational pharma lobby, the Organisation of Pharmaceutical Producers (OPPI), also expressed disappointment at the Novartis verdict.

The ruling ends Novartis' attempts to secure a patent for the drug and continues to keep the price of anti-blood cancer drugs low in the country.

India will be isolated as far as the pharma industry is concerned, considering the fact that multinationals have been at the receiving end of some adverse court judgements in the recent past. Hyderabad-based firm Natco Pharma was granted a compulsory licence for Bayer's liver and kidney anti-cancer drug Nexavar over the German firm's objections.

Swiss firm Roche was stripped off its patent for Peginterferon in February by the Intellectual Property Appellate Board (IPAB), eight years after it was granted. But Commerce and Industry Minister Anand Sharma defended the ruling, asserting that India's patent laws were in line with global norms.

Celebrated lawyer Harish Salve, who represented generic maker Cipla in the Supreme Court, rubbished claims that the ruling could hit India's image. "The ruling strikes a balance between patents and affordability.

If MNCs consider India a bad country for evergreening, it is welcome," he told ET NOW. Moreover, patented drugs form a miniscule 1% of India's Rs 18,000 crore a year market, experts said. Multinationals make more money by selling generics or branded generics than by selling patented products. "We believe that the event (the Novartis ruling) will have a neutral impact on the industry dynamics," says Sarabjit Kour Nangra, vice-president research at Angel Broking. "With generics being a major proportion of the overall market, the growth of the Indian markets will not change because of the judgement."

But India could lose out on some new products, though experts say the uncertainty of the past few years did not prevent multinationals from introducing about 20 new patented drugs in the country. Many of these products have not been challenged at all. "It is poor posturing by multinational drugmakers," said DG Shah, secretary general of the Indian Pharmaceutical Association, (IPA), a lobby group of Indian drugmakers.

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Costly disease for poor country | Durgesh Nandan Jha, TNN | Apr 2, 2013, 02.59 AM IST

NEW DELHI: Just three months ago, Raju and Sumati Mullick were thinking hard how to end their wretched lives. It wasn't just their younger daughter Sanjana's leukemia that was killing them. The family, in trying to meet the cost of her treatment, had lost everything they had earned and were in deep debt. Then there were the two other children they had to fend for.

The couple from Madhubani district in Bihar had already quit farming in their native village to look for a job in Delhi so that they could be close to Sanjana. The best they could do was work as daily wage labourers. Then, as all hope ended, a cancer support group volunteered to bear the cost of treatment of the eight-year-old girl.

"Sanjana has developed infection again and is admitted at AIIMS," Sumati said on Monday. "She is not able to eat and can barely speak. My husband and I have not been able to go to work for over a week now due to the deterioration in her condition. We have almost no money left."

The mainstay of treatment for acute leukemia, the type of blood cancer Sanjana suffers from, is chemotherapy. Doctors say treatment costs can vary between Rs 5 lakh to Rs 10 lakh in private hospitals. In government-run centres, though, it can be availed for free. But invariably there are additional costs which patients have to bear.

Gitanjali Bhalla, head of the NGO PallCanCare, says that over the years treatment options for cancer have increased. But so have care costs, a big hindrance for many in a poor country like India. "First, government-run facilities that offer cancer treatment remain few. Secondly, there, too, patients have to spend from their own pocket for indirect expenditures like transport, food and lodging, and direct expenses on medicines not available at the hospitals. Newer treatment options like targeted therapy are not available in most government hospitals," she says.

A report on the 'Economic burden of cancer at tertiary care public hospitals' -- conducted on 432 patients who visited AIIMS for treatment between October 2006 and December 2007 -- substantiates this. It says that on an average a patient has to shell out Rs 36,812. Of this, Rs 14,597 is spent before coming to the hospital, Rs 14,031 at the hospital and Rs 8,184 during the prolonged radiotherapy course. In private, it can go up to anywhere between Rs 5 lakh to Rs 40 lakh or more.

Unavailability of cancer care centres across the country is another major problem. India has a population of approximately 110 million with a requirement of 1200 radiotherapy machines. As of now, we have an abysmal 45 such machines. Modern radiotherapy facilities are concentrated in private hospitals but the cost of the course is prohibitively high -- from Rs 60,000 to Rs 1, 20,000 and beyond, out of the reach of common Indians.

The fact that in 80% of the population is not covered under any insurance scheme makes it even harder for people to deal with the crisis. But do the ones who are insured fare any better? In a 2006 survey in America, almost a quarter of insured patients reported using most of their savings during treatment; a similar proportion said their insurance plan paid less than expected for a medical bill. And this is the US we are talking about.

"There are about 30 lakh cancer patients in India and every year 10 lakh more such cases are detected. With increased longevity and unhealthy lifestyles, the incidence is likely to go up. We will have to focus now on the preventive aspect of the disease," says a worried Dr G K Rath, heads of the cancer centre at AIIMS.

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Supreme Court’s decision on Section 3(d) historic: Anand Grover | Times of India, Mumbai, Tuesday 2nd April 2013

After 2005, India started granting product patents on medicines. However, Section 3(d), one of the safeguards introduced by Parliament, seeks to prevent patenting of new forms of known substances unless they exhibit enhanced efficacy. Were it not for section 3(d), the standards for grant of product patents on medicines in India would be lower, almost identical to the standards in countries such as the United States and European Union, where a large number of patents are granted on minor modifications of a single medicine.

Section 3(d), along with other safeguards such as allowing patent oppositions by public interest groups, has been used as one of the grounds to successfully challenge patents for minor modifications of several antiretroviral (ARV) medicines used to treat people living with HIV.

Section 3(d) also became the basis for the refusal of a patent to Novartis for the beta-crystalline form of imatinib mesylate, a drug used to treat chronic myeloid leukemia (CML), a type of blood cancer. In 1998, Novartis filed a patent application in India for this medicine. In 2005, the Chennai Patent office heard patent oppositions to this application including one filed by the Cancer Patients Aid Association (CPAA). The CPAA challenge was spurred by great concern over the price Novartis set for its version of the drug (sold as Glivec) at Rs 1,20,000 ($2,400) per month as against generic versions that were available at a cost of around Rs 8,000 to Rs 12,000 per month.

In 2006, the Patent Office rejected Novartis’ patent application on several grounds, including section 3(d). Novartis immediately challenged the constitutional validity of Section 3(d) before the Madras High Court arguing that the term “efficacy” was vague. In 2007, dismissing the challenge, the Madras High Court held that the word “efficacy” had a definite meaning in the pharmaceutical field, i.e. therapeutic efficacy. In 2009, the Intellectual Proper ty Appellate Board (IPAB) rejected Novartis appeal against the patent application rejection on the ground that it did not satisfy section 3(d). Novartis then approached the Supreme Court asking for a liberal interpretation of section 3(d) that would allow it to get a patent on imatinib mesylate.

Novartis tried to argue that the physico-chemical properties of the polymorph form of the imatinib molecule, i.e. better flow properties, better thermodynamic stability and lower hygroscopicity, resulted in improved efficacy. The Supreme Court firmly rejected this contention holding that in the case of medicines, efficacy means “therapeutic efficacy” and these properties while they may be beneficial to some patients do not meet this standard. The Supreme Court also held that patent applicants must prove the increase in therapeutic efficacy based on research data in vivo in animals.

Eight years after India’s patent law was amended, the Supreme Court decision has firmly established the legality and validity of Section 3(d) and has lain to rest the controversy raked up around the section by the pharmaceutical industry. The commerce minister has said that India’s law is fully in compliance with the TRIPS Agreement. However, on April 15, commerce minister Anand Sharma travels to Brussels to potentially sign the EU-India FTA that threatens to impose on India obligations far in excess of the TRIPS Agreement; obligations known to undermine generic production and access to medicines.

The Indian Parliament has balanced India’s obligations under TRIPS with the right to health through Section 3(d). The Supreme Court has unequivocally interpreted the true intention and spirit of this provision. It behooves the Indian government to respect the Parliament and the Supreme Court and ensure that it does not sign away these hard fought victories by health and public interest groups in trade negotiations.

The author is a senior  advocate and director, Lawyers Collective

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PATENT WAR: Drug price negotiation may be way forward | Sidhartha TNN 2nd April 2013

New Delhi: When the patent law was amended to provide for product patents, the big fear was aspike in the price of medicines, especially life-saving ones.

But eight years down the line, the government has managed to use provisions available to it under World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (Trips) to ensure that drug companies do not abuse the monopoly rights vested in them through patents. To begin with, Section 3(d) was inserted to ensure that minor changes were not passed off as invention.

 “At the heart of every international agreement and national laws is consumer interest, especially when it comes to medicines and food. So, you can’t put patents on a machine and on a medicine at the same level,” a government official said.

But the law was still seen to be favouring multinationals with the monthly supply of some life-saving cancer drugs adding up to Rs 1 lakh or more. That prompted local manufacturers to resort to the use of a virtually unused provision in India — known as compulsory licensing, which allows the Patent Office to waive the patent rights in favour of a cheaper drug, provided a royalty is paid to the patent holder.

The compulsory licence (CL) for Nexavar, a renal cancer drug, seemed to open the floodgates for those seeking patent waiver. Health ministry has already moved a proposal for three cancer drugs — Trastuzumab, Ixabepilone and Dasatinib — citing “extreme urgency” and “public non-commercial use”, whose fate is yet to be decided. In the meantime, little-known BGR Pharma sought a CL for Dasatanib with the Patent Office.

The rush for CLs even prompted local players such as Cipla, known for its generic acumen, to start paring prices in the domestic market.

While all this was underway, there were instances of patents on some medicines being revoked. The Intellectual Property Appellate Board revoked Roche’s patent on hepatitis C drug Pegasys, citing lack of evidence that the drug was any better than existing treatments as also the high price. Schering Corporation and Novartis’s patents on two asthma medicines and Pfizer’s patent on cancer drug Sutent were also revoked.

 Separately, the government has set up an inter-ministerial group to put in place norms on negotiated price for patented medicines, a practice followed in several developed countries such as the UK, Canada and Australia. “A CL is like a death sentence, which can’t be given in every case. A negotiated price system will be in the interest of foreign companies,” said a government official privy to the developments. SC verdict a blow to MNCs Big Pharma’s Ability To Sell Blockbuster Drugs May Be Hit Rupali Mukherjee TNN

Mumbai: The Supreme Court’s decision on Monday came as a big relief to patients suffering from serious diseases like cancer, and is a huge positive for generic companies which manufacture affordable drugs. But at the same time, it deals a big blow to Novartis, and on MNCs’ ability to sell lucrative blockbuster medicines in the country.

 The main beneficiaries of the Supreme Court ruling will be generic companies like Cipla, Natco Pharma and Sun Pharma which already market generic Glivec in India at a fraction of the cost of the Novartis product. The ruling cements the role of domestic companies as major suppliers of inexpensive generics not only to its Rs 70,000-crore domestic market, but also across the developing world, and further establishes India as a “the pharmacy of the world” (nearly 98% of anti-retrovirals are exported to developing countries from India).

Says Cipla chairman Dr Y K Hamied, “India can continue to produce affordable, high quality medicines without the threat of patents for minor modifications of known medicines. This judgement will not only benefit patients in India, but patients around the world. This stops evergreening and all this is good for the patients in our country and for the generic industry in general. Competition also leads to reduction in prices and therefore this judgement is of benefit to everyone. Apart from cancer, Section 3(D) applies to all drugs. Hence this judgement will benefit all therapies, which again will be good for everyone.”

 D G Shah, secretary general of the Indian Pharmaceutical Alliance, said, “The judgement serves to rest the controversy that was raised regarding the scope of section 3(d) in the Patents Act, which is a crucial safeguard against the extension of patent monopolies of known drugs and the consequent delay in the availability of affordable generic versions.”

If Novartis had won the case, it would have impacted access of affordable medicines by extension of monopoly rights to new forms of known medicines, hence delaying and blocking affordable versions, for India and for millions across the world.

 However, MNC industry body, Organisation of Pharmaceutical Producers of India, said the decision would only inhibit India’s own pharmaceutical industry from developing products for India, while doing little to improve accessibility of medicines for its population. “Sustainable solutions to India’s healthcare concerns should be found through programs that address the lack of healthcare financing,” it said.

 Said Novartis India VC and MD Ranjit Shahani, “The current climate for intellectual property in India is uncertain, as so many pharmaceutical companies have experienced patent challenges. Besides, domestic companies need to first be a pharmacy to India rather than the world. This is a significant threat to medical advances since it seriously jeopardizes further investment in innovation.”

 MNCs will turn cautious in making capital investments in the country, and may delay the launch of patented products. “Money flows only where it is welcome,” said a MNC executive.

 Kewal Handa, who recently retired as MD of Pfizer India, said, “The Indian government needs to do introspection. Innovation will not flow to a place where there is no respect for patents. On the other hand, MNCs will also have to re-look at their strategies to build scale, and how to balance their portfolio more in terms of volume, rather than price.”

 “What the ruling basically does is, provide a safe environment for generic companies to operate without the fear of injunctions, infringement suits, and the threat of secondary patents. The ruling will curb the practice of frivolous patents and évergreening, and provides a better interpretation of law for patent offices who have been lax by allowing secondary patents,” said Leena Menghaney, an IPR expert and coordinator of MSF, an international NGO.

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Good news for Indian pharma, consumers | LEARNING WITH THE TIMES, 2nd April 2013

What is a patent?

It is a right given to the inventor, either of a new product or a new process for manufacturing a product. Usually, it is valid for a period of 20 years. The idea behind a patent is that if everybody was free to copy a new invention immediately, there would be no incentive for anyone to invest in creating a new product or technology.

From 1972 to 2003, India only allowed process patents, which meant that even a patented product could be produced by someone other than the patent-holder if they could find a different method to manufacturing it. However, in 2005 the law was amended retrospectively to allow for product patents so that India could be compliant with the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). But even before the law was amended, India agreed to invite applications for product patents under the TRIPS agreement. These “mailbox” applications were opened in 2005 when the law was finally enacted. Novartis filed an application for patent for Glivec, the blood cancer drug, under the mailbox provision.

Why was Novartis denied a patent for Glivec in India?

The key issue revolved around whether Glivec was a “new product” under the terms of the law. In January 2006, the Indian patent office ruled that the drug was not substantially different from one for which patents had already been given in the US and Europe. Thus, it did not pass the novelty test. While moving to the new patent regime, Indian lawmakers had inserted a provision — section 3(d) in the Patents Act — to check against ‘evergreening’. This is the term used to describe a practice under which firms slightly tweak an existing process or product to seek a fresh patent once the original protection expires. This helps them retain monopoly rights for a longer period. The patent office’s ruling was upheld by the Intellectual Property Appellate Board (IPAB) and now by the Supreme Court.

How will the SC judgment impact consumers?

If Novartis had won the case, it would have been granted a monopoly on Glivec, and denied Indian companies the right to make the drug. This would obviously have allowed Novartis to sell the medicine at a much higher price. Already, there is a huge differential with generic versions by Indian companies costing Rs 5,000-9,000 for a month’s treatment, compared to Glivec’s cost of around Rs 1.2 lakh a month. The order is also likely to encourage existing Indian manufacturers to step up production and perhaps new players to enter the market. This should lead to a further fall in prices.

What will be the impact on the drug industry?

The multinational drug companies are worried that this could be a trendsetter and are even threatening to block supplies of new patented medicines to India. But this is unlikely to deter Indian industry from developing “copycat” versions that would sell at a lower price. In short, while this is bad news for Big Pharma, it is as much good news for domestic manufacturers as it is for consumers. Big Pharma could also be worried that the Indian example may be emulated by others.

 

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THE JUDGMENT WILL CHANGE THE CANCER SCENE IN INDIA’ | VINOD KUMAR MENON, Mid-Day, 2nd April 2013

Founder chairman and CEO of the Cancer Patients Aid Association hails the SC’s ruling rejecting the attempt of Novartis to patent an updated version of a cancer drug

IN a milestone judgment that will be regarded as the gold standard to deal with patent bids by multinational pharmaceutical companies in India, the Supreme Court on Monday rejected Swiss drug maker Novartis AG’s plea to patent an expensive anticancer drug Glivec.

The verdict allows Indian manufacturers to continue making inexpensive replicas of the drug at a fraction of the cost of Glivec, which like many patented foreign drugs, is out of reach for a majority of the country’s population. It also delivers a blow to international drug firms, which may have to rework their formula of marketing costly brands in the country.

Glivec is effective in treating chronic myeloid leukemia ( CML), a type of blood cancer.

Its major component is imatanib mesylate, which is used by local firms to make generic anticancer drugs. The apex court’s ruling has been hailed by domestic manufactures as well as health activists, who say poor Indians will now be able to afford the cancer treatment.

Y K Sapru ( 70), founder chairman and CEO of the Cancer Patients Aid Association ( CPAA), the petitioner in the patent case, said “ Today’s landmark judgment will make life- saving anti- cancer drugs affordable so that no lives will be lost to cancer just because the drug available for treatment is unaffordable. The judgment will totally change the cancer scene in India as well as over 75 other countries where India exports cancer drugs.” Novartis stocks plunged following the judgment, while the local pharma stocks soared.

It has been learnt that Novartis will rationalise the price of its drug to stay competitive with domestic manufacturers. It is likely to slash the price to an amount costing less than the Indian variants cost.

“ I always had a fear in the back of my mind of losing the case as the legal battle was against a pharma MNC, which is very strong in all aspects including monetarily. But the judgment has only strengthened my trust and faith in Indian judiciary.” His wife Rekha ( 70), who has always stood by Sapru, said, “ I always had faith in him and our work for a cause to reach those in need.” The CPAA helps 3,000 patients avail of the drug either for free or at a very nominal price.

The patent war

In 2001, Novartis introduced its wonder drug Glivec, effective in treating chronic myeloid leukemia (CML), a form of blood cancer, Sapru said.

The launch came after the firm had applied in India for a patent for Glivec in 1998 and was granted exclusive marketing rights (EMR) in January 2003. As a result Indian courts forbade 6 out of 9 generic producers to market imatanib mesylate ( IM), the main component of Glivec.

Sapru said, “ The CPAA went to the Supreme Court against granting of EMR to Novartis. In March 2005, Parliament passed the Indian Patent Act. In January 2006, the Patent Controller of India rejected the application of Novartis for Glivec after evaluating all the points raised by CPAA. As a result once again generic versions of Glivec were available in the Indian market at affordable prices. And in May 2006, Novartis appealed against this judgment and filed a case against the Indian Patent Act. The CPAA, MSF, Oxfam and other NGOs launched a global agitation against Novartis.”

 GLOBAL SIGNIFICANCE

The court's decision has global significance since India’s $ 26 billion generic drug industry, which supplies much of the cheap medicine used in the developing world, could be stunted if Indian law allowed global drug companies to extend the lifespan of patents by making minor changes to medicines.

Once a drug’s patent expires, generic manufacturers can legally produce it. They are able to make drugs at a fraction of the original manufacturer's cost because they don’t carry out the expensive research and development. — Agencies

Rs 1.2 lakh for month- long course:

Doctors usually recommend CML patients to have three tablets of imatanib mesylate per day, which means the patients had to pay almost over Rs 1.2 lakh for a month- long course of Glivec — an amount unaffordable for most Indians. Indian pharma companies make a similar drug priced at roughly Rs 11,000 for the same course.

A chemist at Parel said Glivec 400 mg tablets usually costs around Rs 40,000 for 30 tablets and the entire course of 90 tablets costs Rs 1,20,000, which may be discounted to cost up to Rs 1.05 lakh. He added that Glivec 100 mg tablets would cost around Rs 65,000 for 120 tablets.

HOPE FOR PATIENTS

Manish Sarviya ( 41), a resident of Dahisar, was detected with CML in 2006 and since then was prescribed by his treating doctors to have IM tablets. Sarviya said, “ I earn a mere Rs 3,000- 4,000 a month selling incense sticks. I have been asked to take this medicine lifelong and cannot afford it. I hope the SC judgment would make expensive drugs affordable for common man.”

Mohit Gupta ( 6), a resident of Goregaon, was detected with CML five months ago and put on IM tablets, which is being given for free. His father Manoj finds it difficult to provide treatment to his son. Thankfully, the CPAA is giving him free medicines, he said.

Abed Shaikh ( 8), a resident of Jogeshwari also detected with CML five months ago, has been put on IM tablets, given for free.

Efforts made to contact his parents did not yield result. However, it is learnt that Shaikh is responding to the treatment and is presently being treated at Sion hospital.

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Landmark judgment: No SC cure for Novartis patent pain Tuesday, Apr 2, 2013, 3:06 IST | Place: DNA | Agency: DNA
Kanu Sarda & Priyanka Golikeri

In a landmark judgment, the Supreme Court has rejected the plea of Swiss drugmaker Novartis to patent Glivec, used to treat chronic myeloid leukemia, paving the way for other manufacturers to make and sell versions of the medicine.

In a landmark judgment, the Supreme Court has rejected the plea of Swiss drugmaker Novartis to patent Glivec, used to treat chronic myeloid leukemia, paving the way for other manufacturers to make and sell versions of the medicine.

Novartis has been fighting for a patent on Glivec since 1998. Earlier, the Chennai patent office denied it one, saying imatinib mesylate, used in Glivec, was not a new molecule, but an altered version of something that had already been in the market for many years. On Monday, a bench of justices Aftab Alam and Ranjana Prakash Desai, too, dismissed the company’s plea on the same ground.

“The judgment is a victory for Indian companies, they can now manufacture cheaper drugs so long as there is no patent,” said Pratibha Singh, advocate for Ranbaxy and Cipla, which had opposed Novartis’ plea.

“The court has held that the drug is not novel, not inventive and does not satisfy the requirements of section 3(d) (of the Indian Patent Law),” said advocate Anand Grover, who appeared for the Indian Cancer Patients Aid Association.

Though visibly upset, Ranjit Shahani, managing director of Novartis India, said the company will file patents and carry on investing in the country, but with caution, and will continue to refrain from research and development activities here. “The intellectual property ecosystem in India is not very encouraging,” he said.

 

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Key cancer drug will stay cheap after patent ruling | Hindustan Times (Mumbai),  2 Apr 2013, Bhadra Sinha & Sanchita Sharma

 NEW DELHI: Indian patients will be able to get a key cancer drug at a fraction of the price charged by its inventor, Swiss multinational Novartis, after the Supreme Court dismissed the company’s efforts to win a patent on it, likely sparking more such attempts to bring costly Western medications to the masses.

Novartis had tried to extend the patent on Glivec, its treatment for blood and intestinal cancer, with a modified version of the original drug. But the apex court ruled against it on Monday on grounds that the tweaked form was not a truly new product. Generally, multinational drug companies charge high prices for drugs protected by patents.

 “It is a huge victory for human rights. A month’s dose of Glivec costs around Rs1.2 lakh, while the generic drug costs Rs8,000. This judgment will save the lives of the many thousands who cannot afford Rs1.2 lakh charged by companies that keep patenting new forms of known drugs,” says YK Sapru , chairman of the Cancer Patients Aid Association.

 In addition to benefitting patients, the verdict will give a boost to domestic generic drug manufacturers, such as Cipla, as they can continue to sell copies of the drug at a lower price in India. It is a big blow to multinationals banking on easy patent power, and will also reignite a debate in the West about intellectual property protection in India. The new form of Glivec enjoys patent protection in more than 40 countries.

 The bench of justice Aftab Alam and justice Ranjana Prakash Desai said that no material had been offered to prove that the new form of Glivec would produce enhanced or superior efficacy “apart from the adroit submissions of the counsel”

Novartis had tried to extend the patent on Glivec, its treatment for blood and intestinal cancer, with a modified version of the original drug. But the apex court ruled against it on Monday on grounds that the tweaked form was not a truly new product. Generally, multinational drug companies charge high prices for drugs protected by patents.

 “It is a huge victory for human rights. A month’s dose of Glivec costs around Rs1.2 lakh, while the generic drug costs Rs8,000. This judgment will save the lives of the many thousands who cannot afford Rs1.2 lakh charged by companies that keep patenting new forms of known drugs,” says YK Sapru , chairman of the Cancer Patients Aid Association.

 In addition to benefitting patients, the verdict will give a boost to domestic generic drug manufacturers, such as Cipla, as they can continue to sell copies of the drug at a lower price in India. It is a big blow to multinationals banking on easy patent power, and will also reignite a debate in the West about intellectual property protection in India. The new form of Glivec enjoys patent protection in more than 40 countries.

The bench of justice Aftab Alam and justice Ranjana Prakash Desai said that no material had been offered to prove that the new form of Glivec would produce enhanced or superior efficacy “apart from the adroit submissions of the counsel”

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Novartis verdict a boon for health care in India: Doctors | HT Correspondent, Hindustan Times  Mumbai, April 02, 2013

Generic drugs available at one-tenth the cost of their patented counterparts for blood cancer have helped many patients continue their battle against the disease, said city doctors, while welcoming the Supreme Court judgment which rejected Swiss pharma giant Novartis AG’s plea to patent Glivec, a drug given to patients suffering from blood cancer.

“When Glivec was introduced in the market, not many patients were able to take it despite knowing its effectiveness as it was too expensive. What is the point of a drug which patients can’t afford?” said Dr S Banavali who is the  head of paediatric department at Tata Memorial Hospital, Parel. “The research done at our hospital shows that generic drugs have the same effect as patented ones, and hence they are a boon for patients,” he said.

The Cancer Patients Aid Association was the first agency to challenge the Glivec’s patent in the 1990s. “With this judgment, we will not have to pay exorbitantly for old drugs that have been reintroduced with a slight change, especially when it is a matter of life and death,” said YK Sapru, founder-chairman, CPAA.

Oncologists said those suffering from chronic myeloid leukemia, a type of blood cancer, need to take the drug every day throughout life. “A month-long course of Glivec will cost around Rs1.5 lakh but its generic versions cost between Rs6,000 and Rs8,000,” added Sapru.

Dr Rajeev Boudhankar, vice president, Kohinoor hospital, described the judgment as a benchmark model for patents in developing countries. “Had Novartis won the case, it would have made healthcare very costly in India,” said Boudhankar. “It would have opened floodgates for multinationals to file patents for even molecules, which are not new inventions but slight modifications with questionable efficacy,” he added.

Dr Ganpathi Bhat, medical oncologist, Jaslok hospital, Peddar Road, said companies producing generic drugs are needed, but the authorities should also ensure the quality, dose and purity of the product is closely monitored.

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Novartis ruling opens doors for Indian pharma firms... | HT Correspondent, 2 Apr 201,  Hindustan Times (Mumbai)

Domestic majors Cipla, Ranbaxy, Natco cheer verdict; More generics companies may be emboldened to enter the Indian market

NEW DELHI: The Supreme Court’s rejection of Swiss drugmaker Novartis’ patent application for its blockbuster anti-cancer drug Glivec is poised to give a boost to domestic generic drug manufacturers by providing clarity on the extent of innovation required to retain patents in India.

The decision means Indian generic drugmakers can continue to sell copies of the drug at a lower price in India — and that is a blow for some multinationals banking on easy patent power.

Novartis shares plunged 6.8% to R558 on the Bombay Stock Exchange, a 14-month low after the judgment, before recovering losses to end down 1.8% to R588. Domestic drug majors, however, registered gains with Cipla climbing 1.2% to R384, Ranbaxy 2.7% to R452 and Natco Pharma 5.4% to R452.

Glivec, which is used to treat chronic myeloid leukaemia and other forms of cancer, costs R1,20,000 a month. The generic equivalent is currently available in India for about R8500. For Indian generic firms, especially Cipla, Ranbaxy and Natco, which have been selling similar versions of the drug, it is a welcome move.

Imatinib, "generic" Glivec is on India's National List of Essential Medicines and sells at around one-tenth of the price of the branded drug in the country.

“The decision of the Supreme Court will come as a relief to patients suffering from these dreadful diseases as several Indian companies can continue marketing Imatinib at a fraction of the cost of the Novartis product,” said DG Shah, secretary-general of the Indian Pharmaceutical Alliance, an industry group. 

The judgment does not immediately add anything financially to the Indian companies because they are already in the market. However, more generic companies or companies trying for generic versions of existing patented products are set to be emboldened to foray into the domestic pharmaceutical market.

 “The ruling does not add any further sales or does not add any more revenues, profits for them as such,” explained Manoj Kumar, a corporate law expert at law firm Hammurabi & Solomon. “More companies may come and all will continue to sell.”

Indian pharma majors gave the ruling a thumbs-up. “We are pleased with the judgment, which prevents the use of frivolous patents to deny access to medicines for patients,” said YK Hamied, chairman, Cipla.

“The judgment in the Novartis case is a victory for patients both in India and around the world.”

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SC’s Glivec ruling setback to foreign pharma firms: SC rejects Novartis’s patent plea for Glivec, says it does not meet any standard of novelty or inventiveness | Vidya Krishnan |  C.H. Unnikrishnan The Mint, Tue, Apr 02 2013. 12 48 AM

New Delhi/Mumbai: In a landmark judgement, India’s apex court rejected Swiss drug maker Novartis AG’s legal challenge aimed at securing a patent for blockbuster anti-cancer drug imatinib mesylate, branded Glivec in the country.

The verdict, which is seen as a setback to multinational pharmaceutical companies operating in India, may influence a rash of pending disputes at various stages of litigation. While domestic pharma companies manufacturing generics will breathe a sigh of relief, consumers stand to gain as the expectation is that the decision could lead to lower drug prices.

Glivec, used in treating chronic myeloid leukaemia, is priced at Rs.1.2 lakh per person per month while the generic version of the drug costs around Rs.8,000.

The verdict will discourage innovative drug discovery essential to advancing medical science for patients, Novartis India vice-chairman Ranjit Shahani said on Monday.

“We brought this case because we strongly believe patents safeguard innovation and encourage medical progress,” Shahani said at a press briefing in Mumbai. “This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.”

Overseas drug makers are keen on gaining a bigger share of India’s pharmaceutical market, which is seen growing to Rs.5 trillion from Rs.1 trillion by 2020, according to India’s department of pharmaceuticals.

This has also led to the acquisitions or part-acquisition of local firms by overseas companies including the purchase of Ranbaxy Laboratories Ltd by Japanese drug maker Daiichi Sankyo Co. Ltd, Matrix Laboratories Ltd by Mylan Inc., Dabur Pharma Ltd by the Singapore unit of Germany’s Fresenius Kabi AG, Shantha Biotechnics by Sanofi-Aventis SA, Orchid Chemicals and Pharmaceuticals Ltd’s generic injectables business by Hospira Inc. and Piramal Healthcare Ltd’s branded generics unit by Abbott Laboratories.

A bench of justices Aftab Alam and Ranjana Prakash Desai dismissed the Novartis plea for the exclusive right to manufacture the blood cancer drug on the grounds that it “did not meet any standard of novelty or inventiveness”, according to Pratibha Singh, an intellectual property rights expert and lawyer for generic drug maker Cipla Ltd.

Essentially, they ruled that the changes made to the drug by Novartis did not add any significant therapeutic value.

In their verdict, the court stated that “the beta crystalline form of imatinib mesylate, fails in both the tests of invention and patentability as provided under of section 2(1) and section 3(d) respectively”. Section 2(1) refers to enhanced efficacy and section 3(d) addresses the issue of patentability.

The keenly followed legal battle, which lasted seven years, is significant because Novartis had challenged interpretation of section 3(d) of the Indian Patents Act, a public health safeguard introduced by Parliament in 2005 to prevent so-called evergreening. This refers to a process supposedly used to extend patents on known drugs by tweaking them.

Under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement formulated by the World Trade Organization, innovator firms are granted patent monopoly for 20 years, after which generic companies are allowed to make cheaper copies of the original drug without paying the innovator.

Monday’s judgement provides clarity on evergreening or incremental innovation undertaken by pharmaceutical companies to protect patents. The company can file a review petition in 30 days, but Shahani refused to comment when asked about the possibility of such a petition.

Y.K. Hamied, chairman of local drug maker Cipla, one of the key opponents to the Novartis claim in the case, welcomed the verdict.

“We are pleased with the judgement which prevents the use of frivolous patents to deny access to medicines for patients,” he said in a statement. “India, being the pharmacy capital of the world, can continue to produce affordable, high quality medicines without the threat of patents for minor modifications of known medicines. This judgement will not only benefit patients in India, but patients around the world.”

Anand Grover, senior counsel for the Cancer Aid Patients Society, which opposed Novartis in the case, also hailed the decision.

“The Supreme Court’s interpretation of section 3(d) keeps it intact. It gives life to Parliament’s intent of facilitating access to medicines and of incentivizing only genuine research,” he said. “By refusing patent monopolies on minor changes to known molecules, this judgement will facilitate an early entry of generic medicines into the market for other diseases too. The impact of this judgement will not be felt in India alone, but across the developing world.”

The Novartis India stock dropped nearly 7% in intraday trade after the verdict was announced, then recouped its losses. It closed at Rs.587.95, down 1.81%, on BSE. The benchmark S&P BSE Sensex rose 0.15% to 18,864.75 points.

The Swiss drug maker has a patent for the same drug, in a modified version, in 40 countries including the US, Russia and China.

In 2006, Indian authorities denied Novartis a patent for Glivec stating that the drug wasn’t a new molecule, but an altered version of one that had already been on the market for around 15 years. Novartis then challenged the rejection of its patent application by the Indian patent office and subsequently by the Intellectual Property Appellate Board. Following this, the company challenged the interpretation of section 3(d) in the Chennai high court in 2009. It filed its appeal in the Supreme Court as well the same year.

The top local generic drug makers’ body, the Indian Pharmaceutical Alliance (IPA), welcomed the Supreme Court verdict. “This is a landmark judgement that will serve to set at rest the controversy that was raised regarding the scope of section 3(d) in the patents Act, which is a crucial safeguard against the extension of patent monopolies of known drugs and the consequent delay in the availability of affordable generic versions,” IPA secretary general Dilip G. Shah said in a statement.

Imatinib is on the national list of essential medicines and is used in the treatment of certain blood and stomach cancers. The decision of the Supreme Court will mean several Indian companies, including Cipla, Ranbaxy and Natco Pharma, can continue selling imatinib at a fraction of the cost of the Novartis product, said Shah of IPA, which was an intervenor in the litigation before the Supreme Court.

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Voices on the Verdict, Times of India, Mumbai, Tuesday 2nd April 2013

This is a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers like MSF. The SC decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law

Unni Karunakara | INTERNATIONAL PRESIDENT, MSF

The judgment is a victory for patients both in India and around the world. We are pleased with the judgment which prevents the use of frivolous patents to deny access to medicines for patients

YK Hamied | CHAIRMAN, CIPLA

It gives the much required boost to Indian generics, which were being throttled in many ways.

Daara Patel | SECRETARY GENERAL, INDIAN DRUG MANUFACTURERS’ ASSOCIATION

The SC verdict is a  landmark judgment  which will not only affect Glivec but will avoid patenting of older compounds and avoid ever-greening of patented products. More than that, it will make anti-cancer life-saving drugs affordable and consequently result in saving many lives. And this will happen not only in India but in over 75 other countries where India exports generic drugs

Y K Sapru | CHAIRMAN & CEO, CANCER PATIENTS AID ASSOCIATION

It is a historic judgment which reaffirms the position of the Indian law and in particular, provisions of Section 3(d) of the Patents Act which mandates the need for a substantive innovation while deciding on a case for grant of a fresh patent. Indian Patent Law is fully in conformity with our international obligations under the TRIPS agreement

Anand Sharma | COMMERCE AND INDUSTRY MINISTER

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