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Novartis lawsuit (re India patent law & access to medicine)

Glivec Novartis By: D. Meyer, creative commons
Worldwide, Novartis is the main producer of Glivec, a drug used for treating blood cancer.  The company has sought a patent that would give it the exclusive right to produce Glivec, stopping production by the generic drugs industry in India.  

In 1997, when India did not allow protection for pharmaceutical products, Novartis filed a patent application in the Chennai Patent Controller’s office for what Novartis claimed was a new form of Glivec.  The application was kept on hold until 2005 when India amended its patent system.  In January 2006, the Patent Controller rejected the application, stating that the Patents Act does not allow protection for products that are a modified version of an existing drug, and that in this case the new version lacked novelty.  In May 2006, Novartis challenged this decision in the Chennai High Court. 

In August 2007, the Chennai High Court transferred the case to the newly-created Patent Office in the Intellectual Property Appellate Board.  In June 2009, the Appellate Board disagreed with the Patent Controller and found that Glivec was new and involved an inventive step.  However, it still denied patent protection because it said Novartis did not demonstrate that the new product was more effective than the previous one, as laid required by the Patents Act.

Novartis petitioned the Supreme Court to review the Intellectual Property Appellate Board’s decision.  The company argued that Glivec had satisfied key criteria including novelty, and hence it should be considered an “invention” under the Patents Act.  In April 2013 the Supreme Court upheld the Appellate Board’s decision and its finding that Novartis failed to prove improved therapeutic efficacy of the new version.

- “To patent or not to patent? the case of Novartis’ cancer drug Glivec in India”, Ravinder Gabble, Dalla Lana School of Public Health, Univ. Toronto, & Jillian Clare Kohler, Associate Professor & Director Global Health, Leslie Dan Faculty of Pharmacy, & Munk School of Global Affairs, Univ. Toronto, in Global Health, 6 Jan 2014
- “5 Take-Home Points From India’s Historic Novartis Patent Case”, Arvind Subramanian, Senior Fellow at Peterson Institute for International Economics & Senior Fellow at Center for Global Development, in Asian Scientist, 29 Apr 2013
- “Why Novartis case will help innovation”, Achal Prabhala, Sudhir Krishnaswamy, Azim Premji Univ., & Dr. B.R. Ambedkar, Visiting Professor of Indian Constitutional Law at Columbia Law School, in The Hindu, 15 Apr 2013
- “India’s Patently Wise Decision” Joseph E. Stiglitz, Nobel laureate in economics, Columbia Univ., & Arjun Jayadev, Univ. of Massachusetts, in Project Syndicate, 8 Apr 2013
- “Indian Supreme Court Delivers Verdict in Novartis Case”, NGO Pulse (So. Africa), 2 Apr 2013
- “Landmark verdict gives big boost to cancer patients”, J. Venkatesan, Hindu, 1 Apr 2013

Novartis: “Supreme Court denial of Glivec patent clarifies limited intellectual property protection and discourages future innovation in India”, 1 Apr 2013

Supreme Court of India: “Novartis AG v. Union of India & Others”, Judgment, 1 Apr 2013

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Article
6 January 2014

To patent or not to patent? the case of Novartis’ cancer drug Glivec in India

Author: Ravinder Gabble & Jillian Clare Kohler, in Global Health (USA)

Glivec...produced by the pharmaceutical company Novartis, is prescribed [to treat]...one of the most common blood cancers in eastern countries...[T]he Supreme Court of India gave its final decision...rejecting the appeal of the Swiss...drug manufacturer...[T]he Supreme Court stated that even if the bioavailability of the drug was improved, it did not demonstrate enhanced efficacy and that Glivec was not patentable...[T]he drug needs to be taken lifelong…For this reason, along with the fact that 95% of Indians do not possess private health insurance, its pricing plays a critical factor in cancer patients’ ability to access a continuous supply of Glivec for effective treatment...The pricing of cancer treatment is arguably the most important factor in determining India’s position in the case: a monthly dose of the patented version of Glivec…is over three times an average Indian’s annual income...

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Article
14 May 2013

Patent wars: has India taken on Big Pharma and won?

Author: Tim Smedley, Guardian [UK]

On 1 April, pharma giant Novartis lost a six-year legal battle after the Indian supreme court ruled that small changes to its leukaemia drug Glivec did not deserve a new patent.…And only one month before, India upheld a compulsory licence of Bayer's cancer drug Nexavar…Both rulings are landmark cases, vehemently criticised by both Big Pharma and major drugs-producing countries…The Novartis spokesperson argues, …”[w]ithout patents, investment in R&D will plummet…there will be no new medicines for untreated diseases and no new generics."…Some view the recent fights in the Indian courts as a sign of Big Pharma's growing desperation; stubborn attempts to cling to old business models rather than face the truth of spiralling R&D costs…The danger Big Pharma faces is unlikely to be developing countries wielding compulsory licences…It is more from their own inability to keep costs down and offer drugs to markets at affordable prices...

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Article
29 April 2013

5 Take-Home Points From India’s Historic Novartis Patent Case

Author: Arvind Subramanian, Asian Scientist (Singapore)

...[T]he Indian Supreme Court dismissed the attempt by Novartis...to obtain patent protection for...Glivec...The verdict follows the Indian Patent Office’s decision last month to grant an Indian drug manufacturer a compulsory licence to sell a generic version of a kidney cancer drug…patented by Bayer. These rulings raise five important points. The first point relates to the perceived effectiveness of the rule of law in India…Second, taken individually, the patent cases do not indicate any categorical hostility to intellectual property (IP) protection or foreigners…A third point relates to criticisms…that India is…the only country where Novartis’ claim has been rejected…[E]ven in the United States, Novartis’ application…only succeeded on appeal…Fourth, the Novartis case was sui generis...Finally, other developing countries, such as Brazil, Thailand, and even China, could be emboldened by the Indian example and decide to dilute their own patent protection regimes…

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Article
15 April 2013

Why Novartis case will help innovation [India]

Author: Achal Prabhala & Sudhir Krishnaswamy, in Hindu (India)

[T]he Supreme Court upheld the Intellectual Property Appellate Board’s decision to deny patent protection to Novartis’s application…[T]he…judgment effectively recast Indian patent law as being nuanced and original…[T]he global gold rush for patents has been dominated by filings for minor and mostly inconsequential innovations — at the expense of breakthrough innovation. In large part, this is because weak standards in the patent laws of developed countries…have explicitly encouraged this shift… A British Medical Journal report [said]…"pharmaceutical research and development turns out mostly minor variations on existing drugs, and most new drugs are not superior on clinical measures.”… The genius of the Supreme Court judgment on Novartis’s patent application lies in restoring the connection between patents and innovation by upholding and legitimising a regime with a higher threshold of inventiveness…

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Article
8 April 2013

India’s Patently Wise Decision

Author: Joseph E. Stiglitz & Arjun Jayadev, Project Syndicate

The Indian Supreme Court’s refusal to uphold the patent on Gleevec, the blockbuster cancer drug developed by the Swiss pharmaceutical giant Novartis, is good news for many of those in India suffering from cancer. If other developing countries follow India’s example, it will be good news elsewhere, too: more money could be devoted to other needs, whether fighting AIDS, providing education, or making investments that enable growth and poverty reduction. But the Indian decision also means less money for the big multinational pharmaceutical companies. Not surprisingly, this has led to an overwrought response from them and their lobbyists: the ruling, they allege, destroys the incentive to innovate, and thus will deal a serious blow to public health globally. These claims are wildly overstated. Indeed, there is a growing consensus among economists that the current IP regime actually stifles innovation.

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Article
7 April 2013

Finally, the patients prevail [India]

Author: Sarah Hiddleston, The Hindu

The Supreme Court has denied Novartis a patent for its anti-cancer drug Gleevec. This leaves the door open for Indian pharmaceutical companies to produce their own versions of the drug. Since these are sold at roughly one tenth of the patented brand price, for thousands of cancer patients it means the difference between medicine and no medicine at all…It is not just cancer patients that will benefit, but millions of people dependent on medicines for survival, including those with HIV, diabetes, hepatitis and more. Had the judgement gone the other way, it would have set a precedent for other big pharmaceutical companies to simply make minor modifications to any existing medicines to receive fresh patents.

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Article
7 April 2013

More battles in store [India]

Author: Aarti Dhar, The Hindu

Well before the Supreme Court rejected Novartis’ application for patent for Glivec (Gleevec in the U.S.), drawing attention to the dichotomy of generic and patented drugs, activists have been demanding access to expensive drugs used in the treatment of cancer, hepatitis C and serious HIV. Trastuzumab is one such, used in the treatment of HER2+ type of breast cancer, which affects about one in four patients with the disease…. Kalyani Menon-Sen (women’s activist), Leena Menghaney (lawyer), and Third World Network have written to the Prime Minister, appealing that Trastuzumab be made available free to patients in government hospitals, and at affordable cost in the open market…Another group of health activists has demanded that the government either reject the patents given to hepatitis drugs or issue compulsory licences…HCV treatment is unavailable in the public healthcare system and not affordable in the private sector.

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Article
2 April 2013

Indian Supreme Court Delivers Verdict in Novartis Case

Author: Médecins Sans Frontières South Africa

The landmark decision by the Indian Supreme Court...to uphold India's Patents Act in the face of…pharmaceutical company Novartis is a major victory for patients' access to affordable medicines in developing countries...Médecins Sans Frontières/Doctors Without Borders (MSF) stated today…“The Supreme Court's decision now makes patents on the medicines that we desperately need less likely…”…India began granting patents on medicines to comply with international trade rules, but designed its law with safeguards…that prevent companies from…gaining patents on modifications to existing drugs, in order to ever extend monopolies…In a first case before the High Court in Chennai, Novartis claimed that the Act did not meet rules set down by the World Trade Organisation and was in violation of the Indian Constitution. Novartis lost this case…but launched a subsequent appeal before the Supreme Court…All of Novartis's claims have been rejected by the Supreme Court…[T]he company has raised concerns about the implications of the decision on the larger question of financing of medical innovation...

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Article
2 April 2013

The Novartis Saga: a timeline [India]

Author: The Hindu

Novartis had sought to overturn a clause in Indian Patents Law that restricts patent protection for newer forms of existing molecules. The case started in 1997 when Novartis filed a plea for a patent for Glivec...April 1, 2013: Supreme Court rejects Novartis’ plea for patent.

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Article
1 April 2013

Landmark verdict gives big boost to cancer patients [India]

Author: J. Venkatesan, The Hindu

In a ruling that will help patients continue to buy several life-saving medicines as generic drugs, the Supreme Court on Monday held that the modification of a well known cancer-fighting drug is not a patentable new invention…The judgment allows suppliers to continue making generic copies of Swiss firm Novartis’ Glivec or Gleevec, which has been shown to fight chronic blood cancer effectively. While the Novartis drug costs more than Rs 1 lakh per month, with doctors often advising patients to take it lifelong, the generic equivalents cost less than one-tenth. The ruling would be a relief to some 300,000 patients in India currently taking the drug.

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