Healthy Skepticism Library item: 19484

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Novartis, Gleevec And A Patent Dispute In India
Pharmalot 2011 Apr 4
http://www.pharmalot.com/2011/04/novartis-gleevec-and-a-patent-dispute-in-india/

Full text:

Two months ago, several non-governmental organizations urged Novartis to drop its “persistent legal actions” in India, where the drugmaker has spent five years waging a legal battle in hopes of securing a patent for its Gleevec med for treating chronic myeloid leukemia. Novartis made an appeal to the Supreme Court there two years ago and a hearing is scheduled for April 19.
The groups argue the challenge is designed to influence the government to introduce laws and policies that would hinder access to medicines at a time when the issue is also the subject of trade negotiations (see here). Meanwhile, the groups charge that Novartis has tried to abuse the Indian patent sytem by continuing to file patent applications with, allgedly, minor chemical variations of the existing active pharmaceutical ingredient.
Last month, Novartis responded and its reply has just been released. In its letter, the drugmaker disputes that its effort will not prevent access to needed meds nor is it challenging the provisions under the existing trade agreements – known as TRIPS and the Doha Declaration. Novartis also maintains that it has created a patent access program that is open to anyone whose doctor
determines need. And Novartis notes that as a big generic drugmaker – its Sandoz unit is the world’s second-largest – the economics of generics are fully understood.
“In India we are seeking guidance on the proper interpretation of the Indian Patent Law. The conflict in India on Glivec(/Gleevec) is about the patentability of pharmaceutical innovation in India and not about access to medicine. We are not challenging any of the trade flexibilities that exist under the TRIPS agreement and the Doha Declaration in place to resolve any tension between IP rights and access to medicine. As a consequence, patients’ access to in the developing world will not be affected by this legal action,” writes.Kim Stratton, head group country for management and external affairs (read the letter).
“…But generics alone do not solve the issue of access. The vast majority of the 354 medicines on the WHO’s model list of essential drugs is not covered by patents, yet over a third of the world’s population still has no access to these essential drugs. Nor does the cost of generic medicines solve the issue. Generic imatinib, which is and will continue to be available in India irrespective of the outcome of the legal action, is considered still tao expensive for the majority of the Indian patient population. Based on data from the World Bank Group, the cost of one year of treatment in India with generic imatinib is 4.5 times the annual average income.”
We asked Brook Baker, who is active in the Health GAP (Global Access Project) advocacy group and a professor in the program on human rights and the global economy at the Northeastern University School of Law, for his reaction to the Novartis response. He offered this: “Novartis’s reply letter is non-responsive to the NGO demand that it drop its frivolous challenge to the denial of a patent on Glivec and its indirect challenge to existing judicial interpretations of India’s law that apply strict standards of patentability. Novartis tries to hide the its relentless pursuit of monopoly profits and unbridled patent rights behind the fig leaf of corporate responsibility and half-truths.”
He maintains that, in court, Novartis continually appeals judicial decisions denying its claim that one new variation satisfies the patent law requirements that its filing must show “significantly improved efficacy if a variation of a previous chemical entity is to be deemed patent worthy. The grounds of improved efficacy asserted by Novartis, improved bioavailability, has been rejected in India as have attributes like better stability…
“Not only is Novartis involved in a war of attrition burdening India’s patent system and judicial resources, but also continues to raise red-herrings about it right to exploit middle-class consumers, its honorable defense of the patent system, its reverence for India’s right to use flexibilities in patent law, and its drug donation program.
“Novartis’ defense of its right to charge high prices to India consumers neglects the impact of those monopoly rights on access by poor consumers. The patent system is indefensible when it fails to deliver the medical innovations needed by low- and middle-income countries for so-called neglected diseases, and when the system is subject to multiple distortions, including the one at issue here – seeking additional 20-year monopolies for trivial changes in existing medicines.
“Contrary to its assertion that it respects India’s flexibilities under international law, it is part of pharmaceutical association that are trying to eliminate those flexibilities for India and that has punished other countries, like Thailand, when they use their lawful flexibilities. Finally, it is no doubt true that Novartis’ Glivec donation program benefits some patients, but it by no means reaches all deserving patients in India.”