Drugstore cowboy: Will India keep Novartis at bay?

Last Updated: Wed, Sep 05, 2012 19:37 hrs

The outcome of the case will have huge ramifications

Much of the world — from patients to pharmaceutical companies to health activists and even governments — is watching an intense battle currently being fought by Swiss pharma giant Novartis in India’s Supreme Court. The company wants to patent and sell its anti-cancer drug, imatinib mesylate, known as Glivec, in India but, so far, its efforts have failed. This is a high-stake contest, with serious implications for many of the above constituents.

At the heart of the dispute is the Indian government’s contention that Glivec, which treats myeloid leukaemia and some gastrointestinal cancers, is simply a retooled avatar of a pre-existing version patented in the US in 1993, and, therefore, doesn’t deserve one here. The core issue, then, is over the degree of innovation required to obtain a patent in India. Section 3(d) of the Indian Patent Law prevents what the industry calls ‘evergreening’ — a process of churning out a version of the medicine with incremental modification and no innovation, simply in order to prolong the life of the patent.

The case has an acrimonious history. Novartis had filed for a patent in 2006, which was denied. Then, in 2007, the Madras High Court rejected Novartis’ plea. The company also lost the case at the Intellectual Property Appellate Board, which rejected the company’s appeal in 2009. Novartis, then, decided to take the case to the highest court in the country.

Is Novartis ‘evergreening’?
Novartis describes the case as a crucible for the future of pharma investment. “Novartis is seeking clarity on the patent law in India,” says Novartis India Vice-Chairman & Managing Director Ranjit Shahani. “Knowing we can rely on patents in India benefits the government, industry and patients, because research-based organisations will know if investing in the development of better medicines for India is a viable long-term option.”

Besides, Novartis cannot be accused of evergreening, says Shahani. According to the company, imatinib mesylate is the salt form of an older medicine, imatinib, and the new version represents a 30 per cent increase in the bioavailability of the medicine. “Scientists at Novartis developed the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to make it suitable for patients to take in a pill form, which would deliver consistent, safe and effective levels of medicine. This process resulted in a viable drug which revolutionised cancer treatment,” says Shahani.

However, health activists argue that granting a patent on such incremental innovations would be violating the basic principles of inventive science. “The selection of a salt of the active ingredient with the purpose of improving bioavailability is well known in pharmaceutical art, and is an often-used form of what is known as ‘evergreening’,” says Leena Menghaney of Medecins Sans Frontieres, which campaigns for access to essential medicines.

The drug has been granted a patent in 40 countries, including China, Russia, Mexico and Taiwan. The Supreme Court will hear final arguments in the case on September 11.

Pharmacy to the world
India provides half the world with AIDS medication, most of it in the generic form. Various developing countries, and now even developed ones, depend on India for low-cost, quality drugs, hence the country’s nickname, ‘pharmacy to the world.’ If Novartis wins its case, this spigot of cheap drugs to those who cannot afford them could be turned off.

One reason India has become such a big drugstore: Until 2005, India did not grant patents on medicines, which allowed drug makers to manufacture and sell generic versions at a much lower price. Eventually, India’s stance on patents changed after it joined the World Trade Organization (WTO) and signed the trade-related aspects of intellectual property rights (TRIPs) agreement. From then on, patents would be applied in India as well. However, the Doha round gave a large degree of flexibility to governments to decide what kind of innovation was patentable, what should be the criteria included in ‘novelty’, what constituted an ‘inventive step’, and so on. There was another important clause from the Doha Declaration: “Each member has the right to grant compulsory licence and the freedom to determine the grounds upon which such licences are granted.”

The government was, thus, able to legitimately award Natco Pharma a compulsory licensing deal that made it possible for the company to sell Bayer’s anti-cancer drug, Nexavar, used in the treatment of liver and kidney cancer, for Rs 8,880, versus Rs 2.8 lakh under Bayer.

  • 1994: India signs World Trade Organization (WTO)’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). It must now start granting patents on medicines no later than 2005
  • 2003: Novartis launches imatinib mesylate as a blood cancer medicine (brand name: Glivec) in the US at $2,600 per patient per month. Generic versions of Glivec soon become available in India for under $200 per patient per month
  • 2005: India changes its patent law to comply with the TRIPS Agreement, and medicines can now be patented
  • 2005: India’s patent office starts examining patent applications on medicines including Novartis’s patent application for imatinib mesylate
  • Jan 2006: Novartis’s patent application on imatinib mesylate (Glivec) is rejected by an Indian patent office on several grounds, including on Section 3(d) that it is simply a new form of a known substance
  • May 2006: Novartis files two legal challenges in the Madras High Court. One is to appeal the rejection of the patent. The second to have Section 3(d) of the Indian Patents Act declared contrary to the TRIPS Agreement and to the Indian Constitution
  • Aug 2007: The Madras High Court rules against Novartis in its case to overturn Section 3(d) in India’s patent law. The Court also rules that ‘efficacy’ under Section 3(d) would require Novartis show an increase in therapeutic efficacy
  • Jun 2009: The Intellectual Property Appellate Board rejects Novartis’ appeal and confirms that imatinib mesylate does not deserve a patent, on the grounds that the company was unable to show significant increase in efficacy as required under Section 3(d)
  • Aug 2009: Novartis approaches the Supreme Court of India in a new case – this time seeking to challenge the interpretation and application of Section 3(d) by Indian courts and patent offices
Final arguments are expected to start before the Supreme Court on 11 September 2012

It is widely understood that the US and Europe are both petrified that Glivec and Nexavar are just the tip of the iceberg, and that if the patent suit was rejected, an avalanche of drugs that cost a fortune at home would continue to be sold to half the world in the form of cheap generics. Consequently, they have been exerting substantial pressure on India to stop these kind of decisions, calling them a violation of a global standard in intellectual property rights.

Pharmaceutical and biotechnology companies say that the enormous amount spent on researching and developing these drugs necessitate a rigorous policing of patents.

But, do they? Yusuf Hamied, the outspoken chairman of Cipla, says that over 50 per cent of blockbuster drugs sold by big pharma companies are actually developed by third-party researchers and then sold to the industry, allowing companies to make “super-profits,” simply because of their comparatively low R&D spend on that drug. Industry sources say that Novartis collaborated with scientist Brian Drucker and the Oregon Health Science University for Cancer, where Drucker was a researcher, for the development of Glivec.

Nevertheless, health groups are worried that the US and Europe are trying to influence the matter through free-trade agreements (FTAs) like the one proposed between India and the European Union (EU). According to Amit Sengupta of Jan Swasthya Abhiyan, most of the free-trade agreements have actually incorporated provisions that go beyond the TRIPs agreement signed at the WTO. Experts say that the India-EU FTA negotiation agenda, which is being discussed since 2007, includes medicine data exclusivity, intellectual property enforcement measures and patent term extension, among others, and, if it is enacted, it may enforce changes in the Indian patent law. “Once data exclusivity is granted, it would not be possible to make generic drugs, or even ensure the public use of patent rights, like compulsory licensing,” Sengupta said.

Health activists and patients say that secondary patenting is not only a threat to affordable medicines but also to innovation of meaningful drugs. “There is no bar on granting patents on new molecules, but by giving patents to ‘me-too’ versions of older molecules, one can actually abuse the patent system. Why should a company go for new R&D if the threshold for the incentive is so low?’ says Menghaney.

Then, there’s the issue of what would happen to existing drugs that are made here on the cheap. “If the court decides in favour of Novartis then there is a possibility that various old cases where patents were denied on the basis of Section 3 (d) would be reopened. Besides, there are many drug patent applications from companies across the world, for drugs which are not made in India so far and generics for which are available here. It is possible that a large number of new patent applications can be made here then,” Sengupta said.

That’s not the best news for patients in India or in other developing countries who depend on cheap medicines to stay alive.

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