22 February 2012 14:43
The crucial Indian patent case concerning Novartis? anticancer Glivec (imatinib mesylate) and its rejection due to Section 3(d), a controversial provision in India?s patent law, comes up for hearing next week, amid hope and concern for the parties involved.
The case is set to be heard on 28 February, before the Supreme Court, with NGOs and health activists claiming that a Novartis win would cut off Indian supplies not just within the country but also across much of the developing world.
The stakes are high for Novartis too and perhaps much of Big Pharma. Glivec is patented in about 40 countries including China and Taiwan. Asked how important a favourable ruling for Novartis would be in terms of its overall India outlook, and as an opportunity barometer, Ranjit Shahani, vice chairman and managing director of Novartis India told?Scrip?that the ruling is important for ?all innovators, national and global?, having a presence or wanting to have a presence in India.
?This is about safeguarding incentives for better medicines so that patients? needs will be met in future. As a manufacturer of generics, Novartis understands and recognises the contribution of generics once drug patents expire; our concern is with the non-recognition of intellectual property rights that ultimately help sustain and advance pharmaceutical R&D,? he said, adding that India is a formidable world power with international rights and obligations.
Mr Shahani said that patents provide an incentive to the pharmaceutical industry to invest in the development of new medicines to treat diseases that are currently untreatable or incurable, and provide options when patients develop resistance to older drugs. Novartis has, however, all along stressed that generic versions of Glivec would remain on the Indian market regardless of the outcome of the case before the Supreme Court, since Indian law allows generics launched before January 2005 [when India implemented a product patent regime] to stay on the market.
The company also said that generics alone will not solve the issue of access and that even its critics recognise that generic versions of Glivec are not the solution for the poor in India, with the real barriers to access in India being issues such as lack of diagnosis, infrastructure and distribution.?Dr Paul Herrling, Head of Corporate Research at Novartis, dismisses the argument that a win at the Supreme Court for the company would result in patients losing access to Glivec. ?More than 95% of all patients diagnosed with CML in India receive their medicine free of charge through the Glivec International Patient Assistance Program (GIPAP). Whether we win or lose that will be maintained? he told?Scrip.
The drug is used to treat patients with chronic myeloid leukaemia (CML).While imatinib mesylate is sold by Novartis in India for Rs.1,20,000 ($2,400) per patient per month, Indian generic companies sell generic versions for Rs. 8,000 ? 10,000 ($160 ? 200) per patient per month.
?The poor cannot even afford the generic versions, which would be allowed to be sold even if the patent was granted, and so we have to find more innovative ways of getting the drug to those patients. Our fundamental position is that we always try to find ways of getting life-saving drugs to patients who cannot afford them. These include public-private partnerships, tiered pricing arrangements and shared contribution models in addition to donation programs.,? he added.
Activists and NGOs, though, will have none of that. They argue that Novartis is attempting to get the legal framework for examining patent applications in India relaxed. If Novartis wins this case, it will affect not only the examination of patent applications related to imatinib and its improved formulations, but also, critically, all other essential and life saving drugs, including those for AIDS and TB treatment, Leena Menghaney, India manager of the M?decins Sans Fronti?res (MSF) Access Campaign, said.
?By taking this to the highest court in India, it means that the manner in which section 3(d) ? the clause against evergreening ? is interpreted will be applied across the four patent offices in the country,? Ms Menghaney added. A Novartis win, NGOs claim, will put pressure on Indian patent offices to grant other patent applications on improvements of drugs which are currently off-patent in India.
India?s Intellectual Property Appellate Board had earlier rejected Novartis? patent application for Glivec on the grounds that the product did not meet the criteria set under Section 3(d) of India?s Patent Act. This section broadly deals with incremental inventions that are not patentable unless they show improved efficacy or unless a known process results in a new product or employs at least one new reactant.
Predictability
Novartis, which had earlier claimed that the current case does not challenge Section 3(d), says that it needs a ?predictable? interpretation of section 3(d). It, however believes that section 3(d), intended as a hurdle for evergreening, was ?never? applicable to Glivec.
Novartis claims that the patent that was granted on the pure molecule should have no bearing on the application for the patent covering the salt as the original was never sold as a drug.
Mr Shahani explained that for any industry and for any law, interpretation must be predictable in that it is not left to ?subjective? interpretation. ?This gains importance for all technology innovators including the pharmaceutical industry. We are seeking clarity on whether we can rely on patents in India and whether we as a research-based organisation can continue to invest in the development of better medicines for India. The case is now before the Supreme Court and it is expected that the decision of the Court will be made by applying universally accepted principles of law without prejudice to any party,? he said.
NGOs claim it?s the generic industry that?s threatened by litigation, which affects predictability of generic production, instead. They claim that for Novartis and many other pharmaceutical companies patents are not synonymous with innovation and are also used very often to legally ?fence in or block? generic competitors. They also claim that the interpretation of the definition of ?efficacy? [under Section 3d] is central to this case and to the future of India?s role as pharmacy of the developing world.
Dr Herrling thinks the biggest losers, should the Supreme Court uphold the findings of the previous courts, will be India?s burgeoning innovator pharmaceutical companies and Indian patients who might find access to life-saving medicines more difficult.?Novartis? special leave petition before the Supreme Court of India challenging the decision of the Intellectual Property Appellate Board, which turned down its appeal for a patent on the beta-crystalline form of imatinib mesylate, and related petitions, was originally scheduled to be heard on 29 November 2011, but is now set to be heard on 28 February. Activist groups claim that the Attorney General of India, Goolam E Vahanvati, is expected to represent the government, with Novartis being represented by T R Andhyarujina and Gopal Subramaniam, senior counsels. Mr Subramaniam is a former Solicitor General of India.
The attorney general?s appointment comes after NGOs and health activists had been pressing for the appointment of the ?senior-most? legal advisor to the government of India to take on the line up of ?very senior and very expensive lawyers? that Novartis had appointed to the case that involves complex patentability issue. A confirmation on the attorney general?s appointment could not immediately be got.
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