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SC Verdict: BOOST TO HEALTHCARE, By Col (Dr) PK Vasudeva (Retd), 10 April, 2013 Print E-mail

Open Forum

New Delhi, 10 April 2013

SC Verdict


By Col (Dr) PK Vasudeva (Retd)


Supreme Court’s recent dismissal of the Swiss drug multinational Novartis’ petition for patent protection of its cancer drug Glivec is vital for India’s healthcare industry and the intellectual property regime which regulates the production of important medicines.


This indeed is a landmark decision, which not only impacts over 30 lakh cancer patients in the country but also ensures patients around the world get access to cheap versions of lifesaving medicines as India is a large exporter of its generic drugs in the developing world.


The apex court has rightly rejected the patent claim by the Swiss pharma giant, Novartis, for an alternative chemical structure (‘beta crystalline’) for a pre-existing chemical compound. The original invention pertained to a compound, Imatinib, having anti-tumour properties and for which Novartis was granted a US patent in 1996 — when India did not allow product-specific patents at all. Subsequently, it filed a patent in India for a ‘beta crystalline’ form of one particular ‘Mesylate’ salt derived from Imatinib.


The Court verdict does not over-rule or discard the principle of Patents. This patent applied is on a molecule originally patented over 20 years ago. The current application is about a new process that creates better consistency of the drug, which is in a different form that delivers better results. It is not a new drug. The Court held that the increased efficacy due to this process, for the patients, has not been proven. The pharma and plant science sector has had many cases of patented molecules that didn't commercialize till after patent expiry. Patents have not been renewed on those products.


The basis of the apex Court's judgment was not the expensive nature of the drug (its still going to cost a packet that's way beyond the means of most Indians). It was on the principle of not endorsing “cosmetic” changes that had little to do with novelty and effectiveness in use.


According to Novartis, the new product represented significant technical advance and brought into existence a new substance, which had superior therapeutic efficacy compared with Imatinib in its original ‘free base’ form. The Court, however, has refuted this claim, basically stating that the said product did not constitute a new chemical entity. A mere change of form, which enables more effective administration of the underlying active ingredient (Imatinib) as an anti-cancer drug to humans, cannot be the basis for granting patents.


It is also a major victory for people around the world who receive substantially cheaper drugs from India. The judgment underlined the case of many western drug firms, which have sold their products in the country at exorbitantly high prices, tweaking the provisions of the laws that govern intellectual property. Novartis has been trying to secure a patent for an amended form of Glivec since 2006. It has a patent for a cancer drug but has claimed that Glivec is a new product, which needs patent protection.


It is standard practice of drug companies to claim patent protection on the ground that the new drugs are based on new research and are radically different from the patented drugs from which they are derived. The cost of new research is most often marginal but the drug companies base their prices on inflated costs and other expenses and sell the products at prices, which are unaffordable to most people.


India’s intellectual property laws have refused to grant patent protection to such drugs, which are only slightly, changed versions of known compounds. The Supreme Court has now upheld this position. Indian companies that can produce the drug on the basis of their in-house research cannot be prevented from doing so. Since they can sell the drug at drastically lower prices they also serve the public interest. The judgment gives a big boost to them. The domestic drug industry has expanded in a major way recently by catering to the needs of the large population. This has helped to curb the exploitative practices of multinationals.


The decision can be considered part of the reform process to ensure access and affordability to high cost drugs. Earlier this month, the Intellectual Property Appellate Board (IPAB) upheld its decision by the Patent Controller on India’s first-ever compulsory licencing case which allowed Natco pharma to continue to sell generic version of Bayers AG cancer drug. Last year it was Pfizer’s cancer drug Sutent and Roche’s treatment drug lost their patented status in India. Surely, this will influence other patent applications under scanner, which include large MNCs.


Linked to this is the issue of the compatibility of the Indian law on rejection of claims for patent, with the norms on intellectual property rights or TRIPS of World Trade Organisation (WTO). The Supreme Court has evidently been persuaded by the argument that the Indian law on patents must be judged and interpreted on its own terms and not on the basis of certain standards of the western world. Even so-called incremental inventions have to involve modifications leading to substantially new attributes beyond what was already present in the existing product. This, in a sense, strikes at the heart of ‘ever-greening’ of patents, wherein technology providers seek to pre-empt competition by extending their exclusive rights through minor changes that are claimed as new inventions.


Multinational firms, especially those in the pharma and chemicals space, are bound to view the latest verdict negatively and project it as inimical to innovation. But this amounts to an unfair reading of India’s patent law, which, after all does give 20-years exclusive rights as per TRIPS Agreement for firms or individuals to make commercial use of their inventions. Moreover, patents today are also granted on products and not only on processes, as in the past.


If the idea of bestowing such monopoly is meant to reward innovation and encourage further research and development, it is only fair to grant it to products embodying genuinely new knowledge. By charging prices that make their drugs unaffordable to even ordinary folk, not supplying these in adequate quantities and, on top of it, portraying Indian generic pharma manufacturers as villains, the multinationals are causing damage to their own long-term interests. There is enough in the current patent law for multinationals to leverage their bona fide intellectual property strengths.

 However, there is a caution for policy makers as well as health activists’ group to not get complacent on these decisions, as the larger issue of access and affordability has more to do with the country’s health infrastructure, which also includes insufficient human resource and health insurance and inadequate public spending in healthcare, which clearly needs a greater push. ---INFA


(Copyright, India News and Feature Alliance)

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