| Ranjit Shahani addressing the media after the Supreme Court verdict on Glivec |
In a 112-page judgment, the Supreme Court of India today upheld the refusal by the Patent Office to grant a patent to Novartis for the ß-polymorphic form of imatinib mesylate.
Ranjit Shahani, Vice Chairman and Managing Director, Novartis India sees this ruling as a setback for patients that will hinder medical progress for diseases without effective treatment options. “We strongly believe that original innovation should be recognised in patents to encourage investment in medical innovation especially for unmet medical needs,” he said explaining that the company brought this case because they strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs.
When asked if the company would appeal the judgment or consider any further legal recourse, he said he needed to analyse the judgment completely before commenting on such action. For the same reason, he refused to comment on the implications of the judgment (Para. 195, page 96) which mentions that the appeals filed by Novartis “are dismissed with cost.”
When quizzed on the larger impact of today’s judgment on other MNC pharma, he predicted, “No MNC will invest in R&D in India after this judgement. R&D investment will move to places which have an ecosystem which protects intellectual property. For instance, China has seen an inflow of such investment in the past few years while India has not,” he pointed out.
Though Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon agrees that the Supreme Court ruling on patent grant to Novartis for Glivec is certainly very disappointing for Novartis, she analyses that it is not a surprise as it was a borderline case that was based on a decision related to recognising incremental innovation, which the Indian Patent Law does not favour.
She, however, opines that this decision should not be confused with the subject of patentability of original innovation. “India is a signatory to WTO, TRIPS and must respect intellectual property associated with original innovation. India needs to be seen as actively encouraging innovation and creating an enabling ecosystem that delivers affordable innovation in order to find solutions to meet the burgeoning healthcare needs of Indian patients.”
Criticising the Indian Government and the pharma industry in India (both global and local companies), she says, “The Indian government has abdicated its responsibility to provide life saving drugs to its patients, which has led to frivolous compulsory licensing issues jeopardising India’s image as a country that safeguards IP and encourages innovation. However, MNCs must also address access and affordability by engaging with the Indian Government to evolve a pricing mechanism that is linked to purchasing parity.”
Also in the same vein, Dr Swati Piramal, Vice Chairperson, Piramal Enterprise, comments that the Supreme Court judgment should be seen on the merits of one case rather than viewing it as weak IP rights in a country. She points out that even the US Supreme Court is debating patent rights on a diagnostic gene assay for breast cancer.
Legal eagles dissect the order
Hailing this as a landmark judgment, DG Shah of the Indian Pharmaceutical Alliance, commented that it will serve to set at rest the controversy that was raised regarding the scope of section 3(d) in the Patents Act, which is a crucial safeguard against the extension of patent monopolies of known drugs and the consequent delay in the availability of affordable generic versions.
Shah pointed out that imatinib is on the National List of Essential Medicines and is an important drug in the treatment of several cancers such as certain blood and stomach cancers. The decision of the Supreme Court will come as a relief to patients suffering from these dreadful diseases as several Indian companies including Cipla, Ranbaxy and Natco can continue marketing imatinib at a fraction of the cost of the Novartis product.
Quoting Justice Chinnappa Reddy (in Para. 27, 28 and Para 159), Dr Gopakumar G Nair, Gopakumar Nair Associates points out how the Learned Bench emphasises “9. … A statute is best understood if we know the reason for it. The reason for a statute is the safest guide to its interpretation.” and “A statute is best interpreted when we know why it was enacted.”
Nair comments that the order has adopted an excellent techno-legal approach to dissect the disputed Gleevec Patent application of 1998 via-a-vis the prior art Zimmerman patent of 1994 to expose lack of novelty and inventive step and consequent non-patentability, and opines that “the Supreme Court has hit the last nail on the decade-long debate on constitutional validity on Sec. 3(d) and on the patent abuse practices by “evergreening.”
Putting forth an example of the “many beautiful gems of wisdom” in the order, Nair quotes: “We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.”
Such observations will hopefully minimise the frivolous and costly litigations being undertaken by MNCs in India, he opines. In conclusion, he comments that the fact that the Novartis appeal have been rejected with COSTS, speaks volumes for the finality in the matter.
One up for Indian Pharma Inc
Initial responses from Indian pharmaceutical majors have hailed the verdict as an affirmative action, pending a more detailed analysis of the 112-page judgment document.
As one of the companies directly benefiting from this decision, Dr P Bhaskara Narayana, Director and Chief Financial Officer, Natco Pharma welcomes this judgement and underlines that ”the uniqueness of this judgement is that it has attempted to distinguish between a “genuine” invention and a “non-genuine invention” which does not increase the efficacy of the drug.”
Commenting on the judgment, Dr Y K Hamied, Founder and Chairman, Cipla said, “The judgment in the Novartis case is a victory for patients both in India and around the world. We are pleased with the judgment which prevents the use of frivolous patents to deny access to medicines for patients. India, being the Pharmacy Capital of the World can continue to produce affordable, high quality medicines without the threat of patents for minor modifications of known medicines. This judgement will not only benefit patients in India, but patients around the world. We will review the judgment in detail before commenting further.
Likewise Leena Menghaney, Médecins Sans Frontières Access Campaign Manager, India cautioned that although MSF has yet to see the text of the verdict, this appears to be the best outcome for patients in developing countries as fewer patents will be granted on existing medicines. “Novartis’ attacks on the elements of India’s patent law that protect public health have failed. The Supreme Court’s decision prevents companies from abusing the patent system to get unwarranted patents on existing medicines, to block price-busting generic competition on HIV and other essential medicines. This confirms that all patent offices in India have to use this interpretation and the law is now clear and must be strictly applied,” she concluded.
Way forward for Novartis
Speaking at a press meet at Novartis India’s Mumbai head office, Shahani said that though they were clearly disappointed with the decision, they would continue with the full donation programmes, through which the company provides Glivec free of charge to 95 per cent of patients prescribed the drug in India, currently more than 16,000 patients. The remaining five per cent of patients are either reimbursed, insured, or participate in a very generous co-pay programme.
Since Novartis began its first donation programme in 2002, the company has provided more than $1.7 billion worth of Glivec to patients in India. When quizzed on how this verdict would impact profits of the company, Shahani said that they do not break out profits or revenues for separate products but underlined that in India, “we do not make any profits from Glivec.”
“We believe that Glivec is a breakthrough drug which has changed the way cancer research will be done globally. We will continue to invest in India but on a more cautious note.”
Hoping that the ecosystem for patents in India will improve, he stressed,”It (the protracted legal battle) was not just about Glivec. It was about getting clarifications You have to test the system. In addition to seeking a patent for Glivec, the company filed the case to help clarify these unique aspects (Sections 3(d) and 3(b)) of the patent law. We will continue to apply for product patents in the future as well. We understand the value of generics. But without patented drugs, there will be no generics pipeline in the future.”
EP News Bureau – Mumbai