Glivec, used in treating chronic myeloid leukemia and some other cancers, costs a patient about Rs 1.2 lakh/month, much higher than Rs 8,000 which is the price of the generic drug.
New Delhi: In a major blow to Swiss pharma giant Novartis, the Supreme Court Monday rejected its plea for a patent on cancer drug Glivec, a verdict that is expected to pave the way for Indian firms to provide affordable drugs to lakhs of cancer patients in the country.
Ending a seven-year legal battle by Novartis to have exclusive right for manufacturing Glivec and to restrain Indian firms from making generic medicine, the apex court while dismissing its plea held that there was no new invention and no new substance used in the drug prescribed for treating blood, skin and other types of cancer.
A bench of justices Aftab Alam and Ranjana Prakash Desai refused to give credence to Novartis' claim that 'Imatinib Mesylate', a substance used in the cancer drug, is a new product and the outcome of an invention.
In its 98-page verdict, the bench said that law of patent in the country should not be developed on the lines where patent is determined not on the intrinsic worth of invention but by the artful drafting of companies' claims.
The legal battle over the patent, in which the claim of the Swiss firm was vehemently opposed by the Indian companies and health activists, was keenly watched by pharma companies across the world and will clear hurdles coming in the way of the manufacture of generic drugs in the country for cancer patients.
According to official estimates there are over 28 lakh cancer patients in the country.
"We certainly do not wish the law of patent in this country to develop on the 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," the bench said.
The apex court judgement can pave the way for cancer patients getting cheaper drugs as a one-month dose of Glivec costs around Rs 1.2 lakh, while generic drugs, manufactured by Indian companies, for the same period, are priced at Rs 8,000.
Reacting on the verdict, Novartis said, "This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options". A spokesperson for the Swiss firm said it will continue to file for patents in India.
Domestic drug manufacturer associations, including Indian Pharmaceutical Alliance (IPA) and Indian Drug Manufacturers' Association (IDMA), however, termed the apex court's verdict as a landmark judgement in favour of poor patients.
"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," IPA Secretary General D G Shah said in a statement.
Novartis had approached the apex court in 2009 against the order of Chennai-based Intellectual Property Appellate Board (IPAB), which had rejected its claim for patent. The multinational company (MNC) had applied for patent in 2006.
Earlier, the Comptroller General of Patent and Design had denied patent to Glivec on several grounds including its alleged failure to meet stipulations under sections 3(d) and 3(b) of the Indian Patent Law.
Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy while Section 3(b) bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products.
Upholding the verdict of the appellate board, the apex court said, "We firmly reject the appellant’s case that Imatinib Mesylate is a new product and the outcome of an invention beyond the Zimmermann patent", its earlier patent.
"We are completely unable to see how Imatinib Mesylate can be said to be a new product, having come into being through an invention that has a feature that involves technical advance over the existing knowledge and that would make the invention not obvious to a person skilled in the art. Imatinib Mesylate is all there in the Zimmermann patent. It is a known substance from the Zimmermann patent," the bench said.
"In this case, there is absolutely nothing on this score apart from the adroit submissions of the counsel. No material has been offered to indicate that the beta crystalline form of Imatinib Mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with Imatinib free base in vivo animal model.
The bench, however, made it clear that the judgement does not mean that Section 3(d) of Patent Law bars protection for all incremental inventions of chemical and pharmaceutical substances.
"We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances.
"It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment," it clarified.
"In view of the findings that the patent product, the beta crystalline form of Imatinib Mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja) of section 2(1) and section 3(d) respectively, the appeals filed by Novartis AG fail and are dismissed with cost," the bench said.
Novartis' claim was opposed by Indian pharma companies, as well as by health aid activists which had claimed that the MNC is not entitled for patent and it is indulging in "ever-greening" of patent by simply changing the composition of the ingredients of the drug.
Ever-greening of patent right is a strategy allegedly adopted by the innovators having patent rights over products to renew them by bringing in some minor changes such as adding new mixtures or formulations. It is done when their patent is about to expire.
A patent on the new form would have given Novartis a 20-year monopoly on the drug.