)
The Supreme Court today dismissed the appeal of Novartis AG and ruled that the Swiss pharma company was not entitled to get patent for the improved version of its cancer drug Gleevec (Glivec).
The medicine, used to treat cancer and certain kinds of tumours, costs around $2,600 a month while the generic version available in this country costs around $175 per month. The drug is the beta crystalline form of a chemical compound called Imatinib Mesylate.
The legal issue involved in this 7-year-old litigation was the new Patent Act provision aimed at preventing companies from getting fresh patents after making minor changes to generic drugs, a practice called ‘evergreening’. This bar, introduced in 2005, is contained in Section 3(d) of the Act. The Indian rivals of the Swiss multinational, Cipla, Ranbaxy and others submitted that there was no invention in the new drug, but it was mere evergreening.
The court applied Section 3(d) of the Patents Act and ruled that the new version of the drug was not an ‘invention’. The provision says that the claim of invention cannot be made by “the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant”.
Applying its interpretation of the provision, the judgment said that the drug was not “an invention as understood in the law of patent in India.”
The bench consisting of Justice Aftab Alam and Justice Ranjana Desai said in their 110-page judgment: “We firmly reject Novartis’ case that Imatinib Mesylate is a new product and the outcome of an invention… We hold and find that Imatinib Mesylate is a known substance. Imatinib Mesylate does not qualify the test of 'invention' as laid down in section 2(1)(j) and section 2(1)(ja) of the Patents Act.”
The judges, after a detailed analysis of the chemicals and their efficacy, added that there was no material to show that there was increased efficiency in the use of the new version of the medicine.
The court clarified that this judgment did not apply to all improvements in products. It said it has not barred patent protection “for all incremental inventions of chemical and pharmaceutical substances.” It will be a “grave mistake” to read this judgment to mean that it prohibited all fundamental changes in a product.
The Swiss firm had earlier approached the patent authorities but its application was rejected as they did not consider the modified version of the drug an ‘invention’ to qualify for a patent. The company then moved the Madras high court and later the Intellectual Property Appellate Board against the denial of the patent. Both were dismissed, against which the company appealed to the Supreme Court.
The board held that the patentability of the drug was hit by section 3(d) of the Act. It said that “Since India is having a requirement of higher standard of inventive step by introducing the amended section 3(d) of the Act, what is patentable in other countries will not be patentable in India.”
The Madras High Court, dismissing the company’s challenge to the constitutionality of the patent law, stated that the object of Section 3(d) was to prevent evergreening; to provide easy access to the citizens of the country to life saving drugs and to discharge their constitutional obligation of providing good health care to its citizens.”
