Supreme Court rejects Novartis’ plea for patent; green signal for cheaper generic drugs

In a ruling that will help patients continue to buy several life-saving medicines as generic drugs, the Supreme Court on Monday held that the modification of a well known cancer-fighting drug is not a patentable new invention.

The judgment allows suppliers to continue making generic copies of Swiss firm Novartis’ Glivec or Gleevec, which has been shown to fight chronic blood cancer effectively. While the Novartis drug costs more than Rs 1 lakh per month, with doctors often advising patients to take it lifelong, the generic equivalents cost less than one-tenth. The ruling would be a relief to some 300,000 patients in India currently taking the drug.

Observers say that the Court’s judgment sets a precedent against the practice of “evergreening” — a strategy through which drug manufacturers introduce modifications of drugs to extend the five-year patents on them. They say that other “evergreening” patent applications could be rejected citing this judgment, helping to keep many life-saving drugs out of the patent regime and pushing down costs.

Glivec is the brand name of Imatinib. Novartis had applied for a patent for a modification of this drug, a “beta crystalline” salt form of Imatinib Mesylate or IM, which it said could be better absorbed by the body – by up to 30% more. After its patent application was rejected by the Patent office, Novartis moved the Intellectual Property Board, Chennai. The Board rejected the claim, but gave certain findings favourable to the company. Instead of filing an appeal before the Madras High Court, Novartis moved the Supreme Court.

A Bench of Supreme Court Justices Aftab Alam and Ranjana Desai said: “We firmly reject the appellant’s case that Imatinib Mesylate is a new product and the outcome of an invention beyond the Zimmermann [original] patent.”

The Bench said that the patent application contains a “clear and unambiguous averment” that all the therapeutic qualities of the modified form, for which the patent was applied, “are possessed” by the original version.

The court held that patents can be granted only for medicines that are truly new and innovative. For new forms and new uses of existing medicines, patent applicants should prove improved efficacy.

The court said that the Patents (Amendment) Act, 2005 established that the “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not an invention — for the purpose of patenting. The Bench also dismissed the argument that the modified form had better “solubility”, saying the “efficacy” of this property over its predecessor chemical is not established.