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Tuesday, April 2, 2013

SC Ruling in Novartis Case -Monday April 1,2013


 SC Ruling in Novartis Case -Monday April 1,2013
In a ruling that will help patients continue to buy several life-saving medicines as generic drugs, the Supreme Court on Monday April 1,2013 held that the modification of a well known cancer-fighting drug is not a patentable new invention. 

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 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. 

Note

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. 



Timeline

1997: Novartis files a patent application in India for its drug Gilvec
2005: India introduces the Indian Patent Act preventing frivolous patents.
Jan 2006: The Patent Controller in Chennai denies Novartis a patent
May 2006: Novartis challenges the Indian government and four other companies in the Madras High Court
Aug 2007: The Madras High Court rules against Novartis’ case
June 2009: The Intellectual Property Appellate Board rejects a fresh appeal
August 2009: Novartis approaches the Supreme Court of India
April 1, 2013: Supreme Court rejects Novartis’ plea for patent

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