Generic drug trade wins big after court refuses cancer medicine patent

The Supreme Court in India has left the door open for the generic drug trade to manufacture cheap versions of groundbreaking drugs. The court today rejected a patent application from Novartis, the world’s second-largest drug manufacturer, for the breakthrough leukemia drug Glivec. It ruled that Novartis’ new drug represents only a “minor tweak to an existing drug” whose patent has expired, echoing critics’ complaints that the manufacturer was attempting to exploit a loophole to squeeze more money out of the medicine. The practice of making minor changes to drugs to extend their patents — known in the industry as “evergreening” — was effectively outlawed in 2005 by Indian lawmakers, and today’s decision solidified that ruling.

Glivec, the brand name for Imatinib, has been the subject of many court battles over the past six years. Its progress through the Indian court system has been seen as a test case for laws relating to patent expiry and generic drugs. In 2007, Novartis’ attempt to challenge the legality of the Indian patent system was squashed by a High Court in what was seen as a victory for the generic drugs industry as a whole. India’s legal system is especially relevant to the generic trade as some of the industry’s largest manufacturers are located in the country. Speaking with the Associated Press, a spokesperson for Cipla, a manufacturer of a generic Imatinib drug, said that today’s ruling will serve as a precedent for preventing pharmaceutical companies from attempting to refresh their drug patents in the future.