Landmark Ruling Sees Big Pharma Lose Drug Patent Battle

A landmark decision regarding drug-patenting laws has been made. India’s Supreme Court has rejected pharma giant, Novartis AG’s attempt to patent a new version of its cancer drug Glivec – a decision that healthcare activists say will ensure poor patients around the world get access to cheap versions of lifesaving medicines.  

Novartis argued that it needed a new patent to protect its investment in the cancer drug Glivec, while activists said the company was trying to use loopholes to make more money out of a drug that’s patent had expired. Many big pharma companies agreed with Novartis, stating that patents for improved drugs should be granted to facilitate further research and development.

The decision has global implications, since India's $26 billion generic drug industry supplies much of the cheap medicine used in the developing world.

The ruling has set a precedent that will prevent international pharmaceutical companies from obtaining fresh patents in India on updated versions of existing drugs. The landmark court ruling states that patents can only be given to new drugs.

Novartis has not yet made a comment regarding the outcome of the trial. The Swiss pharmaceutical giant has fought a legal battle in India since 2006 for a fresh patent for its leukemia drug Gleevec, known in India and Europe as Glivec.

India's patent office had rejected the company's patent application because it was not a new medicine but an amended version of its earlier product. The patent authority cited a legal provision in India's 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines, a practice known in the industry as “evergreening”.

Novartis appealed, arguing Glivec was a newer, more easily absorbed version of the drug and qualified for a fresh patent.

Aid groups, including Doctors Without Borders, have opposed Novartis' case, fearing that a victory for the Swiss drugmaker would limit access to important medicines for millions of poor people around the world.

Gleevec, used in treating chronic myeloid leukemia and some other cancers, costs about $2,600 a month. Its generic version was available in India for around $175 per month.