India’s Supreme Court Decides to Provide Generic Drugs to the Poor Instead of Enforcing Patent

Earlier last month, the Supreme Court in India ruled on whether or not Novartis, a pharmaceutical company, should be given a patent for Glivec, a cancer drug. The Court decided a patent should not be given because the formula in question was too similar to Novartis’ earlier version of the drug.

The India Patents Act prevents pharmaceutical companies from gaining a monopoly on patent protection on updated drugs that are not demonstrably more effective than previous versions.  India’s laws prevent patent holders from extending the duration of a patent by making small changes to existing patented formulas, a concept known as “evergreening.”

Chapter II of The Patents Act states: “3. What are not inventions? The following are not inventions within the meaning of this Act” and lists several items.

Section 3(d) states: “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 or 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.”

Novartis argued that the new drug is more effective than its predecessor because it is 30% easier for the body to absorb the drug. However, the Supreme Court of India decided that Novartis did not prove that the new drug provided the “enhanced efficacy” required.

As a result of the Court ruling, India’s generic drug manufacturers can continue to make generic version of Glivec. The impact for the sick in India is huge: a year’s supply of Novartis’ Glivec can cost about $70,000 while a year’s supply of a generic version costs around $2,500 a year. This ruling has no impact on the price of Glivec in the United States.