By Dennis Crouch
In the U.S., Gleevec costs around $70,000 per year. In India, that price is only $2,500 (for a generic version). The difference is that the Indian government has refused to grant patent rights over the Swiss-created drug while five different patents cover the drug and its use in the US.
Today’s Indian Supreme Court decision is online here: http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212.
The Indian Supreme Court focused on the question of obviousness:
Does the product for which the appellant claims patent qualify as a “new product” which comes by through an invention that has a feature that involves technical advance over the existing knowledge and that makes the invention “not obvious” to a person skilled in the art?
India recognizes that its inventive step is a higher standard than that of different countries around the world – especially in the area of pharmaceuticals. And pushing in that direction is India’s statute stating that:
(3)(d) 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.
Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
In reading the statute, the Indian Supreme Court found that section 3(d) “clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.”
The active ingredient in Gleevec is a beta crystal form of Imatinib Mesylate. It turns out that Imatinib was already known to be useful for inhibiting BCR-Abl tyrosine kinase (the function of Gleevec) and the court found that the difference between the two insufficient to allow the new patent.
The decision is important because it attempts to offer wide leeway for India’s generic drug industry while also fit within the TRIPS guidelines. The inventors of Gleevec were awarded both the Lasker Award and the Japan Prize for their contributions to medicine and science.