Right: Imatinib mesilate
To comply with TRIPs requirements, India modified its patent law in 2005, allowing new chemical entities (post 1995) to be patented. The law was, however, also modified to prevent the practice of 'evergreening', making small modifications to a chemical entity to acquire a new patentable drug, thus extending the patented life of the drug. The amendment to the Indian Patents Act, at section 3, reads:
"The following are not inventions within the meaning of this Act, -
(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".
The explanation provided in the amendment goes:
"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."
This clause therefore effectively prevents drugs that are not new chemical entities from being patentable. Patenting new salts or crystal forms is not possible, unless there is some improved efficacy.
The Indian government's argument is that Glivec is not a new entity because forms of it were known of before 1995, and Glivec does not show any enhancement in efficacy. Novartis, however, argue that Glivec is more easily absorbed by the body and is therefore more effective. More significantly, Novartis also argue that the law as amended is unconstitutional, and does not comply with India's requirements under TRIPs.
The case has prompted a public outcry, including demonstrations in New Delhi. Many people view Novartis' appeal as being an attempt to restrict the availability of medicines to people who may not be able to afford them, because generic manufacturers will not be able to cheaply produce copies of patented drugs to supply the large market in India and elsewhere.
The IPKat is on the fence on this one. If Glivec is really no better in efficacy than previously available drugs, then it shouldn't really matter whether Novartis gets a patent for it or not. Generic suppliers can simply make and sell the old drug, which will work just as well. On the other hand, if Glivec really is substantially better than what was available before, don't Novartis deserve to get a patent for it, in accordance with Indian patent law? Fundamentally, it seems to come down to the old argument of whether new and innovative drugs should be the subject of patent protection at all.