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14 July 2008
Drug manufacturers are racing to obtain patents in India. The Patent Office is inundated with applications from both multinational corporations and domestic players. The pharmaceuticals sector, the most vibrant and active in the Indian patent scene, has attracted both bouquets and brickbats in its attempt to obtain patents.
Applicants are finding it hard to obtain patents. The most crucial hurdle is Section 3(d) of the Patents Act 2005. This section, which deals with chemical substances, declares that discoveries which do not lead to enhancement of efficacy, discovery of a new property, use (for a known substance) or a product resultant of an already known process, machine or apparatus constitute non-patentable subject matter. In addition, all possible derivatives of a chemical substance (ie, salts, metabolites, esters, polymorphs and isomers) are deemed to be non-patentable subject matter, except where the forms differ significantly with regard to the efficacy of the original form.
Section 3(d) has recently proved a stumbling block to various patent applications. As one of the most common grounds for rejection at the Patent Office, it has attracted further attention following the Novartis decision. The section was the bone of contention in the Novartis litigation over the drug glivec, which is used in the treatment of myeloid leukaemia and gastrointestinal stromal tumours. The Swiss company argued for incremental innovations or new discoveries made over existing patent filings by claiming that scientific research on a compound is progressive and thus every stage of research can be patented. However, the Chennai High Court rejected the patent application on the grounds laid down by Section 3(d). This case also witnessed a debate on the constitutionality of the provision.
However, Indian drug manufacturers are achieving more from their research and development investments. Even though several applications to patent generic versions have been rejected, modified forms are being awarded patents. The most recent example of this is Cipla’s triumph in obtaining patents for its drugs osemaprazole and alendronate.
The patents obtained by Cipla are for modifications of AstraZeneca’s renowned drug nexium and Merck’s best-selling drug fosamax. The patents were routed through the Patent Cooperation Treaty application and Cipla has also been granted patents by the European and US patent offices. Fosamax’s patent expired in February 2008, while nexium’s patent expires in 2014.
Cipla’s triumph seems to be based on it convincingly conquering Section 3(d) of the Patents Act. While the Patent Office’s assessment of the application seems to qualify the drugs as patentable subject matter in view of the fact that they are modifications, for the greater benefit of the pharmaceuticals sector, Section 3(d) needs to be clarified by the authorities to give an insight into the line of consideration that they are adopting when interpreting the section.
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Manisha Singh Nair