The new financial year began with a landmark judgment by the Supreme Court on Novartis which will have far reaching effects on the patentability of therapeutic drugs. Though it is seen as a triumph of generic drug companies over pharmaceutical giants, of hope for the common man, a socio-legal fairytale, its actual legal implications are lost in the excitement.
At the core of the judgment is whether a patent should be given to an invention comprising a new form of a known drug, which does not enhance the efficacy of the drug - and, in this context, what is the efficacy of the drug. The drug in question was Imatinib Mesylate (brand name: Gleevec/Glivec), used to treat chronic myeloid leukaemia.
The judgment has analysed the Indian Patents Act, specifically the provisions relating to what are patentable inventions as far as chemical or pharmaceutical substances are concerned. It has laid down standards for patentable inventions relating to medicines. The judgment has interpreted those provisions and has curbed attempts at repetitive patenting of known medicines. The apex court has held that for grant of patent the subject must satisfy two distinct tests at the heart of the Patents Act, namely of "invention" and "patentability".
The test of patentability sets up a second and higher tier of qualifying standards, especially for chemical substances/medicines, in order to leave the door open for true and genuine inventions, but, at the same time, check any attempt at extension of patent term on spurious grounds. Under the scheme of patent, a monopoly is granted to an individual in exchange of the invention being made public so that, at the end of the patent term, the invention will belong to the people at large who may benefit from it.
The apex court has observed that a patent should not be traded as a commodity, especially for making high profits and filing infringement actions. In the case of a new form of a known medicine, it must possess therapeutic efficacy, that is the ability to produce a desired result, which must be judged strictly and narrowly. The court also discussed bio-availability (the degree to which a drug becomes available to the target tissue after administration) and held that increased bio-availability does not necessarily imply increased therapeutic efficacy.
What does this mean for future patents in this arena
? A patentee will think twice about evergreening patents. A drug merely passing the test of inventive step, that is a technical advance as compared to the existing knowledge, and not obvious to a person skilled in the art, is not enough. It must clear the test of enhanced therapeutic efficacy. Future patentees would do well to remember that evidence of enhanced therapeutic efficacy must be shown.
The judgment is not meant to deter patenting inventions but rather to exclude claims to patents on spurious grounds. It is not a strike against the pharmaceutical industry, nor is it a ruling meant to appease the masses. It will be a grave mistake to read the judgment to mean that the Act bars patents for all incremental inventions of chemical and pharmaceutical substances. The judgment attempts to strike a balance between public interest and inventor interest.The writer is Managing Partner, W.S. Kane & Co. (Shalini Sitaraman, Advocate & Patent Attorney, W.S. Kane, also contributed to the column)