In India where death among poor or middle class in absence of affordable medicine is not uncommon, evergreening of pharma patents pose a big threat to the battle of providing affordable medicine to the mass. Pharmaceutical companies make minor changes to the already patented product in order to gain further monopoly period. “Evergreening” has been the cause of concern and debates across the globe and particularly in India post Supreme Court’s decision against such practice in the Novartis case, it has now become mandatory to be strict while interpreting “improved efficacy” of new version/enhancements of patented product.
Glaxo ‘s Patented Breast cancer drug “Lapatinib” and its Patented Salt version, claiming to enhance its efficacy and marketed as “Tykerb” , came under attack when “Fresenius Kabi Oncology Ltd” initiated Revocation proceedings against them.
Patent no.221017 and Patent no. 221171 were opposed by Fresenius Kabi Oncology Ltd., taking the ground that both patents lacked innovations. On 27th July 2013 the Intellectual Property Appellate Board of India (IPAB) upheld patent no. 221017 granted for the main compound Lapinitib, confirming it passed the patentability test, whereas Patent no. 221171 was Revoked on the ground that invention is obvious and hit by section 3(d).The Revoked Patent for “Tykerb”, a medicine indicated in treatment of breast cancer, is the salt form of Lapatinib compound i.e lapatinib ditosylate salt.
Analysing the main objection under Section 3(d) of Patent Act, IPAB pointed out that this invention cannot be held to enhance therapeutic efficacy. The enhancements compared to the prior art are moisture absorption property and increase in stability of the salts. IPAB ruled keeping in view Novartis Ag v/s Union of India (2007 4 MLJ 1153) – in which elaborate explanation is given on “efficacy” and which also emphasizes checking any attempt at repetitive patenting or extension of the patent term on spurious grounds. It clearly states that section3(d) meant specially to deal with chemical/pharmaceutical products, sets up a second tier qualifying standards in order to leave the door open for true and genuine inventions. It further explains how “for enhancement of known efficacy” not all advantages or beneficial properties are relevant, but only those properties that directly relate to efficacy are relevant for section 3(d). “Therapeutic efficacy” must be a narrow and strict interpretation.
IPAB Ruled that although there may be advantages in ways when compared to invention in Patent no. 221017, yet the advantages do not result in therapeutic efficacy. IPAB considering the law under section 3(d) and the guidelines laid by the Supreme Court in the Novartis case, concluded that Patent no. 221171 is not an invention and the same deserves to be Revoked, it further ruled that to a person skilled in the Art, the invention was obvious.
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