Updated on 4 January 2013
Boon or Bane - India's patent wars and its changing scenario
To say that the last few months have been tumultuous for the India pharma patent landscape would be an understatement. Indian pharma has witnessed a number of landmark decisions, that have far reaching consequences not only on international players but also on the domestic entities in the Indian market.
On November 2, 2012, India's Intellectual Property Appellate Board (IPAB) revoked Roche's patent on its hepatitis C drug, Pegasys, on the basis that it contained PEGylated interferon, which had nothing novel about them. This judgment was noteworthy on two counts. To begin with, the Pegasys patent was the first ever product patent granted in 2006 in India, after the adoption of the new patent regime. Secondly, the IPAB observed that a patent can be challenged not only by the patentee's competitor but also by groups that represent the sections of the population directly affected by it.
Mr Anand Grover, senior counsel and director, Lawyers Collective HIV/AIDS Unit, India, who appeared on behalf of Sankalp Rehabilitation Trust, the group that had challenged the Pegasys patent, says, "We are happy that the IPAB has recognized the element of public interest in setting aside undeserving patents and held the patients' groups, who are directly impacted by patents on medicines, and can challenge granted patents. This will be of importance, as concerned patients' groups will now have better clarity in challenging patents on medicines for HIV, cancer and other diseases."
Earlier in September, the Supreme Court of India revoked a patent held by Sugen (now Pfizer) for its drug Sunitib, citing the absence of any inventive step. Cipla, a generics giant, produces a much cheaper generic version of Sunitib. The revocation was followed by order by the Indian High Court order, banning Cipla from producing the drug, which as of now has been stayed by the Supreme Court.
This was not the first of such victories for Cipla. The Delhi High Court ruled in favor of Cipla in a patent infringement case over Roche's anti cancer drug Tarceva in September 2012. The battle, which had extended over four years, successfully proved that Cipla's generic version of the drug did not infringe on any patent. Earlier, Roche had applied for a patent for the polymorph B version of erlotinib (Tarceva), which was rejected on the basis of Section 3(d), since it was a variant without an enhanced therapeutic efficiency and hence not patentable.