Earlier this year the first compulsory license, regarding the anti-cancer drug Sorafenib, was granted in India. (See previous blog post.) The compulsory license was granted inter alia on the ground that the patented invention was not available to the public at a reasonable affordable price.
The battle towards affordable medicaments in India continues. In a decision issued 2 November 2012, the Intellectual Property Appellate Board (IPAB) of India came to a decision in favour of the patients in India by the revocation of Patent No. 198952 (Roche). The patent concerns PEG derivatives of IFN?. Roche’s product was sold under the name Pegasys® and used for the treatment of Hepatitis C.
The process began when two post-grant oppositions were filed against the grant of the patent, one by M/s. Wockhardt Ltd. and the other by an NGO (non-governmental organization) named Sankalp Rehabilitation Trust. Both oppositions were disallowed, resulting in an appeal filed by the NGO.
During the appeal, Roche challenged the right of an NGO to oppose a patent in a post-grant proceeding, since, acording to S.25 (2) of the Patents Act, 1970, only “any person interested” may challenge a patent after grant. Roche meant that Sankalp was neither a competitor nor a researcher in the sector, and that a non-profitable organization working for the benefit of drug users cannot be said to have any interest of the nature as required by the act.
The IPAB stated: “We must take a common sense approach to construe the interest that the opponent has in opposing the grant of the patent. In the present case, the appellant claims that it is a society which works for the community of HCV and HIV sufferers. This is not challenged. The invention is admittedly for the use in the case of hepatitis-C. The continuance or removal of the patent will definitely affect the interest of the community for whom the appellant claims to work………We therefore hold that the appellant who works for a community which needs the medicine is definitely a “person interested” The locus standi objection is rejected”.
The IPAB held that the invention was obvious in view of prior art. The appeal was allowed and the grant of Patent No. 198952 was set aside.
This case is of great importance since NGOs are given the status of “interested person” under the Patents Act, giving them the possibility to challenge granted patents in India.
The decision in this case is seen as a victory for public health and for affordable drugs in India. The immediate effect of a revocation like this is the availability of cheaper generic products for the people in India.
The drug companies, however, consider that intellectual property is not being valued in India. This might result in them changing their plans regarding development of drugs well needed in for instance India. Thus, the long-term effects of this decision are still to be seen.
Jeanette Jakobsson, European Patent Attorney