Suo Motu Revocation of Patents by Indian Government

29 November 2012

In a rare case of suo motu intervention, the Indian government revoked a patent that had been granted by the patent Office to Avesthagen. Indian patent 252093, “A synergistic ayurvedic/functional food bioactive composition (cincata) and a process of preparation thereof” was granted by the patent office on April 25, 2012. The patent was granted for a composition for managing diabetes and related disorders comprising extracts of at least two plants selected from a group comprising Eugenia, Cinnamomum and Salacia optionally along with pharmaceutically acceptable excipients.

It is interesting to note that the corresponding patent application based on the priority of the above said Indian patent was filed and later withdrawn in Europe. Prior art references were brought to the notice of examination division under Article 115 EPC via third party submissions by the office of Traditional Knowledge Digital Library (TKDL) based on which the European Patent Office (EPO) search report stated that each of the references submitted by TKDL office disclosed compositions comprising all of the three specified components for use in the treatment of diabetes and thus denied the novelty of the filed claim set over these references. Avesthagen, however, did not contest the search report and decided not to pay the renewal fee and, as a result, the application was deemed to be withdrawn.

The Indian patent to Avesthagen was revoked under Section 66 of the Indian Patent Act that empowers the Government to revoke a patent in Public interest on the grounds of the patent being “mischievous to the state and generally prejudicial to the public.” It is pertinent to mention here that once a patent is granted, the Indian Patent Office has no suo motu power to revoke that patent. It is only a ‘person interested’ who can file a post grant opposition under Section 25 (2) before expiry of one year from the date of publication of grant of patent. After the expiry of one year, the patent can be revoked by the Intellectual Property Appellate Board under the grounds provided under Section 64 (1) on a petition of any person interested or of the central government or on a counterclaim in a suit for infringement of the patent by the High Court. However, Section 66 of the Indian Patent Act empowers the government to revoke a patent the in public interest when it is of the opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public. In such cases the Central Government ‘may’, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked. The words of the said provision make it amply clear that it empowers the Central Government to decide on the subjective question of what is prejudicial to the public and the patent holder is not entitled to be heard as a matter of right.

The analysis of the Avesthagen case in the light of the above said provisions draws attention to the fact that the Government of India invoked a rare and indirect provision under Section 66 to revoke the patent and did not utilize the relevant grounds for revocation under Section 64 (1) involving lack of novelty and/or inventive step or having being anticipated with regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere. Rather, the issue raised for the revocation was of the invention being generally prejudicial to the public. In this context, an instant reminder is the utilitarian balancing test that was devised by European patent Office in order to address the ‘ordre public’ or morality exception in the Harvard oncomouse case, which aimed to assess the potential benefits of a claimed invention against negative aspects.

The Avesthagen formulation provides an accessible, convenient and a synergistic formulation for treatment of diabetes. The nationwide prevalence of diabetes in India now tops 9%, and is as high as 20% in the relatively prosperous southern cities. In light of such statistical data, it is difficult to fathom that the invention is prejudicial to the public. If the invention had been revoked merely on being prejudicial to the public without considering any references from the TKDL database affecting the patentability of the invention, it might be worth considering the adoption of the utilitarian balancing test in cases of inventions being prejudicial to public interest.

Although the basis of application of Section 66 for revocation of the Avesthagen patent may be debatable, TKDL has undoubtedly proven to be a valuable database that helps India protect its traditional knowledge. It remains to be seen whether similar inventions based on traditional knowledge which have earlier been granted also follow the same route as the Avesthagen patent.

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