The Indian Patent Office has rejected American drug maker Pfizer's patents for its rheumatoid arthritis drug tofacitinib in India.

“After having considered the submissions submitted by the applicant (Pfizer) in the hearing, the written submission and amended claims filed as well as in view of the discussions and findings by me, it is hereby ordered that the invention disclosed and claimed in the instant application is not considered as an invention under the provisions of the Act”, said Bharat N S, assistant controller of patents & designs, Mumbai.

Quoting an apex court judgment, the assistant controller said that the applicant will have to establish the therapeutic enhanced efficacy of the claimed compound over the base compound.  

“For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy,” he said.

Earlier, the Intellectual Property Appellate Board (IPAB), Chennai in October last year had set aside an order rejecting patent for Pfizer’s rheumatoid arthritis treatment drug, Tofacitinib, in India. The IPAB bench of Justice KN Basha, chairman, and DPS Parmar, technical member--patents, on an appeal by Pfizer, ruled that the assistant controller of patents & design had erred in rejecting the patent and there exists flagrant violation of principles of natural justice.

The IPAB bench ordered that the matter be reconsidered by an assistant controller other than the one who authored the impugned rejection order, within the next three months, providing sufficient opportunity to Pfizer to argue their case.