India rejects Pfizer’s new patent application for tofacitinib arthritis drug

The office said it did not improve the efficacy of the current approved drug.

Indian Patent Office assistant controller of patents and designs Bharat N.S said in an order, "After having considered the submissions of the applicant, it is hereby ordered that the invention disclosed and claimed in the application is not considered as an invention under the provisions of the act."

Quoting an apex court judgment, the order said 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.

Pfizer said its base patent for tofacitinib remains valid in India. The company is reviewing its options for further action.

The patent office had earlier rejected Pfizer’s application for tofacitinib in 2011. The Intellectual Property Appellate Board later urged the authority to reconsider the decision following an appeal by the company.

Pharmaceutical firms such as Pfizer, Bayer and Roche have faced problems in recent years to retain exclusivity on drugs in India. They argued that patent laws are designed in favor of the local industry.