Yet another drug has lost its patent in India after the Intellectual Property Appellate Board (IPAB) found that it lacked enhanced efficacy over its original form. The IPAB revoked the patent for ‘Tykerb’, a widely used drug for treatment of breast cancer, made by the Glaxo group.

The IPAB said Tykerb was only the salt form of labatinib, the original compound, and was not an invention.

In Indian law, a new drug must show enhanced efficacy over known drugs to be eligible for a patent. The ruling followed the principle laid down in the case of Novartis AG’s cancer drug Glivec. Pfizer’s cancer drug Sutent, Roche Holding’s hepatitis C drug Pegasys and a few others also lost their patents for lack of innovation, among other reasons.

Disposing of an application by Fresenius Kabi Oncology, the Indian subsidiary of German healthcare group Fresenius SE, the IPAB, comprising its chairman Justice Prabha Sridevan and technical member D.P.S.Parmar, found that Tykerb did not fulfil a mandatory provision requiring that the drug for which patent is sought must show enhanced efficacy. Fresenius wanted the patent given to the Glaxo group to ‘Quinazoline Ditosylate Salt compounds’ in India.

Counsel for Fresenius argued that there was neither an inventive step nor technical contribution by the patentee.

Countering that, Glaxo’s counsel submitted that Tykerb was the only approved reversible dual protein kinase inhibitor for the treatment of breast cancer. The unexpected result achieved by the drug in the effective treatment for breast cancer had unique potential benefits. It had got patents in over 30 countries.

The IPAB pointed out that in the Novartis case, the Supreme Court had held that physico-chemical properties had nothing to do with therapeutic efficacy. Applying Section 3(d) of the Patent Act and the apex court decision, Ms. Justice Prabha Sridevan said, “We find that this is not an invention. The patent deserves to be revoked.”