Patent rejected for MNC’s cancer drug, generics to follow

NEW DELHI: In what could be good news for patients, Indian Patent Office (IPO) has rejected MNC AbbVie’s patent application for its blockbuster cancer drug Venetoclax citing lack of inventive step.

AbbVie markets the drug under the brand, Venclexta, in India. The company holds another patent on a composition of Venclexta, which is facing opposition in courts.IPO’s Delhi office declined to grant a patent on Venetoclax used in treatment of certain blood cancers, including chronic lymphocytic leukemia and acute myeloid leukemia. The decision, if not challenged, paves way for entry of affordable generics in country, legal experts told TOI.

The application faced sustained opposition at pre-grant stage, with seven parties filing challenges between 2018 and 2025. The patent office held that the claimed invention was “obvious” and lacked inventive step, a violation of Section 3(d) of Indian Patent Act.Section 3(d) bars patents on new forms or derivatives of known substances unless they demonstrate a significant enhancement in therapeutic efficacy, a provision aimed at preventing “evergreening” of pharmaceutical patents.

It is the same provision under which Swiss firm Novartis lost patent on its blockbuster cancer drug, Glivec, in 2013. The order, accessed by TOI, said “claims of complete specification is not patentable under the Act, does not describe the invention”, and added it offered “no enhancement in therapeutic efficiency”, and hence, is a case of evergreening.

Further, applicants have failed to give data of better therapeutic efficacy of compounds claimed in the present application over compounds disclosed in the prior art document, it added. “In absence of any biological data for all claimed compounds in the present specification, it cannot be decided whether the claims actually have the claimed anti-cancer activity or not. Hence, applicants have completely failed to establish any pharmacological activity and/or therapeutic efficacy for all the millions of claimed compounds,” the order said.