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New Delhi: The Indian Patent Office (IPO) has rejected a patent application filed by multinational pharmaceutical company AbbVie for its cancer drug Venetoclax, citing lack of inventive steps, according to a report by The Times of India (TOI).
AbbVie markets Venetoclax in India under the brand name Venclexta. The company holds another patent related to the drug’s composition, which is currently facing legal challenges in court.
The IPO’s Delhi office declined to grant the patent for Venetoclax used in the treatment of certain blood cancers, including chronic lymphocytic leukemia and acute myeloid leukemia. Legal experts told TOI that if the decision is not challenged, it could pave the way for the entry of lower-cost generic versions of the drug in India.
The application faced sustained opposition at the pre-grant stage, with seven parties filing challenges between 2018 and 2025. The patent office held that the claimed invention was “obvious” and lacked an inventive step, in violation of Section 3(d) of the Indian Patent Act.
Section 3(d) restricts patents on new forms or derivatives of known substances unless they demonstrate a significant enhancement in therapeutic efficacy, a provision intended to prevent “evergreening” of pharmaceutical patents. The same provision was applied in 2013 when Swiss drugmaker Novartis lost its patent claim on its cancer drug Glivec.
In its order, accessed by TOI, the patent office said the claims in the complete specification were not patentable under the Act and did not adequately describe the invention. It added that the application failed to show any enhancement in therapeutic efficacy and therefore amounted to evergreening.
The order further stated that the applicant had not provided data demonstrating improved therapeutic efficacy of the claimed compounds over those disclosed in prior art. In the absence of biological data for all claimed compounds, the patent office said it could not determine whether the claims had the stated anti-cancer activity, concluding that the applicant failed to establish pharmacological activity or therapeutic efficacy for the compounds claimed.
With inputs from TOI
AbbVie markets Venetoclax in India under the brand name Venclexta. The company holds another patent related to the drug’s composition, which is currently facing legal challenges in court.
The IPO’s Delhi office declined to grant the patent for Venetoclax used in the treatment of certain blood cancers, including chronic lymphocytic leukemia and acute myeloid leukemia. Legal experts told TOI that if the decision is not challenged, it could pave the way for the entry of lower-cost generic versions of the drug in India.
The application faced sustained opposition at the pre-grant stage, with seven parties filing challenges between 2018 and 2025. The patent office held that the claimed invention was “obvious” and lacked an inventive step, in violation of Section 3(d) of the Indian Patent Act.
Section 3(d) restricts patents on new forms or derivatives of known substances unless they demonstrate a significant enhancement in therapeutic efficacy, a provision intended to prevent “evergreening” of pharmaceutical patents. The same provision was applied in 2013 when Swiss drugmaker Novartis lost its patent claim on its cancer drug Glivec.
In its order, accessed by TOI, the patent office said the claims in the complete specification were not patentable under the Act and did not adequately describe the invention. It added that the application failed to show any enhancement in therapeutic efficacy and therefore amounted to evergreening.
The order further stated that the applicant had not provided data demonstrating improved therapeutic efficacy of the claimed compounds over those disclosed in prior art. In the absence of biological data for all claimed compounds, the patent office said it could not determine whether the claims had the stated anti-cancer activity, concluding that the applicant failed to establish pharmacological activity or therapeutic efficacy for the compounds claimed.
With inputs from TOI
