Indian Patent Office Rejects AbbVie's Cancer Drug Patent Application
In a significant development that could benefit numerous cancer patients across India, the Indian Patent Office (IPO) has rejected multinational corporation AbbVie's patent application for its widely-used cancer medication Venetoclax. The rejection was based on the determination that the drug lacks an inventive step, a crucial requirement under Indian patent law.
Details of the Patent Rejection
The IPO's Delhi office specifically declined to grant a patent for Venetoclax, which is utilized in treating specific blood cancers including chronic lymphocytic leukemia and acute myeloid leukemia. AbbVie markets this medication under the brand name Venclexta within the Indian market. It is important to note that the company retains another patent concerning the composition of Venclexta, which is currently under opposition in various courts.
Legal experts have indicated that this decision, provided it remains unchallenged, could facilitate the introduction of more affordable generic versions of the drug in the country. This potential development is seen as a positive step toward enhancing accessibility to essential cancer treatments for Indian patients.
Opposition and Legal Grounds
The patent application encountered substantial opposition during its pre-grant stage, with seven different parties filing challenges between 2018 and 2025. The patent office concluded that the claimed invention was obvious and did not meet the criteria for an inventive step, thereby violating Section 3(d) of the Indian Patent Act.
Section 3(d) is a pivotal provision in Indian patent law that prohibits patents on new forms or derivatives of known substances unless they demonstrate a significant enhancement in therapeutic efficacy. This regulation is specifically designed to prevent the evergreening of pharmaceutical patents, a practice where companies extend patent protection through minor modifications without substantial therapeutic benefits.
Historical Context and Order Details
This same provision was instrumental in the 2013 case where Swiss pharmaceutical giant Novartis lost its patent for the blockbuster cancer drug Glivec. The order accessed by sources detailed that the claims within the complete specification were not patentable under the Act and did not adequately describe the invention. It further stated that the application offered no enhancement in therapeutic efficiency, categorizing it as a case of evergreening.
The order elaborated that the applicants failed to provide data demonstrating better therapeutic efficacy of the compounds claimed in the application compared to those disclosed in prior art documents. It emphasized, 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. Consequently, the applicants were deemed to have completely failed in establishing any pharmacological activity or therapeutic efficacy for the millions of compounds claimed.
Implications for the Pharmaceutical Industry
This decision underscores the stringent standards upheld by the Indian Patent Office in evaluating pharmaceutical patents, particularly concerning cancer medications. By prioritizing therapeutic efficacy over minor modifications, the IPO aims to balance innovation with public health interests, ensuring that life-saving drugs remain accessible and affordable.
The rejection of AbbVie's patent application may set a precedent for future cases, reinforcing the importance of substantial evidence in demonstrating therapeutic advancements. As the pharmaceutical landscape evolves, such rulings play a critical role in shaping drug accessibility and affordability for patients across India.
