Case Overview: AbbVie Biotherapeutics Inc. v. Assistant Controller of Patents & Designs
In AbbVie Biotherapeutics Inc. v. Assistant Controller of Patents & Designs [C.A. (COMM.IPD-PAT) 44/2023], the Delhi High Court upheld the Controller’s rejection of a national phase patent application concerning an anti-cMet antibody-drug conjugate (ADC). The application was originally claimed solely as a method of treatment and was refused under Sections 2(1)(j), 3(i), and 59(1) of the Patents Act, 1970.
Issue of Post-Filing Claim Amendments
The applicant sought to amend the inadmissible method-of-treatment claims—barred under Section 3(i)—into standalone product claims during the prosecution stage. However, the Court determined that these amendments did not qualify as a disclaimer, correction, or explanation as required under Section 59(1) of the Act.
Court’s Rationale on Scope Expansion
The Court found that the attempted amendments substantially broadened the claim scope, which is explicitly prohibited under Indian patent law. The original PCT application and corresponding national phase claims focused entirely on treatment regimens for cMet-overexpressing cancers, such as non-small cell lung cancer (NSCLC). These included dosage schedules and diagnostic markers, but no standalone claim for the ADC molecule itself.
The Court described the move to introduce product claims at a later stage as a “clever drafting move” aimed at bypassing statutory limitations—an approach firmly rejected by both the Controller and the Court.
Key Legal Takeaways from the Judgment
This decision reinforces three crucial principles of Indian patent law:
- Section 3(i): Explicitly bars patentability of method-of-treatment claims in India.
- Section 59(1): Prohibits claim amendments that enlarge the scope of the originally filed claims.
- Section 2(1)(j): Requires industrial applicability—a condition that method-of-treatment claims typically do not fulfill under Indian standards.
Strategic Implications for Patent Filings
This ruling serves as a cautionary reminder that effective patent strategy must be mapped out at the PCT filing stage itself. Attempting to change claim types post-filing—especially from method to product—may not withstand India’s strict statutory scrutiny on claim amendments.
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