The Delhi High Court has delivered two significant rulings that reinforce stringent requirements for patent disclosure and claim amendments in pharmaceutical applications, potentially impacting how biotechnology and pharmaceutical companies approach patent prosecution in India.
University of California Vaccine Patent Rejected for Insufficient Disclosure
In The Regents of the University of California vs The Controller of Patents, decided on February 21, 2025, the Delhi High Court upheld the Indian Patent Office's rejection of a patent application titled "Vaccine for livestock production systems." The application covered recombinant Salmonella microorganisms with specific mutations for veterinary vaccine applications.
The Controller of Patents had refused the application on grounds that it failed to meet mandatory requirements under Sections 10(4) and 10(5) of the Patents Act, 1970, and that the claimed subject matter was ineligible for patent protection under Section 3(c).
The court emphasized that the word "shall" in Sections 10(4) and 10(5) makes disclosure and enablement requirements mandatory for complete specifications. "Insufficient disclosure in respect of insertion and substitution mutations renders the subject patent application non-compliant with the mandatory requirements of Section 10(4)(a) of the Act," the court observed.
Critical Disclosure Gaps Identified
The court found that while the patent application provided working examples limited to deletion mutations, it lacked detailed support or embodiments covering insertion and substitution mutations. This gap prevented a person skilled in the art in microbiology from performing the claimed invention across its full scope.
The court also addressed biological material deposition requirements under the Budapest Treaty, clarifying that "it is the deposition of the recombinant Salmonella that is required and not the source bacteria, since the invention relates to a biological material which is not described in a sufficient manner and is not available to the public."
AbbVie's Claim Amendment Strategy Rejected
In a separate case, Abbvie Biotherapeutics INC & ANR. v. Assistant Controller of Patents and Designs, the Delhi High Court rejected AbbVie's attempt to convert method-of-treatment claims to product claims for their anti-cMet antibody drug conjugate (ADC) patent application.
The original patent application, titled "Anti-cMet antibody drug conjugates and methods for their use," contained claims entirely focused on methods of treating various cMet-overexpressing cancers, including specific dosing regimens, administration frequency, and patient populations.
To address a Section 3(i) objection in the First Examination Report, AbbVie amended the claims from method-of-treatment to product claims covering anti-cMet antibody drug conjugates. However, the Controller of Patents refused the application, determining that the amendments constituted "a clever move to avoid the provisions of Section 59(1) of the Patents Act."
Scope Enlargement Violation
The court found that the amended product claims had broader scope than the originally filed method claims, which were limited to specific cancers like non-small cell lung cancer and specific treatment protocols. The amended claims covered the anti-cMet ADC product itself without disease or treatment limitations.
"This removal of limitations broadened the scope of claims beyond the original specification and claims because the specification does not have reference to a stand-alone product/composition claim without the treatment details," the court noted.
The court distinguished this case from the precedent in Allergan Inc. v. Controller of Patents, where similar amendments were allowed. In Allergan, the amended claims pertained to the same disease as disclosed in the unamended claims and specification, whereas AbbVie's amended claims removed limitations to any specific disease.
Implications for Patent Strategy
Both rulings underscore the Delhi High Court's strict interpretation of Indian patent law requirements. The University of California case reinforces that biotechnology patents must provide comprehensive working embodiments across the full scope of claimed mutations or variations.
The AbbVie decision establishes clear boundaries for claim amendments, particularly the conversion from method-of-treatment to product claims. The court emphasized that amendments under Section 59(1) are permitted only as "disclaimers, corrections, or explanations" and cannot introduce new subject matter or broaden the original scope.
For pharmaceutical companies, these decisions highlight the importance of comprehensive initial disclosure and careful consideration of claim scope during patent prosecution. The court's reference to the Supreme Court's cautionary remarks in Novartis AG v. Union of India reinforces that Indian patent law does not favor "artificially broadening of claims through artful drafting."
The rulings suggest that patent applicants must retain disease-specific limitations when amending from method-of-treatment to compound or product claims to ensure amendments stay within the original scope and avoid rejection by both the Controller and courts.
