The Delhi High Court has dismissed an appeal filed by the Regents of the University of California challenging the refusal of a patent for their recombinant Salmonella microorganism-based live vaccine. The court found that the patent application lacked sufficient disclosure and did not meet the statutory requirements outlined in the Patents Act, 1970.
Case Background
The appellant, Regents of the University of California, filed a patent application under the Patent Cooperation Treaty (PCT) for a vaccine aimed at preventing enteric bacterial infections. The application sought to protect a recombinant Salmonella microorganism with specific genetic modifications. However, the Assistant Controller of Patents and Designs refused the application, citing non-compliance with Sections 10(4), 10(5), and 3(c) of the Patents Act.
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Justice Amit Bansal upheld the Assistant Controller’s decision, emphasizing that the application did not sufficiently disclose the claimed inventive contributions. The court noted several deficiencies in the application, including:
Non-Compliance with Section 10(4): The application failed to provide a detailed explanation of insertion and substitution mutations within the genes of the Salmonella microorganism. The court stated,
“The lack of specific disclosures in respect of insertion and substitution mutations results in an insufficiency of disclosure, which renders the subject patent application non-compliant with the mandatory requirements under Section 10(4)(a) of the Act.”
Failure to Meet the Best Method Disclosure Requirement (Section 10(4)(b)): The court observed that partial disclosure would not enable a skilled microbiologist to replicate the invention without additional guidance. The judgment highlighted that the application did not describe the best method for performing the invention as required by law.
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Ambiguity in Claim Scope (Section 10(5)): The claims were found to be too broad and indefinite. The court remarked, “The claims of the subject patent application fail to provide a clear and precise definition of the full scope of recombinant Salmonella organisms covered.” It also emphasized that a patent’s scope should align with the disclosed invention and not extend to undisclosed methods or naturally occurring variations.
Patentability Concern under Section 3(c): The court ruled that the claims in the application potentially covered naturally occurring mutations in Salmonella microorganisms, making them ineligible for patent protection under Section 3(c) of the Act. The judgment referenced the Supreme Court’s ruling in Novartis AG v. Union of India, which emphasized that patents should not be granted for mere discoveries of naturally existing substances.
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It held that the patent application also failed to meet the requirements of Sections 10(4)(c) and 10(5) of the Act.
The Court thus upheld the Controller's order and dismissed the appeal.
Case Title: THE REGENTS OF THE UNIVERSITY OF CALIFORNIA VS. CONTROLLER OF PATENTS (C.A.(COMM.IPD-PAT) 481/2022)
