The Regents of the University of California v. The Controller of Patents

Case Title: The Regents of the University of California v. The Controller of Patents

Date of Order: 21st February 2025

Case No.: C.A. (COMM.IPD-PAT) 481/2022

Neutral Citation:2025:DHC:1105

Name of Court: High Court of Delhi

Name of Judge: Hon’ble Mr. Justice Amit Bansal

Facts: The case concerns an appeal filed under Section 117A of the Patents Act, 1970, against the order of the Assistant Controller of Patents and Designs dated 14th July 2022. The appellant, The Regents of the University of California, had filed an Indian patent application (No. 201717005699) for a recombinant Salmonella microorganism-based live vaccine designed to prevent enteric bacterial infection in livestock.

The application was initially refused by the Controller on the grounds that the invention lacked an inventive step, was non-patentable under various sections of the Act (Sections 3(c), 3(d), 3(e)), lacked unity of invention, and was insufficiently disclosed. The appellant challenged the refusal, arguing that the invention was novel, involved an inventive step, and had been granted in other jurisdictions like the European Patent Office and the United States Patent and Trademark Office.

Issues:

1. Whether the subject patent application was sufficiently disclosed as required under Section 10(4) of the Patents Act.

2. Whether the claims in the application were clear and succinct as mandated by Section 10(5) of the Act.

3. Whether the invention fell within the scope of non-patentable subject matter under Section 3(c) of the Act.

4. Whether the requirement of depositing the biological material under Section 10(4)(d) was applicable in this case.

Reasoning and Analysis:

Insufficiency of Disclosure Under Section 10(4):

The court examined whether the invention was sufficiently disclosed in the complete specification. The patent application covered Salmonella strains with specific genetic modifications, including loss-of-function mutations in the dam gene and additional mutations in genes like sifA, spvB, and mgtC. The appellant argued that the disclosure was sufficient for a skilled person to reproduce the invention without undue experimentation.

However, the court found that while the application described deletion mutations, it did not adequately disclose insertion or substitution mutations, which were also claimed. The court held that this lack of specificity created ambiguity and imposed an undue burden on a skilled person attempting to replicate the invention. Since Sections 10(4)(a) and 10(4)(b) require full and clear disclosure, the court ruled that the application failed to meet these statutory requirements.

Lack of Clarity in Claims Under Section 10(5):

The appellant asserted that the scope of the invention was limited to 42 combinations of genetic modifications. However, the court rejected this argument, stating that the claims encompassed a much broader range of permutations, including different types of mutations. Citing AGFA NV & Anr. v. The Assistant Controller of Patents and Designs & Anr., the court emphasized that unclear and overly broad claims could create ambiguity and were not fairly based on the disclosure in the specification.

Non-Patentability Under Section 3(c):

The Controller had rejected the application on the ground that the claims covered naturally occurring Salmonella microorganisms with loss-of-function mutations. The appellant argued that recombinant microorganisms are artificially created and do not occur naturally. However, the court found that the broad wording of the claims could include naturally occurring mutants, making the invention ineligible for patent protection under Section 3(c).

Requirement of Biological Material Deposit Under Section 10(4)(d):

The court held that since the invention involved a genetically modified microorganism and the disclosure was insufficient, a deposit of the recombinant Salmonella strain with an International Depository Authority (IDA) was necessary under the Budapest Treaty. The appellant’s failure to make such a deposit further weakened the patent application.

Decision:

The court upheld the refusal of the patent application, dismissing the appeal. It concluded that:

The claims lacked sufficient disclosure under Section 10(4).

The claims were broad and indefinite, violating Section 10(5).

The application covered naturally occurring mutations, making it non-patentable under Section 3(c).

The failure to deposit the biological material was a critical deficiency under Section 10(4)(d).

Accordingly, the court found no merit in the appeal and dismissed it, directing the Registry to communicate the decision to the Office of the Controller General of Patents, Designs, and Trade Marks for compliance.