Regents of the University of California v Controller of Patents (2025)

Summary

“The present appeal has been filed under Section 117A of the Patents Act, 1970” (para 1) against “the order dated 14th July, 2022” (para 1) by which the Indian patent application “titled ‘VACCINE FOR LIVESTOCK PRODUCTION SYSTEMS’” (para 1), which “relates to a recombinant Salmonella microorganism based live vaccine for preventing enteric bacterial infection, has been refused” (para 1). The application had been refused “on the ground that the claims of the subject patent application do not fulfil the mandatory requirements under Section 10(4) and 10(5) of the Act and that the subject matter claimed is not eligible for patent protection on account of Section 3(c) of the Act” (para 3).

The Court held that “Section 10(4) and 10(5) of the Act uses the word ‘shall’” (para 12), making every requirement “mandatory for the complete specification of a patent application to be valid in India” (para 12). It found the working example and description “limited to deletion mutations” (para 18), so that “the lack of specific disclosures in respect of insertion and substitution mutations results in an insufficiency of disclosure” (para 18), and concluded that the application “fails to sufficiently disclose the invention as mandatorily required under Section 10(4)(a) and 10(4)(b) of the Act” (para 20). It held the claims “fail to provide a clear and precise definition of the full scope” (para 26) and “fail to fulfil the requirements under Sections 10(4)(c) and 10(5) of the Act” (para 27); that the recombinant Salmonella “is liable to be deposited” under “the Budapest Treaty referred to in Section 10(4)(d)(ii)” (para 29); and that the application “is so broad that it covers naturally occurring mutations as well” (para 33), bringing it within “Section 3(c) of the Act” (para 33). “Consequently”, the Court held, “I do not find any merit in the present appeal and the same is dismissed” (para 35).

What the court decided

1. Section 3(c) read with disclosure. The Court held that “the objection under Section 3(c) has to be seen in conjunction with the objections under Section 10(4) and 10(5) of the Act.” (para 10)

2. Mandatory requirements of Section 10. The Court held that “Section 10(4) and 10(5) of the Act uses the word ‘shall’, which makes it clear that every requirement under Sections 10(4) and 10(5) is mandatory for the complete specification of a patent application to be valid in India.” (para 12)

3. Disclosure limited to deletion mutations. The Court found that “the target genes do not necessarily need to be deliberately mutated as long as the expression of the native gene product is functionally disrupted in some way” (para 16) and that this “broadens the scope of the subject patent application to include any method of gene disruption, not limited to deliberate genetic modifications” (para 16); the working example and description, “which are limited to deletion mutations, do not disclose the inventive contribution fully that also covers insertion and substitution”, so that “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.” (para 18)

4. Enablement and best method. The Court held that “such partial disclosure as made in the subject patent application will also not be sufficient to enable a person skilled in the field of microbiology to perform the invention as mandated under Section 10(4)(b) of the Act, without additional guidance” (para 19), and concluded that “the subject patent application fails to sufficiently disclose the invention as mandatorily required under Section 10(4)(a) and 10(4)(b) of the Act.” (para 20)

5. Lack of clarity standard. Recalling its ruling in Agfa NV v Assistant Controller of Patents and Designs (2023), the Court recorded that “lack of clarity arises when the language of the claim is ambiguous, imprecise, or fails to clearly define the scope of the invention, rendering the claims indefinite and consequently making it difficult for a person skilled in the art to ascertain its precise boundaries.” (para 22)

6. Coverage cannot exceed disclosure. Applying Novartis AG v Union of India (2013), the Court recorded that “the scope of the claims must be commensurate with the actual disclosure in the complete specification and, under no circumstances, can it exceed the extent of that disclosure.” (para 25)

7. Numerous permutations undefined. The Court held that the three mutations “would cover a large number of mutant Salmonella organisms, which has not been clearly defined in the amended claims of the subject patent application”, and that “The Controller has correctly held that the recombinant Salmonella microorganism claimed in the subject patent application with a loss of function mutation consisting of an insertion, deletion and/ or substitution of one or more nucleotides in said genes/ gene sequence results in numerous permutation and combination of genetic modifications in the genes which are harboured in the organisms.” (para 24)

8. Claims not fairly based. The Court held that “the claims of the subject patent application fail to provide a clear and precise definition of the full scope of recombinant Salmonella organisms covered in the subject patent application, even after a conjoint reading of the claims and the complete specification” (para 26) and that “the claiming of insertion and substitution mutation will not be considered to be fairly based on the subject matter disclosed in the specification, on account of the absence of detailed support or working embodiments demonstrating these mutations” (para 26), so that “the claims of the subject patent application fail to fulfil the requirements under Sections 10(4)(c) and 10(5) of the Act.” (para 27)

9. Deposit of the modified microorganism. The Court held that under “proviso (ii) of Section 10(4) of the Act, the patent applicant is required to deposit the biological material with an International Depository Authority (IDA) under the Budapest Treaty if the biological material mentioned in the specification is not able to meet the requirements under Section 10(4)(a) and 10(4)(b) of the Act, and if the said biological material is not available to the public” (para 28), and that “it is the deposition of recombinant Salmonella that is required; not the source bacteria” (para 29), the recombinant Salmonella “being a modified bacteria which will not be accessible to the public, is liable to be deposited in the recognised depository according to the Budapest Treaty referred to in Section 10(4)(d)(ii) of the patents act, 1970.” (para 29)

10. Breadth covering natural mutations. The Court held that “the subject patent application is so broad that it covers naturally occurring mutations as well” (para 33), and that “unless the subject patent application has been sufficiently disclosed with enabling disclosure and with clear claims, there shall be a serious prejudice that the endogenous mutations claimed in the subject patent application could cover those present naturally and would consequently be non-patentable under Section 3(c) of the Act.” (para 33)

11. Appeal dismissed. The Court held that “all the grounds cited by the Controller for refusing the subject patent application under Section 15 of the Act are upheld”, the application being “hit by non-patentability under Section 3(c) of the Act, lacks sufficient disclosure in terms of Section 10(4) of the Act and the claims of the subject patent application are indefinite and not fairly based on the disclosure made in the specification in terms of section 10(5) of the Act” (para 34), and “Consequently, I do not find any merit in the present appeal and the same is dismissed.” (para 35)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 30 October 2026.