Delhi High Court upholds rejection by the Indian Patent Office and clarifies disclosure requirements for microbiology applications

Introduction

The Hon’ble Delhi High Court (hereinafter, ‘the Court’) in the appeal of The Regents of the University of California vs The Controller of Patents (Judgement date: February 21, 2025) held that the word ‘shall’ in Section 10(4) and 10(5) of the Patents Act, 1970 (hereinafter rereferred to as ‘the Act’) held that it is crucial to provide adequate support in the complete specification and working embodiments to demonstrate the mutations in the recombinant Salmonella organisms covered in the subject patent application. Further, the scope of the claims must commensurate with the disclosure of the specification.

Background

An appeal under Section 117A of the Act was filed before the Honorable Delhi High Court by The Regents of the University of California (hereinafter ‘the Appellant’) challenging the impugned order passed by The Controller of Patents (hereinafter ‘the Respondent’) for refusing a patent application titled ‘Vaccine for livestock production systems’.

The Respondent issued a First Examination Report (FER), raising objections for lack of inventive step and for falling under the purview of Section 3 and 10 of the Act. After the Appellant filed a response to the FER, the Respondent maintained the objections under Section 3 and 10, and an objection on claiming broader scope under Section 59 of the Act was raised in the Hearing Notice. After reviewing the written submissions filed by the Appellant, remaining dissatisfied, the Respondent refused the subject patent application on the grounds that the claimed invention does not fulfil the mandatory requirements of Section 10(4) and 10(5) of the Act, and that the claimed subject matter was ineligible for patent protection as per Section 3(c) of the Act.

The Appellant submitted that the impugned order is erroneous with respect to the rejection under Section 3(c) of the Act and stated that the claimed invention specifically covers a novel recombinant Salmonella microorganism whose mutations have been exemplified in the subject patent application and therefore is not naturally produced but is artificially produced. The Appellant further submitted that the patent specification met all the necessary requirements outlined in Section 10 of the Act, including clarity, completeness, and the best method of performing the invention. The Appellant also claimed that the Respondent's decision lacked adequate reasoning, thereby violating the principles of natural justice.

Contending the Appellant’s submissions, the Respondent submitted that the appeal was baseless since the claims of the subject patent application could result in innumerable unique recombinant Salmonella variants lacking adequate support in the complete specification and further stated that the invention did not meet the subject-matter eligibility criteria as outlined under Section 3(c) the Act.

Observations and findings of the court

After considering the arguments and evidence presented, the Court upheld the Respondent’s decision to refuse the patent application. The Court concurred that the grounds cited by the Controller for refusing the application were valid.

The Court held that the word ‘shall’ in Section 10(4) and 10(5) of the Act makes the disclosure and enablement requirements mandatory for the complete specification to be valid in India. It was observed that 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. Further in view of insufficient disclosure, the requirement to disclose the best method for performing the said invention under Section 10(4)(b) of the Act, was also not met. The Court, relying on the precedents AGFA NV & Anr. v. The Assistant Controller of Patents and Designs & Anr and Novartis AG v. Union of India and Ors held that the claimed invention is not clear and extends beyond the actual disclosure with respect to covering insertion and substitution mutation, which were not supported by working embodiments and lack support in the complete specification, while also encompassing naturally occurring mutations. Thus, the claimed invention failed to fulfil the requirements of Section 10(4)(c) and 10(5) of the Act.

Another observation that the Honorable High Court made was in respect of submission of the biological material with an International Depository Authority (IDA) under the Budapest Treaty. It was held that since the patent application did not meet the requirements of sufficiency of disclosure and enablement as provided under Section 10(4)(a) and Section 10(4)(b) of the Act, the proviso to Section 10(4)(d) of the Act would be applicable and it was also clarified that for the subject application 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 (reference is made to The Patent Office Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, October 2014).

It was further held that since the scope of the subject patent application is broad and insufficiently disclosed, the claimed invention also covers naturally occurring mutations. Thus, the claims do not qualify as patent eligible subject-matter as per Section 3(c) of the Act.

In conclusion, while dismissing the appeal, the Honorable Court upheld the decision and findings of the Indian Patent Office (IPO) in respect of insufficient disclosure, since the working examples are limited to deletion mutations would not enable a PSITA (microbiology) to perform the claimed invention, absence of detailed support or embodiments covering insertions and substitutions, and the naturally occurring mutations to Salmonella render it ineligible for patentability under the Indian patents laws.