In Regents of the University of California (the ‘Appellant’) vs Controller of Patents and Designs (the ‘Respondent’) [C.A.(COMM.IPD-PAT) 481/2022], the Delhi High Court upheld the rejection of a patent application for genetically modified salmonella vaccine due to insufficient disclosure and overly broad claims, non-patentable subject matter, and failure to deposit recombinant microorganism as required under Indian Patent law.

Background:

The Appellant filed a patent application for a recombinant Salmonella microorganism with loss-of-function mutations aiming to create a safe and effective vaccine for livestock. The Respondent raised objections in the First Examination Report (‘FER’) on the basis of lack of inventive step, insufficient disclosure, and non-patentability. Despite amendments to the claims as well as written submissions filed, the Respondent refused the application. Thereafter, the Appellant  filed an appeal against the said decision, before the Delhi High Court.

Appellant’s submissions:

The Appellant argued that subject patent application specifically covered a novel recombinant Salmonella microorganism that does not occur naturally. Moreover, sufficient disclosure had been made to enable a skilled person to reproduce the invention without undue experimentation. The claims were not overly broad and were based on clearly defined genetic modifications. The requirement of depositing the recombinant organism under Sections 10(4)(d)(ii) did not arise, as the disclosure was detailed enough. The subject patent application was granted in the US, EU, and other jurisdictions, proving its patentability.

Respondent’s submissions:

The Respondent defended the rejection on the basis that the subject patent application is very broad. The scope of the claims does not cover specific microbes exemplified, and it is more of a concept claim covering the genus Salmonella with mutations in dam gene + one or more of (sifA, spvB and mgtC), which also occurs naturally. The respondent alleged that the claims provide innumerable permutation and combination, lack adequate support in the complete specification, and do not encompass the range and scope of the subject matter covered in the claims. Moreover, deposition of the organism to an International Depository Authority under the Budapest Treaty as required under law  was also not made.

Court’s analysis and decision:

The Court dismissed the appeal, and upheld the Respondent’s decision to reject the patent application. The Court held that:

• it is crucial to have sufficient disclosure to define the scope of the subject patent application, and to make sure that the subject patent application did not cover naturally mutated Salmonellamicroorganism;
• lack of specific disclosures for insertion and substitution mutations resulted in insufficiency of disclosure and overly broad claims;
• The failure to deposit the recombinant microorganism meant that skilled professionals could not reproduce the invention.

Conclusion:

The decision emphasized that biotech patents must be clear, detailed, and comply with deposit requirements.