In Regeneron Pharmaceuticals v Controller of Patents and Designs ((T)CMA(PT) No.191 of 2023), the Madras High Court set-aside an order passed by the Indian Patent Office (‘IPO’) on the grounds of lack of sufficient reasoning and absence of a speaking order.. Consequently, the matter was remanded back to the IPO for consideration afresh.

Background:

The Appeal was instituted by Regeneron Pharmaceuticals (Appellant) challenging the order of the IPO (Respondent) in relation to the Appellant’s patent Application 1554/CHENP/2013, which was refused on grounds including that the invention was not patentable under Section 3(b) of the Indian Patents Act, 1970 (as amended) (the ‘Act’) (which stipulates, that an invention- the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment, is not patentable).

Appellant’s submissions:

Preliminarily, the Appellant argued that amendments to the claims were based on the specification and the substances that had already been disclosed therein. Therefore, the amendment sought falls within the ambit of a permissible amendment, and that the said amendment also addresses the objection raised under Section 3(b) of the Act

Additionally, the Appellant argued that the invention would be for the benefit of humankind.

Respondent’s submissions:

The Respondent argued that that no materials have been placed before the IPO to conclude that the subject invention (namely, the modifying of the genetic identity of the animal) would be beneficial to humankind. The IPO further submitted that the amendment sought to be incorporated to the specification, is non-permissible.

Court’s analysis and findings:

The Court held that the claims and complete specifications in a patent must be read together and as a whole. The claims must be understood in the light of the complete specifications. They form an integral whole and cannot be treated as two distinct parts of one document. The Court clarified that the very use of the expression “scope of a claim” in the concluding part of Section 59(1) of the Act should consider the complete specifications of the pre- amended claim, and not merely a textually cabined reading of the pre-amended claims themselves.

The Court held that no substantive changes were made to the specification, or the substances disclosed, therefore, rejection of a claim of the Appellant under Section 59 of the Act cannot be countenanced.

With respect to the objection under Section 3(b) of the Act, the Court opined that the Appellant had indicated in their response that such genetic modification in a mouse would be beneficial to humankind. The same had been briefly recorded by the IPO in their order. However, the reasoning proffered by the IPO that there is no substantial medical (or other) benefit to mankind is contradictory to their own findings of fact.

In light thereof the Court remanded the matter back to the IPO for consideration afresh.