The Madras High Court in the case of Regeneron Pharmaceuticals Inc. vs Controller of Patents and Designs [(T)CMA(PT) No.191 of 2023] adjudicated the appeal challenging the refusal of patent application number 1554/CHENP/2013, entitled “Mice That Make Binding Proteins Comprising Vl Domains”. The Controller disallowed the proposed amendments for being outside the scope of Section 59(1) and for being patent ineligible under Section 3(b) of the Patents Act, 1970.

Section 59(1) of the Patents Act reads as follows:

“No amendment of an application for a patent or a complete specification or any document relating thereto shall be made except by way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact, and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or describe matter not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended would not fall wholly within the scope of a claim of the specification before the amendment.”

Section 3(b) of the Act excludes from patentability inventions that have a primary or intended use or commercial exploitation of which could be contrary public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment.

The subject application originally claimed a mouse, cell and the usage of mouse. In response to the First Examination Report (FER), the Appellant amended the claims to the method of making a genetically modified mouse, an antigen binding protein, a targeting vector, a nucleic acid construct.

Notably, the Controller held that modifying the genetic identity of a mouse would cause suffering to the animal without yielding any substantial medical or other benefit to humans. Accordingly, the invention was held to be ineligible for patent protection under Section 3(b). The Controller also concluded that the amended claims were beyond the scope of the original claims and therefore violated Section 59(1).

The Appellant raised two key objections to the refusal:

• On Section 3(b): The Appellant argued that in their response to the objection of non-patentability under Section 3(b), they had clearly stated that the claimed invention would be beneficial to mankind. However, the Controller proceeded to reject the application on the ground that the invention would cause suffering to the genetically modified mouse without any corresponding benefit to humans. The Appellant contended that this conclusion was reached at without application of mind and in disregard of the justification already placed on record.
• On Section 59(1): The Appellant argued that the Controller had erred in assessing the permissibility of the amended claims. They argued that both the original disclosure and the amended claims were directed towards the novel concept of making a genetically modified mouse, and, therefore, the amendment ought to have been allowed.

In response, the Controller maintained that the amendment was impermissible under Section 59. With respect to patent ineligibility under Section 3(b), the Controller contended that the Appellant had not placed on record any material to substantiate their conclusion that the invention would be beneficial to mankind.

The Madras High Court upheld the Delhi High Court’s decision in Allergan Inc. vs Controller of Patents [C.A.(COMM.IPD-PAT) 22/2021] wherein the Court allowed the claim amendments pertaining to claims directed to a method for treating an ocular condition which involved implants, to the intracameral implant itself. In Allerganit was held that permissibility of an amendment under Section 59 ought to be examined in light of the complete specification as originally filed, and not by relying solely on a textually cabined reading of the pre-amended claims, de hors the complete specification. In a patent application, the claims and the complete specification form an integrated whole and cannot be treated as two distinct parts of one document.

The Court found that in the instant matter, the Controller had compared the amended claims with the original claims de hors the complete specification, and, therefore, the reason attributed by the Controller to disallow the claim amendment was rejected by the Court.

As for the refusal under Section 3(b), the Court did not comment on the contours of Section 3(b) but found that in the impugned order, the Controller had himself recorded that the Appellant responded to the objection by stating that the claimed genetic modification would benefit mankind. Yet, the Controller concluded that the invention lacked any such benefit. The Court held this conclusion to be inconsistent and contrary to the Controller’s own recording of the statement of fact.

In view of these findings, the impugned order was set aside and the application was remanded to the Patent Office for reconsideration.