The Madras High Court, via judgement dated October 22, 2024, in Regeneron Pharmaceuticals Inc vs. Controller of Patents and Designs [(T)CMA(PT) No.191 of 2023] addressed an appeal under Section 3(b) and 59 of the Patents Act (Act) by Regeneron Pharmaceuticals challenging the Indian Patent Office’s (IPO) refusal order dated December 16, 2020 issued in respect of their Indian Patent Application No. 1554/CHENP/2013.
Regeneron Pharmaceuticals sought a patent for a genetically modified mouse model designed to benefit humankind. The IPO rejected the application, citing non-patentability under Section 3(b) of the Indian Patents Act, which excludes inventions contrary to public order or morality, or those causing serious prejudice to human, animal, or plant life, health, or the environment.
The Court noted that the amendments proposed by Regeneron Pharmaceuticals were based on the original specification and did not introduce new subject matter, thus aligning with permissible amendments under Section 59 of the Act.
With regard to section 3(b) Objection, the Court found that the IPO’s reasoning lacked sufficient justification, especially considering Regeneron Pharmaceutical’s assertion that the genetic modification would be beneficial to humankind.
The Court set aside the IPO’s refusal and remanded the matter for fresh consideration by a different Controller, emphasizing the need for reasoned decisions in patent examinations. The Court further ordered that after providing a reasonable opportunity to the Appellant, a reasoned decision shall be issued within a period of four months from the date of receipt of a copy of this judgment. The Court made it clear that it was expressing no opinion on the merits of the application for grant of patent.
This judgment highlights the significance of providing well-reasoned decisions in patent office proceedings and emphasizes the need for procedural fairness in assessing patent applications.
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