TMPatentDismissed 9 February 2024
Ovid Therapeutics, Inc. v. Assistant Controller of Patents and Designs
2024:DHC:974
- Court
- Delhi High Court
- Bench
- Justice Prathiba M. Singh
- Outcome
- Dismissed
- Date of judgment
- 9/2/2024
Statutory provisions
Section 117A, Patents Act 1970 — Appeals to High CourtSection 3(d), Patents Act 1970 — Non-patentability of new forms of known substances unless enhanced efficacy is shownSection 3(e), Patents Act 1970 — Non-patentability of substances obtained by mere admixtureSection 2(1)(ja), Patents Act 1970 — Definition of inventive stepSection 59, Patents Act 1970 — Amendment of application or specification
Key issue
Whether an amended patent application for a pharmaceutical composition, comprising a known substance, could be granted a patent despite objections of lack of inventive step, non-patentability (under Section 3(d) and (e)), and scope broadening under Section 59, especially without sufficient data demonstrating enhanced therapeutic efficacy.
Summary
This case involved an appeal against a Controller's order refusing a patent application for a pharmaceutical composition to treat secondary insomnia and certain neurological disorders. The Controller had rejected the application primarily because the amended claims expanded beyond the original scope and failed to demonstrate enhanced therapeutic efficacy for a known substance, as required by law. The High Court affirmed the Controller's decision, finding that the appellant failed to provide sufficient data, especially Phase 3 clinical trial results, to prove significant therapeutic improvement. The Court concluded that the amended claims broadened the invention's scope and did not overcome the non-patentability objections.
Result: Appeal against the refusal of a patent application dismissed; the Controller's order upheld.
Tags
#patent appeal#pharmaceutical composition#Section 3(d)#enhanced therapeutic efficacy#scope of claims#amendment of claims#clinical trial data
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