The Hon’ble Delhi High Court has overturned an injunction order passed by the Single Bench in a patent infringement claim by Novartis AG and ANR (“Novartis”) against Natco Pharma (“Natco”), after finding out that Novartis’s patented drug, ELT-O (“Suit Patent”) was a non-patentable subject matter and also ordered the Suit Patent to be cancelled.
The Single Bench had, though its order, restrained Natco from using the Suit Patent, in any manner, to which Natco preferred an appeal on the ground that Novartis’ suit patent is invalid. Natco argued that the Suit Patent was covered under an earlier expired patent (IN’176) and the former was merely a new form of Novartis’ expired patent, ELT, a known substance, without enhancing ELT’s efficacy in ELT-O, and hence, the Suit Patent, being a non-patentable subject matter, is invalid.
Novartis, on the other hand, contended that its expired patent only discloses ELT and not ELT-O. Additionally, ELT-O has higher therapeutic efficacy since it has enhanced solubility and bioavailability over ELT and hence, the Suit Patent is patentable.
The Divisional Bench (DB) observed that patent validity is not presumed merely because a patent is granted, and emphasised a defendant’s right to challenge patent validity in patent infringement cases. The DB highlighted that enhanced bioavailability does not necessarily imply higher therapeutic efficacy and concluded that ELT-O, a pharmaceutical salt of a known substance ELT does not have enhanced therapeutic efficacy. Accordingly, the DB invalidated Noravtis’ suit patents and set aside the Single Bench’s injunction order.
Natco Pharma v. Novartis Ag And Anr., [FAO(OS) (COMM) 178/2021, judgment dt. April 24, 2024]
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