The Delhi High Court observed that under Section 64(1)(a) of the Patents Act, the claim asserted in the suit patent must have been claimed in a complete specification relating to a patent of an earlier priority date, and only then, can a plea of invalidity on the ground of anticipation by prior claiming be successfully laid.

In that context, the Bench of Justice C Hari Shankar observed that, "Section 64(1)(a) is clear and categorical in the words it uses. It states that the invention, so far as claimed in the suit patent, has to have been claimed in a valid claim of earlier priority date for the suit patent to be regarded as vulnerable to invalidity on the ground of anticipation by prior claiming. There has, therefore, to be identity of claims. The claim asserted in the suit patent, must have been claimed in a complete specification relating to a patent of earlier priority date. Then, and only then, can a plea of invalidity on the ground of anticipation by prior claiming be successfully laid."

Counsel Praveen Anand, along with others, appeared for the plaintiffs, while Counsel J Sai Deepak, along with others, appeared for the defendant.

Kudos Pharmaceuticals Ltd. held an Indian Patent for a "Phthalazinone derivative," particularly Olaparib, an oral PARP inhibitor used in cancer treatment. The patent, issued on March 12, 2004, was valid for 20 years. Natco Pharma Limited (Natco) challenged the patent's validity under Section 64(1) of the Patents Act, seeking revocation.

Claim I of the suit patent had described Olaparib's chemical structure, and Kudos had alleged that Natco infringed by manufacturing and selling a generic version named BRACANAT. Although no pre-grant or post-grant opposition had occurred, Natco had filed for revocation after Kudos initiated legal action.

Kudos had filed a suit seeking a permanent injunction against Natco's manufacturing and selling of Olaparib, claiming infringement. The compound Olaparib had acted as a PARP inhibitor, targeting cancer cells. To halt Natco's activities during the legal proceedings, Kudos had filed an interlocutory injunction under Order XXXIX Rules 1 and 2 of the CPC.

The High Court observed that, "Particularly when dealing with a challenge to the validity of the suit patent on the ground of anticipation by prior claiming, once the Court finds, on facts, by claim to claim comparison, that there is no anticipation by prior claiming, statements made in other jurisdictions, or in documents filed by the plaintiffs elsewhere, cannot make out a case of anticipation by prior claiming, even at the prima facie stage. ought not to legitimately form part of the consideration. The plaintiffs would have, during the course of trial, every opportunity to explain the circumstances in which such statements were made, and before grant of such opportunity, where a prima facie clear case of lack of anticipation of prior claiming is made out, the matter must rest there, when dealing with an Order XXXIX Rule 1 and 2 applications."

Subsequently, the Court observed that the defendant was indeed exploiting the suit patent by manufacturing and selling Olaparib. In that context, it was observed that, "No credible case of vulnerability of the suit patent to invalidity on any of the grounds contained in Section 64 of the Patents Act can be said to have been made out by the Natco."

The application was allowed, and Nacto was restrained from manufacturing and selling, or in any manner, dealing with Olaparib, either under the brand name BRACANAT or under any other brand name until disposal of the suit as long as the suit patent continues to remain alive and subsisting.

Appearances:

Plaintiffs: Counsels Praveen Anand, Vaishali Mittal, Siddhant Chamola, Pallavi Bhatnagar, Hersh Desai, Shivang Sharma

Defendant: Counsels J Sai Deepak, G Natraj, Harshita Agarwal, Varsha Jhavar

Cause Title: Kudos Pharmaceuticals Limited & Ors. vs Nacto Pharma Limited

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Delhi High CourtJustice C Hari ShankarPatents Act

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