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2014 Supreme(Del) 2299

High Court of Delhi
PRADEEP NANDRAJOG & MUKTA GUPTA, JJ.
Ranbaxy Laboratories Ltd.
Versus
Novartis AG & Another
FAO(OS) No. 447 of 2014
Decided on: 18-10-2014

Advocate Appeared:
For the Appellant:P. Chidambaram, Pratibha M. Singh, Sr. Advocates instructed by Saya Choudhary, Saurabh Anand, Advocates.
For the Respondents:Gopal Subramanium, Sunil Gupta, Sr. Advocates instructed by Hemant Singh, Mamta Jha, Manish Kr. Mishra, Shilpa Arora, Kritika Sethi, Talha, Advocates.

The main legal point established in the judgment is the importance of timely completion of pleadings and the determination of the credibility of challenges to patents after the completion of pleadings.

Headnote:

Patent Infringement - Pharmaceutical Product - Indian Patent Act - Order 39 Rule 1 and 2 of the Code of Civil Procedure - Patent No.212815 - 2013 (54) PTC 452 Merck Sharp and Dohme Cororation & Anr. vs. Glenmark Pharmaceuticals Ltd. - 2009(40) PTC 125 F. Hoffmann – LA Roche Ltd. & Anr. Vs. Cipla Ltd.

Fact of the Case:

The suit involved a request for a permanent injunction to restrain the appellant from infringing the respondent's Indian Patent 212815. The court considered whether to grant an ad-interim injunction based on the pleadings of the respondents and the documents filed, as the appellant's defense through a written statement had yet to come on record.

Finding of the Court:

The court found that the respondents had a strong prima facie case pertaining to their formulations containing the compound Vildagliptin, and granted an ad-interim injunction based on previous orders in favor of the plaintiffs in similar suits.

Issues: The issues included whether the respondents were entitled to an ad-interim injunction, whether there was concealment of a material fact, and the credibility of the challenge to the patent granted to the respondent.

Ratio Decidendi: The court clarified that the observations made were tentative and not a final expression on the merits of the case, and that the credibility of the challenge to the patent would be determined after the completion of pleadings. The court also emphasized the need for timely filing of documents to facilitate early adjudication.

Final Decision: The appeal was disposed of without interfering with the impugned order, with a request to the learned Single Judge to hear arguments in the interim application and make a decision within the calendar year.

Judgment

Pradeep Nandrajog, J.

1. Suit seeking permanent injunction restraining the appellant from infringing respondents Indian Patent 212815 along with IA No.17139/2014, under Order 39 Rule 1 and 2 of the Code of Civil Procedure, came up for preliminary consideration before the learned Single Judge on September 08, 2014, on which date the appellant appeared to oppose the grant of any ad-interim injunction.

2. It is apparent that on September 08, 2014 the learned Single Judge did not have the benefit of any written statement to the plaint. Obviously, the learned Single Judge had to decide : whether case was made out to grant an ad-interim injunction on the pleadings of the respondents and the documents filed; for the reason the defence of the appellant through the medium of a written statement had yet to come on record. The action being quia timet.

3. With respect to the pleadings in the plaint the learned Single Judge has noted that the patent relates to a pharmaceutical product Vildagliptin. It treats Type 2 Diabetes Mellitus. The learned Single Judge has noted that apart from the product Patent No.212815, the respondents have three pending patent applications before the Indian Patent Office relating to Vildagliptin formulations, Vildagliptin and Metformin hydrochloride formulations under the brands GALVUS and GALVUSMET. It has been noted that one application pertaining to Vildagliptin formulations and Vildagliptin and Metformin hydrochloride containing formulations has been rejected by the Indian Patent Office against which appeal is pending. The learned Single Judge has thereafter noted that the pharmaceutical product containing Vildagliptin formulation was launched by the plaintiffs globally in the year 2007 under a trade name ‘GALVUS’ and Vildagliptin with Metformin hydrochloride in the year 2008 under the trade name ‘GALVUSMET’ and ‘EUCREAS’. The learned Single Judge has thereafter noted that the appellants are intending to launch in the market a pharmaceutical preparation which is an anti diabetic drug containing the formulation Vildagliptin. Thus, the action was a quia timet action.

4. The learned Singe Judge has noted various orders in favour of the plaintiffs passed by various Courts in different suits concerning pharmaceutical products having formulation or combination containing Vildagliptin. The learned Single Judge has noted that the pharmaceutical product which appellant intends to market contains formulation Vildagliptin. Law declared in the decision reported as 2013 (54) PTC 452 Merck Sharp and Dohme Cororation & Anr. vs. Glenmark Pharmaceuticals Ltd. has been noted by the learned Single Judge which holds that a patent formulation cannot be used in combination of other works unless it is shown that the product so obtained is materially different from the way patent product works. The learned Single Judge has noted that the patent granted vide Patent No.212815 in respect of the compound Vildagliptin on December 14, 2007 was effective from October 12, 1998. Therefrom the learned Single Judge has prima facie opined that the application for patent was in public domain and for last 16 years no objections whatsoever were filed by the appellants and only on August 11, 2014 the appellants filed a revocation petition. Therefrom, though not expressly stated, the learned Single Judge has prima facie concluded that the respondents would have a strong prima facie case pertaining to its formulations containing the compound Vildagliptin.

5. A projected defence that there is a concealment of a material fact which disentitles the respondents to the grant of an ad-interim injunction, in that the respondents have not disclosed abandonment of an application filed by them on June 13, 2007 disentitles the respondents to the grant of any injunction has been noted. The learned Single Judge has noted a related objection, being that the use of the compound Vildagliptin in a crystalline form cannot infringe the patent of the respondents. Th

















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