Topic: Ranbaxy Laboratories Ltd. vs Novartis

Ranbaxy Laboratories Ltd. vs Novartis Ag
bench: Pradeep Nandrajog - IN THE HIGH COURT OF DELHI AT NEW DELHI - FAO(OS) 447/2014 - Date of Decision: October 18, 2014

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. The application for grant of patent which was abandoned, as per the appellants pertained to Vildagliptin compound in a crystalline form.

6. The opinion given by the learned Single Judge on said contention urged is in paragraph 27 as under:-

"As against this, in the instant case, the second application IN4530/DELNP/2007 dated 13.06.2007 was made by Plaintiff no.1 while the application in respect of the suit patent was pending The certificate in the suit patent was issued by the Controller of Patent only on 1412.2007. Thereafter, the second application is stated to have been abandoned and therefore, at this stage it cannot be said that non-disclosure of the application no.IN4530/DELNP/2007 dated 13.06.2007 amounted to concealment of a material fact."
7. In view of the fact that in as many as five suits filed by the respondents against different companies five learned Judges have granted an ad-interim injunction in respect of the product in question, the ad- interim injunction has been granted. The learned Single Judge has taken pains to observe that the observations in the order dated September 08, 2014 are only tentative and are not to be treated as an expression on the merits of the case as since pleadings have to be completed. The next date for hearing the application is October 28, 2014.

8. Attacking the impugned order Sh.P.Chidambaram learned senior counsel for the appellant took us through the claim application filed by the respondent for grant of the patent on which cause of action is founded as also the application for grant of patent which was ultimately abandoned to urge that the application for grant of patent which was abandoned pertained to the formulation Vildagliptin in crystalline formulation and urged that the patent on which the suit is based relates to Vildagliptin in a polymorphous state. The grievance of the learned senior counsel was to the positive finding returned in paragraph 27 that it was not a case of concealment and that the law declared by the Division Bench of this Court in the decision reported as 2009 (40) PTC 125 F.Hoffmann - LA Roche Ltd. & Anr. Vs. Cipla Ltd. was not applicable. Learned counsel urged that the application which was ultimately abandoned would evince the claim of the respondent that Vildagliptin in crystalline formulation is an inventive step distinct from Vildagliptin polymorphous formulations and therefrom it was urged that as per the respondent itself Vildagliptin in crystalline formulation was distinct from Vildagliptin in a polymorphous state.

9. Sh.Gopal Subramanium learned senior counsel for the respondents took us through the patent application pertaining to the patent granted to the respondent to urge that a perusal thereof would evidence that at the heart of the invention was the process pertaining to bringing into being or commercially spoken, to manufacture Vildagliptin; be it in any form.

10. The second issue raised qua the impugned order is the prima facie finding returned by the learned Single Judge that since the respondent has a subsisting patent granted in the year 2007 but relating back to year 1998, it being challenged in the year 2014 would prima facie entitle the respondent to a view being taken that the patent held was valid. Learned counsel for the appellant urged that the learned Single Judge has overlooked the law which requires a prima facie view to be taken not with respect to the patent held by the plaintiff but with respect to the credibility of the challenge to the patent.

11. We note that vide the impugned order the learned Single Judge has required pleadings to be completed by October 30, 2014. Written statement along with relied upon documents had to be filed within two weeks. Replication within next two weeks. Admission/denial had to be conducted on October 13, 2014.

12. The interim application has been listed for hearing on October 28, 2014.

13. The suit record would reveal that the appellant has delayed filing the written statement. On October 13, 2014 the learned Joint Registrar gave further time to file the written statement.

14. As regards the first contention urged, it appears to be a case where the sentences penned by the learned Single Judge, who obviously was rushed into authoring the order, have not brought out the true import of what was intended to be conveyed. Observations in paragraph 27 have to be understood with reference to the observations in para 30 wherein the learned Single Judge has taken pains to state that any observation made is only tentative and would not be treated as an expression on the merits of the case since pleadings had yet to be completed.

15. We thus clarify that the observations in paragraph 27 would effectively mean that whether or not there was a suppression of a material fact would be determined after the pleadings are completed and the necessary documents filed and that for the purposes of grant of an ad- interim injunction (as distinct from an interim injunction), as the pleadings were available before the learned Single Judge, he was of the opinion that at said stage it could not be conclusively opined whether there was a concealment of a material fact and thus the learned Single Judge proceeded on the assumption that as of said date he would not treat it to be a case of suppression of a material fact. This would obviously mean that the observations by the learned Single Judge in paragraph 26 concerning applicability of the decision of the Division Bench reported as 2009 (40) PTC 125 F.Hoffmann - LA Roche Ltd. & Anr. Vs. Cipla Ltd. would not be treated as a final opinion that law declared in said decision is not applicable to the facts of the case, for the obvious reason this issue, as noted hereinbefore, would need an adjudication after pleadings are completed.

16. As regards the second plea urged regarding the view taken by the learned Single Judge at the stage of grant of an ad-interim injunction that the plaintiff had a valid patent granted in the year 2007 but effective from the year 1998 and this would entitle the plaintiff to a finding in its favour of their existing a prima facie case, we simply observe that the observations would simply mean that till pleadings are brought on record through the medium of a written statement laying a challenge to the patent granted, credibility of the challenge cannot be prima facie considered and thus we clarify that the learned Single Judge would decide for the purposes of the interim injunction whether the appellant has succeeded in prima facie establishing a credible challenge to the patent granted.

17. Since the learned Single Judge has yet to apply his mind to the issues raised concerning grant of an interim injunction, we have deliberately not noted in detail the arguments advanced by both sides concerning the patent obtained by the respondent and the patent application abandoned by the respondent and the credibility of the challenge raised to the patent in favour of the respondent. The learned Single Judge would do the needful.

18. Before bringing the curtains down we would simply observe that if the appellant was so much aggrieved of the impugned order it ought to have facilitated an early adjudication of the issue by filing a written statement along with relied upon documents within two weeks time granted and not have sought extension of time for filing the written statement. What has happened is that required to file the written statement by September 22, 2014 so that a replication could be filed by October 08, 2014 and the parties could have admitted/denied the respective documents on October 13, 2014, the appellant having not filed the written statement, the date October 13, 2014 has been lost. This would disable the learned Single Judge to hear arguments on the injunction application on October 28, 2014. Obviously, time would have to be granted to the plaintiff to file the replication. A date would have to be given for admission/denial of documents before the injunction application could be considered to either confirm the ad-interim injunction granted or vacate the same.

19. With the clarifications and observations above, we dispose of the appeal not interfering with the impugned order but with a request to the learned Single Judge that since an ad-interim injunction operates against the appellant, endeavour would be made to hear arguments in the interim application and decision taken within this calendar year.

20. No costs.

(PRADEEP NANDRAJOG) JUDGE (MUKTA GUPTA) JUDGE OCTOBER 18, 2014 skb