Roche and Tarceva in Delhi HC again, this time vs. Natco


F Hoffman La Roche, the Swiss-based drugs multinational, has re-entered the Delhi High Court in an infringement matter over the Tarceva patent. This time, Roche has sued Natco Pharma, and specifically, their anti-cancer drug sold “Erlonat”, which it is alleged infringes Roche’s patent rights over their anti-cancer drug, Tarceva.
Readers will recall instantly that Tarceva is the same drug over which Roche has fought Cipla before various benches of the Delhi High Court and the Supreme Court, all of which we have covered extensively here.

The matter was posted for arguments on the interim injunction before Justice V K Shali of the Delhi High Court yesterday, i.e., 26 April, where Roche was represented by Anand and Anand and led by Senior Counsel C S Vaidyanathan, and Natco was being briefed by Gaurav Barathi and led by Senior Counsel Arvind Nigam.

The arguments are still at a preliminary stage, with parties having had just about time to introduce the case briefly. Roche took the stage first, and spent some time discussing how the present case was different from that of Roche vs Cipla, and how the judgement in CIPLA was not binding on Roche. Specifically, Roche drew the attention of the court to two issues, i.e., that Natco had filed a pre-grant opposition against the Tarceva application, as also a compulsory licensing application for the same drug. Roche argues that Natco had, in the compulsory licensing application, acknowledged that they could not manufacture their anti-cancer drug without infringing Roche’s drug.

Natco, on its part, got relatively less time to address the court, compared with Roche. In a nutshell, they argued that there was no reason for Justice Shali to not follow the court’s previous judgement in the Cipla matter, since the patent that was alleged to have been infringed was the same.

By way of a quick background, I quote from Shamnad’s post on this, which also brings you up to speed with the status of the Roche-Cipla matter.–

“Roche dragged Cipla to the Delhi High court, alleging that Cipla infringed their patent rights over Tarceva, an anti cancer drug (sold as “Tarceva”). The trial judge, Justice Ravindra Bhat, refused to grant an interim injunction on the ground that since Cipla was selling the drug at 1/3rd of the price of Roche, an injunction would have meant lack of affordable access for a large number of cancer patients in India. Therefore, “public interest” demanded that no injunction (restraining order) be granted.

Roche then appealed to the Division Bench, whose order proved much more detrimental for Roche. Not only did the appellate bench uphold the key findings of the trial judge, it went on to impose costs on Roche for suppression of material “patent” information. It also went on to find that Roche had not established a prima facie case of infringement, since the patent in question did not seem to be implicated by Cipla’s generic product. And in any case, the court suggested that Roche’s patent was susceptible to a serious validity attack. As we noted earlier on the blog, this order was very poorly reasoned and demonstrated the relative lack of sophistication of Indian judges with complex patent disputes.”

The matter comes up for arguments again on April 28, and we shall try our best to get you an update on things.

Meanwhile, there are a few notes worth making on this matter that has just begun:

1. This suit against Natco was filed by Roche in December 2009. There are two other suits alleging infringement of the same patent, against Glenmark and Dr Reddy’s. Both these suits are also in the Delhi High Court, and are scheduled to come up for hearing on 14 July 2010. There will be more action to watch out for.

2. Natco’s usual litigation attorneys, the tier 1 law firm K&S Partners, appear to be absent in the present litigation. Instead, Natco is being represented by a relatively low-profile attorney, Gaurav Barathi, and we look forward to seeing how things proceed with the new counsel.

3. The most key question of all — why is Roche repeatedly returning to the court over the same patent, despite the general opinion that Roche may be wasting its time? It’s approached the Delhi High Court twice, and both times had its application for interim injunction refused for the same patent. The Supreme Court too dismissed Roche’s Special Leave Petition challenging the Delhi High Court division bench order. Each time the courts raised issues which suggested that Roche had no prima facie case in connection with the Tarceva patent, including that “public interest” demands no injunction be granted. Public interest, in the words of the court, refers to cheaper drugs made available by manufacturers in India in comparison with proprietary drugs manufactured at higher costs — in that case, it was Cipla. Here, the argument could well be extended to Natco, since the prices of “Erlonat” are equally low.

More on this as and when.

9 comments.

  1. AvatarAnonymous

    I would like to see more of compulsory licences or drug price control legislation in action instead of “public interest” surfacing every now and then.

    Reply
  2. Avatarmnbvcxzaq1

    i can only say ‘no comments’ n LOL. n people who know me, can very well discern why such a reaction from me. regarding blog-author’s ‘key question’ in point no.3, all i can say is that i seriously lament the lack of honest legal advice rendered by counsels (of roche) regarding filing of new infringement suits, at least under the current circumstances.
    -aditya kant

    Reply
  3. AvatarSumathi Chandrashekaran

    @Anon – agree, “public interest” in patents is getting a little cliched. We need a breath of fresh air in patent litigation here. Can we hope to hear something different from Justice Shali, I wonder.

    @aditya – agree there too. Someone I was discussing this matter with yesterday suggested there’s a “bruised ego in Basel” that’s behind all of this! (entirely appropriate phrase, i thought) The legal advice may well be just pandering that ego.

    Reply
  4. Avatarmnbvcxzaq1

    lol. i think i can make a fair guess (tho i may b wrong, too) abt the person with whom u might ve had that discussion n who might ve referred to the ‘bruised ego’.
    -aditya kant

    Reply
  5. AvatarAnonymous

    I think “public interest” is something which is very ill defined or undefined. We need to make use of the instruments provided in law in order to address a situation. It is about time we start walking.

    Reply
  6. AvatarAnonymous

    I guess it takes a few “bruised egos” to set things right. While some of us might feel passionately about patent law..i am as a litigator losing hope unless the Judges show little indulgence. there is so much to be fixed in the Act and the precedents we have had.

    I wonder however, would an MNC like Roche be doing this only out of ego? it has to be more complicated than that.

    Public interest is a crappy argument for a generic company to raise..”organisation engaged in a purely commercial enterprise wearing the cloak of public interest”…NGO-may be.

    Reply
  7. Avatarmnbvcxzaq1

    dear anonymous,
    i fully empathise with u (as a ligator). as i ve said umpteen times, “no one, absolutely no one, is above board” in this pharma patent scene (n why only in pharma patenting scene, this may be true of most walks of life). the imperfections inherent in each of the players in this pharma patent arena (i.e. innovators, generics, counsels, judiciary n legislature) interplay in such a way that the most crucial player (i.e. the general public) is the ultimate sufferer.
    although i dont know u r on which side of the divide (innovator, generics or general public), yet i can say that why only you as a litigator, but also all other players often feel dejected/dis-illusioned by the current state-of-affairs. but if one has to survive these imperfections, one cannot afford to lose hope. conscientious elements among all these key players must keep on working towards removing these imperfections. i am a totally impartial votary of law n it has always been my endeavour to help in dispensing fair n equitable justice, irrespective of the mnc or generic or ngo/public status of the litigant. similary, on your part, u also have a duty to persevere n keep fighting for the removal of imperfections (which i agree, r galore in the extant patent act).
    -aditya kant

    Reply
  8. AvatarJ. Sai Deepak

    Hi,
    If a party chooses to apply for a compulsory license merely to avoid a protracted invalidation proceeding, can this be used to buttress arguments about validity of the patent by imputing diffidence on the part of the party seeking such a license?

    Bests,
    Sai.

    Reply
  9. AvatarAnonymous

    Haha, as a patent litigator in Delhi- who says K&S are not on the matter?

    Time to lift the veil, and see exactly how ethical they are?

    Reply

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