Delhi High court grants ex-parte injunction order against Aprica Pharma


On 17th June, in a patent infringement suit initiated by Merck, the Delhi High Court passed an ex parte injunction order, preventing Aprica pharmaceuticals from launching generic versions of Januvia and Janumet. The high court order can be accessed here.

Merck’s counsel argued that the drug (sitagliptin) has been patented in over 102 countries. Merck’s counsels also contended that the invention entailed huge investment and the sales of the medicine in India alone exceeded several crores and in case the defendants (Aprica) are able to launch their product, irreparable loss and injury would be caused to them.

Justice Sanjeev Sachdeva opined “The plaintiff has established a prima facie case on merits and I am of the view that in case ex parte injunction is not granted to the plaintiff and defendant is able to launch the product, irreparable loss and injury would be caused to the plaintiff, which cannot be compensated in terms of money. Balance of convenience is in favour of the plaintiff.
Vague order?
The order employs standard language and does not seem to address the general principles issued by Supreme Court in such cases. (Not that I am complaining about the outcome itself!). Prashant, in his previous posts has discussed the general principles laid down by the Supreme Court precedents.Although not explicitly stated in the order, the fact that the patent had been granted in other major jurisdictions worldwide seemed to have worked in Merck’s favour.

The order does not discuss the patent claims and there was no finding of infringement of any specific product. The order restrains the defendant from dealing with any product that infringes subject matter of the patent (talk about vague!).Also what’s more, there is no reference to the previous order where the court refused to grant interim relief to Merck, for the very same drug. Readers may recall that we had covered the previous order denying interim relief to Merck over here.
What was different in the previous order? Well, Glenmark argued that their product comprises three components (sitagliptin, a dihydrogenphosphate and a crystalline form). Glenmark also argued that Merck had filed separate patents for sitagliptin, a dihydrogenphosphate salt form considering the salt form to be a new invention worthy of a separate patent. The patent to the dihydrogenphosphate salt form was abandoned. Merck failed to satisfactorily plead the circumstances for obtaining a separate patent application and the court denied interim relief to Merck.
Image from here

Mad rush for sitagliptin? 
As Prashant points out, The Form 27 working statement filed by Merck for the year 2012, reveals that the sales of Januvia and Janumet put together exceeds 180 crore (whopping amount)! The sales of its closest rivals Novartis’s (Vildagliptin) i.e. Galvus and Galvus-met is around 165 crores for the year 2012!!
Also,the health ministry in India recently banned pioglitazone belonging to the thiazolidinedione class of anti-diabetic drugs because of reports of increased risk of bladder cancer associated with its use. Another anti-diabetic drug Rosiglitazone belonging to the thiazolidinedione class was banned a few years ago following reports of the drug causing cardiac problems. So apart from metformin and sulphonylureas, the only alternative left for Type-II diabetics amongst oral hypoglycemic drugs are gliptin class of molecules. No wonder everybody seems to want to have a piece of the sitagliptin pie!

Madhulika Vishwanathan

Madhulika Vishwanathan

Madhulika is a registered Indian patent agent and has completed her Master’s in Pharmacology from the Institute of Chemical Technology (ICT), Mumbai. Her interests include issues involving pharmaceutical and biotechnology patent law, regulatory aspects like Hatch Waxman litigation and antitrust law.She is currently working at law firm based out of Memphis, TN.

11 comments.

  1. AvatarAnonymous

    I wonder if the denial of an injunction by the same High Court was brought to the attention of the judge by the Plaintiffs?. Believe that this would be essential to establish equitable conduct – would not be surprised if the ex parte is vacated on the ground of inequitable conduct alone

    Always Anon

    Reply
  2. AvatarAnonymous

    Is it possible to put a copy suit and an application of injunction and may be all material produced before the Hon’ble Court be put here so that anyone can have a look on it.

    Reply
  3. AvatarAnonymous

    For Anon @ 11.39: Pleadings are Court property once they are filed. In fact, there is a significantly serious stream of thought that believes that pleadings once filed should not be open to public view till the Court permits it. Oral arguments are open – unless of course the proceedings are in camera. Therefore, Madhulika is right is referring to the proceedings in Court and the decision given – this is classic reportage. Making the pleadings available to the public could be construed as contempt of court.

    Regards,

    Forever Anon.

    Reply
  4. AvatarPrashant Reddy

    @ Forever Anon:

    I’ve always been intrigued by this claim that pleadings are confidential and not open to public viewing – is there some specific provision of the law which supports this claim of yours?

    Prashant

    Reply
  5. AvatarAnonymous

    @Prashant – Order XII, Rule 6 of Supreme Court Rules 1966. Chapter 1, Rule 10 of Delhi High Court Rules, 1967. Both stipulate that the Registrar shall have custody of the records and evidence filed in Court and that even parties who wish to access them will have to apply for certified copies. Third parties have to file separate applications. This was also discussed briefly in the Sahara India judgment of September 2012 by the SC.

    Reply
  6. AvatarAnonymous

    Interestingly the Delhi High Court vacation bench was moved. Th natter was therefore of grave importance. I wonder why there is no mention of the urgency to move the vacation bench??!!

    Reply
  7. AvatarPrashant Reddy

    @ Anon (8:57);
    I’ve reproduced both the provisions below, where do they say that court documents cannot be shared with the members of the public?

    Rule 10 of the Delhi High Court says this: 10. Custody of the Records—The Registrar shall have the custody of the records of the Court and no record or document filed in any cause or matter shall be allowed to be taken out of the custody of the Court without the leave of the Court.

    Order XII Rule 6 of Supreme Court Rules says this: (vi) Interactive Voice Response System (I.V.R.S.) Interactive Voice Response System has been installed in the Court thereby enabling a person to know the position of his case on telephone without using the internet. This facility is of immense use to those who do not own a computer or do not have the facility of internet available to them. Telephone Number of I.V.R.S. is 24357276.

    Reply
  8. AvatarAnonymous

    Make that OXIII Rule 6 – not O XII. And read this with Mirajkar and the Sahara judgements. That may give some pointers on how Courts view their records.

    Reply
  9. AvatarPrashant Reddy

    Are you sure?

    Order XIII Rule 6 is as follows “6. The decree passed or order made by the Court in every appeal, and any
    order for costs in connection with the proceedings therein, shall be transmitted by the Registrar to the Court or Tribunal from which the appeal was brought, and steps for the enforcement of such decree or order shall be taken in that Court or Tribunal in the way prescribed by law.”

    Reply
  10. AvatarAnonymous

    For the said patent, the patentee’s licensee Sun Pharmaceutical Limited has filed statement of working in Form 27. Sun Pharma is just doing formulation, means from Patented product, tablets are made, which is not the subject matter of the patent. It is cheating and fraud played with IPO, so that no one can file Application for Compulsory License. Making tablets from patented product is not working of the patent. IPO must initiate action against the licensee who has filed Form 27 for submitting false information.

    Reply
  11. AvatarAnonymous

    In this matter I have learnt that there is no territorial jurisdiction as Aprica Pharmaceutical has no business place in Delhi, moreover address of Delhi shown in the plaint of Delhi was never the business place of the defendant, it is registered office of some third party, and Defendant does not know that addressee. The plaintiff put this address of Delhi mischeviously just to drag the jurisdiction to Delhi. Plaintiff has mislead the Hon’ble High Court of Delhi. The Hon’ble High Court should consider this behavior of the plaintiff very seriously.

    Reply

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