Patent

Public Interest Prevails? Bristol-Myers Denied Interim Injunction in Patent Infringement Suit Regarding Export of HIV Drug to Venezuela


Image from here- http://www.citizenvox.org/tag/generic-drug/

Image from here

On 26th September, 2014, a Hyderabad Trial Court denied an interim injunction to Bristol-Myers Squibb (BMS) in a suit against generic manufacturer Mylan regarding the export of HIV Drug Atazanavir to Venezuela. While BMS had no product patents in either India or Venezuela, they had brought the suit on the basis of two secondary process patents.

The Trial Court had earlier denied them an ex-parte interim injunction, following which BMS had approached the High Court to secure a status quo order. The High Court had amended the Trial Court order and asked Mylan to deposit Rs. 30 lakh with the Court following which they could continue exporting 1/8th of the purchase order until the Trial Court decides on the interim injunction application after hearing both sides. This application has now been dismissed by the Court. Unfortunately, the order of the Court is not available online.

What is interesting is that BMS is also suing Mylan (then known as ‘Matrix) in a US Court regarding the export of the same drug to Venezuela. BMS and Mylan had entered into an “immunity from suit agreement” (similar to a voluntary license) where Mylan could distribute Atazanavir in certain territories without being sued for patent infringement by BMS.  When Mylan sold the drug to the Pan American Health Organisation, who supplied it in Venezuela, BMS sued Mylan for breach of the agreement (as the agreement had only covered India and Sub-Saharan Africa). While the District Court held that though Mylan may be liable for patent infringement, it is not liable for breach of the Immunity from Suit Agreement, the Federal Appeals Court has overturned this order on October 7th.

Coming back to the Indian case, I found this decision to not grant an interim injunction heartening for two reasons. The first is because of the dangers of granting interim injunctions in patent suits, which we have blogged about before on SpicyIP (here, here and here, for example). Patent suits are often complicated and involve issues that require expert evidence, and a wrong decision often has dire consequences- especially in this case, where it is regarding a life-saving drug for HIV patients.

The second reason is because Mylan raised the defense of ‘public interest’ in its arguments. It argued that the export of a drug to a sovereign government in pursuance of a WHO order does not strictly constitute “sale for commercial purpose” due to the larger interests at stake.  In Roche v. Cipla, Justice Ravindra Bhat of the Delhi High Court had read in “public interest” into the 3 step test for temporary injunction, by making it a factor to consider when testing whether there is irreparable injury. That was a big moment in India’s Access to Medicines jurisprudence. While I don’t know if the public interest argument was instrumental in the Court’s decision in the present case, it is still great to see an Access to Medicines angle being argued in the Courts.

News Source: Pharmabiz

 

Spadika Jayaraj

Spadika Jayaraj

Spadika is a student of the National Law School of India University, Bangalore. Apart from Intellectual Property Law, she is also interested in Law and Technology issues.

5 comments.

  1. AvatarAnon

    Spadika,

    It amazes me that all that matters is some potential public interest in denial of an interim injunction. Your post makes no reference to the merits of the case and the strength of either of BMS’s or Mylan’s case. What’s worse is that you do not even mention as to how the public interest angle plays out in this case i.e. what is the comparative price of the innovator drug and the generic drug. The generic is bound to raise public interest defence in every case but the readers should have the opportunity of not taking an interested party on face value and having facts in front of them to form an opinion. I hope you do not stand for the proposition that every time a Court decides not to grant an injunction in a patent infringement lawsuit, it is in the public interest irrespective of the price of the drugs involved.

    I anticipate a response that further information was not available on the merits or the price of the drugs. Then my question would be this – how did you form your opinion without having these facts? I hope again that you would not deny that your post is an opinion/ comment and not merely a reporting of facts.

    Best regards,

    Anon

    Reply
    1. Spadika JayarajSpadika Jayaraj Post author

      Dear Anon,
      Thank you for your comment.

      It’s certainly clear from my post that it is my opinion and not a mere reporting of facts, I never intended it to be otherwise. I’ve mentioned in the post that as the order is not available, I cannot tell whether the public interest argument was the deciding factor (arguably, the title of my post suggests otherwise- if it does, I accept that it is my bad). With respect to public interest, my argument was simply that it should be a consideration in such suits, and therefore it is heartening that it was argued.

      However, I did mention about the general dangers of granting interim injunctions in patent infringement suits, given the complexity of the facts involved, especially since the drugs are life saving ones.

      Edit: I’ve edited the title of the post based on your feedback.

      Reply
  2. AvatarAnon

    Spadika,

    It amazes me that all that matters is some potential public interest in denial of an interim injunction. Your post makes no mention of the merits of the case or the relative strength of BMS’s case or Mylan’s case. What’s worse is that you do not even provide the comparative price of the drug offered by BMS or Mylan or provide more details about the effect of the agreement between BMS and Mylan. The generic will always take the defence of public interest. The readers should have the opportunity to not simply accept the defence taken by an interested party and form an opinion on their own. I hope you do not stand for the proposition that public interest is served each time an interim injunction is denied to a patentee irrespective of the merits of the case.

    I anticipate the response that further facts about the merits of the case or the comparative price of the drug was not available to you. Then my response would be this – how did you form your opinion? I again hope that you would agree that your post is an opinion/ comment and not merely a reporting.

    Anon

    Reply
  3. AvatarAnon

    Hi Spadika,

    Can you please clarify if you are raising concerns only regarding grant of ex-parte interim injunctions or the grant of interim injunctions even where the Defendant has appeared and has had an opportunity to defend the lawsuit? The previous posts you cite all criticize grant of ex – parte injunctions.

    As you have probably figured, the most recent decision in the BMS – Mylan case was decided after Mylan entered appearance.

    Anonymous

    Reply
    1. Spadika JayarajSpadika Jayaraj Post author

      Dear Anon,
      I am of the opinion that while we should be extremely concerned about ex-parte injunctions, the concerns do not completely fade away merely because both sides are heard. From my understanding of injunctions, the Court does not analyse the case beyond a prima facie level at the level of granting a temporary injunction.

      Reply

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