Teva v. Natco : Copaxone litigation update

In 2007, Teva and others filed CS (OS) No. 1708 of 2007 against Natco before the Delhi High Court seeking a permanent injunction in order to restrain Natco from infringing Teva’s Indian Patent No.190759. The prayer also asked the court for an order to restrain Natco from exporting infringing drugs outside India. The patent is a process patent for producing Glatiramer Acetate (also known as Copolymer 1 or ‘Copaxone’ as marketed by Teva). Copaxone is used for the treatment of multiple sclerosis which is an inflammatory disease that damages the insulating covers of the nerve cells in the brain and spinal cord. Again in 2012, after a reported agreement between Mylan and Natco, Teva filed CS (OS) No. 3193 of 2012 before the Delhi HC, seeking permanent injunction restraining Natco from manufacturing glatiramer acetate product in India for sale in the US. Mathews has covered the developments in the 2012 suit here. In this case, the Delhi High Court returned Teva’s plaint for want of jurisdiction. As on February 27, 2015, the arguments have been heard and judgement is reserved.

The 2007 case, however, seems to have been disposed off by the Delhi High Court in 2014 due to a unique development: neither the plaintiffs nor the defendants led any evidence. Because the plaint and the counter claim were not supported by evidence the court disposed off the case in August 2014. After keeping the case alive for 7 years – why this abrupt end?

The developments of CS (OS) No. 1708 of 2007 suggest that in 2007 Natco submitted to the court that “the process employed by them for producing glatiramer acetate which is marketed by them under the name of glatimer is entirely different from the process which has been patented by the plaintiffs under Indian Patent No. 190759.” Natco also filed a counter claim for revocation of this patent in 2007. The grounds stated in the counter claimed included lack of novelty in view of Teiltelbaum et al., 1971 and US 3,849,550, the process of preparation of Copolymer-1 was published, the process conditions for its extraction, isolation and purification were known to a person skilled in the art, the process lacked inventive step etc. Also, in 2007, an affidavit was filed by Dr. A.K.S Bhujanga Rao, Executive Vice President (R&D) disclosed that Natco had been working on glatiramer acetate since 2003. It was also stated that Natco had developed a novel route for producing the product and that Natco had applied for a patent for the same. Thereafter, in 2011 Natco stated that there was no possibility of settlement. After which, in May 2012, issues were framed. There were 9 issues including: jurisdiction, whether the plaintiff was the proprietor of patent no. 190759, whether the defendant infringed this patent, whether the patent is liable to be revoked, damages, rendition of accounts etc. Arguments were heard in November, December and January of 2014. Thereafter, the plaint in CS (OS) No. 3193 of 2012 was rejected and the plaintiffs filed an appeal. And finally, after all of this, in August 2014, the Delhi High Court disposed off the case due to absence of evidence from both sides.

Thank you so much to Prashant Reddy for bringing some of these developments to our notice!

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6 thoughts on “Teva v. Natco : Copaxone litigation update”

  1. What is the point of this post? It is confused and muddled, gives incomplete facts and a wrong picture to the readers. Are you aware that CS(OS) 3139/2012 was restored by the DB, arguments were re-heard on the injunction application and orders are reserved? With respect to the “abrupt end” of CS(OS) 1708/2007, the order records the reasons for it. The question should be “why the parties did not lead evidence?” If you really did follow the developments in CS(OS) No. 3193/2012, you would get your answers.

  2. Aparajita Lath

    Dear Anonymous,
    Thank you for your very ‘insightful’ comment, which leaves me muddled and confused too. I dont see how my post gives a ‘wrong picture’. All of it comes directly from the Delhi HC website. If you read carefully, i think i have specifically mentioned that the judgement in CS(OS) 3139/2012 is reserved. The order in relation to CS(OS) 1708/2007 does not record the reasons… you can read it for yourself
    A more helpful comment would have been actually revealing the reasons…

  3. I must say that I agree with anon here.
    This is old news(2014)! Wondering what’s the point of this update ?
    No offence!

  4. Is it true that Teva has now even withdrawn their subsequent patent application for a improved process after Mylan filed a pregrant opposition?

  5. Shamnad Basheer

    Yes indeed. I just confirmed from one of the parties to this dispute that the patent application for an allegedly improved process was indeed withdrawn.

  6. Thank you Shamnad Sir for the clarification. This must be the second time then for Mylan. If news reports are to be believed, Roche had refused to renew their trastu patent a few years ago and abandoned all their divisional applications after Mylan objected to the patent office about evergreening cascade effect there.

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