30 April 2014AsiaArchana Shanker

The Copaxone battle: an update

Copaxone (glatiramer acetate) is a blockbuster drug for the treatment of multiple sclerosis, created by Yeda Research and Development Co Ltd. The patents that cover Copaxone, including the process for its preparation, have been extensively litigated around the globe, and in India the patent for the preparation of Copaxone expires on May 23, 2015. For this process patent, several proceedings are currently pending before various bodies in India, including the Delhi High Court, the Intellectual Property Appellate Board and the Indian Patent Office (IPO).

The battle in India began in 2007, when Teva Pharmaceutical Limited, the exclusive licensee of Yeda, initiated infringement proceedings against Natco Pharma Ltd, a generics company based in Hyderabad. Mylan, a US-based pharmaceutical company, is the partner of Natco for Copaxone. While the infringement proceedings were pending, Mylan Pharmaceuticals filed a review petition in November 2013 under Section 77 of the Indian Patents Act before the IPO, challenging the term of the patent granted by the Indian process patent 190759 which was granted on May 15, 2004.

The Indian Patents Act, since its inception in 1970, has been amended several times to make its provisions compliant with the World Trade Organization’s Agreement on Trade- Related Aspects of IP Rights (TRIPS). One such provision was in relation to the term of a patent. There have been revisions to the 1970 Act through three amendments: the Patents (Amendment) Act 1999, the Patents (Amendment) Act 2002 and the Patents (Amendment) Act 2005.

The 2002 amendment increased the term of a patent in relation to all inventions to 20 years. Prior to that amendment, the term of every patent granted under the unamended act was 14 years in respect of all inventions, except for inventions relating to the process for preparing food or pharmaceuticals, for which the term was seven years from the date of filing of the application, or five years from the date of sealing of the patent, whichever was shorter.

The main challenge in Mylan’s review petition was on the issue that a patent could not have been granted in relation to the patent application for the process for preparing Copaxone, as the term of a patent for this application under the unamended act expired prior to the grant of a patent. (A similar writ petition has been filed by Natco but is pending before the Delhi High Court and is therefore sub judice.)

Under review

The main arguments by Mylan in its review petition can be summarised as follows:

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