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:
- The term of a patent under Section 53 of the Indian Patents Act should have expired on May 23, 2002 in relation to the process patent application for Copaxone; and
- The IPO made an error in issuing the Letters Patent on March 15, 2004 for a period of 20 years from the date of filing of the application based on the amendments made by the Patents (Amendments) Act 2002. The grant of a patent was therefore void ab initio.
Without going into the merits of the case, the patentee dealt with the review petition on these preliminary issues:
- A similar issue is pending before the High Court of Delhi in a writ filed by Natco and, therefore, does not merit any interference by the Controller;
- The review petition is time-barred, having been filed after 11 years from the grant of a patent and, therefore, suffers from laches and delay;
- Mylan has no locus standi to file a review petition as Mylan was neither the applicant nor party to any proceedings under the Indian Patents Act; and
- The Patents (Amendment) Act of 2002 came into effect on May 20, 2003 and the payment of the sealing fee, a condition prior to the grant of a patent, was effected on March 15, 2004. For this reason, the IPO rightly granted the applicant a patent term of 20 years.
In March 2014, the Joint Controller of patents issued the order on the review petition but did not comment on the interpretation of law relating to the provisions of the term of a patent. The main findings of the Controller included the following:
- A similar issue is pending before the High Court in relation to the same patent and, therefore, this matter did not merit any interference;
- Under Section 77 of the Indian Patents Act, the review petition filed by Mylan suffered from delay and laches as it took ten years and three months for Mylan to file the review petition;
- Mylan does not have the locus standi to file the review petition as Section 77 makes it clear that a review petition can be entertained only if filed by an applicant/opponent or by a concerned party to the proceedings. Mylan is neither the applicant to the concerned application nor the patentee or the licensee; and
- On condonation of delay, the Controller refused to condone the delay and held that the timelines prescribed under the law are not merely directory in nature. He further held that any delay in filing the review petition cannot be cured by filing a petition, particularly as the delay in filing the review petition was unreasonable and unexplainable.
The Controller also held that the Patent Act does not empower the Controller to disregard the institutional mechanism and timelines prescribed by the act and the rules as that would result in the total collapse of the system.
Mylan challenged the order of the Controller of patents before the Delhi High Court. The court dismissed the writ petition filed by Mylan but permitted it to file an intervention application before the Delhi High Court in the pending writ petition filed by Natco. The High Court petition is likely to come up for hearing in July this year.
The Delhi High Court’s interpretation of the provisions relating to the term of a patent will be interesting. On the delay in the grant of patents by the IPO, the Delhi High Court in Nitto Denko Corporation v UOI (WP[C] Nos. 3742/2013 and 3756/2013) directed the Indian government to constitute a committee to look into the issues of providing a programme for a time-bound disposal of pending patent applications and to recommend ways and means to ensure that new applications are decided within the statutory timeframe fixed by the statute.
Archana Shanker is a senior partner and head of patents and designs at Anand and Anand. She can be contacted at: archana@anandandanand.com
