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U.S. Buyers and Their Legal Advisors Beware: Indian Court’s Injunction Against Glenmark’s Continued Infringement of Symed Lab’s Process Patent Suggests That Pharmaceutical Method Claims Are Becoming More Readily Enforceable in India

Posted on Jan 23, 2015 in Blog

An ad interim injunction passed by the Honorable Delhi High Court (on January 19, 2015) against Glenmark restrained infringement of Symed’s Process Patent Nos. IN 213062 and IN 213063.

SYMED LABS LIMITED is the proprietor of several patent rights in relation to the Linezolid API/bulk drug. In particular, Symed holds, among others, the following granted process patents viz. IN213062 and IN213063 titled “NOVEL INTERMEDIATES FOR LINEZOLID AND RELATED COMPOUNDS” and “A NOVEL PROCESS FOR THE PREPARATION OF LINEZOLID AND RELATED COMPOUNDS” respectively, which are currently in force in India, and also in several European Countries & the United States of America viz. US 7429661 B2 and EP 1768967 B1 respectively (equivalents of IN213062); and US 7307163 B2, US 7351824 B2, US 7524954 B2, US7741480 B2 and EP 1737850 B1 (equivalent to IN213063).

The said novel intermediate compounds invented by Symed, when used in the synthesis of Linezolid led to the development of the inventions as claimed in the suit patents, led to great commercial success since it makes the process for the manufacture of Linezolid by the Plaintiff’s proprietory method significantly more commercially viable and industrially advantageous as the manufacturing cost of Linezolid is dramatically reduced to 2 to 3 times below that of the known processes for the preparation of Linezolid as disclosed in the prior art.

Symed has filed several law suits against third party infringers before the Delhi and Madras High Courts and has obtained a number of ex parte injunctions.

On 12th April 2013, Symed filed a suit before the Delhi High Court (C.S. (OS) No. 678 of 2013) seeking an injunction restraining ‘Glenmark Pharmaceuticals Limited’ and ‘Glenmark Generics Limited’ from infringing Symed’s process patents in their manufacture of Linezolid. As they had sent a legal notice to Glenmark prior to filing the lawsuit, Glenmark was able to pre-empt an ex parte injunction by filing a caveat. After battling it out for more than a year and a half the application for interim injunction was finally heard and reserved for Orders on 1st December 2014.

In a well-reasoned order (33 pages) pronounced on 19th January, 2015, Justice GP Mittal of the Delhi High Court granted an ad interim injunction against Glenmark, their agents, distributors etc. from infringing the Plaintiff’s Patent Nos. IN 213062 and IN 213063. The judgment is a clear signal that the court is willing to come to the aid of patent owners irrespective of delay strategies and other procedural hurdles that Defendants may create, which at best delay the inevitable.

Upholding the Plaintiff’s contention that in a process patent infringement it is the Plaintiff’s process as disclosed in the patent and the Defendant’s process that ought to be compared and in using this yardstick in the backdrop of the lack of a disclosure by the Defendants as to the process in actual use by them, the Court held that the presence of the two novel intermediates which were proprietary to the Plaintiff’s processes in the Defendants’ product was clear evidence of infringement by the Defendants. The presence of these intermediates had not only been found by the Plaintiffs who had tested the Defendants’ samples in their own laboratories but had also been confirmed by IICT (Indian Institute of Chemical Technology). The presence of these intermediates coupled with the absence of any disclosures by the Defendants as to the processes being used by them was sufficient reason to conclude that the Plaintiff’s patents were being infringed.

The Court dismissed Glenmark’s objections of suppression and concealment which was based on earlier business relations between the two companies and in fact remarked that a purchase of a total of 2316 kgs of Linezolid by the Defendant from the Plaintiff over a period of 9 years was not relevant in a suit for infringement when admittedly the Defendants’ monthly consumption was significantly higher and in fact demonstrated that the Defendants were well aware of the Plaintiff’s proprietary processes for manufacture of Linezolid and possibly provided them the necessary incentive/ information to infringe the same.

The court also noted with approval the fact that the processes were patented in the US and EU and the novelty of the intermediates had been upheld in both jurisdictions, while remarking at the same time that ultimately it was the grant of the Indian patents that mattered in a suit for infringement filed in India.

Although pharmaceutical patent injunctions probably occupy the maximum amount of newsprint in recent patent litigation news reports from India, they mostly pertain to product patents in relation to new molecules. Pharmaceutical process patents, despite being grantable since 1970 in India, are not as often litigated or written about. The primary reason for this is the relative difficulty in proving that a process has been infringed when the end product is off-patent. Given that the process followed by a pharmaceutical company is the subject of their personal knowledge, the Patents Act itself provides for a reversal of burden of proof in a case of process patent infringement, where a Defendant is required to establish that it did not actually employ the patented process, provided the Plaintiff has discharged the initial burden to demonstrate that there was a “substantial likelihood” of infringement.

Most Plaintiffs are unable to demonstrate that a Defendant is employing an infringing process to arrive at the same product as it does not have the “smoking gun” aids that it does in a product patent infringement case, such as for example X-ray analysis of the Defendant’s product to show that it is a polymorphic form of the Plaintiff’s.

In this backdrop, a 33 page order of Justice G P Mittal of the Delhi High Court, pronounced on 19th January 2015 provides immense evidentiary guidance to Plaintiffs seeking an injunction for violation of a process patent.

Hailing the order, Managing Director of Symed Labs. Dr. D Mohan Rao remarked, “We are happy that the court has recognized and upheld the exclusivity of our process patents in a hard hitting judgment. This triumph over a company like Glenmark shows how patents have become the most valuable currency in the pharmaceuticals business today. If anything, it gives a fillip to smaller pharmaceutical companies to continue to invest in R & D in the secure belief that statutorily recognized rights will be protected and enforced against infringers irrespective of their commercial might.

This holding is important for practitioners who counsel pharmaceutical clients on products produced abroad which may or may not be then imported into the U.S. This holding warns them, that the false sense of security that they may have developed because the molecule patent itself may have expired is insufficient in the infringement analysis. In today’s pharmaceutical world, there are likely other relevant intermediate and process patents of third parties which are likely not listed in the Orange Book, which must be searched for and examined to determine potential infringement before there is commercial offer for sale, importation, use and/or marketing in the United States and elsewhere where such patents exist.

As the case law has held, since even trace amounts of intermediates and/or polymorphs found in the final imported active ingredient product or finished dosage product can constitute infringement, companies and practitioners advising such clients need to be on the alert for this type of protection.

– by Robert Silver


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