Merck Vs Glenmark India's First Decree In Favour Of Patentee In Contested Patent Infringement Suit

In a first, the Delhi High Court has held the patent of the plaintiff, Merck, valid and infringed upon by Glenmark in what is a welcome decree for innovators The decision passed by Hon'ble Justice A. K. Pathak of the Delhi High Court on October 7, 2015, decreeing the suit in favour of the Plaintiff/ Patentee in Merck Sharp & Dohme Corp. & Anr. V Glenmark Pharmaceuticals Ltd., not only vindicates the patent law system of the country but also appears to be a silver lining in the cloud for innovators. This decision where the Hon'ble Court held the patent of the Plaintiff valid and infringed is the first of its kind passed in favour of a Plaintiff/patentee ever since the enactment of the Patents Act, 1970.

Brief Facts Of The Case:

• Patent in question: Patent covering Sitagliptin and its pharmaceutically acceptable salts
• Drug in question: Sitagliptin Phosphate Monohydrate (a pharmaceutically acceptable salt of Sitagliptin)
• Ailment that the drug cures: Diabetes Mellitus type II
• Product of the Plaintiffs: JANUVIA/ JANUMET and ISTAVEL/ISTAMET
• Infringing product of the Defendant: ZITA/ZITA-MET

The patentee Merck Sharp & Dohme Corp. (Merck), along with its licensee Sun Pharmaceutical Industries Ltd., filed a patent infringement law suit against Glenmark Pharmaceuticals Ltd. in April 2013, when the latter marketed competitor drug products which infringed Merck's patent for Sitagliptin and its pharmaceutically acceptable salts.

When the matter initially came up before the Hon'ble Single Judge, he refused to grant an interim injunction and disposed of the application of the Plaintiffs seeking interim injunction. The Plaintiffs preferred an appeal against this decision of the Hon'ble Single Judge and the Hon'ble Division Bench of the Delhi High Court (Ravindra Bhatt and Najmi Waziri, JJ) reversed this decision vide their order dated March 20, 2015, by way of a speaking order which held the Plaintiffs' patent to be prima-facie valid and infringed by the Defendant's product.

This order of the Hon'ble Division Bench was challenged by the Defendant before the Hon'ble Supreme Court, which vide order dated May 15, 2015 not only re-instated the interim injunction granted by the Division Bench of the Delhi High Court, but also took cognizance of the "commercial" nature of the matter and the delay already caused in the matter, and passed strict directions expediting the suit.

As a result of the "one of a kind" directions passed by the Hon'ble Supreme Court (Ranjan Gogoi and N. V. Ramana, JJ), evidence recorded in the matter, which involved crossexamination of seven witnesses – three of whom were foreigners, was concluded in around one and a half months. Further, in less than five months from the ordering of an expedited trial in the matter, the Judgement had been finally delivered.

Highlights/Achievements Of The Case:

• It is the first patent infringement contested law suit under the 1970 Act to have been decreed in favour of the Plaintiffs.
• An expedited trial ordered by the Delhi High Court which resulted in disposal of the law suit within five months from the date the trial was expedited.
• The finding that there would be an infringement of a claim of a basic patent for a compound and its pharmaceutically acceptable salts even if a subsequent salt patent had been abandoned, if the claim of the basic patent could be construed as being broad enough to cover the commercial product or salt.

  In this case Merck had a basic patent for Sitagliptin and its pharmaceutically acceptable salts. It had also applied for a separate improvement patent application for the Sitagliptin Phosphate Monohydrate salt, which it had subsequently abandoned. The Court found that the Defendant's infringing product containing Sitagliptin Phosphate Monohydrate was squarely covered by Merck's basic patent.

• The finding that biological activity was displayed by the Sitagliptin moiety and not by the salt moiety, which only improved the physical or chemical properties to provide better carriage of Sitagliptin to the binding site.
• The finding that the contention of the Defendant's that Sitagliptin was not used by them in the process of making Sitagliptin Phosphate Monohydrate was misplaced as the said process was not disclosed by a company witness but by the expert who had demonstrated huge contradictions in his evidence.
• The Court gave a lot of weightage to expert testimony and opined that in highly technical matters (like the present case involving chemical compounds in the medical field) the Court has to go by the opinion of the experts in the field, whose testimony is found trustworthy and reliable and supported by documents. The Court has not to superimpose its view over and above the technical experts, more so when the Judges are not experts in the chemical and medicinal field.
• Also, in this case the Court looked at the admissions made by the Defendant at various places and found serious contradictions in them. This was in contrast to the earlier cases where the Courts had looked at admissions of the Plaintiff.

This decision of the Delhi High Court indicates that the Indian Judiciary (and the Indian Legislature in view of the recently enacted Commercial Courts, Commercial Division and Commercial Appellate Division of the High Courts Act, 2015) is cognizant of the urgent need for a proper, effective and efficient system to safeguard Intellectual Property, including patents, so as to foster a conducive commercial environment in the country, and are implementing measures to provide for such a system.

Disclaimer - The views expressed in this article are the personal views of the author and are purely informative in nature.