Pravin Anand, Dhruv Anand and Udita M Patro examine a landmark patent case
A recent decision passed by Justice AK Pathak of Delhi High Court on 7 October 2015 in favour of the plaintiffs/patentee inMerck Sharp & Dohme Corp & Anr v Glenmark Pharmaceuticals Ltd not only vindicates India’s patent law system but also offers a silver lining beyond dark clouds for innovators. The court upheld the validity and infringement of the plaintiff’s patent, in a first-of-its-kind order since the enactment of the Patents Act, 1970.
- Patent in question: Patent covering sitagliptin and its pharmaceutically acceptable salts.
- Drug in question: Sitagliptin phosphate monohydrate (a pharmaceutically acceptable salt of sitagliptin).
- Purpose of drug: To treat diabetes mellitus type II.
- Plaintiffs’ products: Januvia/Janumet and Istavel/Istamet.
- Defendant’s infringing products: Zita/Zitamet.
The patentee, Merck Sharp & Dohme (Merck), along with its licensee, Sun Pharmaceuticals, filed a patent infringement suit against Glenmark Pharmaceuticals in April 2013 when the latter marketed competitor drug products that infringed Merck’s patent for sitagliptin and its pharmaceutically acceptable salts.
When the matter initially came up before the judge, he disposed of the plaintiffs’ application seeking an interim injunction. The plaintiffs preferred an appeal against the decision of the judge. The division bench of Delhi High Court (Ravindra Bhat and Najmi Waziri) reversed this decision through their order dated 20 March 2015 by way of a speaking order, which held the plaintiffs’ patent to be prima-facie valid and infringed by the defendant’s products.
The defendant challenged the order of the division bench before the Supreme Court, which through an order dated 15 May 2015 not only reinstated the interim injunction granted by Delhi High Court’s division bench, but also took cognizance of the “commercial” nature of the matter and the delay already caused when it passed strict directions expediting the suit.
As a result of the landmark directions passed by the Supreme Court (Ranjan Gogoi and NV Ramana), evidence recorded in the matter, which involved the cross-examination of seven witnesses – three of whom were foreigners – was concluded in around one-and-a-half months.
Highlights and achievements
- It is the first patent infringement lawsuit under the 1970 act decreed in favour of the plaintiffs.
- An expedited trial ordered by Delhi High Court resulted in disposal of the law suit within five months from the date of that order.
iii. The finding that the claim of a basic patent for a compound and its pharmaceutically acceptable salts constitutes infringement (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 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 defendant’s contention that it did not use sitagliptin in the process of making sitagliptin phosphate monohydrate was misplaced, as this process was not disclosed by a company witness, but by an expert who had demonstrated huge contradictions in his evidence.
- The court placed substantial weight on expert testimony and opined that in highly technical matters (like the present case involving chemical compounds in the medical field) it had to trust the opinions of specialists in the field, supported by documents. The court stated that it should not impose its view over and above technical experts, particularly when the judges themselves lack such expertise.
vii. The court examined and found serious contradictions in the admissions made by the defendant. This was in contrast to earlier cases where courts had looked at the plaintiff’s admissions.
This decision of 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 all intellectual property. It is clear there is a will to foster a conducive, commercial environment in the country as current measures to provide for such a system illustrate.