Close to two years after Merck filed a suit for injunction against Glenmark and after a quite a struggle, MSD has finally been granted an injunction and Glenmark has been restrained from making and marketing its versions of the drug. The Delhi High Court laid down a detailed analyses of the facts and came to the conclusion that the Glenmark had infringed MSD’s patented drug.

Injunction against Glenmark

Facts:

The plaintiff, Merck Sharp and Dohme Corporation (MSD) imports and sells its patented (patent – IN 209816) drug in question under the trademarks “Januvia” and “Janumet”, in India. The suit patent concerns a drug which lowers blood sugar levels in Type 2 Diabetes Mellitus (“T2DM”) patients. The defendant, Glenmark launched its products under the trademarks “Zita” and “Zitamet”. Both Glenmark‟s and MSD’s products seek to treat T2DM. MSD alleges that Glenmark‟s products infringe its patent.

MSD contended that Sitagliptin is the active pharmaceutical ingredient in the said drugs and has been covered in 13 of 20 claims of MSD. Further, MSD alleged that Glenmark was aware of the suit patent – specifically Sitagliptin and its pharmaceutically acceptable salts – especially since it cited them in support of its patent claim in the United States, being US Patent 8334385 dated 18.12.2012. Based on this, MSD filed a suit for infringement before a Single Judge but injunction was not granted on the basis that MAS had failed to make a case.

Arguments:

Plaintiff:

It was argued that Glenmark does not have freedom to operate in the US based on its patent because of MSD’s US compound Patent No. 6699871. MSD argued that Glenmark infringed its suit patent as its product Sitagliptin Phosphate Monohydrate is covered by Claim 19 and well as the other 13 claims made under it, and further that Glenmark infringed its suit patent as its product Sitagliptin Phosphate Monohydrate cannot be prepared without manufacturing the active ingredient, the Sitagliptin molecule. Therefore, it was argued that the use of Sitagliptin claimed by IN 209816 to prepare Sitagliptin Phosphate Monohydrate by Glenmark infringed MSD’s exclusive right.

MSD also contended that Section 48 of the Indian Patent Act, 1970 extends exclusive rights to exclude others from making, using or offering for sale or importing into India products which fall within the scope of a suit claim. MSD claimed that since the drug the defendants manufacture cannot be manufactured without using Sitagliptin, the defendants are infringing the suit patent. MSD further argued that patent protection was sought for Sitagliptin “with pharmaceutically acceptable salts thereof”.

Defendant:

Glenmark urges that MSD’s patent suit is liable to be dismissed on the grounds that MSD had not revealed its title and moreover, MSD had failed to disclose the corresponding applications, two of which were abandoned. Further, they argued that the patent application that has been abandoned is the one that has Sitagliptin Phosphate Monohydrate as the active pharmaceutical ingredient and hence their use of the particular ingredient does not amount to infringement.

Glenmark alleged that the patent is invalid under Section 64(1) of the Indian Patent Act, 1970 (“the Act”) because it is obvious, it is not useful and lacks industrial applicability, the complete specification of the patent does not sufficiently and fairly describe the invention, non-compliance of Section 8, claims go overboard.

Analysis and judgment:

The bench analysed various issues like whether the invention relates to the Sitagliptin free base or the salt as such, whether the Sitagliptin free base and further SPM were disclosed sufficiently for a sustainable patent claim etc. The Court also dealt with Section 10 of the Act which stipulates the manner in which a claim must be made and observed that SPM was not specifically disclosed in the suit patent, apart from a generic reference as a pharmaceutically acceptable salt. However, this does not disentitle MSD from getting an interim relief. The Court further observed that the abandoned applications are not of great importance to this particular case. With respect to it being a Markush claim (ambiguous and overboard claims), the Court observed that it was an overgenerous claim but does not bar them from getting an injuction.

With respect to Section 8 non-compliance by MSD, the Court observed that it is prima facie insufficient for revocation under Section 64(1)(m).

Based on the detailed analysis, the Court came to a conclusion that there was a prima facie case of infringement and thus an injunction against Glenmark was granted, dismissing the order passed by the Single Judge. Further, Glenmark was permitted to sell the products in question which are already in the market.

It will now be interesting to see what the Supreme Court decides in the appeal.

This article has been authored by Durga Bhatt, an IP Law practitioner.