A quia timet action can proceed when the plaint alleges sufficient facts indicating an imminent threat of patent infringement, necessitating judicial scrutiny.

JUDGMENT

IA 6051/2022 in CS(COMM) 681/2021

1. I proceed to dispose of IA 6051/2022, filed by the defendants Zydus Healthcare Ltd. and Cadila Healthcare Ltd. under Order VII Rule 11 of the Code of Civil Procedure, 1908 (CPC), whereby the defendants seek rejection of the plaint in CS (Comm) 681/2021, instituted by Novartis AG and Novartis Healthcare Pvt. Ltd..

Facts

2. Novartis asserts Indian Patent IN 229051, titled "Pharmaceutical Compositions comprising Valsartan and NEP inhibitors".

3. The suit patent, it is asserted, consists of a combination of Valsartan and Sacubitril, which is novel and inventive in nature, and treats cardiovascular diseases. The plaint asserts that administration of the combination claimed in the suit patent has greater therapeutic effect than the administration of Valsartan or the administration of a vasodilator or NEP (Neutral Endopeptidase) inhibitors alone. Sacubitril is a NEP and Valsartan is a vasodilator. The "unexpected and surprising synergistic antihypertensive effect" of the combination of Sacubitril and Valsartan is asserted as being novel, non-obvious and inventive.

4. It was in these circumstances, asserts the plaint, that IN 229051 was granted to Novartis, with no sustainable opposition either at pre-grant or post-grant stage. Post the grant of the suit patent, Torrent Pharmaceutical Ltd. filed a revocation petition before the learned Intellectual Property Appellate Board (IPAB) which was withdrawn. The suit patent IN 229051 is, therefore, valid and subsisting. It is due to expire on 16th January 2023.

5. The suit alleges that Zydus applied to the Registrar of Trade Marks for registering the trademark "ARNX" on "proposed to be used" basis. The mark ARNX was described as covering "medicinal, pharmaceutical and veterinary preparations for medical purpose, for medical use and chemical preparations of Valsartan and Sacubitril for cardiovascular purposes". The application was filed by Zydus on 16th August 2021 and was published in the Trademarks Journal on 13th September 2021.

6. The plaint further alleges that Zydus and Cadila are companies of the Zydus Cadila Group and that Cadila filed Patent applications IN 2655MUM2015 and IN 201621044625 for obtaining product and process patents in respect of different forms of Valsartan and Sacubitril tablets and of their manufacturing process.

7. Novartis has also relied upon an investigation stated to have been conducted by Strategic Analysis India Pvt. Ltd. (SAI), an independent investigation agency. According to the report dated 14th December 2021 of the said agency, Cadila had obtained a manufacturing license from the Central Drugs Standard Control Organisation (CDSCO), Ahmedabad, for manufacturing a pharmaceutical formulation of Sacubitril and Valsartan, which it intended to launch in December 2021.

8. The application made by Zydus to the Registrar of Trade Marks for registration of the ARNX trade mark, the two patent applications IN 2655MUM2015 and IN 201621044625 filed by Cadila before the patent office and the investigation conducted by SAI, the plaint seeks to contend, make out a case of imminent threat to the commercial interests of Novartis by the defendants.

9. In these circumstances, the plaint has been filed as a quia timet action, seeking, essentially, a decree of permanent