The scope of patent claims is defined by the claims themselves; any pharmaceutical composition containing the claimed ingredients constitutes infringement, regardless of the specific formulation.

JUDGMENT

Jayant Nath, J.

IA No.1803/2019 in CS(COMM) 62/2019 IA No.9072/2020 in CS(COMM) 425/2020 IA No.12284/2020 in CS(COMM) 557/2020 and IA No.4728/2021 in CS(COMM) 156/2021

1. The issue in the aforenoted four suits are largely common and pertains to the plea of the plaintiffs' of alleged infringement of the Indian Patent IN 229051 of plaintiff No.1.

2. For the purpose of present judgment, I will deal with the facts of the first suit, namely, IA No. 1803/2019 in CS(COMM) 62/2019, titled `Novartis AG & Ors. v. NATCO Pharma Limited'.

3. This is an application filed on behalf of the plaintiffs under Order 39 Rules 1 and 2 CPC seeking an ex parte injunction to restrain the defendant, its agents, etc. from manufacturing, importing, selling, offering for sale, etc. any pharmaceutical composition comprising a combination of Valsartan or a pharmaceutically acceptable salt thereof and Sacubitril or a pharmaceutically acceptable salt and a pharmaceutically acceptable carrier or more specifically a pharmaceutical composition comprising combination of Sacubitril +Valsartan as a sodium salt complex or in any other form which may amount to infringement of Indian Patent No.229051 of plaintiff No.1.

4. It is pleaded by the plaintiffs that plaintiff No.1 filed a patent application for the suit patent on 09.07.2004 as national phase entry of Patent Cooperation Treaty (PCT) International Application dated 16.01.2003 claiming priority from US Application dated 17.01.2002.

5. It is stated that the Indian Patent was examined for patentability and statutory compliances in accordance with the provisions of The PATENTS ACT . The patent application was published in the official gazette on 10.02.2006. The suit patent was granted as Indian Patent No.229051 on 13.02.2009(hereinafter referred to as `IN 051').

6. The case of the plaintiffs is that plaintiff No.1 before filing of the patent application continued its research and development and used two compounds namely, Valsartan and Sacubitril in combination to treat cardiovascular diseases. It was found that the combination of Valsartan and Sacubitril achieves greater therapeutic effect than the administration of Valsartan, ACE inhibitors or NEP inhibitors alone. Hence, it is stated that the combination of Valsartan and Sacubitril for effective treatment of heart failure and hypertension involved great amount of research and experiments on the part of plaintiff No.1. It is stated that the suit patent has been granted in 50 countries and in India, there was no challenge to the grant of the suit patent IN 229051 either at the pre-grant stage or post-grant stage or by way of a revocation petition. It is urged that the suit patent is therefore a well established patent and is prima facie valid and subsisting and will expire on 16.03.2023.

7. Claim I of the suit patent is reproduced in the plaint as follows:-

"1. A pharmaceutical composition comprising

(i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof and

(ii) N-(3-carboxy-l-oxopropyl)-(4S)-p-phenylphenylmethyl)-4- amino-2R-methylbutanoic acid ethyl ester or N-(3-carboxy-l- oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-2R- methylbutanoic acid or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier."

8. It is claimed that on a reading of Claim I, the invention comprises a pharmaceutical composition comprising combination of Valsartan and Sacubitril without any limitation in terms of salts, crystalline form, amorphous form, polymorphic forms, hydrates, supramolecular structure or mixture thereof. It is stated that the suit patent would be infringed by any unauthorised making, use, offering for sale any pharmaceutical composition comprising a combination of Valsartan and Sacubitril irrespective of a pharmaceutical formulation or arrangement thereof. It is stated that the plaintiff sells the drug formulation, marketed under the trade mark 'Vymada' in India and 'Entresto' internationall