Back
IN THE HIGH COURT OF DELHI AT NEW DELHI
JAYANT NATH, J.
Novartis Ag & Ors. – Respondents
Versus
Natco Pharma Limited. – Respondent
CS(COMM) 62 of 2019, CS(COMM) 557 of 2020, CS(COMM) 156 of 2021, CS(COMM) 425 of 2020
Decided on : 28-10-2021
PATENT - INFRINGEMENT - SUIT FOR INJUNCTION - INTERPRETATION OF CLAIMS - SCOPE OF PATENT - SUPRA MOLECULAR COMPLEX - WHETHER COVERED BY CLAIM - SCIENTIFIC ADVISER'S OPINION - RELIANCE - SECTION 10(4)(C) OF THE PATENTS ACT 1970.
Fact of the Case:
Plaintiffs filed a suit for injunction to restrain the defendant from manufacturing, importing, selling, etc. any pharmaceutical composition comprising a combination of Valsartan or a pharmaceutically acceptable salt thereof and Sacubitril or a pharmaceutically acceptable salt thereof 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 IN 229051 of plaintiff No.1. The defendant contended that the invention of the suit patent comprises a combination of Valsartan and Sacubitril which together inhibit AT-1 and NEP receptors respectively. The invention is hence nothing but a physical combination of the aforesaid Valsartan and Sacubitril. On the other hand, the defendant’s product is a supra molecular complex comprising of Valsartan and Sacubitril anions with sodium cations and water molecules and does not fall within the scope of the suit patent.
Finding of the Court:
The court held that a plain reading of Claim I shows that it includes a composition of Valsartan, Sacubitril and the carrier. The defendant’s product falls within such a composition. The claim does not prima facie deal with all compositions of Valsartan, Sacubitril and the stated carrier. The court also held that the subsequent abandonment of an application cannot remove what is patented earlier nor can it include something that was excluded earlier, abandonment of a claim plays no part in the claim construction.
Issues: Whether the defendant's product, a supra molecular complex of Valsartan and Sacubitril, is covered by Claim I of the suit patent IN 229051.
Ratio Decidendi: The scope of an invention is defined and determined by the granted claims. Hence, the scope of the invention for which protection has been granted in respect of the suit patent is as per Claim I, namely, a pharmaceutical composition comprising of Valsartan or a pharmaceutically acceptable salt thereof or Sacubitril or a pharmaceutically acceptable salt thereof along with pharmaceutically acceptable carrier and a pharmaceutical composition comprising of the same. The impugned tablets fall within the coverage of the suit patent.
Final Decision: An injunction was passed in favour of the plaintiffs and against all the defendants restraining the defendants, their agents etc. from manufacturing, importing, selling, offering for sale, etc. any pharmaceutical composition comprising a combination of Valsartan or a pharmaceutically acceptable salt, 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 IN 229051 of plaintiff No.1.
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
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.
IA No.4728/2021 in CS(COMM) 156/2021
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:-
(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-loxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-2Rmethylbutanoic 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® internationally.
9. It is further urged that after
The scope of an invention is defined and determined by the granted claims.
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.
A quia timet action can proceed when the plaint alleges sufficient facts indicating an imminent threat of patent infringement, necessitating judicial scrutiny.
Validity of specific patents is upheld while assessing distinctions between coverage and disclosure, emphasizing protection of intellectual property rights against infringement.
Patent infringement requires the plaintiff to prove unauthorized use of a patented process, while the validity of the patent must meet criteria of novelty, description, and utility.
Intellectual Property right - Infringement of Indian patents - It is also a well settled position in law that damages are entirely insufficient as panacea for holder of a valid patent, which is infri....
Patent is prima facie invalid due to prior claiming and non-working, infringing on patent system integrity by prolonging monopoly post-expiration.
An indispensable Tool for Legal Professionals, Endorsed by Various High Court and Judicial Officers
Please visit our Training & Support
Center or Contact Us for assistance
Scan Me!
India’s Legal research and Law Firm App, Download now!
For Daily Legal Updates, Join us on :
Back to top
