Delhi HC Restrains Eris Lifesciences from Infringing Novartis Sacubitril, Valsartan FDC

"Sacubitril, valsartan" is a new drug developed by Novartis for the treatment of heart failure and was named Entresto in the market. Entresto is a kind of salt complex which is composed of two active ingredients – Sacubitril and Valsartan. It uses valsartan to block the angiotensin II type-1 (AT1) receptor and sacubitril to inhibit enkephalinase.

Novartis filed an application seeking an injunction order to restrain the Gujarat-based drugmaker from manufacturing by itself or through third parties, importing, selling, offering for sale, exporting, directly or indirectly dealing in a pharmaceutical composition comprising a combination of valsartan or a pharmaceutically acceptable salt and a pharmaceutically acceptable carrier or more specifically a pharmaceutical composition comprising a combination of sacubitril plus valsartan as sodium salt complex or compound or in any other form as it amount to infringement of Indian Patent No. IN 229051.

Also Read: Sacubitril, Valsartan Combo Effective In High-Risk Heart Failure Patients: Circulation

In response to Novartis's application, Eris Lifescience counsel submitted that the company will follow the directions of the High Court for the State of Telangana dated 26.02.2021 as well as the affidavit submitted by it on 04.01.2021.

Telangana High Court in its order dated 26.02.2021 had observed;

"There shall be an interim injunction restraining the defendant/respondent, by itself or through its directors, group company, associates, divisions, assigns in business, licensees, franchisees, agents, distributors and dealers from using, manufacturing, importing, selling, offering for sale, exporting, directly or indirectly dealing in a 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 a combination of sacubitril + valsartan as sodium salt complex/compound or in any other form as may amount to infringement of Indian Patent No.229051 of the plaintiff No.1."

At this stage, it had been submitted that the Eris had manufactured a certain quantity of subject drug and they have an expiry date and unless said stock is disposed of, grave prejudice will be caused to the firm. 

Accordingly, the court had held, "Eris Life sciences is permitted to sell the quantity of drugs already manufactured before the status quo order was granted by this Court on 11.12.2020."

"However, Eris shall maintain account of the details of the quantity of drugs already manufactured, sold in pursuant to this order and the sale proceeds. He shall furnish the details to Novartis and shall also file an affidavit to that effect in the suit," the court had added.

Taking note of the order by the Telangana High Court, Delhi High recently court noted,

"As per the affidavit filed by the Eris Lifescience dated 04.01.2021, it has sold all the products mentioned in para 4 of the affidavit to the distributors/ stockist on a principal to principal basis."

In view of the above observation, the Delhi High Court pronounced its order as quoted;

"Defendant will abide by the above order/statement made in the affidavit. The application stands disposed of"

To access the official order, click on the link below-

https://indiankanoon.org/doc/170952457/