Interim relief to Novartis: Delhi HC reinstates Entresto (Sacubitril-Valsartan) patent in India

The patents of the Entresto Fixed Dose Combination (FDC) were set to expire on January 16, 2023. The new patent secured by Novartis on December 14, 2022 prohibits companies from launching the chemically combined complex of the sacubitril and valsartan till 2026.

However, Justice Hari Shankar in his order on January 2023 had stayed the patent awarded to Novartis, and had asked the Controller of Patents & Designs to hear the opposition to the patent.

The stay had come in response to a writ petition filed by Natco Pharma against the grant of patent by IPO to the pharmaceutical composition comprising combination of sacubitril + valsartan as a sodium salt complex of the Vymada.

Natco had filed writ petition citing procedural irregularities and violation of principles of natural justice by the Assistant Controller of Patents & Designs in awarding patent to Novartis drug on December 14, 2022.

Also Read: Novartis In Tight Spot As HC Stays Grant Of Patent For Entresto Amid Generics Fight

"Erroneous Interpretation of Rule 55"

Lately, Gopal Subramanium, counsel for Novartis, submitted an "erroneous interpretation of Rule 55" and emphasized that the impugned order was passed without directing or giving an opportunity to file a counter affidavit. He also called for a stay of the impugned order on the ground that the patent in question was granted after 16 years of the application being filed and with only three and a half years of the patent term left.

Relying upon the judgment of the learned Single Judge of Delhi High Court in W.P.(C)-IPD 15/2021 titled as Haryana Pesticides Manufacturers Association vs. Willowood Chemicals Limited, Subramanium argued;

"The said interpretation is erroneous as Rule 55 only prescribes procedure for disposal of pre-grant opposition under Section 25(1) of the Patents Act, 1970, whereas the procedure for examination of patent applications is prescribed under Sections 14 and 15 of the Act read with Rules 24B, 28 and 28A."

He added that;

"The learned Single Judge has given a finding of violation of principle of natural justice based on erroneous interpretation of Rule 55 which relates to procedure prescribed for disposal of pre-grant opposition under Section 25(1) and not examination under Sections 13, 14 and 15 for which procedure is prescribed under Rule 24B."

Meanwhile, Amit Sibal, learned senior counsel for Natco Pharma submitted that in the present case there has not only been violation of principles of natural justice, but also of the statutory mandate as enshrined in Sections 14 and 15 and Rule 55 of the Patent Acts and Rules. He submitted that;

"The procedure adopted by the Controller of Patents is contrary to the procedure laid down by this Court in Best Agrolife Limited vs. Deputy Controller of Patents & Anr., 2022 SCC OnLine Del 1982 and Regents of the University of California vs. Union of India & Ors., 2019 SCC OnLine Del 8590 as well as the directions given by the learned Single Judge in inter party writ petition being W.P(C)-IPD 91/2021, Natco Pharma Limited vs. Union of India & Ors. dated 12th July, 2022."

After hearing the counsel for the parties, the Court said;

"Issues as to whether once the pre-grant opposition is filed both examination and opposition proceedings stand merged and also whether any examination of the application can be undertaken by the Controller without issuance of a Notice to the opponent, arise for consideration in the present appeal. Accordingly, issue notice."

The bench asked the contesting parties to file their written submissions not exceeding five pages before the next date of hearing, and directed the Controller to produce its relevant original record wherein the order dated 14th December, 2022 has been passed in a sealed cover. It held;

"Till the next date of hearing, there shall be stay of the impugned judgment. However, the Novartis shall maintain accounts of its expenses and sales."

"The Controller is directed to produce its relevant original record wherein the order dated 14th December, 2022 has been passed in a sealed cover on the next date of hearing."

The matter has been listed for hearing and disposal on February 1, 2023.

To view the original judgement, click on the link below: