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Interim relief to Novartis: Delhi HC reinstates Entresto (Sacubitril-Valsartan) patent in India
Delhi: In an interim relief to Swiss pharma major Novartis, the Delhi High Court has reinstated Entresto (sacubitril/valsartan) patent in India amid the high drama that prevailed in view of the blockbuster heart failure drug going off-patent on January 16, 2023.Right after Vymada or Entresto patent expiry, the decks cleared for other domestic players to manufacture their own generic...
Delhi: In an interim relief to Swiss pharma major Novartis, the Delhi High Court has reinstated Entresto (sacubitril/valsartan) patent in India amid the high drama that prevailed in view of the blockbuster heart failure drug going off-patent on January 16, 2023.
Right after Vymada or Entresto patent expiry, the decks cleared for other domestic players to manufacture their own generic counterparts. Various drug makers jumped on the chance to market generic versions of the heart failure-drug at slashed prices, causing major disruptions in India’s cardiology sector.
JB Chemicals & Pharmaceuticals Ltd (JB Pharma), announced a substantial price decrease of approximately 50% for the critical heart failure drug "Azmarda", which contains the patented molecule Saccubutril-Valsartan.
Also Read: JB Pharma Slashes Price Of Critical Heart Failure Medicine AZMARDA (Sacubitril-Valsartan) By Nearly 50 Percent
Glenmark launched sacubitril and valsartan combination tablets under brand 'Sacu V' and is priced at Rs 19 per tablet for a dose of 50mg (sacubitril 24mg + valsartan 26mg), Rs 35 per tablet for a dose of 100mg (sacubitril 49mg + valsartan 51mg), and Rs 45 per tablet for a dose of 200mg (sacubitril 97mg + valsartan 103 mg) in India.
Mankind Pharma reduced the price of its drug, NEPTAZ, (launched in a collaborative agreement with Novartis in 2022) by 70 percent in India. Further, Dr Reddy's, which has acquired Cidmus (sacubitril/valsartan) from Novartis in April last year, also cut the price by over 60% to Rs 29 a tablet of 50 mg, and 100 mg tablet by 49% to Rs 49.
Also Read: Dr Reddy's Labs, Novartis Ink Pact For Cardiovascular Brand Cidmus
However, during the recent hearing on the ongoing Natco Pharma Vs Novartis case, the Swiss drug maker got some breather as a two-judge bench consisting of Justice Saurabh Banerjee and Justice Manmohan stayed a previous order that invalidated the stay on the patent granted to Novartis by the Indian Patent Office (IPO) in 2022.
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:
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at email@example.com Contact no. 011-43720751