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A Single Bench of Delhi High Court has issued an interim order restraining various Indian manufacturers from manufacturing, selling, offering for sale any pharma preparations infringing the patent of Novartis’ cardiovascular drug marketed as Vymada in India. The Court has also directed Eris Lifesciences to deposit a sum of Rs, 5 crore for allegedly marketing the drug after a Court’s restraining order on December 21, 2022.
Novartis filed suits against Eris Lifesciences Ltd, Windlas Biotech Pvt Ltd and Chhabra Healthcare Solutions Pvt Ltd, seeking permanent injunction restraining them from infringement of its Indian patent No. IN 229051, damages, rendition of accounts, delivery up etc. The patent relates to a pharmaceutical composition of Valsartan and Sacubitril, used for the treatment of cardiovascular disease.
Novartis has been engaged in patent litigation with various pharma companies to protect the patent right of the drug, and in December, 2020, a Telengana Court has issued a status quo order in a suit against MSN Laboratories Pvt Ltd. In February, 2021, the Division Bench of Telangana High Court permitted the sale of the quantity of drugs MSN has produced before the status quo order and submitted the details of the sales to Novartis and to the Court.
Parallelly, Novartis has approached the Delhi High Court against Eris LifeSciences and the Court directed the latter to file an affidavit detailing the stock of the product available with it, along with a direction to maintain status quo.
Eris LifeSciences informed the Court that it purchases the product Zayo from MSN Laboratories and the batches it has received in December, 2020, before the status quo was ordered, was sold to the hospitals and pharmacies across the country through stockists and distributors.
The Court also directed Eris Lifesciences to disclose the stocks received from Windlas Biotech and the company has submitted that it has received certain batches of the product from the latter in February and March, 2021 and it has been sold to the distributors and stockists who in turn sell to various hospitals and pharmacies across the country.
Eris, in an affidavit on July 5, 2021, submitted to the Court that the value of goods received from MSN for the tablets under the trade mark Zayo is around Rs. 43 crore and the total value of goods on MRP basis received from Windlas Biotech is around Rs. 60.5 crore, of which around Rs. 43 crore would be realisable in the hands of the company as it sells the product on wholesale basis.
Novartis’ Counsel alleged that an illegal modus operandi has been adopted by MSN Laboratories, Eris Lifesciences and Windlas Biotech to circumvent the injunction order passed by the Telangana High Court. The literature in the product Zayo refers to MSN Laboratories.
Eris argued that Novartis’ suit patent does not cover the combination of drug it sells. It added that the order on December 21, 2020 mandating status quo on Eris was passed only on MSN products and did not cover any products manufactured by Windlas. The order against Windlas was passed only on March 26, 2021 and the company has not violated the injunction.
Justice Prathiba M Singh, hearing the arguments, observed that the order on MSN Laboratories permits the company to sell the products manufactured prior to December 11, 2020 and the question as to whether the products manufactured by Windlas were those which were manufactured by MSN Laboratories or not is a question which would have to be established at trial. The appearance of the name MSN Laboratories in the product literature of Windlas is inexplicable, at this stage, said the Judge.
The Court also considered that the patent under dispute is due to expire in January, 2023 and the data submitted by Novartis is more than 10 months old. Recall from distributors or retailers would be an extremely cumbersome exercise and may result in panic, it observed.
The Court, following this, on March 25, 2022, ordered that there shall be an interim injunction restraining all the defendants in these matters from manufacturing, selling, offering for sale any pharmaceutical preparations which are a combination of Sacubitril and Valsartan, either in tablet form or any other form, either packaged as strips or in bottles/containers, and from infringing the patent of Novartis, in any manner.
In respect of the stocks captured, marketed by Eris Lifesciences post the passing of the order on December 21, 2020, Eris Lifesciences is directed to deposit a sum of Rs. 5 crore with the worthy Registrar General of the Court, within a period of six weeks, subject to the outcome of the suits. The Court directed to list the matter for framing of issues and case management, on August 1, 2022.
Novartis AG last year received a favourable order in four petitions, filed by Novartis against Natco Pharma, Torrent Pharmaceuticals, Eris LifeSciences and Windlas Biotech regarding the same patent.
The patent was granted on February 13, 2009. The combination is an effective treatment of heart failure and hypertension involving a great amount of research and experiments on the part of Novartis, claims the company.
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