Nation

Cheaper High BP drug blocked: This is the reason

The product is a ‘supramolecular’ complex of the two compounds, for which a patent application filed in 2007 is still pending

The Health Master

November 5, 2021

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Last Updated on November 6, 2021 by The Health Master

Mumbai: Affordable versions of a hypertensive combination drug, Valsartan, will go off retail shelves soon.

The Delhi High Court has temporarily restrained drug companies — including Natco Pharma, Torrent Pharma, Eris Lifesciences and Windlas Biotech — from marketing generic copies of the popular combination Valsartan and Sacubitril, responding to a suit filed by the MNC Novartis.

The High Court ruled that the generic versions infringed the patent held by Novartis (IN051) on the combination of Valsartan and Sacubitril, used for treating hypertension.

The product is a ‘supramolecular’ complex of the two compounds, for which a patent application filed in 2007 is still pending, legal experts told TOI. The generic companies are also selling supramolecular versions of the drug.

Click for another orders of High Courts

A supramolecular complex is a structure where the two entities are arranged and bonded to form a single unit. As against this, in the patented version, the compounds are isolated, as in a physical mixture. The generic companies, including Natco, are expected to file an appeal soon.

The High Court held that the supramolecular complex is covered by the patent IN051 and is infringing it, the experts added. The order passed by Justice Jayant Nath hence upheld ‘prima facie’ validity of the patent.

“Hence, merely because the plaintiffs have filed an application for registration of a supramolecular complex of the two components of Valsartan and Sacubitril, being application No. 4412, does not modify or change the position vis-a-vis interpretation of claim 1 of the suit patent.

Prima facie, there is no merit in the said plea of the defendant,” the order, a copy of which is available with TOI, said.

Click for more on Novartis

The combination drug marketed by Natco as Valsac is priced at Rs 1,260 for the 50mg (28 tablets) and at Rs 1,540 for the 100mg, which was launched in 2019. Novartis markets the combination drug under the brand Vymada 50mg for around Rs 1,100 per 14 tablets’ strip.

When contacted, a company spokesperson said, “Novartis believes strongly in the intellectual property covering all our medicines and will continue to defend our IP rights.” Officials representing the generic companies were not available for comments.

According to the defendant, “The plaintiff, it is stated, has misleadingly and falsely stated that the said supramolecular complex is covered under the suit patent IN051.”

Further, the plaintiff has deliberately suppressed the fact that the plaintiff has also a supramolecular complex which is covered by the pending patent application.

In the said application, it is stated that the plaintiff has taken a stand that the supramolecular complex was invented much after the suit patent and was not known at the time of filing of the suit patent.

Further, the defendant has also filed a counter-claim for revocation of the Indian patent IN051, the order said.