US Supreme Court Upholds Lower Court’s Ruling On Norwich Infringing Bauch Health’s Patent

US Supreme Court Upholds Lower Court’s Ruling On Norwich Infringing Bauch Health’s Patent

According to the US Securities and Exchange Commission, the diarrhea drug generated over $1.8 billion in sales in 2023

The US Supreme Court has spurned a bid by Alvogen's subsidiary Norwich Pharmaceuticals to sell a generic version of Canada-based Bausch Health's blockbuster medicine Xifaxan.

The court upheld a lower court's ruling that found Norwich's generic would infringe on patents held by Bausch.

The bench declined Norwich’s appeal against the lower court that its proposed generic would infringe patents owned by Bausch unit Salix Pharmaceuticals for using Xifaxan to treat liver-related brain disorder hepatic encephalopathy.

The US Food and Drug Administration approved Xifazan to treat traveler's diarrhea and irritable bowel syndrome. It can also be used to prevent hepatic encephalopathy.

Meanwhile, Bausch has agreed to allow Xifaxan generics from Teva Pharmaceuticals, Sun Pharmaceuticals and Sandoz starting in 2028 after settling patent disputes.

In 2020, Salix sued Norwich over its proposed generic of Xifaxan. In 2022, a Delaware federal judge ruled it would infringe three Salix patents related to hepatic encephalopathy while declaring other Salix patents invalid.

Norwich approached the patent-focused US Court of Appeals for the Federal Circuit to reverse the decision, but it was affirmed.

It pleaded before the apex court that the patents did not cover Xifaxan uses for which Norwich sought the approval of the Food and Drug Administration (FDA).

The New York state-based Norwich stated, "The cost of the delay in generic alternatives will be borne by patients and the healthcare system that will pay monopoly prices for treatments that are either not covered by a valid patent or are covered by patents that would have been proven invalid or not infringed by a generic alternative.”