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Lower court found Norwich generic infringes Salix patents

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Alvogen has Xifaxan generic deals with Teva, Sun, Sandoz

By Blake Brittain

WASHINGTON, Nov 18 (Reuters) - The U.S. Supreme Court

turned away on Monday a bid by Alvogen's subsidiary Norwich

Pharmaceuticals to sell a generic version of Canada-based Bausch

Health's ( BHC ) blockbuster diarrhea drug Xifaxan.

The justices declined to hear an appeal by Norwich

Pharmaceuticals of a lower court's ruling that its proposed

generic would infringe patents owned by Bausch unit Salix

Pharmaceuticals for using Xifaxan to treat the liver-related

brain disorder hepatic encephalopathy. In doing so, the justices

let the lower court's ruling stand.

Xifaxan has been approved by the U.S. Food and Drug

Administration to treat traveler's diarrhea and irritable bowel

syndrome and can also be used to prevent hepatic encephalopathy.

Bausch earned more than $1.8 billion from Xifaxan sales in 2023,

according to a company filing with the U.S. Securities and

Exchange Commission.

Bausch has separately agreed to allow Xifaxan generics from

Teva Pharmaceuticals, Sun Pharmaceuticals and

Sandoz starting in 2028 after settling related patent

disputes.

Salix in 2020 sued New York state-based Norwich over its

proposed generic of Xifaxan. A Delaware federal judge decided in

2022 that the generic would infringe three Salix patents related

to treating hepatic encephalopathy while declaring other Salix

patents invalid.

Norwich asked the patent-focused U.S. Court of Appeals for

the Federal Circuit to reverse the judge's decision to block its

generic. The Federal Circuit affirmed the decision in April.

Norwich in a filing told the Supreme Court that the patents

did not cover Xifaxan uses for which Norwich had sought FDA

approval.

"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 that are covered by patents that would have been

proven invalid or not infringed by a generic alternative,"

Norwich said in the filing.

Bausch did not respond to Norwich's Supreme Court petition.