WASHINGTON, Jan 16 - Drugmaker MSN Pharmaceuticals
cleared another hurdle on Thursday toward launching its generic
version of Novartis' blockbuster heart-failure drug
Entresto after a U.S. appeals court ended a temporary pause on
MSN's launch.
The U.S. Court of Appeals for the District of Columbia
Circuit lifted the pause less than 24 hours after it started,
potentially freeing MSN to launch its generic in the U.S. amid
an ongoing patent dispute between the companies.
Spokespeople and an attorney for Novartis did not
immediately respond to a request for comment and more
information on the ruling. An attorney for MSN declined to
comment.
India-based MSN's version of Entresto was approved by the
U.S. Food and Drug Administration last year. Novartis sued MSN
and others seeking to launch Entresto generics for patent
infringement.
Entresto is Switzerland-based Novartis' best-selling drug,
which brought the company more than $6 billion in revenue in
2023.
The U.S. Court of Appeals for the Federal Circuit last week
reversed a 2023 decision that invalidated one of the patents.
Novartis argued in a court filing that the appeals court ruling
maintained the company's exclusive rights to sell Entresto until
July.
The company said MSN was preparing to launch its generic on
Thursday, when Novartis' patent expired and MSN said that the
ban would end.
The Federal Circuit and U.S. district courts in Washington
and Delaware rejected Novartis requests for a mandate that would
immediately block the generic.
The D.C. Circuit paused MSN's launch on Wednesday night to
consider Novartis' bid for a longer delay as the court hears an
appeal related to the FDA's approval of the generic.
A three-judge D.C. Circuit panel lifted the pause on
Thursday and denied Novartis' request for a ban on the launch
for the duration of the appeal.