WASHINGTON, Jan 15 - A Washington, D.C. federal judge on
Wednesday refused Novartis' eleventh-hour bid to block
drugmaker MSN Pharmaceuticals from launching a generic version
of Novartis' blockbuster heart-failure drug Entresto.
The decision by U.S. District Judge Dabney Friedrich clears
a hurdle for MSN to introduce the first U.S. generic version of
Switzerland-based Novartis' best-selling drug, which brought the
company more than $6 billion in revenue in 2023.
An attorney for MSN declined to comment on the decision. An
attorney and spokespeople for Novartis did not immediately
respond to a request for comment.
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. The U.S. Court of Appeals for
the Federal Circuit last week reversed a 2023 decision by a
Delaware judge 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 expires
and MSN said that the ban would end.
MSN told the appeals court that the ban would expire on
Thursday regardless of the decision.
The Federal Circuit on Tuesday rejected Novartis' request
for a mandate that would immediately block the generic.
Novartis separately sued the U.S. Food and Drug
Administration in Washington federal court on Monday to block
the launch. The FDA responded on Wednesday that only the courts
hearing the patent case could halt it.
Friedrich agreed with the FDA and said she would reject
Novartis' request during a hearing late Wednesday.
A separate Novartis emergency request to pause the launch is
still pending in the U.S. Court of Appeals for the District of
Columbia Circuit.