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  • US Appeals Court...

US Appeals Court decision favors MSN Pharma in Novartis heart drug Entresto generic dispute

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-12-09T10:00:31+05:30  |  Updated On 9 Dec 2024 4:46 PM IST
Novartis arm commences tender offer to acquire Regulus Therapeutics
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Novartis suffered a legal setback on Wednesday as the company failed to persuade a U.S. appeals court to halt MSN Pharmaceuticals' proposed generic of Entresto, Novartis' blockbuster heart medication.

The U.S. Court of Appeals for the Federal Circuit upheld an earlier decision by a Delaware federal judge that found Novartis failed to prove it was likely to succeed in its patent lawsuit against MSN Pharmaceuticals, clearing the way for MSN to introduce the first U.S. generic version of Entresto.

As per a Reuters report, Novartis said in a statement that it disagrees with the ruling and is "considering all available options to vigorously defend our intellectual property rights, including further appellate options."

Spokespeople and attorneys for MSN did not immediately respond to a request for comment.

Entresto is Switzerland-based Novartis' best-selling drug, bringing the company more than $6 billion in revenue last year. MSN's version of Entresto was approved by the U.S. Food and Drug Administration in July.

Novartis sued MSN and others seeking to launch Entresto generics in Delaware federal court in 2022 for allegedly infringing a patent that expires in 2026. It requested a preliminary injunction after the FDA's approval that would block MSN from launching its generic during the case, which is set to go to trial on Monday.
Read also: Novartis Kisqali gets European Commission nod in patients with HR+/HER2-early breast cancer at high risk of recurrence
U.S. District Judge Richard Andrews rejected Novartis' request in August, ruling that it was not sufficiently likely to win on its infringement claims to justify the injunction. The judge paused MSN's launch of its proposed generic while Novartis appealed to the Federal Circuit.

The Washington-based appeals court affirmed Andrews' decision on Wednesday and said it saw "no clear error in the district court's analysis."

Read also: Novartis bolsters Neuroscience pipeline with in-licensing of PTC518 for Huntington's disease

novartisnovartis newsmsn pharmaheart drugentresto
Source : with inputs
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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