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Preliminary Injunctions › Abbreviated New Drug Application (ANDA) › Food and Drug Administration (FDA)

Rothwell, Figg, Ernst & Manbeck, P.C.

Personal Jurisdiction Over Foreign Companies that File an ANDA or aBLA in the U.S.

Rothwell, Figg, Ernst & Manbeck, P.C. on

On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more

Knobbe Martens

Novartis Loses Bid for Preliminary Injunction Against MSN Pharmaceuticals

Knobbe Martens on

Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals.  Novartis Pharm. Corp. v. MSN Pharm. Inc., Civil Action No. 20-md-2930-RGA, Dkt. No. 1456...more

Robins Kaplan LLP

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Robins Kaplan LLP on

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Momenta Case

McDonnell Boehnen Hulbert & Berghoff LLP on

The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more

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