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ARTICLE · 21 JANUARY 2011

Intellectual Property Update - January 2011

Morgan Lewis
Explore more from Morgan Lewis

In a recent decision, AstraZeneca LP v. Apotex, Inc., No. 2009-1381 (Fed. Cir. Nov. 1, 2010), the Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the District of New Jersey’s grant of a preliminary injunction barring defendant Apotex from distributing the generic version of AstraZeneca’s Pulmicort®.

United StatesIntellectual Property
C. Hawes
C. Hawes
Robert Busby
Robert Busby
Robert Gaybrick
Robert Gaybrick
William Matney, Jr.
William Matney, Jr.
David Levy
David Levy
Collin Park
Collin Park

The Federal Circuit Affirms the New Jersey District Court's Preliminary Injunction to Bar Generic Drug Pulmicort

In a recent decision, AstraZeneca LP v. Apotex, Inc., No. 2009-1381 (Fed. Cir. Nov. 1, 2010), the Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the District of New Jersey's grant of a preliminary injunction barring defendant Apotex from distributing the generic version of AstraZeneca's Pulmicort®.

Apotex filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to manufacture and sell a generic version of Pulmicort, a budesonide inhalation suspension developed and patented by AstraZeneca for treating asthma. AstraZeneca then filed a declaratory judgment action and moved to enjoin Apotex from distributing the generic drug. The district court granted AstraZeneca's request for a preliminary injunction, finding that Apotex would not likely prevail at trial in proving the AstraZeneca claims were invalid and that

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