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ARTICLE · 23 AUGUST 2017

Court Dismisses Infringement Theory Premised On Speculated Future Formulation Changes

McDermott Will & Emery
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The US District Court for the District of New Jersey granted generic manufacturer's motion for judgment on the pleadings under Fed. R. Civ. P. 12(c) on the basis of non-infringement.

United StatesIntellectual Property
Shon Lo
Shon Lo
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The US District Court for the District of New Jersey granted generic manufacturer's motion for judgment on the pleadings under Fed. R. Civ. P. 12(c) on the basis of non-infringement. Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Case No. 16-cv-02290 (D.N.J. Feb. 1, 2017) (Walls, J.).

Par is the New Drug Applications (NDA) holder and assignee of the two Orange Book-listed patents for Adrenalin®, 1 mg/ mL injectable epinephrine. Adrenalin® is indicated for the emergency treatment of allergic reactions and induction and maintenance of mydriasis (dilation of the pupil) during intraocular surgery. The two Orange Book patents, US Patent Nos. 9,119,876 and 9,295,657, are directed to pharmaceutical compositions comprising epinephrine and various specified excipients, and methods of treatment using such compositions.

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