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Impax Laboratories, Inc. v. Zydus Pharmaceuticals (USA), Inc.

United States District Court, D. New Jersey

July 25, 2019

IMPAX LABORATORIES, INC., Plaintiff,
v.
ZYDUS PHARMACEUTICALS (USA), INC. et al., Defendants.

          OPINION & ORDER

          Stanley R. Chesler, U.S.D.J.

         This matter comes before the Court on the application for claim construction by Plaintiff Impax Laboratories, Inc. (“Impax”) and Defendants Cadila Healthcare Ltd. and Zydus Pharmaceuticals (USA), Inc. (collectively, “Zydus”). In this patent infringement suit involving a pharmaceutical patent, the parties seek construction of a claim term in U.S. Patent No. 9, 089, 608 (“the '608 patent”).

         The parties dispute the construction of the term “a controlled release oral solid formulation of levodopa” in claim 21, which states:

         A controlled release oral solid formulation of levodopa having a median levodopa plasma or serum concentration profile comprising:

a. a time of administration;
b. a first concentration at a first time, that occurs within one hour of said time of administration;
c. a second concentration at a second time, that occurs after said first time;
d. a third concentration at a third time, that occurs at least four hours after said second time;
wherein said second concentration is equal to the maximum concentration of said profile; said first concentration is equal to about fifty percent of said second concentration; said third concentration is equal to about fifty percent of said second concentration.

         Plaintiff contends that the term has its ordinary meaning and does not need construction.

         Zydus contends that the term should be construed as follows:

         A controlled release oral solid formulation of levodopa that contains

(a) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate ...

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