Amgen, Inc. v. Sandoz Inc.

Amgen, Inc. v. Sandoz Inc.

Opinion

SHIPP, District Judge

This matter arises from Hatch-Waxman Act patent infringement claims brought by Plaintiff Amgen, Inc. ("Amgen") against Defendants Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (together, "DRL"), Sandoz Inc., and Zydus Pharmaceuticals (USA) Inc. ("Zydus") (collectively, "Defendants"). The Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338, as well as under 28 U.S.C. §§2201 and 2202. The Court conducted a nine-day bench trial in this matter from June 14, 2021, to June 25, 2021.¹ (See ECF Nos. 479-87.) The parties submitted post-trial briefing, proposed findings of fact, and proposed conclusions of law on July 8, 2021. (ECF Nos. 467-71.) Closing arguments were heard on July 28, 2021. (ECF No. 492.)

Amgen has asserted five patents against Defendants: U.S. Patent No. 7,427,638 (the "'638 Patent"), U.S. Patent No. 8,455,536 (the "'536 Patent"), U.S. Patent No. 10,092,541 (the '"541 Patent"), U.S. Patent No. 7,893,101 (the '"101 Patent"), and [*5]  U.S. Patent No. 8,093,283 (the '"283 Patent") (collectively, the "patents-in-suit"). The asserted patents concern stereomerically pure apremilast, associated methods and dosages for using stereomerically pure apremilast to treat psoriasis, and several crystalline forms of apremilast. Defendants have sought approval from the U.S. Food and Drug Administration ("FDA") to market generic versions of apremilast. Amgen alleges that Defendants' generics will infringe the patents-in-suit.

This Opinion constitutes the Court's findings of fact and conclusions of law under Federal Rule of Civil Procedure 52(a). In evaluating the witnesses appearing at trial, and after the Court had the opportunity to hear their testimony and observe their demeanor, the Court undertook an individualized credibility assessment of each witness. The Court's findings of fact are based on those observations and credibility determinations of the witnesses, as well as a thorough review of the evidence admitted at trial. For the reasons stated below, the Court holds as follows:

1. As to the '638 Patent, Defendants have not met their burden of proving by clear and convincing evidence that the '638 Patent is invalid. As Defendants stipulated to infringement of the '638 Patent,² judgment of infringement will be entered in favor of Amgen [*6]  on the '638 Patent.

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