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Endo Pharms. Sols., Inc. v. Custopharm Inc.

United States Court of Appeals for the Federal Circuit

July 13, 2018, Decided



 [*1376]   [***1411]  Chen, Circuit Judge.

Endo Pharmaceuticals Solutions, Inc. (Endo) holds the approved New Drug Application for Aveed®, a testosterone undecanoate (TU) intramuscular injection. Bayer Intellectual Property GmbH and Bayer Pharma AG (Bayer) own the two patents listed in the Orange Book for Aveed®, U.S. Patent Nos. 7,718,640 (the '640 patent) and 8,338,395 (the '395 patent). Custopharm Inc.'s (Custopharm) predecessor-in-interest, Paddock Laboratories, LLC, submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to produce and market a generic version of Aveed®. In connection with the ANDA filing, Custopharm made a Paragraph IV certification and [**2]  gave notice of the certification to Endo and Bayer on October 8, 2014. On November 20, 2014, Endo and Bayer brought an action alleging infringement of the '640 and '395 patents. During the proceedings, Custopharm stipulated to infringement, and Endo and Bayer limited their asserted claims to claim 2 of the '640 patent and claim 18 of the '395 patent. After a four-day bench trial on invalidity, the district court concluded that Custopharm had not proven that the claims were invalid under 35 U.S.C. § 103. Custopharm appealed. For the reasons below, we find no reversible errors in the district court's conclusion and accordingly, we affirm.


Aveed® is a long-acting injectable testosterone replacement therapy for men suffering from physiologically low levels of testosterone, also known as hypogonadism. Before the 2003 priority date for the invention claimed in the '640 and '395 patents, then-existing testosterone replacement therapies had three significant shortcomings. First, the existing injectable therapies required patients to visit their doctors  [*1377]  every two or three weeks to receive intramuscular injections, and the available topical therapies required daily application. Second, the available therapies required the prescribing doctor to adjust [**3]  the dosage or intervals of administration for each patient, which required doctors to frequently monitor their patients' testosterone levels. Third, the pre-2003 therapies did not provide stable testosterone levels, leading to periods of low testosterone between treatments. Patients would experience elevated testosterone levels immediately after an injection, but testosterone levels would fall to below the normal physiological range before the next injection.

Aveed®'s patented formulation addressed some of these shortcomings: (1) after the initial two injections, Aveed® is only administered five times a year; (2) it is a treatment that works for nearly all men suffering from hypogonadism, thus obviating the need for doctors to personalize testosterone replacement therapy; and (3) patients on Aveed® avoided the fluctuations in testosterone levels associated with other injectable products on the market before 2003. Claim 2 of the '640 patent and claim 18 of the '395 patent cover Aveed®'s formulation and injection regimen. Both patents, entitled "Methods and Pharmaceutical Compositions for Reliable Achievement of Acceptable Serum Testosterone Levels," issued from the same parent application and share a common [**4]  specification.

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894 F.3d 1374 *; 2018 U.S. App. LEXIS 19265 **; 127 U.S.P.Q.2D (BNA) 1409 ***


Prior History:  [**1] Appeal from the United States District Court for the District of Delaware in No. 1:14-cv-01422-SLR-SRF, Judge Sue L. Robinson.

Endo Pharms. Solutions Inc. v. Custopharm, Inc., 234 F. Supp. 3d 587, 2017 U.S. Dist. LEXIS 19035 (D. Del., Feb. 10, 2017)

Disposition: AFFIRMED.


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Patent Law, Jurisdiction & Review, Standards of Review, Clearly Erroneous Review, Nonobviousness, Evidence, Fact & Law Issues, Elements & Tests, Prior Art, De Novo Review, Evidence, Burdens of Proof, Allocation, Clear & Convincing Proof