Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

ENDO Pharmaceuticals Solutions, Inc. v. Custopharm Inc.

United States Court of Appeals, Federal Circuit

July 13, 2018

ENDO PHARMACEUTICALS SOLUTIONS, INC., BAYER INTELLECTUAL PROPERTY GMBH, BAYER PHARMA AG, Plaintiffs-Appellees
v.
CUSTOPHARM INC., Defendant-Appellant

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

          Nevin M. Gewertz, Bartlit Beck Herman Palenchar & Scott LLP, Chicago, IL, argued for plaintiffs-appellees. Also represented by Adam Mortara, John Scott McBride, Taylor A.R. Meehan, Faye Paul.

          Douglass C. Hochstetler, Kelley Drye & Warren, LLP, Chicago, IL, argued for defendant-appellant. Also represented by Constantine Koutsoubas, Sarita Mutha, Mark J. Scott; Clifford Katz, New York, NY.

          Before Moore, Linn, and Chen, Circuit Judges.

          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 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.

         Background

         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 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 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 specification.

         Claim 2 of the '640 patent covers a 750 mg dosage of TU in the composition described in claim 1:

A composition formulated for intramuscular injection in a form for single injection according to claim 1, which contains 750 mg testosterone un-decanoate.

'640 patent, col. 13, ll. 29-31 (emphasis added). Claim 1 reads:

A composition formulated for intramuscular injection in a form for single injection which contains 250 mg/ml testosterone undecanoate in a vehicle containing a mixture of castor oil and benzyl benzoate wherein the vehicle contains castor oil in a concentration of 40 to 42 vol %.

Id. at col. 13, ll. 24-28 (emphases added).

         Claim 18 of the '395 patent covers a 750 mg dosage of TU in the composition and method described by claim 14:

         The method of claim 14, in which each dose contains 750 mg of TU. '395 patent, col. 16, ll. 1-2 (emphasis added). Claim 14 reads:

A method of treating a disease or symptom associated with deficient endogenous levels of testosterone in a man, comprising administering by intramuscular injection a composition comprising testosterone undecanoate (TU) and a vehicle consisting essentially of castor oil and a co-solvent, the castor oil being present in the vehicle at a concentration of 42 percent or less by volume, the method further comprising:
(i) an initial phase comprising 2 initial intramuscular injections of a dose of TU at an interval of 4 weeks between injections, each dose including 500 mg to 1000 mg of TU, followed by,
(ii) a maintenance phase comprising subsequent intramuscular injections of a dose of TU at an interval of 10 weeks between injections, each dose including 500 mg to 1000 mg of TU.

Id. at col. 15, ll. 17-31 (emphases added). The key elements of both claims in dispute are: (1) 750 mg TU, (2) vehicle consisting of castor oil and a co-solvent (benzyl-benzoate in the '640 patent) where the castor oil is 42% or less by volume, and (3) an injection schedule comprising two initial injections at an interval of four weeks followed by injections at ten week intervals ('395 patent only).

         Bayer and Endo sued Custopharm for infringement of the '640 and '395 patents on November 20, 2014. The case proceeded to a bench trial on the sole issues of whether claim 2 of the '640 patent and claim 18 of the '395 patent would have been obvious to a skilled artisan in view of the prior art, which consisted primarily of three scientific articles: Behre, [1] Nieschlag, [2] and von Eckardstein[3] (Articles). These Articles describe small clinical studies involving 1000 mg TU injections. The Articles report using a composition of 250 mg/ml TU in castor oil. The parties agree that the Articles do not disclose or describe the use of a co-solvent. While the actual formulation of the vehicle used in the studies was 40% castor oil and 60% benzyl benzoate, this was not reported and thus unknown to a skilled artisan until 2007, years after the 2003 priority date ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.