On July 13, 2018, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) held that a prior art reference does not inherently disclose the elements of a claim limitation if the prior art describes the performance of the elements but does not include a complete description of the elements, finding the patents of Endo Pharmaceuticals Solutions Inc. (“Endo”) not invalid for obviousness.
Bayer Intellectual Property GmbH (“Bayer”) holds U.S. Patent Nos. 7,718,640 (“the ”²640 patent”) and 8,338,395 (“the ”²395 patent”), both of which disclose three primary elements for drug Aveed, a testosterone undecanoate (“TU”) intramuscular injection: (1) 750 mg dosage of TU, (2) a 40% castor oil and 60% benzyl benzoate vehicle, and (3) a specific injection schedule. Custopharm Inc. (“Custopharm”) submitted an Abbreviated New Drug Application for FDA approval to market a generic version of Aveed. Subsequently, Endo Pharmaceuticals Solutions, Inc. (“Endo”), and Bayer sued Custopharm for infringement of two patents. Custopharm stipulated to infringement, and the U.S. district court for the District of Delaware (“district court”) determined that the asserted claims were not invalid as obvious. Custopharm appealed.
On appeal, the Federal Circuit affirmed the district court”™s decision of nonobviousness, rejecting Custopharm”™s arguments for finding the three elements obvious. Regarding the 750 mg dosage of TU, Custopharm provided that the American Association of Clinical Endocrinologists Guidelines stated that patients in prior art clinical studies were being overdosed based on its identified normal testosterone levels. Custopharm argued that, in light of that fact, a skilled artisan would have been motivated to reduce the dosages identified in the prior art. The Federal Circuit rejected this argument, providing that Custopharm”™s argument “improperly assumes that the only solution to overdosed patients is to reduce dosage rather than extending the injection intervals.”
Per the benzyl benzoatevehicle formulation, the Federal Circuit rejected Custopharm”™s argument stating that the vehicle formulation was inherently disclosed. Custopharm reasoned that the vehicle formulation was “necessarily present” in the prior art because “it was later revealed to be the actual formulation the authors of the Articles used in their reported clinical studies.” The opinion provided that Custopharm incorrectly extrapolated the vehicle formulation in the prior art and that “the incomplete description of the TU injection composition elements denied skilled artisans from having access to that composition, thereby precluding use of the inherency doctrine to fill in disclosure about the product missing from the articles.”
As to the injection schedule, the Federal Circuit did not find Custopharm”™s argument, that the schedule would have been obvious, persuasive. Custopharm provided that because a skilled artisan would have recognized that patients injected with 1000 mg TU as disclosed in the prior art were being overdosed, the injection schedule would have been obvious. The Federal Circuit agreed with the district court”™s finding that “Custopharm failed to meet its burden of showing that a skilled artisan would combine the lowered dose with the injection schedule in the manner claimed.” Accordingly, the Federal Circuit affirmed the district court”™s decision of nonobviousness.