A Shot in the Arm for Low T Patents
In Endo Pharm Solutions v. Custopharm Inc. the Fed. Cir. affirmed the district courts conclusion that Custopharm has not proven obviousness. The claims were directed to a 750 mg composition of testosterone undecanoate for single injection intramuscularly at a concentration of 250 mg/ml in a vehicle containing 40 to 42 vol% of castor oil and benzyl benzoate, as well as to a two-phase injection method of two initial phase injection followed by maintenance injections every 10 weeks. The method provided for stable testosterone levels and avoided doctor prescribed dose adjustments. Custopharm argued that a dosage of 750 mg would have been obvious based on the known 1,000 mg dosage causing an overdosing by AACE Guidelines and provided motive to reduce the dosage. The FDA guidelines at the time were broader and thus not suggestive of overdosing and solutions to overdosing were broader than simply reducing the dosage. The cited art was not found to inherently disclose the claimed solvent/co-solvent combination, in spite of having actually used the claimed combination and reporting pharmacokinetic performance data because there was no evidence that pharmacokinetic data could be conclusively traced to the solvent/cosolvent combination. The claimed two-phase dosing regimen was found not to be the result of a simple adjustment. Inherency requires that the limitation necessarily must be present, or the natural result of the combination of elements explicitly disclosed.