Last month, the Federal Circuit affirmed the Delaware district court’s 2017 decision in Endo Pharms. Sols., Inc. v. Custopharm that patents for Aveed®, a testosterone replacement therapy, were not obvious and, therefore, inherent teachings did not apply.
The Approved Drug Products with Therapeutic Equivalence Evaluations publication, known as the “Orange Book” for Food and Drug Administration (FDA)-approved drugs, includes U.S. Patents Nos. 7,718,640 and U.S. 8,338,395 for Aveed®. While Bayer claims the two patents, Endo has the approved new drug application (NDA) for the testosterone replacement therapy.
When Custopharm submitted an abbreviated new drug application (ANDA) to the FDA for a generic version of Aveed®, Endo and Bayer sued for infringement. Per Foley & Lardner LLP:
“In the district court, 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. The resulting bench trial concerned invalidity of those claims. The district court concluded that Custopharm had not proven invalidity under § 103.”
As Dennis Crouch of Patently-O details, Custopharm’s generic version requires a specific concentration of testosterone undecanoate (TU) and a vehicle composed of approximately 40% castor oil and 60% benzyl benzoate. While prior art references are identical in the composition containing TU and castor oil, they do not include benzyl benzoate. Says Crouch:
“A primary question on appeal was whether the prior art articles inherently taught the benzyl benzoate concentration. ‘Custopharm contends that the Articles inherently describe the vehicle formulation (40% castor oil and 60% benzyl benzoate).’”
While Custopharm had argued in district court that “a skilled artisan” could have determined that the vehicle consisted of the solvent castor oil and co-solvent benzyl benzoate, neither the district court nor the Federal Circuit agreed.
Crouch speculates that the case might have had a different outcome for Custopharm had it been able to rely on uses in experiments as prior sales or public uses. Says Crouch, instead of focusing on what was publicly known or disclosed about the injection, the question would have centered on what was in the injection.