The US Court of Appeals for the Federal Circuit upheld a
district court finding that the patent challenger failed to prove
that patents directed to a testosterone replacement injection
therapy were valid and non-obvious. Endo Pharmaceuticals
Solutions, Inc. v. Custopharm Inc., Case No. 17-1719 (Fed.
Cir. July 13, 2018) (Chen, J).
Endo Pharmaceuticals holds the new drug application for Aveed, a
long-acting injectable testosterone undecanoate (TU) formulation.
Bayer Intellectual Property and Bayer Pharma own the two patents
listed in the Orange Book for Aveed. In 2014, Custopharm's
predecessor in interest, Paddock Laboratories, submitted an
abbreviated new drug application and a Paragraph IV certification.
Endo and Bayer subsequently sued Custopharm for patent
infringement.
