In a suit brought by Amgen Inc., Amgen Manufacturing, Ltd., and Amgen USA, Inc. (collectively, Amgen) against Sanofi, Aventisub LLC, Regeneron Pharmaceuticals Inc., Sanofi-Aventis U.S. LLC (collectively, Sanofi) more than six years ago, the Federal Circuit has affirmed the district court’s determination that certain Amgen patent claims were invalid for lack of enablement. The asserted claims of Amgen’s two patents describe antibodies that help the body regulate low-density lipoprotein cholesterol (LDL).
According to Thursday’s opinion, this was the second time the patents have been before the Federal Circuit. The present dispute concerned whether Amgen’s asserted claims were invalid for lack of enablement. In order to pass the federal enablement requirement, the court explained, the question is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation.
The district court found that the patents’ three asserted claims failed to do so as a matter of law. The appellate court reviewed the decision for clear error. It considered precedential case law in determining whether the specifications enabled the claimed invention, the identification of antibodies that purportedly bind to a specific protein and lower LDL levels by blocking the protein from binding to LDL receptors at the cellular level.
The Federal Circuit first agreed with the district court that “the specification here did not enable preparation of the full scope of these double-function claims without undue experimentation.” It also acknowledged that the claimed inventions were in an unpredictable field of science, consistent with the testimony of two of Amgen’s own experts.
Turning to factors set forth by circuit precedent, the appellate panel confirmed the district court’s estimation that the scope of the claims were “indisputably broad.” It held that the lower court did not err in concluding that undue experimentation would be required to practice the full scope of the claims. The panel explained that “[t]he functional limitations here are broad, the disclosed examples and guidance are narrow, and no reasonable jury could conclude under these facts that anything but ‘substantial time and effort’ would be required to reach the full scope of claimed embodiments.”
Ultimately, the court sided with Sanofi in finding that the asserted claims were invalid for lack of enablement and taxed the appellate costs against Amgen.