On August 28, 2019, the District Court for the District of Delaware issued an opinion related to the validity of two of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab). After a jury found that two of the five asserted claims of the ‘165 and ‘741 patents were invalid for lack of written description, but that Sanofi had failed to prove that the remaining three claims were invalid, the Court granted Sanofi’s motion for judgment as a matter of law that the asserted claims are invalid for failing to comply with the enablement requirement. The Court concluded that “any reasonable factfinder would find that practicing the claims’ full scope would require substantial experimentation,” and “as a matter of law [] undue experimentation would be needed to practice the full scope of the claimed invention.”
The District Court’s decision comes after a relatively long procedural history. In March 2016, a jury issued a verdict that the patents were valid. As a result, the district court entered a permanent injunction against the sale of Praluent®, but stayed the injunction pending appeal. Sanofi then appealed to the Federal Circuit, which vacated the injunction and reversed the District Court for errors made in evidentiary rulings and jury instructions, and remanded the case for a new trial on written description and enablement. On remand, a second jury trial occurred where the parties “tried the issues of written description and enablement to the jury. ” At the second trial, the jury “found claim 7 of the ‘741 patent and claims 19 and 29 of the ‘165 patent valid, but invalidated claims 7 and 15 of the ‘165 patent for lack of written description.” After the second jury verdict, Sanofi asked the Court to overturn the jury verdict or grant a new trial. As discussed above, the Court granted Sanofi’s motion to overturn the jury verdict and find all of the asserted claims invalid.
In the same opinion, the Court upheld the jury’s verdict on the issue of written description; denied Amgen’s motion for a permanent injunction; and conditionally denied Sanofi’s motion for a new trial.