Here is a report on recent news and commentary related to the Federal Circuit and its cases. Today’s report highlights recent discussion of march-in rights by Democratic candidates for president, identification of a trend toward use of the enablement requirement rather than the written description requirement to invalidate patent claims in the life-sciences, and analysis of a revised dataset exploring the divergence in treatment of patent eligibility between the United States and the European Patent Office and/or China.
Valarie Bauman authored an article published by Bloomberg Law discussing how “[s]everal Democratic candidates for president have been touting a method for reclaiming drug patents”—including march-in rights under the Bayh-Dole Act—”as a silver bullet approach they would use to lower the cost of medication.” Bauman notes that “any decision in favor of march-in rights would . . . be appealable to the Court of Federal Claims—which then could be appealed to the U.S. Court of Appeals for the Federal Circuit.”
In commentary published by Law360, Katherine Helm and Vi Tuong Tran contend that, for life-sciences patents, “written description compliance has historically been the most frequent challenge to the validity of patent claims,” but “recent case law reveals a shift in focus” toward “invalidating claims to functionally defined genera involving both small and large molecules based on a lack of enablement.”
Over at IPWatchdog, Kevin Madigan and Adam Mossoff analyze a “dataset of 17,743 patent applications that had been filed in the United States, China, and Europe.” They had previously reported that “the dataset identifies 1,694 patent applications . . . that received initial or final Section 101 rejections and were ultimately abandoned in the United States, only to be granted patents by the EPO, China, or both.” They now note that the have received a revised dataset reflecting the fact that “a number of the applications now have issued U.S. family members, . . . some that were abandoned have had the abandonments withdrawn and now are either pending or have been issued as patents[, and] some of the rejections were withdrawn prior to abandonment.” They now report that the “revised dataset confirms that 1,310 applications were abandoned following rejections under the Alice–Mayo framework for lack of patent eligible subject matter, and yet had issued patent family members in either China or Europe.” As part of their commentary, they note that “patent ineligibility . . . is spreading beyond just medical treatments, drugs, and high-tech innovations,” highlighting that “[c]ourts have invalidated patents covering methods of using garage door openers and operating oil derricks,” before specifically noting the Federal Circuit’s decision in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC in the context of an automobile axle.