The U.S. Patent and Trademark Office (PTO) has posted a notice of proposed rulemaking in response to a case decided by the Supreme Court in 2018, SAS v. Iancu, and the first item on the PTO agenda is to formally require that an inter partes review (IPR) consist of an exhaustive review of all the claims contested by the petitioner.
In a decision that seems to have yet again roiled the patent subject matter eligibility question, the U.S. Court of Appeals for the Federal Circuit determined that a district court had erred in determining the 7,941,207 patent held by Cardionet LLC, of Conshohocken, Pa., is not eligible for patent protection.
The U.S. Supreme Court has declined to hear the case of Athena v. Mayo, which many hoped would ease the patent subject matter eligibility problem. This outcome leaves Congress and the Court of Appeals for the Federal Circuit as the only likely sources of resolution for the problem, but there is skepticism as to whether either of these parties is both willing and able to overcome the impasse.
Those who believe the U.S. Supreme Court must revisit the patent subject matter eligibility problem may get their wish. While Solicitor General Noel Francisco advised the Court that it should not hear the Berkheimer case, he nonetheless said that Athena v. Mayo might avail the Supreme Court of the appropriate fodder for resolving the ongoing subject matter eligibility problem.
The patent lawsuit of Athena v. Mayo revisits previous case law where patent subject matter eligibility is concerned, and numerous parties have weighed in urging the Supreme Court to hear the case. However, the U.S. Solicitor General has not responded with its own friend-of-the-court brief, an omission that would seem to take some of the pressure off the Supreme Court to hear the case.
The U.S. Court of Appeals for the Federal Circuit has decreed that the regulations governing appointment of judges to the Patent Trial and Appeal Board (PTAB) violate the U.S. Constitution – a decision that gives a medical device maker a new bite at patent litigation, but which also raises the question of whether a large number of PTAB decisions will have to be relitigated.
CLEVELAND – Patents took center stage on the final morning of Cleveland Clinic's Medical Innovation Summit, with two experts shedding some light on the issues surrounding patentability – particularly in light of recent legal cases and a hearing before a subcommittee of the Senate Judiciary Committee.
The U.S. False Claims Act has been the subject of a substantial body of jurisprudence and policymaking, but the legal terrain has not necessarily grown any more predictable for makers of drugs and medical devices. A new update on FCA prosecutions by the law firm of Gibson Dunn highlights the fluidity of considerations such as the materiality of an allegation of a false claim despite a Supreme Court decision in 2016 (Universal Health Services, Inc. v. United States ex rel. Escobar) that was expected to provide a more stable interpretation of the law, just one example of a legal landscape that still creates substantial uncertainty for companies in the life sciences.
