The Biotechnology Innovation Organization and the Council of State Bioscience Associations wrote to the U.S. House and Senate leadership this week to urge support for the Advancing Emergency Preparedness Through One Health Act and to advance legislation directing the FDA and the U.S. Department of Agriculture to develop a memorandum of understanding to streamline the regulatory oversight of animal biotechnology. A national One Health framework would help the U.S. better prevent, prepare for and respond to zoonotic disease outbreaks like COVID-19, according to the letter. “One Health collaboration eliminates barriers that often exist between human health, animal health and environmental health strategies to create smarter, multi-faceted and coordinated efforts,” the industry groups said. They noted that more than 60% of known infectious diseases in people can be spread from animals, and three out of every four new or emerging infectious diseases in people come from animals. “Elevating and prioritizing the relationship of living things through One Health strategies and modernizing America’s animal biotechnology regulatory approach … will ensure we are ready for the next potential animal-to-human disease outbreak,” the letter said.
The U.S. Government Accountability Office (GAO) recommended Thursday that the Department of Health and Human Services (HHS) improve the coordination of infectious disease modeling across its agencies, including the CDC, and ensure that the models used are reproducible. The agencies use modeling to “inform public health planning, outbreak response and, to a limited extent, resource allocation,” the GAO noted. While the HHS agencies use multiple mechanisms to coordinate their modeling efforts, they don’t routinely monitor, evaluate or report on the extent and success of that coordination. “Consequently, they risk missing opportunities to identify and address modeling challenges – such as communicating clearly and obtaining adequate data and resources – before and during an outbreak,” according to the GAO report. Consequently, the agencies may be missing opportunities to improve their modeling, and there could be overlap and duplication of cross-agency modeling efforts, which could lead to inefficiencies.
The U.S. Court of Appeals for the Federal Circuit closed the door Thursday on courts awarding attorney fees incurred in preparing for an inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB). The precedential decision in Amneal Pharmaceuticals Inc. v. Almirall SA denied Almirall’s request for attorney fees incurred during an IPR challenging a patent on its acne drug, Aczone (dapsone). In October 2019, Amneal appealed the PTAB ruling that upheld the patent. Five months later, Amneal, of Bridgewater, N.J., filed a motion to voluntarily dismiss the appeal. While Barcelona-based Amirall agreed to the dismissal, it asked for attorney fees, claiming Amneal had pursued the matter in “an unreasonable manner by continuing to litigate the IPR” after Amirall offered the generic company a covenant not to sue and had asked the FDA to remove the challenged patent from the Orange Book. “We have long recognized this court’s ability to award attorney fees under section 285 for work done in district court patent infringement actions. … Appeals from the Board are a different matter,” the Federal Circuit said in the unanimous decision. (Section 285 of the Patent Act gives courts the authority to award attorney fees in “exceptional cases.”) A footnote in the decision pointed out that the PTAB “has its own means for regulating litigation misconduct.” The board can impose sanctions, including attorney fees, against a party for misconduct such as advancing a misleading or frivolous argument or request for relief and “actions that harass or cause unnecessary delay or an unnecessary increase in the cost of the proceeding,” according to the footnote.