- Judge Alberto R. Gonzales, Dean and Doyle Rogers Distinguished Professor of Law, Belmont University and 80th Attorney General of the United States (2005-2007)
In a decision likely to shape not only future biosimilar litigation but the biosimilar industry generally, the U.S. Supreme Court on June 12, 2017 handed down its much-anticipated ruling in Amgen v. Sandoz.
In the first case interpreting the Biologics Price Competition and Innovation Act (BPCIA), the Court (J. Thomas) unanimously reversed the Court of Appeals for the Federal Circuit, holding that biosimilar makers need not wait for FDA approval before providing the reference product sponsor with 180-day notice of commercial marketing. The Court also held that the statute does not provide a federal injunctive cause of action to force biosimilar applicants to provide their FDA application to the reference sponsor, but remanded to the Federal Circuit to determine whether injunctive relief might be available to reference sponsors under state law. The decision raises intriguing questions of statutory construction and policy and is expected to speed market entry of biosimilars and increase competition.The Federalist Society’s uniquely qualified, expert panel discussed the decision and its implications for the industry and patent rights generally.
Please join us for a discussion on legal careers on Capitol Hill.
Microsoft v. Baker involved a class action lawsuit against the Microsoft Company by plaintiffs who alleged that during games on their Xbox video game console, the game disc would come loose and scratch the internal components of the device, permanently damaging the Xbox. Since only .4% of Xbox consoles experienced this issue, the district court determined that "a class action suit could not be certified and individuals in the suit would have to come forward on their own." The named plaintiffs voluntarily dismissed their claims with prejudice. The case was then appealed to the U.S. Court of Appeals for the Ninth Circuit where the court overturned the lower court's decision and held that the district court misapplied the law and abused its discretion in removing the class action allegations.
On Monday, June 12 the Supreme Court unanimously reversed the ruling of the Ninth Circuit and remanded the decision. Ted Frank of the Competitive Enterprise Institute joined us to discuss the holding and its significance.