Intellectual Property Practice Group Podcast
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.
SCOTUScast 5-8-17 featuring Zvi Rosen
- Prof. Gregory Dolin, Co-Director, Center for Medicine and Law, University of Baltimore School of Law
- Prof. Erika Lietzan, Associate Professor of Law, University of Missouri School of Law
On March 22, 2017, the Supreme Court decided Star Athletica, LLC v. Varsity Brands, Inc. Varsity Brands, Inc. designs and manufactures clothing and accessories for use in various athletic activities, including cheerleading. Design concepts for the clothing incorporate many elements but do not consider the functionality of the final clothing. Varsity received copyright registration for the two-dimensional artwork of the designs at issue in this case, which were very similar to ones that Star Athletica, LLC was advertising. Varsity sued Star and alleged, among other claims, that Star had violated the Copyright Act. Star countered that Varsity had made fraudulent representations to the Copyright Office. Both parties filed motions for summary judgment. Star argued that Varsity did not have valid copyrights because the designs were for “useful articles” and cannot be separated from the uniforms themselves, all of which tends to make an article ineligible for copyright. Varsity argued that the copyrights were valid and had been infringed. The district court granted summary judgment for Star and held that the designs were integral to the functionality of the uniform. The U.S. Court of Appeals for the Sixth Circuit reversed, however, and held that the uniforms Varsity designed were copyrightable.
By a vote of 6-2, the Supreme Court affirmed the judgment of the Sixth Circuit. Justice Thomas delivered the opinion of the Court, which held that a feature incorporated into the design of a useful article is eligible for copyright protection under the Copyright Act of 1976 only if the feature (1) can be perceived as a two- or three-dimensional work of art separate from the useful article, and (2) would qualify as a protectable pictorial, graphic or sculptural work -- either on its own or fixed in some other tangible medium of expression -- if it were imagined separately from the useful article into which it is incorporated; that test is satisfied here. Justice Thomas’s majority opinion was joined by the Chief Justice and Justices Alito, Sotomayor, and Kagan. Justice Ginsburg filed an opinion concurring in the judgment. Justice Breyer filed a dissenting opinion, in which Justice Kennedy joined.
To discuss the case, we have Zvi Rosen, who is a Visiting Scholar and Professorial Lecturer in Law at George Washington University School of Law. Intellectual Property Practice Group Podcast
Sandra Aistars April 05, 2017
Last Wednesday the Supreme Court handed down a 6-2 opinion resolving a long mystifying test of when a feature of a useful article may be protected by copyright law. Hewing closely to the text of the Copyright Act, the opinion, authored by Justice Thomas, announced a new separability test holding that a feature incorporated into the design of a useful article is eligible for copyright protection if the feature (1) can be perceived as a 2 or 3 dimensional work of art separate from the useful article and (2) would qualify as a protectable pictorial, graphic, or sculptural work if it were imagined separately from the useful article.
Professor Sandra Aistars of Antonin Scalia Law School at George Mason University explored the implications for copyright in general and industries beyond fashion.
Litigation, Intellectual Property, and Free Speech & Election Law Practice Groups Teleforum
- Prof. Sandra Aistars, Clinical Professor and Senior Scholar and Director of Copyright Research and Policy of CPIP, Antonin Scalia Law School, George Mason University
Can the government police speech it thinks is offensive, even when members of the group the government seeks to protect disclaim any offense? Section 2(a) of the Lanham Act allows the government to deny trademark registration to "disparaging" speech. On Wednesday, January 18, the Supreme Court will hear oral argument in Lee v. Tam, a case challenging the constitutionality of this statute.
In Lee, an Asian-American rock band called “The Slants” was denied trademark registration after the Patent and Trademark Office found the trademark disparaging to Asians. A panel of the U.S. Court of Appeals for the Federal Circuit affirmed the decision. But the en banc Federal Circuit—without being asked—decided to vacate that decision and consider whether § 2(a) violates the First Amendment. The full Federal Circuit ultimately reversed the panel decision. The federal government then asked the Supreme Court to weigh in.
Is the Court likely to affirm the Federal Circuit decision striking down the disparagement clause as violative of the First Amendment? And what will be the implications if it does? Megan Brown and Dwayne Sam of Wiley Rein LLP attended the oral arguments and offered their impressions and predictions during this Courthouse Steps Teleforum conference call.
Intellectual Property Practice Group Teleforum
- Ms. Megan L. Brown, Partner, Wiley Rein LLP
- Mr. Dwayne D. Sam, Associate, Wiley Rein LLP
The Federalist Society will host a one hour Teleforum to discuss the recent Supreme Court decision in Samsung v. Apple--a rare Supreme Court design patent case regarding the shape of the face and grid of icons in Apple's iPhones. Trevor Copeland of Brinks Gilson & Lione, Austin and Art Gollwitzer of Michael Best, Chicago will engage over the specific statutory and policy issues in the decision. Prof. Ryan Holte of SIU School of Law will moderate.
- Mr. Trevor Copeland, Shareholder, Brinks Gilson & Lione
- Mr. Art Gollwitzer, Partner, Michael Best & Friedrich LLP
- Moderator: Prof. Ryan Holte, Assistant Professor of Law, SIU School of Law