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.
Intellectual Property Practice Group Podcast
- 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
The Supreme Court handed down one of its most significant decisions in patent law in recent years on May 30 in Impression Products v. Lexmark International. This case will have a monumental impact on the commercialization of patented innovation in both the U.S. and in global markets. The case arose from Lexmark’s imposing restrictions on the resale and reuse of its patented toner cartridges, and whether this was permissible or not as an exercise of Lexmark’s property rights in its patent. Lexmark sued Impression Products for patent infringement for violating its post-sale restrictions. In a unanimous opinion written by Chief Justice Roberts, the Court held that such post-sale restrictions are not within the scope of rights secured by a U.S. patent. This decision upends decades of licensing and sale practices in the U.S. innovation economy, and raises fundamental questions about the nature of the economic incentives that drive the patent system, as well as the nature of the property rights long secured in a patent under U.S. law. This Teleforum discussed Chief Justice Robert’s opinion in Impression Products, as well as its economic and legal implications for patent-owners and the innovation economy.
Intellectual Property Practice Group Podcast
- Prof. Adam Mossoff, Co-Founder, Director of Academic Programs & Senior Scholar, Center for the Protection of Intellectual Property; Professor, Antonin Scalia Law School, George Mason University
- Mr. Steven Tepp, President & CEO of Sentinel Worldwide; Professorial Lecturer in Law, George Washington University Law School
- Moderator: Prof. Kristen Osenga, Professor of Law, University of Richmond
On May 22, 2017, the Supreme Court handed down its unanimous opinion in the closely-watched TC Heartland LLC v. Kraft Foods Group Brands LLC case. The patent venue statute provides that a domestic corporation may be sued for patent infringement anywhere the defendant “resides,” and the question before the Court was whether that rule incorporates the broader definition of corporate residence found in the general venue statute. The district court and the Court of Appeals for the Federal Circuit both held that it did, thus giving patent owners more choices of where they could sue for infringement. However, the Supreme Court reversed, holding that a corporate defendant only “resides” in its state of incorporation.
While the Supreme Court rested its opinion solely on the statutory language and its own precedent interpreting it, many of the arguments raised in the amicus brief supporting both sides focused on the policy implications. In particular, the briefs argued that the Court should consider the effect its decision would have on certain patent assertion entities (PAEs) or “patent trolls”—non-practicing patent owners who litigate their patents, oftentimes in the Eastern District of Texas. Whether such arguments persuaded the Court is unclear, though it is clear that the Court’s narrow rule for where patent owners may sue will change the litigation landscape for practicing and non-practicing entities alike.
SCOTUScast 5-8-17 featuring Zvi Rosen
- Mr. William J. Brown, Jr., Managing Partner, Brown Wegner LLP
- Prof. J. Devlin Hartline, Assistant Director, Center for the Protection of Intellectual Property (CPIP) and Adjunct Professor, Antonin Scalia Law School, George Mason University
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
The Biologics Price Competition and Innovation Act of 2010 (42 U.S.C. § 262) created an abbreviated pathway for FDA approval of biological products determined to be “biosimilar” to a reference product. The Act outlines a patent resolution and information exchange scheme, with litigation safe harbors during this “patent dance.”
Subsection (l)(2)(A) provides that not later than 20 days after the application is accepted for review, “…the subsection (k) applicant – shall provide to the reference product sponsor a copy of the application…and other information that describes the processes used to manufacture the biological product…” Subsection (l)(8)(A) provides “[t]he subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”
In 2015, Sandoz filed a subsection (k) application based on Amgen’s filgrastim (Neupogen®), but refused to provide its (l)(2)(A) disclosure and claimed that pre-FDA approval notice satisfied (l)(8)(A). Amgen sued in federal court on state law claims of unfair competition and conversion, and patent infringement, and requested a preliminary injunction. The district court granted Sandoz’ motion for partial summary judgment, holding that (l)(2)(A) disclosure was optional and that Sandoz did not have to wait for FDA approval before providing (l)(8)(A) notice.
In a fractured opinion, the Federal Circuit affirmed on the (l)(2)(A) issue, holding that subsection (l)(9)(C) provided a remedy for the reference product sponsor to bring an immediate declaratory judgment action if the subsection (k) applicant failed to provide its (l)(2)(A) information, showing that disclosure was optional. The court reversed on the (l)(8)(A) issue, holding that notice before the FDA approved the subsection (k) application was ineffective under the statute. The Court granted certiorari on both issues.
This case presents intriguing questions of statutory interpretation, as the boundaries of the BCPIA are explored.
- Mr. Andrew A. Hufford, Intellectual Property Attorney, Brinks Gilson & Lione