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2017 National Lawyers Convention

November 16, 2017

The 2017 National Lawyers Convention is scheduled for Thursday, November 16 through Saturday, November 18 at the Mayflower Hotel in Washington, D.C. More information will be posted later this summer.

Courthouse Steps: Two Cases - Matal v Tam and Packingham v North Carolina

Free Speech and Election Law Practice Group Teleforum
Michael R. Huston, Ilya Shapiro June 20, 2017

The Court has ruled today in two important cases, Matal v. Tam (aka "The Slants" copyright case) and Packingham v. North Carolina, which concerns a North Carolina law that restricts the access of convicted sex offenders to “commercial social networking” websites.  Join us for this special Teleforum at which the holdings and reasoning of both cases will be discussed.  

Featuring:

  • Mr. Michael R. Huston, Associate Attorney, Gibson Dunn & Crutcher LLP
  • Mr. Ilya Shapiro,  Senior Fellow in Constitutional Studies, Cato Institute

Courthouse Steps: Sandoz Inc. v. Amgen Inc. - Podcast

Intellectual Property Practice Group Podcast
Gregory Dolin, Erika Lietzan June 20, 2017

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.

Featuring:

  • 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

Courthouse Steps: Sandoz Inc. v. Amgen Inc.

Intellectual Property Practice Group Teleforum
Gregory Dolin, Erika Lietzan June 19, 2017

 

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. Please join the Federalist Society’s uniquely qualified, expert panel as they discuss the decision and its implications for the industry and patent rights generally.

Featuring:

  • 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

Courthouse Steps: Impression Products, Inc. v. Lexmark International, Inc. - Podcast

Intellectual Property Practice Group Podcast
Adam Mossoff, Kristen Osenga, Steven M. Tepp June 14, 2017

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.

Featuring:

  • 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

Courthouse Steps: Impression Products, Inc. v. Lexmark International, Inc.

Intellectual Property Practice Group Teleforum
Adam Mossoff, Kristen Osenga, Steven M. Tepp June 07, 2017

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 will discuss Chief Justice Robert’s opinion in Impression Products, as well as its economic and legal implications for patent-owners and the innovation economy.

Featuring:

  • 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

Courthouse Steps Decision: TC Heartland LLC v. Kraft Foods Group Brands LLC - Podcast

Intellectual Property Practice Group Podcast
William J. Brown, J. Devlin Hartline May 26, 2017

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.

Featuring:

  • 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

Courthouse Steps Decision: TC Heartland LLC v. Kraft Foods Group Brands LLC

Intellectual Property Practice Group Teleforum
William J. Brown, J. Devlin Hartline May 26, 2017

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.

Featuring:

  • 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

Fifth Annual Executive Branch Review Conference

The Relationship between Congress and the Executive Branch
May 17, 2017

The Fifth Annual Executive Branch Review Conference will examine the changing and often convoluted relationship between the legislative and the executive branches in the United States government. This daylong conference will feature plenary panels, addresses, and breakout panels on topics such as “The Unitary Executive,” “Chevron Deference,” and “Congressional Oversight of Voting Rights.”

The Conference will begin with an opening address by Senator Mike Lee and end with a closing address by OMB Director Mick Mulvaney and a reception.

Courthouse Steps: Amgen, Inc. v. Sandoz, Inc. - Podcast

Intellectual Property Practice Group Podcast
Andrew A. Hufford April 28, 2017

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.

Featuring:

  • Mr. Andrew A. Hufford, Intellectual Property Attorney, Brinks Gilson & Lione