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
Under Attorney Generals Eric Holder and Loretta Lynch, the Department of Justice entered into a number of consent decrees with local police departments to change certain police practices. Given the ongoing review of these decrees, how will the federal government’s approach to police practices change during Jeff Sessions’ tenure as Attorney General? What alternative methods might the DOJ employ or encourage states and municipalities to employ to help remedy problematic police practices?
Chuck Canterbury, President, Fraternal Order of Police
Vanita Gupta, President, The Leadership Conference on Civil and Human Rights
Moderator: Brian Fish, Special Assistant, United States Attorney, Baltimore, Maryland
The Missouri Department of Natural Resources (DNR) denied a Learning Center run by Trinity Lutheran Church of Columbia, Inc. (Trinity) federal funding to refurbish children’s playgrounds on the grounds of religious affiliation. The DNR offers Playground Scrap Tire Surface Material Grants to organizations that qualify for resurfacing of playgrounds. Though the licensed pre- school Learning Center incorporates religious instruction into is curriculum, the school is open to all children. Trinity’s Learning Center was denied funding based on Article I, Section 7 of the Missouri Constitution; the section reads: “no money shall ever be taken from the public treasury, directly or indirectly, in aid of any church, section or denomination of religion.”
Trinity claimed that the DNR infringed upon their rights under the Equal Protection Clause of the Fourteenth Amendment and the First Amendment’s protections of freedom of religion and speech. The district court dismissed Trinity’s allegations, claiming that Trinity failed to file a specific claim. Trinity responded by amending its complaint to an allegation that other religious institutions had previously received the DNR funding; nevertheless, the district court denied the motions. The Eighth Circuit Court of Appeals upheld the lower court decision, agreeing with both the dismissal and denial of motions.
The question at the heart of the case is whether or not the First Amendment’s free exercise of religion and the Fourteenth Amendment's Equal Protection Clause protect religious institutions from discrimination regarding the distribution of public funds. Ilya Shapiro of the CATO Institute and Hannah C. Smith of The Becket Fund for Religious Liberty joined us after oral arguments to discuss the case and the potential weight of the precedent set by decision.
Ilya Shapiro, Senior Fellow in Constitutional Studies, Cato Institute
Hannah C. Smith, Senior Counsel, The Becket Fund for Religious Liberty
Members of the Federalist Society’s Financial Services & E-Commerce Practice Group Executive Committee provided an update on recent important activity at the Consumer Financial Protection Bureau (CFPB). The call will cover many interesting topics including an update of PHH’s D.C. Circuit U.S. Court of Appeals case against the CFPB, a recent Executive Order which appears to apply to the CFPB, congressional activity regarding the CFPB, the CFPB’s recent fines and other actions, and the CFPB’s (and Federal Reserve Board’s) Office of Inspector General (OIG) audit report entitled “The CFPB Can Strengthen Contract Award Controls and Administrative Processes.”
Hon. Wayne A. Abernathy, Executive VP for Financial Institutions Policy and Regulatory Affairs, American Bankers Association
Julius L. Loeser, Of Counsel, Winston & Strawn LLP
In late March, Congress used the Congressional Review Act to reverse the FCC’s controversial Broadband ISP Privacy Order. The FCC had overwritten the FTC’s prior regulation of ISP privacy, after President Obama took to YouTube following the 2014 mid-term elections, to call for the regulation of ISPs as common carriers, under a framework dating from the monopoly provision of telephone service.
The current FCC Chairman, Ajit Pai has announced he aims to deregulate, focused on removing outdated regulations to encourage investment and innovation. Pai’s Digital Empowerment Agenda sees competitive broadband networks as engines of economic growth. Observers expect the underlying decision from the Obama era to regulate ISPs as common carriers – aka Open Internet or Net Neutrality – to be re-considered soon. The Chairman has also proposed revising broadcast ownership rules to reflect today’s more diverse media landscape, and repurposing spectrum to facilitate the next generation of mobile broadband and Internet of Things. Maximizing access to spectrum for “5G” broadband and IoT will require repurposing some federal spectrum, so the President’s federal spectrum manager at Commerce (NTIA) will play a critical role.
In our third segment of the Legal Options for the New Administration Teleforum Series, Bryan Tramont, Chair of the Federalist Society Telecommunications Executive Committee, moderated a discussion with Chairman Ajit Pai’s Senior Counsel, Nick Degani, and Patricia Paoletta, a telecom partner at the law firm of Harris, Wiltshire & Grannis LLP.
Nicholas Degani, Senior Counsel to FCC Chairman Ajit Pai; formerly Wireline Legal Advisor to FCC Commissioner Ajit Pai
Patricia Paoletta, Partner at Harris, Wiltshire & Grannis LLP, named by the Trump-Pence Transition Team to the FCC Landing Team
Moderator: Bryan Tramont, Managing Partner of Wilkinson, Barker & Knauer, former FCC Chief of Staff; Chair of the Federalist Society Telecommunications Executive Committee