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.
Financial Services & E-Commerce Practice Group Podcast
- Mr. Andrew A. Hufford, Intellectual Property Attorney, Brinks Gilson & Lione
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.”
Telecommunications & Electronic Media Practice Group Podcast
- 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.
Administrative Law & Regulation Practice Group Podcast
- 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
How might America reform the modern administrative state—not only to limit its power, but to restore its constitutional accountability to Congress, the President, and the courts? That is the subject of a recent report by National Affairs, on policy reforms for a more accountable administrative state. In its four chapters, the report:
1. Diagnoses the fundamental problems underlying the modern administrative state, which reflect a failure of republican governance;
2. Proposes to restore Congress to its crucial constitutional role as the "First Branch" in lawmaking, policymaking, appropriations and oversight;
3. Proposes to modernize White House oversight of agency regulatory actions, primarily by shifting the Office of Information and Administration's role from one of reaction to one of action; and
4. Proposes to reform both the laws governing agency process and the laws governing judicial review of agency action, in order to improve the quality of agency actions and, relatedly, to ensure more meaningful judicial review of agency actions.
To discuss these issues and proposals, please join us for a teleforum discussion with the report’s three authors: Adam White, Oren Cass, and Kevin Kosar.
Religious Liberties Practice Group Podcast
- Oren Cass, Senior Fellow, Manhattan Institute
- Kevin Kosar, Governance Project Director and Senior Fellow, R Street Institute
- Adam White, Research Fellow, The Hoover Institution and Adjunct Professor, Antonin Scalia Law School
Eric Baxter March 31, 2017
This case is a combination of three cases, Advocate Health Care v. Stapleton, St. Peter’s Healthcare v. Kaplan, and Dignity Health v. Rollins, that confront the Employee Retirement Income Security Act of 1974 (ERISA) as it applies to churches and non-church religious non-profits. ERISA sets minimum standards for pension plans in private industry, such as an appeals process for participants and the right to sue for benefits. Churches are exempted from ERISA, however, the circuit courts have split over whether non-profit hospitals and schools are also exempted. Eric Baxter of the Becket Fund joined us to recap the oral arguments for this case, which were held on March 27.
- Eric Baxter, Senior Counsel, The Becket Fund for Religious Liberty