News & Analysis as of

Life Sciences Supreme Court of the United States BPCIA

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

Hogan Lovells on

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for September 2018?

Morrison & Foerster LLP on

This month we highlight the possibility that the Supreme Court will consider the standard for adequacy of written description and a Federal Circuit exposition on the relationship between “blocking patents” and objective...more

Morrison & Foerster LLP

Hatch-Waxman and BPCIA Developments in June 2018

This month, we highlight significant developments in June 2018, including a Supreme Court decision regarding the PTAB, a federal court affirmation in Impax Laboratories Inc. v. Lannett Holdings Inc., and new legislation...more

Ladas & Parry LLP

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Robinson+Cole Health Law Diagnosis

Supreme Court Decision Allows Faster Marketing of Biosimilars

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more

Foley & Lardner LLP

Industry Perspectives On The Biosimilar Patent Dance

Foley & Lardner LLP on

The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more

Knobbe Martens

Supreme Court Grants Certiorari in Amgen v. Sandoz

Knobbe Martens on

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

Fenwick & West Life Sciences Group

Biosimilars: Supreme Court Grants Certiorari in Amgen v. Sandoz

On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the...more

Fenwick & West Life Sciences Group

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

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