Amicus Briefs

BIO submits amicus briefs on a variety of topics because of the strong interest and relevance to the biotechnology industry.

Featured Amicus Briefs
BIO Files Amicus Brief in Continuing Effort to…
BIO filed an amicus brief in a continuing effort to challenge courts' decisions that undermine FDA authority and hinder patient access to medications.The brief was filed in the Supreme Court of the United States (SCOTUS), following the August 2023…
BIO Files Amicus Brief Supporting Reversal of…
BIO filed an amicus brief in the U.S. Court of Appeals for the Sixth Circuit, seeking the reversal of a lower court's ruling that would set aside the 2022 rescission of the Securities and Exchange Commission (SEC) 2020 Rule regulating proxy advisory…
BIO Files Amicus Brief Urging Harmonization of…
BIO filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit on an important and recurring question concerning the framework for determining patent obviousness in patent litigation. BIO argues that courts, when considering whether…
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August 26, 2024
BIO filed an amicus brief July 19 in the case of Bristol Meyers Squibb and Janssen, who are appealing a decision by the U.S. District Court for the District of New Jersey. The companies argue that the Inflation Reduction Act (IRA) drug…
June 21, 2024
BIO filed an amicus brief supporting Supreme Court review of a recurring question about the common-law “double patenting” doctrine and its interplay with the statutory adjustment of the patent term due to patent examination delays in the USPTO. The…
May 9, 2024
BIO filed an amicus brief supporting Supreme Court review of a patent case involving the public disclosure bar of the False Claims Act (FCA). The brief argues that the 9th Circuit erred when it held that an administrative patent challenge proceeding…
October 25, 2023
BIO filed an amicus brief supporting Supreme Court review of the time-bar and joinder provisions governing patent review proceedings in the Patent Trial and Appeal Board (PTAB). BIO’s brief argues that time-barred patent challengers, who themselves…
October 12, 2023
BIO filed an amicus brief in a continuing effort to challenge courts' decisions that undermine FDA authority and hinder patient access to medications.The brief was filed in the Supreme Court of the United States (SCOTUS), following the August 2023…
August 24, 2023
The Biotechnology Innovation Organization (BIO) today signed onto an amicus brief to challenge the Federal Trade Commission (FTC) lawsuit to block the acquisition of Horizon by Amgen. The amicus brief was filed in the U.S. District Court, Northern…
June 27, 2023
BIO filed an amicus brief in the U.S. Court of Appeals for the Sixth Circuit, seeking the reversal of a lower court's ruling that would set aside the 2022 rescission of the Securities and Exchange Commission (SEC) 2020 Rule regulating proxy advisory…
April 11, 2023
The Biotechnology Innovation Organization (BIO) today signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to a single drug known as mifepristone) that would create regulatory barriers and potentially upend FDA’s…
March 28, 2023
BIO has filed an amicus brief in U.S. ex rel. Scutte v. SuperValu Inc., which addresses the issue of the intent requirement under the False Claims Act (FCA). Specifically, BIO urges the Court to uphold the view that a firm does not…
June 29, 2021
BIO and AUTM have filed an amicus brief in petition for a writ of certiorari the in American Axle & Manufacturing, Inc., v. Neapco Holdings LLC, et al., at the Supreme Court of the United States. BIO and AUTM are concerned that…