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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 Delaware Supreme Court…
BIO filed an amicus brief in the Supreme Court of the State of Delaware, urging the Court to exclude Plaintiffs’ expert opinion, thereby ensuring that Delaware’s standard for the admission of such evidence remains consistent with the federal …
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BIO Files Amicus Briefs Supporting the Lawfulness…
On February 10, 2025, BIO filed an amicus brief in the U.S. District Court for the District of Columbia, supporting the lawfulness of plaintiff Eli Lilly's proposed 340B rebate model. The 340B Drug Pricing Program ("340B"), through which Medicaid…
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BIO Files Amicus Brief on FDA Orange Book Listing…
BIO filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit urging rehearing of a case involving whether certain Teva Pharmaceuticals patents had been properly listed in FDA’s Orange Book (Approved Drug Products with Therapeutic…
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BIO Files Amicus Brief in Continuing Effort to Preserve FDA’s Expert, Scientific Authority on Drug Approvals
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…
BIO FILES AMICUS BRIEF CHALLENGING FTC’S OVERREACH ON MERGER ENFORCEMENT THAT THREATENS DRUG DEVELOPMENT INNOVATION
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…
BIO Files Amicus Brief Supporting Reversal of Court Decision Regarding SEC Regulations on Proxy Advisory Firms
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…
BIO JOINS AMICUS BRIEF CHALLENGING COURT’S EFFORTS TO UNDERMINE FDA’S AUTHORITY TO BRING TREATMENTS AND CURES TO PATIENTS
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…
BIO Files Amicus Brief in U.S. ex rel. Scutte v. SuperValu Inc. at the Supreme Court of the United States
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…
BIO Files Amicus Brief in Petition for a Writ of Certiorari in American Axle & Manufacturing, Inc., v. Neapco Holdings LLC, et al., at the Supreme Court of the United States.
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…
BIO Files Amicus Brief Urging Harmonization of Federal Court Frameworks for Determining Patent Obviousness in Patent Litigation
October 16, 2020
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…
BIO Files Amicus Brief in Support of Rehearing Case Addressing Patent-Eligibility of Diagnostic Technology (U.S. Court of Appeals for the Federal Circuit)
April 22, 2019
BIO files amicus brief in support of a petition for rehearing related to patent-eligibility of diagnostic technology. 
BIO Files Amicus Brief on Case Addressing the America Invents Act’s Joinder Provision
December 28, 2018
BIO files an Amicus Brief on rehearing by the Precedential Opinion Panel of the Patent Trial and Appeal Board.
BIO Files Amicus Brief in Case Addressing Clear and Predictable Rules of Patent-Eligibility (U.S. Court of Appeals for the Federal Circuit)
April 20, 2018
Natural Alternatives International v. Creative Compounds (BIO Brief as Amicus Curiae supporting appellant in the US Court of Appeals for the Federal Circuit)