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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 California Supreme…
BIO filed an amicus brief in the Supreme Court of the State of California, encouraging its review of the lower court decision in the Gilead Tenofovir Cases.The Court of Appeal decision operates from a misunderstanding of the drug development and FDA…
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BIO files Amicus Brief in Colorado PDAB Case
The Biotechnology Innovation Organization (“BIO”) respectfully moves the Court for leave to file an amicus brief in support of Plaintiffs’ response in opposition to the Defendants’ cross-motion for summary judgment. Copies of the proposed brief and…
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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…
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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)
BIO Files Amicus Brief on Case Addressing Unfairness or Imbalance in Post-Grant Proceedings at PTO (U.S. Court of Appeals for the Federal Circuit)
April 9, 2018
BIO and PhRMA have submitted a brief in the U.S Court of Appeals for the Federal Circuit on behalf of appellant in Virnetx Inc. v. The Mangrove Partners. 
BIO files Amicus Brief in Patent Case Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. (U.S. Court of Appeals for the Federal Circuit)
August 14, 2017
BIO submitted an amicus brief in the U.S. Court of Appeals for the Federal Circuit, supporting Acorda Therapeutics and reversal. 
BIO Files Amicus Brief Supporting Rehearing of Case Addressing Patent Rights and America Invents Act (AIA) at the U.S. Court of Appeals for the Federal Circuit
July 14, 2017
BIO files Amicus Brief supporting rehearing en banc in Helsinn v. Teva Phamaceuticals (US Court of Appeals for the Federal Circuit)
BIO Submits Amicus Brief in Sandoz Inc. v. Amgen Manufacutring Inc. and Amgen Manufacturing Ltd v. Sandoz Inc. (U.S. Supreme Court)
March 17, 2017
BIO Submits Brief of Amicus Curiae in Sandoz Inc. v. Amgen Inc. v. Sandoz Inc. (Supreme Court of the United States)