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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 California Supreme Court in Continuing Gilead Tenofovir Cases
November 4, 2024
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…
BIO files Amicus Brief in Colorado PDAB Case
September 13, 2024
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…
BIO Files Amicus Brief Challenging IRA Drug Price Controls
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…
BIO Files Amicus Brief Supporting Supreme Court Review of “Double Patenting” Doctrine and its Role in Patent Term Adjustments
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…
BIO Files Amicus Brief Urging Supreme Court Review of Patent-Related False Claims Act Case
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…
BIO Files Amicus Brief Supporting Supreme Court Review of Provisions that Protect Patent Owners in PTAB Review Proceedings
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…
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…