Amicus Briefs

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…

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 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 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 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 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 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…

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 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…

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…