Amicus Briefs

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…

BIO filed an amicus brief in the U.S. District Court for the District of Columbia, supporting plaintiff Teva Pharmaceuticals' position that the definition of Qualifying Single Source Drug (QSSD) in CMS's IRA-implementing Guidance violates the…

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…

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 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 …

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…