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 Equivalence). Pharmaceutical companies filing a New Drug Application with FDA are obligated to list patents that meet statutory requirements. This process is intended to advance the Hatch-Waxman Act’s objective of speeding access to generic drugs by ensuring that any patent infringement claims are addressed prior to market entry. BIO’s brief supports neither party, but instead urges the appellate panel to correct "foundational errors" in its opinion – specifically, the panel’s incorrect, and potentially harmful misreading of the patent listing requirements. As the brief explains, the panel chose to assess the question of whether a patent claims “the drug” without considering whether it is a “drug substance” or “drug product” patent. This approach, which is based on mistaken identification of an interpretive “redundancy,” would lead to unnecessary confusion in the lower courts, potentially resulting in both the under-listing and over-listing of patents.