BIO Files Amicus Brief in California Supreme Court in Continuing Gilead Tenofovir Cases

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 approval processes, particularly failing to see that biopharmaceutical companies cannot reasonably estimate future FDA approval from positive preliminary data from Phase I and II studies, and as such, should not be penalized for making the difficult business decisions to invest in one drug compound over another. This risk of penalization underscores how the Court's decision disincentivizes innovation and biopharma investment.