USIJ has released a new white paper analyzing USPTO data on the use of PTAB proceedings in pharmaceutical patent disputes. The paper finds that these cases represent only a small share of PTAB activity, and that generic market entry is determined through the Hatch-Waxman framework in federal court. As a result, proposed PTAB rule changes would have no meaningful impact on drug pricing.
“Any claims linking PTAB rule revisions to drug affordability concerns lack evidentiary support and mischaracterize how pharmaceutical patent disputes are actually resolved in the United States.”