Recommendations for Statutory Reform of the Patent Term Extension System to Increase Public Accountability and Fight Soaring Drug Prices

In the past 40 years, patent protections on pharmaceutical drugs have effectively lengthened to nearly double the standard 20-year monopoly intended by patent law. The lengthening of patent monopolies has contributed to skyrocketing pharmaceutical drug prices and healthcare costs. A significant driver of this trend has been the patent term extension (PTE) provision of the Hatch-Waxman Act, 35 U.S.C. § 156, which allows drug companies to delay the expiration dates of already-issued patents on prescription drugs, lengthening their patent monopolies.

The recommendations aim to increase transparency at the PTO and its accountability to the public in processing PTE applications. The recommendations also aim to curb abuse of the PTE system by drug companies that can harm patients and competition. The proposed solutions include amending the statutory provision to:

• provide a pathway at the PTO for third parties to challenge a breach of the duty of disclosure by the PTE applicant,

• specify a minimum set of information considered “material” under the duty of disclosure and therefore subject to mandatory disclosure, including certain information relevant to the public interest,

• create a range of penalties for failure to disclose material information, and

• place the burden of proof of meeting the duty of disclosure and the due diligence requirement on the PTE applicant.