Washington, D.C. – U.S. Representative Pramila Jayapal (D-Wash.) and U.S. Senator Elizabeth Warren (D-Mass.) sent a letter to Kathi Vidal, Director of the United States Patent and Trademark Office (USPTO), calling on USPTO to take immediate action and use its existing administrative authorities to help lower drug prices and hold pharmaceutical companies accountable for anti-competitive business practices. The lawmakers outline six specific actions that the USPTO should take.
“For decades, powerful pharmaceutical companies and other large corporate actors have repeatedly abused the patent system to stifle competition and prolong their market power, showing no regard for the harm done to patients through sustained high prices,” wrote the lawmakers. “The pharmaceutical industry’s continued abuse of the patent system, which has resulted in enormous corporate profits and inexcusable harms to patients, has demonstrated that more aggressive steps are needed.”
The lawmakers recommend that the USPTO use its existing authority to take the following actions:
- Revise the USPTO’s practice of granting obvious patents by rejecting additional obvious patents filed by pharmaceutical companies for a single drug product, regardless of terminal disclaimers.
- Stipulate that patents tied together by terminal disclaimers should all stand or fall together when challenged to help combat the patent thickets pharmaceutical companies have created that intimidate potential competitors from entering the market.
- Raise filing fees and limit the number and time period for continuation applications to discourage pharmaceutical companies from using excessive indistinct patents to create problematic patent thickets.
- Require applicants to disclose at the time of filing whether the drug compound covered by the patent application is in clinical trials and assign more examiners to scrutinize those applications.
- Reverse policies that have led to an increase in discretionary denials of petitions filed through the inter partes review (IPR) process, which offers a quick and less expensive alternative to litigation for challenging patents.
- Establish an office dedicated to building public transparency, serving the public interest, and improving interagency communication to ensure the public can better access basic information about patents, such as expiration dates, owners, licensing, and application statuses and to strengthen accountability of the U.S. patent system.