Recommendations on how the U.S. Patent and Trademarks Office can improve access to generic drugs

Reform is needed to stop drug company abuse of the patent system

U.S. PIRG submitted recommendations in response to a Request for Comments from the U.S Patent and Trademark Office related to agency initiatives to ensure the robustness and reliability of patent rights.

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Drug patent applications need closer scrutiny to ensure they are claiming meaningful innovations.

Excerpt from U.S. PIRG comments:

When drug patents are inappropriately granted, it unnecessarily extends market exclusivity for the patent-holder and unjustifiably precludes innovation.  The PTO’s policies and procedures must be changed to prevent pharmaceutical companies from piling up low-quality patents that create barriers to competition and allow brand name drug companies to keep charging more for their medicines.

The American public needs more timely access to lower cost life-saving generic and biosimilar medicines.  Improved patent examination processes mean fewer patent thickets, less need for expensive patent litigation to challenge weak or overbroad patents and a return to an emphasis on high quality patent approvals.

The public benefit will be measurable: more generic drug competitors will make it to market sooner and patients, insured families and our government health plans will benefit from the resulting price competition.  These benefits in turn will strengthen the public’s confidence in the patent system and respect for the quality of granted patents.


Patricia Kelmar

Senior Director, Health Care Campaigns, PIRG

Patricia directs the health care campaign work for U.S. PIRG and provides support to our state offices for state-based health initiatives. Her prior roles include senior policy advisor at NJ Health Care Quality Institute, associate state director at AARP New Jersey and consumer advocate at NJPIRG. She was appointed to the Ground Ambulance and Patient Billing Advisory Committee in 2022 and works with patient advocates across the U.S. Patricia enjoys walking along the Potomac River and sharing her love of books with friends and family around the world.