From Patent Quality to the Pharmacy Counter: How PTAB’s Current IPR System Supports Affordable Care for Young Adults

By Grace Shults

In October 2025, The United States Patent and Trade Office’s Patent Trial and Appeal Board (PTAB) recently proposed a rule that would change the institution of the Inter Partes Review (IPR) system, which is a system created to allow third party challenges to the validity of existing patents.   Created under the Leahy-Smith America Invents Act (2011), or the AIA,  the IPR system allows the general public to challenge the validity and quality, or patentability of an existing patent.  This could become an issue as the new rule proposes a “one-and-done” approach, where it would become exceedingly difficult to challenge the validity of a patent after the first challenge has been shut down.  This proposed rule change would also limit the challenger’s ability to bring a challenge to the patent in other venues like a U.S. district court or the U.S. International Trade Commission.  

This rule change will lead to generic companies having even more difficulties to be able to bring generics to market.  Successful challenges of invalid and/or low quality patents in the IPR system have historically led to the price reduction of medications under the invalid patent; thus allowing more affordable generic medications to get into the hands of patients. 

An example of this is the drug glatiramer acetate, a generic drug for the treatment of multiple sclerosis. After the invalid patent of this drug was cancelled, the price of this drug dropped by 75%.   The typical age range of onset for multiple sclerosis is between the ages 20-40-years-old, meaning many young adult patients could be prescribed this drug to treat their MS.  This overturning of a bad patent and subsequent price reduction made this drug, which improves the  quality of life for many young adult patients, within a much more affordable grasp. 

Generation Patient recently submitted a public comment to the USPTO opposing this proposed rule to change the IPR system under PTAB.  Most members of our young adult patient community rely on some kind of prescription medication; most of us requiring said prescription long-term.  Bad patents on drugs, and their inability to be challenged, will continue to lead to higher drug prices for young adults. In a time where the cost of healthcare is already too high and inaccessible for millions of Americans, restricting the use of the  IPR system could make prescription drug access for  young adult patients even more limited.