Press Release

The ERISA Industry Committee Calls on the U.S. Patent and Trademark Office to Improve the Patent Access Process to Enhance Prescription Drug Competition

Issued by ERIC [ERISA Industry Committee]

Feb. 1, 2023

WASHINGTON – The ERISA Industry Committee (ERIC) called on the U.S. Patent and Trademark Office (USPTO) to limit or eliminate patent policies that allow drug manufacturers to extend monopolies for certain prescription drugs for longer than 20 years in the United States, far longer than Congress intended. USPTO practices have led to less competition in U.S. drug markets compared to other developed countries with shorter patent timeframes and simpler rules. 

In a letter in response to USPTO’s “Request for Comments on USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights,” ERIC said that the USPTO “must take steps to eliminate abuse of the patent system, which is harmful to competition in the American health care system.” 

ERIC called on the USPTO to address “obvious-type double patenting” (OTDP) and “terminal disclosures.” OTDP allows drug manufacturers to submit patent requests multiple times on the same drug to protect the drug’s long-standing exclusivity in the U.S. market. USPTO currently allows OTDP through the use of “terminal disclaimers,” which are used to link different, multiple patents together for a single drug forming a “patent thicket.” 

 “USPTO patent policies should be aligned with Congressional intent to balance innovation with competition. Currently, however, some of those policies allow drug manufacturers to submit hundreds of questionable patent requests on the same drug, or seek to continue a drug’s market exclusivity using secondary-structure patents, directly impacting competition,” said James Gelfand, President of ERIC.  

“The United States is the only nation in the developed world that allows OTDP and terminal disclosures,” added Gelfand. “We see no reason that the U.S. patent system should be so different from other developed countries which do not allow for such gimmicks.” 

To read ERIC’s comments in response to the “Request for Comments on USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights,” visit ERIC’s website here.  

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