How the US Patent Office can help address high drug prices

“Generic drugs and biosimilars must be able to enter the market to bring about the competition necessary to drive down drug prices,” said U.S. PIRG’s senior director for health care campaigns,  Patricia Kelmar. “But patents that wrongly confer or extend rights to exclusive market access block generic and biosimilar competition, inappropriately keeping prices high for consumers, plans and our government health programs.”

U.S. PIRG filed comments today with the US Patent and Trademark Office (PTO) to improve patent examination and approval processes to best reach that balance of supporting medical advances and ensuring generic drugs and biosimilars reach pharmacy shelves. 

The PTO issued a request for comments “on proposed initiatives directed at bolstering the robustness and reliability of patents to incentivize and protect new and nonobvious inventions while facilitating the broader dissemination of public knowledge to promote innovation and competition.”

PIRG has worked for decades to improve access to generics and biosimilars as a way to increase drug price competition. The patent system is an important part of the process.

An excerpt from PIRG’s comments:

“When companies wrap their original patents with follow-on patents, they create a thicket of protection designed to ward off competition. Generics have the right to challenge patents and when they do, they will about 73% of the time. But the cases can take years and are expensive ($2.5 – $3.5 million dollars). With costs that high, competitors can be deterred from even attempting to challenge the patent thicket. And that means fewer generic and biosimilar competitors will take on the effort it takes to come to market. It also means that the patent system is failing to encourage both innovation and competition.”