U.S. PIRG calls for patent process reform to remove barriers to generic, biosimilar drugs

WASHINGTON — U.S. PIRG filed comments Tuesday with the U.S. Patent and Trademark Office (PTO) to improve patent examination and approval processes. Doing so would better balance supporting medical advances and ensuring generic drugs and biosimilars reach pharmacy shelves. 

The PTO had 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.” Tuesday was the last day the PTO would accept comments.

“Generic drugs and biosimilars must be able to enter the market to bring about the competition necessary to drive down drug prices,” U.S. PIRG’s Senior Director of Health Care Campaigns Patricia Kelmar said. “Patents that wrongly confer or extend rights to exclusive market access block generic and biosimilar competition, inappropriately keeping prices high for consumers, insurance plans and our government health programs.”

Here is an excerpt from the comments that U.S. PIRG filed:

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 win 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.

U.S. PIRG, a nonprofit consumer advocacy group, 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.

“Competition is the cornerstone of a free market, and it’s especially important when it comes to medicines that can sustain health or even save lives,” said Kelmar. “It’s one thing for a drug company to recoup its R&D costs. It’s another thing to, years later, impede competition to milk every drop from patients, who deserve better.”