Mar 28, 2023

Members of Congress Send Letter Encouraging USPTO to Close Loopholes Exploited by Big Pharma to Block Competition from More Affordable Alternatives

In case you missed it, a bipartisan group of lawmakers sent a letter this week to Kathi Vidal, Director of the U.S. Patent and Trademark Office (USPTO), encouraging the agency to take additional action to crack down on Big Pharma’s anti-competitive practice of building patent thickets around blockbuster brand name prescription drugs.

“As you know, branded pharmaceutical manufacturers will often seek numerous patents on a single feature of a drug, creating a dense web, or thicket, of patents that delay generic and biosimilar competition,” the lawmakers, including Representative Jodey Arrington (R-TX), Representative Lloyd Doggett (D-TX), Representative Michael Burgess (R-TX), Representative Ann McLane Kuster (D-NH) and Representative Darrell Issa (R-CA), wrote. “Scholars have found that in some instances up to 80 percent of patents in these ‘thickets’ are non-distinct, or duplicative.”

They also point to a “recent study, which was published in the Journal of Clinical Pharmacology & Therapeutics and analyzed only a single drug, estimated that from 2016-2019 Medicare spent $2.2 billion dollars more on that one drug than if competition had entered as expected.”

“Delayed entry into the market by generics and biosimilars doesn’t just cost the U.S. government and taxpayers more money, it also severely limits patients’ cost-effective options for treatment,” the Members of Congress continue. “This is happening across the nation, and millions of Americans have had to make tough decisions as to whether they can afford to continue their medication regimen as prescribed.”

To hold Big Pharma accountable, the authors suggest:

“…[R]equiring a branded manufacturer seeking multiple patents on the same drug feature to admit that the claims rejected for double patenting are not patentably distinct. Such admission would ensure that if one of the duplicates is later found to be invalid, courts may consider that fact as evidence against the others. In other words, non-distinct patent claims could ‘rise or fall together.’ This would promote innovation that would improve patient care and end the practice of blocking lower-cost alternatives by stacking duplicative patents on old drugs.”

The USPTO has taken positive steps toward cracking down on Big Pharma’s anti-competitive tactics by seeking greater coordination with the U.S. Food and Drug Administration (FDA). Enacting additional regulatory solutions to hold Big Pharma accountable for gaming the patent system can build on that positive progress and help more affordable alternatives come to market more quickly for patients.

Read the full letter HERE.

Read more on USPTO’s positive progress toward holding Big Pharma accountable HERE.

Read more on the overwhelmingly bipartisan support for solutions to stop Big Pharma’s patent abuse HERE.

Learn more about market-based solutions to hold Big Pharma accountable and lower prescription drug prices HERE.