Experts, lawmakers express support for select drug patent reforms

Senators on both sides of the aisle agreed that patent reform is needed to stop pharmaceutical companies from extending patents on minor modifications to products and linked this problem to high prescription drug prices. Witnesses at a Senate Judiciary Committee hearing on Tuesday suggested one way to address patent reform is to have greater coordination between the Food and Drug Administration and the US Patent and Trade Office (USPTO) on patents listed in the Orange Book.

Committee Chair Dick Durbin (D-IL) said that “patients in the United States pay the highest prescription drug prices in the world—nearly three times what people in other developed countries pay for common medications… And prices just keep going up. In 2022, drug manufacturers raised the prices on more than 1,200 medications by an average of 32 percent—four times the rate of inflation.”

Sen. Peter Welch (D-VT) concurred. “The bottom line is the cost of health care is killing folks … Folks who are having trouble paying their rent, or they’re having trouble paying for groceries.” He added that “the biggest driver is healthcare costs. And whether you want to call it abuse, or gaming, that fact is people can’t afford it and its not sustainable.”

Earlier this year, Welch introduced a bill that would limit the number of patents that a drug company can introduce and make it easier for generic companies to enter the market. The bill was co-sponsored by Sen. Mike Braun (R-IN) and Sen. Amy Klobuchar (D-MN) Rep. Jodey Arrington (R-TX) introduced a companion bill in the House.

Senator John Cornyn (R-TX) also expressed his frustration at what he sees as “abuse of the patent system.”

In her testimony, Arti Rai, law professor at Duke University Law suggested that one way to reform the patent system is to have better coordination between the USPTO and FDA.

She said that “an applicant may provide a variety of evidence to the FDA to support its argument that a particular product is only a trivial variation of an already marketed product and therefore does not require additional testing prior to approval. Meanwhile, at the USPTO, the same applicant withholds this evidence and instead states that the product is truly nonobvious and therefore deserving of a patent.”

Rai also expressed support for S. 79, the Interagency Patent Coordination and Improvement Act of 2023 to establish an interagency task force between the USPTO and FDA that would allow sharing of patent information. The bill was introduced by Sens. Durbin and Thom Tillis (R-NC).

William Feldman, a physician at Brigham and Women’s Hospital, also urged for reform of patent laws. He said that “one key tactic that brand-name manufacturers employ to delay generic competition is erecting large thickets of patents.”

He noted that many patents do not cover active pharmaceutical compounds, known as primary patents, but cover “peripheral” features such as alternative formulations and new methods of use for delivery devices.

Feldman further noted that “FDA does not review what gets listed in the Orange Book but instead serves in a purely ministerial” role, listing patents that manufacturers choose for submission.

Feldman said that Ozempic has had 25 patents listed in the Orange Book; 21 of these were on the delivery device.

At the hearing, Sen. John Neely Kennedy (R-LA) expressed frustration that the Senate has yet to pass legislation on drug pricing or patent reforms and suggested that this would not be the case if a Republican was a majority leader.

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Experts, lawmakers express support for select drug patent reforms

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