The U.S. Department of Commerce should prioritize addressing the issue of patent thickets surrounding branded pharmaceutical products, particularly biologics, as a critical pro-competition reform, according to U.S. House Budget Committee Chairman Jodey Arrington (R-TX) and a bipartisan group of lawmakers.
Patent thickets are a strategic tool used by branded pharmaceutical companies to extend market exclusivity beyond the intended scope of patent law.
“Duplicative patent thickets create significant barriers to market entry for biosimilars and generics, delaying access to affordable medications and sustaining high drug prices for patients,” wrote Rep. Arrington and three colleagues in a Dec. 5 letter sent to U.S. Commerce Secretary Howard Lutnick.
“By tackling this issue, the department can foster competition, reduce healthcare costs, and support domestic manufacturing,” wrote the lawmakers, who also included U.S. Sen. Peter Welsh (D-VT) and U.S. Rep. August Pfluger (R-TX).
Rep. Arrington and his colleagues cited reports showing that biologic drugs in the United States are protected by significantly more patents than in comparable markets like Canada and the United Kingdom, a disparity that correlates with delayed biosimilar market entry in the U.S.
“This means patients are paying more for drugs solely based off pharmaceutical gamesmanship,” they pointed out, adding that “excessive patents” also create a costly and time-consuming barrier for biosimilar manufacturers, who face litigation costs of up to $1 million per patent in inter parte review proceedings — “negatively impacting domestic manufacturing for prescription drugs.”
The result, they wrote, is that such current patent thicket schemes undermine competitive frameworks that are intended to reduce costs for the patient and the Medicare program as a whole.
They called for additional reforms to root out such hidden costs and increase domestic competition, specifically through the bipartisan Eliminating Thickets to Increase Competition Act (ETHIC) Act, H.R. 3269, which Rep. Arrington sponsored on May 8 alongside four original cosponsors, including Rep. Pfluger and U.S. Rep. Lloyd Doggett (D-TX).
If enacted, the lawmakers say that H.R. 3269 would stop such double patenting practices by requiring a branded pharmaceutical manufacturer, during litigation against a biosimilar manufacturer, to choose their preferred patent from each of the patent groups covering a drug to assert.
“This would allow additional biosimilars and generics to enter the market earlier, which will reduce barriers to patient access to lower-cost medicines,” they wrote. “We request the administration’s support of this bill, as the president looks to deliver on reducing prescription drug costs.”