Patent thickets in federal government’s crosshairs as election 2024 looms
Patent thickets in federal government’s crosshairs as election 2024 looms
With prescription drug prices a hot-button political issue this election year, pharmaceutical companies are feeling the heat from Congress and the Biden-Harris administration for taking advantage of the U.S. patent system to extend exclusivity and maximize profits for as long as possible.
Earlier this month, government watchdog Accountable.US released a report detailing how the manufacturers of the initial 10 prescription drugs negotiated under the Inflation Reduction Act’s Medicare Drug Price Negotiation Program have exploited patent laws to prolong monopolies and keep prescription drug prices high. At the center of the controversy is Big Pharma’s practice of filing multiple, overlapping patents for the same product, creating a “thicket” that effectively stifles generic and biosimilar competition.
The report pointed to Johnson & Johnson’s blood thinner Xarelto as a “prime example” of a patent thicket, with the company filing 49 patents for over a decade of market exclusivity. Another is Amgen’ autoimmune disease treatment Enbrel. The company has filed 57 patent applications for the drug since it came to market in 1990, 72% of which came after FDA approval “with the aim of delaying competition by 39 years,” according to Accountable.US.
However, the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry’s lobby in Washington, has repeatedly tried to dispel the “myths” surrounding “so-called patent thickets” and “unsubstantiated allegations” about Big Pharma’s abuses of the U.S. patent system.
“Narratives about the quantity of patents and the families of patents comprising so-called ‘patent thickets’ are driven by questionable data and misunderstandings about patent coverage,” PhRMA wrote in comments last month to the U.S. Patent and Trademark Office (USPTO), opposing a proposed rule that could be a boon for patent challengers.
