Read twice and referred to the Committee on the Judiciary.
This bill (Eliminating Thickets to Increase Competition Act) amends 35 U.S.C. 271(e) to restrict the number of patents a patent owner may assert in certain infringement actions related to generic drug and biosimilar approval and commerce. Under the amendment, a patent owner bringing an infringement claim under section 271(e) against an applicant or a maker/seller of an approved drug or licensed biological product may assert no more than one patent per defined “Patent Group.” A “Patent Group” is defined as two or more commonly owned patents or applications that are connected by terminal disclaimers under 35 U.S.C. 253 (i.e., patents/applications that identify or are identified by such disclaimers to obviate obviousness-type double patenting).
Progressives emphasize affordability and reducing anti-competitive patent thickets; conservatives emphasize protection of patent property rights and innovation incentives.
Relative to its intended legislative type, this bill delivers a focused substantive amendment that defines and limits patent assertions in specific FDA-related infringement proceedings by statutory text.
This bill (Eliminating Thickets to Increase Competition Act) amends 35 U.S.C. 271(e) to restrict the number of patents a patent owner may assert in certain infringement actions related to generic drug and biosimilar approval and commerce.
Under the amendment, a patent owner bringing an infringement claim under section 271(e) against an applicant or a maker/seller of an approved drug or licensed biological product may assert no more than one patent per defined “Patent Group.” A “Patent Group” is defined as two or more commonly owned patents or applications that are connected by terminal disclaimers under 35 U.S.C. 253 (i.e., patents/applications that identify or are identified by such disclaimers to obviate obviousness-type double patenting).
The bill also bars bringing additional separate actions asserting patents from the same Patent Group against the same party, and it applies to applications submitted under FDA approval pathways (505(b)(2), 505(j), or 351(k)) on or after the date of enactment.
On content alone the bill is a narrowly targeted, administrable tweak to patent-litigation rules that aligns with goals of increasing competition and easing generic/biosimilar entry—attributes that can attract bipartisan interest. At the same time, the change directly affects the revenue and enforcement strategies of innovator drug and biotech companies, which are powerful stakeholders likely to oppose it. Lack of a budgetary authorization reduces one obstacle, but expected heavy industry pushback and the higher threshold in the Senate make enactment plausible but not likely without negotiated modifications or tradeoffs.
Relative to its intended legislative type, this bill delivers a focused substantive amendment that defines and limits patent assertions in specific FDA-related infringement proceedings by statutory text. The central rule and definition are reasonably specific, but the bill provides minimal legislative explanation, omits fiscal and oversight provisions, and leaves several practical and edge-case implementation questions to judicial interpretation.
Progressives emphasize affordability and reducing anti-competitive patent thickets; conservatives emphasize protection of patent property rights and innovation incentives.
These are examples from the analysis, not a ranked list of the most-affected groups.
Progressives emphasize affordability and reducing anti-competitive patent thickets; conservatives emphasize protection of patent property rights and innovation incentives.
A mainstream liberal/progressive is likely to view the bill favorably as a targeted reform to reduce abusive patent strategies that delay generic and biosimilar competition and thereby keep drug prices high.
They would see the one-patent-per-Patent-Group limit as a way to cut down on serial or overlapping litigation that effectively creates a patent thicket around a product.
They may want the bill to be stronger (for example, broader definitions or retroactivity) but will generally see it as a useful step for access and affordability.
A centrist/moderate would view the bill as a narrowly tailored, pragmatic reform that addresses a known problem (patent thickets) without wholesale alteration of patent law.
They would appreciate that the bill focuses on patents connected by terminal disclaimers and applies prospectively, which reduces legal and economic disruption.
At the same time, they would have concerns about potential unintended consequences — administrative or litigation complexity, ambiguity in the Patent Group definition, and uncertain impacts on R&D incentives.
A mainstream conservative would be skeptical of the bill as a government-imposed limit on the enforcement of privately held patent rights and as a potential erosion of incentives for pharmaceutical innovation.
They would view restricting patent assertions per Patent Group as an intrusive regulation that could weaken patent value and reduce returns on costly drug development.
Although conservatives support market competition, they typically favor protecting strong IP rights and letting markets and antitrust enforcement handle abuses rather than limiting litigation options by statute.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
On content alone the bill is a narrowly targeted, administrable tweak to patent-litigation rules that aligns with goals of increasing competition and easing generic/biosimilar entry—attributes that can attract bipartisan interest. At the same time, the change directly affects the revenue and enforcement strategies of innovator drug and biotech companies, which are powerful stakeholders likely to oppose it. Lack of a budgetary authorization reduces one obstacle, but expected heavy industry pushback and the higher threshold in the Senate make enactment plausible but not likely without negotiated modifications or tradeoffs.
The bill has not accumulated any surfaced votes yet.
Progressives emphasize affordability and reducing anti-competitive patent thickets; conservatives emphasize protection of patent property r…
On content alone the bill is a narrowly targeted, administrable tweak to patent-litigation rules that aligns with goals of increasing compe…
Relative to its intended legislative type, this bill delivers a focused substantive amendment that defines and limits patent assertions in specific FDA-related infringement proceedings by statutory text. The central rul…
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