H.R.3269 - Eliminating Thickets to Increase Competition Act; ETHIC Act (119th Congress)
Summary
H.R.3269, the "Eliminating Thickets to Increase Competition Act" or "ETHIC Act," aims to address patent thickets in the pharmaceutical industry. It proposes limiting the number of patents that can be asserted in infringement actions against parties seeking approval for generic drugs or biosimilars under specific sections of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. The bill focuses on patents within the same "Patent Group," defined as commonly owned patents with cross-disclaimers.
Expected Effects
The bill, if enacted, would likely reduce the ability of brand-name pharmaceutical companies to use numerous patents to delay the entry of generic drugs and biosimilars into the market. This could lead to increased competition and potentially lower drug prices for consumers. The applicability section specifies that the amendment would apply to applications submitted on or after the date of enactment.
Potential Benefits
- Increased Competition: Limits on patent assertion could foster greater competition in the pharmaceutical market.
- Lower Drug Prices: Reduced patent thickets may lead to quicker generic and biosimilar entry, potentially lowering drug costs for consumers.
- Innovation: By reducing the defensive use of patents, the bill could incentivize innovation focused on genuine advancements rather than patent maneuvering.
- Streamlined Litigation: Limiting the number of patents asserted in a single action could simplify and expedite patent litigation.
- Patient Access: Lower drug prices and increased competition could improve patient access to needed medications.
Potential Disadvantages
- Reduced Patent Protection: Pharmaceutical companies may argue that the bill weakens patent protection, potentially disincentivizing investment in research and development of new drugs.
- Complexity in Defining Patent Groups: The definition of "Patent Group" may lead to disputes and litigation over which patents fall under the limitation.
- Unintended Consequences: Limiting patent assertion may have unforeseen impacts on the pharmaceutical industry and the development of new treatments.
- Potential for Gaming the System: Companies might try to circumvent the limitations by strategically managing patent ownership and disclaimers.
- Impact on Investment: Investors may become wary of investing in pharmaceutical companies if they perceive that their patent rights are weakened.
Constitutional Alignment
The bill's focus on patent law falls under the purview of Congress as defined in Article I, Section 8, Clause 8 of the Constitution, which grants Congress the power to "promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." The bill seeks to balance this right with the goal of promoting competition and affordable access to medications. There are no apparent conflicts with the Bill of Rights.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).