Driving Access to Affordable Drugs - Advancing Patent Policies

Practices like “patent thickets,” “evergreening,” and others extend monopolies on brand-name drugs well beyond intended patent lifespans. ERIC supports commonsense solutions to address such anticompetitive practices. Furthermore, ERIC supports effort to streamline coordination between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (PTO) to prevent the misuse of patent filings that delay the entry of affordable generics and biosimilars. Better collaboration between these agencies can help identify and address abusive practices early, protecting market competition and improving access to cost-effective medications.

• Patent Reform Overview One-Pager
  •  This document outlines key reforms needed to address patent system manipulation
• Needed Patent Reforms Will Lower Drug Costs One-Pager
  • The one-pager argues that curbing patent abuse will facilitate faster entry of generics and biosimilars, directly lowering prescription drug costs for patients and plan sponsors.
• Stop Drug Manufacturers From Abusing the Patent System and Engaging In Anti-Competitive Practices One-Pager
  • This resource details how certain pharmaceutical companies exploit loopholes in the patent system to delay competition and urges policymakers to act.
• Affordability RFI (Pages 12-13)
  • The response advocates for reforms to patent practices that delay market entry of lower-cost alternatives, emphasizing the impact on employers and health plan affordability.
• Budget Committee Health Care Task Force Response (Page 9)
  • The submission supports several policires to prevent anti-competitive patent strategies that drive up drug prices.
• Request for Public Comment to Proposed Rule: Terminal Disclaimer Practice to Obviate Non-statutory Double Patenting
  • The comment supports the proposed rule change as a meaningful step to limit patent gamesmanship and accelerate competition from generics.
• Comments on the Revision to Rules of Practice Before the Patent Trial and Appeal Board
  • ERIC called for the U.S. Patent and Trademark Office (USPTO) to withdraw its proposed rule revising PTAB procedures as it would limit access to the inter partes review (IPR) process which is an essential mechanism for challenging low-quality patents that keep drug prices artificially high by delaying competition from lower cost generic and biosimilar medications. Limiting access to the IPR process will not only undermine efforts to lower health care costs, but this action will directly contradict President Trump’s stated priority to make prescription drugs more affordable for Americans.

Prescription Pricing for the People Act of 2025 (S. 527)

• Grassley, Cantwell Reintroduce Bills to Lower Prescription Drug Prices, Drive PBM Accountability  (02.12.2025 Press Release)
  • This press release highlights bipartisan efforts to increase transparency and accountability in the prescription drug market.
• Bill Summary for the Prescription Pricing for the People Act of 2025
  • The summary outlines provisions to require the FTC to study and report on the role of PBMs and drug pricing, supporting broader competition and affordability goals.
• CBO 2025 Score
  • CBO estimates that implementing the bill would cost $3 million over the next two years; any related spending would be subject to the availability of appropriated funds.

Affordable Prescriptions for Patients Act (S. 1041)

• Affordable Prescriptions for Patients Act One Pager
  • One pager outlining the bipartisan legislation introduced by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT).
• Cornyn, Blumenthal, Grassley, Durbin Introduce Bill to Lower Drug Costs (03.14.2025)
  • Lawmakers reintroduced legislation to curb patent abuses and places a reasonable limit on the number of patents a manufacturer can contest, preventing a “patent thicket.”
• CBO 2023 Score
  • CBO estimates that enacting the bill would reduce direct spending by $2.4 billion and increase revenues by $585 million over the 2024-2034 period, for a net decrease in the deficit of $3.0 billion
• ERIC Letter to Senate Judiciary Members – 118^th Congress
  • ERIC expressed support for patent reform to eliminate anticompetitive tactics that delay lower-cost alternatives.
• House Judiciary Group Letter – 118^th Congress
  • This letter echoes calls for reforms targeting patent strategies that undermine market competition and inflate drug prices.

Stop STALLING Act (S. 1095)

• Grassley, Klobuchar Introduce Bills to Reduce Drug Costs by Promoting Competition, Taking on Abusive Practice (03.26.2025)
  • This release underscores the intent to stop branded drug companies from using sham citizen petitions to block generic competition.
• CBO 2023 Score
  • CBO estimates that enacting S. 148 would not increase net direct spending or deficits in any of the four consecutive 10-year periods beginning in 2034.
• ERIC Letter to Senate Judiciary Members – 118^th Congress
  • ERIC backs this bill as a way to reduce delays in generic entry and improve affordability.

Preserve Access to Affordable Generics and Biosimilars Act (S. 1096)

• Grassley, Klobuchar Introduce Bills to Reduce Drug Costs by Promoting Competition, Taking on Abusive Practice (03.26.2025)
  • The bill seeks to ban pay-for-delay agreements that postpone generic and biosimilar launches.
• CBO 2023 Score
  • CBO estimates that enacting S. 142 would not increase net direct spending or deficits by more than $2.5 billion in any of the four consecutive 10-year periods beginning in 2034.
• ERIC Letter to Senate Judiciary Members – 118^th Congress
  • ERIC supports this legislation to eliminate anti-competitive settlement practices and enhance market competition.

Interagency Patent Coordination and Improvement Act of 2025 (S. 1097 and H.R.4570)

• House Bill
• Grassley, Durbin, Colleagues Introduce Legislation to Improve Coordination between Patent Office and FDA (03.25.2025)
  • This legislation aims to strengthen coordination between the FDA and PTO to prevent misuse of patent filings.
• ERIC Letter to Senate Judiciary Members – 118^th Congress
  • ERIC endorses the bill for promoting agency collaboration to address abusive patent tactics.
• House Judiciary Group Letter – 118^th Congress 
  • The letter advocates for improved FDA-PTO cooperation to ensure timely entry of cost-effective generics and biosimilars.

Eliminating Thickets to Increase Competition Act (ETHIC) Act (S. 2276 and H.R. 3269).

• Eliminating Thickets to Increase Competition Act (ETHIC) Act
  • This legislation targets the practice of creating patent thickets that delay generic drug competition.
  • Senate Press Release This press releases announces the introduction of the legislation naimed at streamlining patent litigation for brand-name drugs by limiting companies to asserting one patent per “thicket,” preventing multiple lawsuits against the same generic or biosimilar competitor, and safeguarding genuine innovation—all to accelerate market entry of lower-cost alternatives and reduce prescription drug costs for patients
• Group Letter Calling for Hearing 
  ERIC, along with other stakeholders, sent a letter to House Judiciary Committee leaders urging them to hold a hearing on the Skinny Labels, Big Savings Act (H.R. 6485) and the Eliminating Thickets to Increase Competition (ETHIC) Act (H.R. 3269). The ETHIC Act (H.R. 3269) will enhance patient access by preventing brand-name pharmaceutical companies from asserting multiple duplicative patents in patent litigation. These duplicative patents create a numbers game for generic and biosimilar companies that ultimately harms patients.
• House Press Release
  • Rep. Jodey Arrington introduced the bipartisan ETHIC Act to lower prescription drug costs by limiting abusive patent practices that block generic and biosimilar competition.
• House Judiciary Group Letter
  • The letter supports curbing excessive and duplicative patents used to prolong exclusivity.
• Welch, Braun, Klobuchar USPTO Rule Letter (9.19.2024)
  • Lawmakers applauded USPTO’s rulemaking to rein in patent abuse and lower drug prices.

Medication Affordability and Patent Integrity Act (S. 2658)

• Press Release 8-25-2025
  • Senators Hassan and Hawley introduced legislation to combat Big Pharma’s patent abuse and lower prescription drug costs.
• One Pager
  • The legislation outlines how to close a loophole that limits patients’ access to low-cost medications.
• H.R. 5429 Congress Fact Sheet
  •  The fact sheet details how the bill would improve the patent process to expedite generic entry.
• FDA-PTO Coordination to Lower Drug Costs
  • Highlights the importance of agency alignment to prevent strategic patent misuse.
• ERIC Support Letter
  • ERIC expresses strong support for comprehensive patent reform to reduce costs for employers and patients.
• House Judiciary Group Letter
  • Lawmakers call for reforms targeting patent abuse and anticompetitive tactics. 
• ASHP Correspondence on HELP Markups of S. 2305 and S. 2780
  • Pharmacy stakeholders endorse the legislation’s focus on reducing high drug costs via patent reform.
• September 2024 AAM Letter
  • The Association for Accessible Medicines endorses the bill for improving generic and biosimilar market entry.