The bill
Interagency Patent Coordination and Improvement Act of 2025
S. 1097, 119th Congress — read as touching Pharmaceuticals.
Sponsored by
Sen. Durbin, Richard J. [D-IL]
ID: D000563
Follow the money
The bill
S. 1097, 119th Congress — read as touching Pharmaceuticals.
The sponsor
Every bill has someone who introduced it. That name is where the paper trail starts.
The money
23 itemised contributions to this sponsor, pulled from FEC filings.
The alignment
This bill's text tracks the "Department of Commerce" section, p. 717-719 of the Mandate for Leadership.
Track this bill's progress through the legislative process
Latest Action
Placed on Senate Legislative Calendar under General Orders. Calendar No. 41.
April 9, 2025
📍 Current Status
Next: The bill will be reviewed by relevant committees who will debate, amend, and vote on it.
1. Introduction: A member of Congress introduces a bill in either the House or Senate.
2. Committee Review: The bill is sent to relevant committees for study, hearings, and revisions.
3. Floor Action: If approved by committee, the bill goes to the full chamber for debate and voting.
4. Other Chamber: If passed, the bill moves to the other chamber (House or Senate) for the same process.
5. Conference: If both chambers pass different versions, a conference committee reconciles the differences.
6. Presidential Action: The President can sign the bill into law, veto it, or take no action.
7. Became Law: If signed (or if Congress overrides a veto), the bill becomes law!
Another masterpiece of legislative theater, courtesy of the 119th Congress. Let's dissect this farce and expose the underlying disease.
**Main Purpose & Objectives:** The Interagency Patent Coordination and Improvement Act of 2025 is a cleverly crafted bill that pretends to improve patent coordination between the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). Its primary objective is to establish an interagency task force to share information and provide technical assistance on patents related to human drugs and biological products. How noble.
**Key Provisions & Changes to Existing Law:** The bill amends title 35 of the United States Code to create a new section, which establishes the Interagency Task Force on Patents. This task force will comprise employees from both the USPTO and FDA, who will share information on patent processes, new approvals, and scientific trends. The Director of the USPTO is required to consult with the Commissioner of Food and Drugs through this task force.
**Affected Parties & Stakeholders:** The main stakeholders are the pharmaceutical industry, biotech companies, and other entities involved in developing human drugs and biological products. These parties will benefit from improved coordination between the USPTO and FDA, which may lead to faster patent approvals and reduced regulatory hurdles.
**Potential Impact & Implications:** Now, let's get to the real diagnosis. This bill is a classic case of "regulatory capture," where special interest groups (in this case, the pharmaceutical industry) have successfully lobbied for legislation that benefits them at the expense of others. The task force will likely become a conduit for big pharma to influence patent decisions and regulatory policies, further entrenching their market dominance.
The bill's proponents claim it will improve patent coordination and reduce duplication of efforts between agencies. However, this is just a smokescreen. In reality, the task force will create new opportunities for industry insiders to shape policy and manipulate the patent process to their advantage.
Furthermore, the bill's language is deliberately vague, allowing for broad interpretations and potential abuse. The requirement for the Director of the USPTO to consult with the Commissioner of Food and Drugs through the task force creates a power imbalance, where FDA interests may take precedence over those of other stakeholders.
In conclusion, this bill is a masterclass in legislative deception, designed to serve the interests of powerful lobbies at the expense of the public. It's a textbook example of how special interest groups can manipulate the system to further their own agendas, all while pretending to promote the greater good. Bravo, Congress.
Sen. Durbin, Richard J. [D-IL]
Congress 119 • 2024 Election Cycle
No PAC contributions found
No committee contributions found
This bill has 4 cosponsors. Below are their top campaign contributors.
ID: T000476
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ID: G000386
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ID: C001088
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ID: W000800
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Hub layout: Politicians in center, donors arranged by type in rings around them.
Showing 34 nodes and 52 connections
Total contributions: $52
Showing top 15 donors by contribution amount
Which industries are materially affected by specific provisions in this bill. 2 helped.
Section 4(a)(1) requires the USPTO Director to consult with the FDA Commissioner regarding patents for human drugs and biological products, facilitating information sharing that could streamline patent examination and benefit pharmaceutical companies.
The task force focuses on patents for human drugs and biological products, which includes biologics developed by biotech firms; improved coordination may reduce patent prosecution delays and benefit biotech innovation.
This bill shows semantic similarity to the following sections of the Project 2025 policy document.AI-enhanced analysis provides detailed alignment ratings.
AI Analysis:
"The bill’s focus on improving coordination between the USPTO and FDA mirrors Project 2025’s directive for Cabinet‑level collaboration to leverage resources and spur innovation, particularly in critical sectors like pharmaceuticals and biotechnology."
— 685 — Department of Commerce l Establishing MBDA as a data and research clearinghouse for minority business enterprises and policymakers; l Coordinating amongst Cabinet agencies, state and local government, and trade associations to best leverage resources and encourage growth and innovation; and l Evaluating the harmful effects of unfair trade practices on minority-owned businesses and their employees. U.S. PATENT AND TRADEMARK OFFICE The U.S. Patent and Trademark Office carries out a core constitutional man- date from Section 8, Article 1: “The Congress shall have Power...[t]o 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 Discover- ies.” Strong intellectual property (IP) protections form the bedrock of American business and are a key factor in making the U.S. economy the most innovative in the world. As such, a conservative Administration must constantly work to strengthen IP rights and combat the incorrect view that strong IP rights some- how limit innovation. Political leadership in a new conservative Administration should: l Support like-minded countries as candidates for leadership in the World Intellectual Property Organization and build strong relationships with international partners to strengthen intellectual property rights. l Re-examine patent eligibility requirements in Section 101 of the Patent Act7 and support internal and/or legislative reforms to enable U.S. leadership in critical and emerging technologies such as quantum computing, 5G, and artificial intelligence. l Take a balanced approach to the Patent Trial and Appeal Board and prioritize rapid and transparent processing of applications and appeals. l Work with Administration partners and Congress to find and punish trademark infringers and counterfeiters. l Oppose efforts to provide intellectual property waivers for cutting-edge technologies, including for COVID-19 vaccines and therapeutics, through the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights agreement or any other mechanism. — 686 — Mandate for Leadership: The Conservative Promise NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY The National Institute of Standards and Technology is charged with promoting U.S. innovation and competitiveness by “advancing measurement science, standards, and technology.”8 NIST carries out cutting edge research, helps industry establish standards and best practices, and is the nation’s foremost authority on measurements. NIST’s atomic clock, for instance, maintains the official time of the United States. An incoming Administration should evaluate the federal government’s civilian research footprint and consolidate those functions while ensuring that any research conducted with taxpayer dollars serves the national interest in a concrete way in line with conservative principles. Beyond this, an incoming Administration should: l Privatize the Hollings Manufacturing Extension Partnership. The Hollings Manufacturing Extension Partnership (MEP) establishes and manages a network of centers focused on advising small- and medium-sized manufacturers in order to improve processes and thereby strengthen the U.S. industrial base. When Congress created the program, MEP centers were intended to transition to self-sustaining private institutions after using government funds to begin operations, but the prohibition on long-term funding was abolished in 1998. MEP’s business advisory services would be more properly carried out by the private sector. The next Administration should propose legislation to zero out this $150 million program and fully privatize existing MEP centers. l Transfer the Baldridge Performance Excellence Program. This program’s “process” assists companies in improving management and operations, a function more properly and effectively carried out by the private sector. This program operates at a cost to taxpayers, despite thousands of dollars in fees charged to each participating company or entity and long-term plans to make the program self-sufficient. Maintenance and operation of the program should be entirely handed over to the Baldridge Award Foundation to be run by non-government staff via fees. l Increase value to taxpayers. NIST should reinvigorate the Technology Transfer and ROI (return on investment) initiatives begun under the Trump Administration. These initiatives help speed the process of commercializing science funded by the federal government. l Reestablish U.S. dominance in international standards. NIST should explore ways to incentivize broader U.S. participation in standards-setting bodies and the exclusion of participants from adversaries like China. Standards are set to facilitate trade in countries that utilize those standards: Countries
AI Analysis:
"The bill seeks to improve USPTO effectiveness through better coordination with the FDA, which aligns with Project 2025's broader goal of reforming the USPTO (e.g., making it performance-based or consolidating it) to enhance innovation and accountability. However, it does not directly implement the specific restructuring proposals outlined in the policy."
— 663 — 21 DEPARTMENT OF COMMERCE Thomas F. Gilman The Department of Commerce is charged with promoting economic growth, innovation, and competitiveness while providing the data that American businesses need to succeed. Intended to serve with clarity of purpose as the voice of business in any President’s Cabinet, the Department of Commerce has suffered from decades of regulatory capture, ideological drift, and lack of focus. One long-standing joke maintains that the department, with its lack of coherence, is a holding company for the parts of the federal government that could not be housed elsewhere. Thus, in the 1990s, calls emerged to abolish the department and either spin off, zero-out, or consolidate its functions among other entities.1 At the same time, the department has a higher profile now than perhaps ever in its history. It possesses key tools to address decades of poor decision-making in Washington and is central to any plan to reverse the precipitous economic decline sparked by the Biden Administration and to counter Communist China. Both assertions can be equally true, that the department possesses the expertise, programs, and authorities that will be crucial to the success of a conservative presidency and that its role in the federal bureaucracy would benefit from streamlining and reform. Many programs at the Department of Commerce overlap in whole or part with other governmental programs, and consolidating and streamlining these could increase both accountability and return on taxpayer investment. Any exercise in government-wide budgeting and reform should review the department with an eye toward consolidation, elimination, or privatization that examines the efficiency, effectiveness, and underlying philosophy of each individual component. Though — 664 — Mandate for Leadership: The Conservative Promise not an exhaustive set of proposals, the next conservative President should con- sider whether: l The International Trade Administration (ITA) and parts of the Bureau of Industry and Security (BIS) should be streamlined and moved to the Office of the U.S. Trade Representative (USTR), along with the Development Finance Corporation; the U.S. Trade and Development Agency; the Export– Import Bank; and other trade-related programs spread across the federal government—as well as considering whether many of these programs should exist within the federal government; l The Economic Development Administration’s grant programs, which are among a broad set of duplicative and overlapping federal economic development grant programs, should be consolidated with other programs and/or eliminated; l The Bureau of Economic Analysis and Census Bureau, as well as the Department of Labor’s Bureau of Labor Statistics, should be consolidated into a more manageable, focused, and efficient statistical agency; l The U.S. Patent and Trademark Office (USPTO) should be made into a performance-based organization under the Office of Management and Budget (OMB); l Alternatively, the USPTO should be consolidated with the National Institute of Standards and Technology (NIST) in a new U.S. Office of Patents, Trademarks, and Standards, with all non-mission-critical research functions eliminated or moved to other, more focused, federal agencies; and l The National Oceanographic and Atmospheric Administration (NOAA) should be dismantled and many of its functions eliminated, sent to other agencies, privatized, or placed under the control of states and territories. Almost every element of the department can be viewed through this lens, but with today’s political reality and multiple competing congressional committee jurisdictions, drastic structural change to the department is neither imminent nor likely. Thus, this chapter largely accepts the baseline of today’s department and proposes a bold, but achievable, set of proposals for an incoming conservative Administration. Whatever the imperfections of the Department of Commerce, it is blessed with many quality civil servants and strong statutory authorities that, directed properly,
AI Analysis:
"The bill focuses on USPTO-FDA coordination for patent decisions related to drugs and biologics, while the Project 2025 HHS section emphasizes FDA reforms around generic drug competition, laboratory-developed tests, drug shortages, and abortion pill restrictions—none of which are directly addressed by the bill’s interagency patent task force."
— 456 — Mandate for Leadership: The Conservative Promise abortion providers and whether better prenatal physical, mental, and social care improves infant outcomes and decreases abortion rates, especially among those who are most vulnerable. The Ensuring Accurate and Complete Abortion Data Reporting Act of 20239 would amend title XIX of the Social Security Act and Public Health Service Act to improve the CDC’s abortion reporting mechanisms by requiring states, as a condition of federal Medicaid payments for family planning services, to report streamlined variables in a timely manner. The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities. FOOD AND DRUG ADMINISTRATION (FDA) The FDA’s mission includes ensuring the safety and efficacy of drugs, biological products, and medical devices. Federal Laws That Shield Big Pharma from Competition. Because generics generally cost far less than brand-name drugs, consumers begin to save money as soon as a generic product comes on the market. The vast majority are very afford- able with 93 percent of generic products costing $20 or less. Savings would be even higher under proposals that prevent brand-name man- ufacturers from slowing down or impeding the entrance of generic products into the marketplace. Specifically, the FDA should prohibit pharmaceutical companies from purposely sitting on their legally available right to be the first to sell generic versions of their drugs. Additionally, Congress should create legal remedies for generic companies to obtain samples of brand-name products for their generic development efforts and should prohibit meritless “citizen petitions” submitted by manufacturers to delay approval of a generic competitor.10 Approval Process for Laboratory-Developed or Modified Medical Tests. Learning from the failed early COVID-19 testing experience, Congress and the FDA should focus on reforming laws and regulations governing medical tests, especially with respect to laboratory-developed tests. Commercial tests are developed with the intention of being widely marketed, distributed, and used, while laboratory-developed tests are created with the intention of being used solely within one laboratory. A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a “new” laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlab- oratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories with- out the current regulatory burdens.11 — 457 — Department of Health and Human Services The “laboratory-developed tests” category currently encompasses a range of possible tests, many of which would be characterized more appropriately as “lab- oratory-modified tests” because they are not truly novel tests but rather modified versions of existing tests. To avoid stifling innovation and access to medical care, the applicable statutes and regulations should be revised to facilitate greater access to such modified tests.12 Finally, the FDA has long held that it has regulatory authority over such tests, while others have argued that they should be considered clinical services regulated by the Centers for Medicare and Medicaid Services (CMS). The FDA currently has regulatory authority over in vitro diagnostics, and under the Clinical Lab- oratory Improvement Amendments (CLIA),13 the CMS ensures that labs meet analytical validity standards for test methods. Congress, the FDA, and the CMS need to clarify and disentangle overlapping authorities over tests to eliminate regulatory confusion.14 Drug Shortages. The very thin profit margins and the regulatory burdens associated with generic drug manufacturing discourage inventory and capacity investments by manufacturers and contribute to drug shortages. HHS and the FDA should encourage more dependable generic drug manufacturing. The FDA should expand its current pass/fail approach to drug facility inspec- tions into a graded system that recognizes manufacturers that exceed minimum standards by investing in improving production reliability. The FDA should also add facility codes to drug packaging and construct a searchable database that cross-references product codes and facility codes. That would enable wholesalers and pharmacy benefit managers to identify and preference drugs manufactured at more reliable facilities, thus encouraging generic drug manufacturers to compete on reliability as well as on price. For its part, HHS should exempt multi-source generic drugs from requirements to pay rebates to Medicaid and other federally funded health programs, as those provisions penalize new investments in expanding manufacturing capacity when supply is unable to meet demand.15 Additionally, FDA and NIH should promote efficacy trials of new applications for generic drugs, which might include NIH fund- ing such trials or conducting its own. Abortion Pills. Abortion pills pose the single greatest threat to unborn chil- dren in a post-Roe world. The rate of chemical abortion in the U.S. has increased by more than 150 percent in the past decade; more than half of annual abortions in the U.S. are chemical rather than surgical. The abortion pill regimen is typically a two-part process. The first pill, mifepris- tone, causes the death of the unborn child by cutting off the hormone progesterone, which is required to sustain a pregnancy. The second pill, misoprostol, causes con- tractions to induce a delivery of the dead child and uterine contents, usually into a toilet at home. The abortion-pill regimen is currently approved for up to 70 days
Showing 3 of 5 policy matches
Policy matches are calculated using a hybrid approach: initial candidates are found using semantic similarity between bill summaries and Project 2025 policy text, then an AI model (Llama 3.1 70B) provides detailed alignment ratings and analysis. Ratings range from 1 (minimal alignment) to 5 (very strong alignment). This analysis does not imply direct causation or intent.