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Hearing “Medicines and IP: Balancing Innovation and Access”
house Courts, Intellectual Property, Artificial Intelligence, and the Internet Subcommittee · Jun 4, 2026 · Transcript · 47 transcript matches
MS. RACHEL GOODE "So it works both sides. They don't lose anything. Yes, they have to demonstrate that for the first of the duplicate patents. After that, what we see, and there's peer-reviewed data on this as well, is once the patent owners start filing and duplicating the patents, it's a given because the first patent was already examined. The issue is that these duplicates add nothing more than the first"
Hearing Hearings to examine genes to machines, focusing on the patent eligibility debate.
senate Judiciary Committee · Jul 14, 2026 · Transcript · 36 transcript matches
GRASSLEY, CHUCK "and Communications Industry Association. He previously served as chief counsel for intellectual property on the House Judiciary Committee. Before that, he worked as lead administrative patent judge on the Patent Trial and Appeal Board at the U.S. Patent and Trademark Office. Mr. Lee received his law degree, B.A.S. in bioengineering and B.A. in biology and"
Hearing Business meeting to consider S.1782, to prohibit discrimination on the basis of mental or physical disability in cases of organ transplants,...
senate Health, Education, Labor, and Pensions Committee · Jun 17, 2026 · Request transcript · 7 transcript matches
BANKS, JIM "Senator Banks. Thank you, Mr. Chairman. I appreciate the intent of the legislation by the bill's authors. What I what I don't favor, though, is doing anything that would help the Chinese Communist Party cheat and steal our IP. And that's what my amendment would would go at lengths to stop. My amendment would that the same protections for trade secrets at the FDA would also apply at the Patent and Trademark Office. We know Chinese biotech companies have been sifting through U.S. patent applications for a long time, looking to steal intellectual property so they can copy our drugs. Now they are..."
CRS Report
Drug Pricing and the Law: Pharmaceutical Patent Disputes
Resources · May 17, 2019
Patent rights play an important role in the development and pricing of pharmaceutical products. Patent law seeks to encourage innovation by granting the holder of a valid patent a temporary monopoly...
CRS Report
Patent-Eligible Subject Matter Reform: An Overview
InFocus · Jan 16, 2026
The U.S. patent system is designed to encourage innovation. The types of inventions that can be patented may affect the patent system’s ability to promote innovation in certain fields, especially in...
CRS Report
Patent Law: A Handbook for Congress
Reports · Sep 16, 2020
A patent gives its owner the exclusive right to make, use, import, sell, or offer for sale the invention covered by the patent. The patent system has long been viewed as important to encouraging...
CRS Report
Patent Law: An Introduction and Issues for Congress
InFocus · Mar 2, 2026
Patents, a form of intellectual property, give their owners certain exclusive rights in new and useful inventions. To encourage innovation, the Constitution gives Congress the power to grant patents...
CRS Report
Amgen v. Sanofi: Supreme Court Holds Patents Claiming Antibody Genus Invalid as Not Enabled
Posts · Jun 1, 2023
In Amgen v. Sanofi, the Supreme Court held that Amgen’s patent on a class of antibodies used to treat high cholesterol was invalid under patent law’s enablement requirement. Justice Neil Gorsuch’s...
CRS Report
Supreme Court Preserves Patent Trial and Appeal Board, but with Greater Executive Oversight
Posts · Jun 29, 2021
In 2011, Congress enacted a major patent reform bill, the Leahy–Smith America Invents Act (AIA). Among other things, the AIA created new adversarial administrative proceedings within the Patent and...
Hearing “Oversight of the U.S. Patent and Trademark Office”
house Courts, Intellectual Property, Artificial Intelligence, and the Internet Subcommittee · Mar 25, 2026 · Transcript · 3 transcript matches
FITZGERALD, SCOTT "incoming low-quality patents. Very good. Let me quickly turn to kind of another area. According to American Intellectual Property Law Association, the average cost of patent litigation in a district court is $5 million, whereas the cost for adjudicating patent disputes before the patent trial and appeal board on average is about 10 times less, or around a half a million dollars. Critics of the proposed changes to the PTAB process have said the result will be more patent cases being litigated by the courts. And assuming that that could be true, did the USPTO take into consideration the..."
CRS Report
Artificial Intelligence and Patent Law
Legal Sidebar · Jan 12, 2026
Advances in artificial intelligence (AI) have raised novel questions for U.S. patent law, just as AI has raised concerns in other branches of intellectual property law, including copyrights and the...
CRS Report
The Patent Trial and Appeal Board and Inter Partes Review
Reports · May 28, 2024
The 2011 Leahy-Smith America Invents Act (AIA) is widely viewed as the most significant patent statute enacted by Congress in over 50 years. Although the AIA made many important changes to U.S....
CRS Report
Patent Listing in FDA’s Orange Book
InFocus · Jan 21, 2026
For over 40 years, the U.S. Food and Drug Administration (FDA) has maintained a resource formally titled Approved Drug Products with Therapeutic Equivalence Evaluations. This frequently updated...
CRS Report
Judges Urge Congress to Revise What Can Be Patented
Posts · Mar 23, 2020
UPDATE (March 23, 2020): On January 13, 2020, the Supreme Court denied the petition for a writ of certiorari in Athena Diagnostics, Inc. v. Mayo Collaborative Services. Accordingly, the Supreme Court...
CRS Report
Pharmaceutical Patenting Practices: A Legal Overview
Resources · Jun 1, 2020
Pharmaceutical manufacturers frequently obtain intellectual property (IP) rights in their products. IP law provides exclusive rights in a particular invention or product for a certain time period,...
CRS Report
Equity in Innovation: Trends in U.S. Patenting and Inventor Diversity
Resources · Nov 30, 2022
Scholars, policymakers, and administrators have expressed interest in who participates in America’s innovation ecosystem—the constellation of people, institutions, and enterprises engaged in research...
CRS Report
Patents and Innovation Policy
Reports · Oct 3, 2022
Encouraging scientific and technological innovation and U.S. economic competitiveness has been a long-standing interest of Congress and other federal policymakers. Motivated by the widely held view...
CRS Report
The Role of Patents and Regulatory Exclusivities in Drug Pricing
Reports · Jan 30, 2024
Intellectual property (IP) rights play an important role in the development and pricing of prescription drugs and biologics. To encourage innovation, IP law grants inventors exclusive rights in a...
Hearing Business meeting to consider S.527, to require the Federal Trade Commission to study the role of intermediaries in the pharmaceutical supply chain...
senate Judiciary Committee · Apr 3, 2025 · Request transcript
Testimony BANKS, JIM
Business meeting to consider S.1782, to prohibit discrimination on the...
senate Health, Education, Labor, and Pensions Committee · Jun 17, 2026
"Senator Banks. Thank you, Mr. Chairman. I appreciate the intent of the legislation by the bill's authors. What I what I don't favor, though, is doing anything that would help the Chinese Communist Party cheat and steal our IP. And that's what my amendment would would go at lengths to stop. My amendment would that the same protections for trade secrets at the FDA would also apply at the Patent and Trademark Office. We know Chinese biotech companies have been sifting through U.S. patent..."
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"So it works both sides. They don't lose anything. Yes, they have to demonstrate that for the first of the duplicate patents. After that, what we see, and there's peer-reviewed data on this as well, is once the patent owners start filing and duplicating the patents, it's a given because the first patent was already examined. The issue is that these duplicates add nothing more than the first"
Testimony FITZGERALD, SCOTT
“Oversight of the U.S. Patent and Trademark Office”
house Judiciary Committee · Mar 25, 2026
"incoming low-quality patents. Very good. Let me quickly turn to kind of another area. According to American Intellectual Property Law Association, the average cost of patent litigation in a district court is $5 million, whereas the cost for adjudicating patent disputes before the patent trial and appeal board on average is about 10 times less, or around a half a million dollars. Critics of the proposed changes to the PTAB process have said the result will be more patent cases being litigated by..."
Testimony KAMLAGER-DOVE, SYDNEY
“Oversight of the U.S. Patent and Trademark Office”
house Judiciary Committee · Mar 25, 2026
"Director Squires, before we get into your recent policies, I just want to make sure that we're grounded in the basics because much of this debate seems to move past them too quickly. To my understanding, IPR is an administrative process allowing parties to ask the Patent Trial and Appeal Board to re-examine whether an already issued patent is valid. It was created to provide a faster, more cost-effective alternative to litigating patent validity in federal court, recognizing that initial patent..."
Witness The Honorable John Squires
U.S. Patent and Trademark Office · 1 hearing
Hearing Hearings to examine the Patent Eligibility Restoration Act, focusing on restoring clarity, certainty, and predictability to the United States...
senate Intellectual Property Subcommittee · Oct 8, 2025 · Request transcript
CRS Report
Terminal Disclaimers of Patent Rights: Background and Issues for Congress
Posts · Feb 24, 2025
Terminal disclaimers are a legal mechanism that allows a patent holder or applicant to relinquish part of a patent’s term, so that the patent expires earlier than it would without the disclaimer....
Testimony HASSAN, MARGARET WOOD
Business meeting to consider S.1782, to prohibit discrimination on the...
senate Health, Education, Labor, and Pensions Committee · Jun 17, 2026
"Mr. Chair. Senator Hassen. Well, first of all, I want to thank the Chair and Ranking Member for supporting this bill that Senator Hawley and I have, which will help lower drug costs for patients. For too long, Big Pharma has abused the patent process and blocked generic competition from entering the market, which has meant higher prices at the pharmacy counter for families. One of the ways in which Big Pharma boxes out generic medication is by filing endless patents to block any competition,..."
Testimony MS. JAMIE SIMPSON
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"But they could meaningfully reduce investment in the next generation of treatments. Consider the debate over patent thickets, the concern that the sheer number of patents covering a product prevents generic competition. But a 2024 USPTO-FDA study found no clear relationship between the number of patents on a drug and when generic competition begins. The argument that terminal disclaimer-linked patents are a separate kind of thicket problem overlooks that patentees agree to limits for these..."
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"The Ethic Act maintains full flexibility for patent owners. If a company believes that its inventions are different from its earlier patents, it can explain that to the patent examiner and avoid grouping them together with terminal disclaimers. And if that's not possible, it can put all of its duplicative claims into a single patent. This reform will bring billions of dollars in health care savings, which most importantly will help patients to afford their drugs. Congress created this pathway..."
Testimony MS. KRISTA HESSLER CARVER
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"I look forward to your questions. So the ETHIC Act would harm innovation. It would allow generics and biosimilars to infringe valid patents with no recourse for the innovator to enforce those valid patents, and it would be a substantial shift, a seismic shift in the balance of Hatch-Waxman. It would also invite gamesmanship. We see that the way the bill is structured, an innovator would need to pick a patent to enforce from a patent group with no information on which to do it. There would be no..."
Testimony MS. JAMIE SIMPSON
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Well, I think the first thing to understand here is I think the version of what is going on with terminal disclaimers that Dr. Good has described is an oversimplification of what is happening. And I think a really important clarification is that, first of all, terminal disclaimers are an agreement by a patent owner to give up patent term if a second patent they're claiming has an overlap with another patent they"
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"And I wrote a paper that showed that there's this really interesting strategy, a huge spike in these duplicate patents, issuing out of the patent office at year 12. The scale and the timing of this spike shows it must be a strategy to put patents in place at year 12, which is when FDA exclusivity expires on biologics. That's the time when the biosimilars are trying to get to the"
Testimony LOFGREN, ZOE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Dr. Good, would the skinny labels bill restore certainty to the pathway in your judgment to help get lawful generics to patients sooner? So just to be clear, the bill that we're we've sponsored does not allow a generic to market a patented use, correct? Exactly. It does not erase valid patents on new uses of medicine, correct? So I think that the practical effect is straightforward. It follows the FDA approved label leaves the patented use out, doesn't promote the patented use, and it can reach..."
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"That's time when patients abroad are getting the drugs and patients in America are waiting for the patent litigations to be resolved. I'm talking about difference between a human and a patient in two different patents, patents that would be rejected by the patent office if they weren't filing terminal disclaimers. The Ethic Act does not weaken"
Testimony ISSA, DARRELL
“Oversight of the U.S. Patent and Trademark Office”
house Judiciary Committee · Mar 25, 2026
"made two decisions. One was that fee setting would be transferred substantially to the trademark office, patent and trademark office, but also that fees collected would be embargoed, meaning they are not to be spent anywhere else in any agency, including commerce, in which the trademark and patent office is nestled. That means that there is an obligation to raise enough funds to modernize the patent office. Federal workers are stressed today in the patent office because they currently do not..."
Testimony OCASIO-CORTEZ, ALEXANDRIA
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Dr. Wang, when it comes to pharmaceuticals, the federal government reviews a company's patent application and determines whether or not it meets specific standards, like creating a brand-new drug to treat a specific disease. Is that correct? And when patents, and these patents, when a drug company earns a patent for a new drug, they get a period of protection from competition when no other company can sell that same"
Testimony GRASSLEY, CHUCK
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"and Communications Industry Association. He previously served as chief counsel for intellectual property on the House Judiciary Committee. Before that, he worked as lead administrative patent judge on the Patent Trial and Appeal Board at the U.S. Patent and Trademark Office. Mr. Lee received his law degree, B.A.S. in bioengineering and B.A. in biology and"
Testimony SUE PESCHIN
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"It's important to understand why passage of the Bipartisan Patent Eligibility Restoration Act, or PARA, has become urgent. For 15 years, the U.S. patent system has struck down thousands of patents and failed to protect some of the most transformative innovations in diagnostics, not because they weren't new or useful, but because a series of Supreme Court rulings created confusion when broadening patent ineligibility and invalidation. The problem is especially severe in medical"
Testimony COONS, CHRISTOPHER A.
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"I have a number of documents I'd like to submit for the record. In support of Pera, a document from the Innovation Alliance on Section 101, an article and summary on AI patentability, and a law review article on the impact of patent eligibility, Congress passed the current Patent Act more than 70 years ago, defining a very broad scope for eligibility, essentially anything under the sun as made by man. And that worked fine for a half century. But as we've discussed starting 15 years ago, the..."
Testimony DEBRA G.B. LEONARD
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"I think what is not understood is that, as a pathologist, I can develop and validate genetic tests in my clinical laboratory that is CLIA-certified and perform that for patients. I don't need a patent. I don't have to license patents because the genes that I'm testing are not patentable now. And that is what will"
Testimony HIRONO, MAZIE K.
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"Thank you. I know that patent law is very complicated, and I also know that the Supreme Court and the mayor and Alice's decisions created a lot of uncertainty in the patent system, so I do thank Senators Tillis and Coons for coming up with a bill, which I am a co-sponsor of, that sought to create some level of predictability so that our patent system can be more useful. That's one way of looking at it, I"
Testimony J. JOHN LEE
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"And what I would say is that we really can have it both ways. We can have a patent system that incentivizes innovation. And then we can have patents that have limits that already exist in the law, limits on those patents to make sure that, you know, whatever benefits- Right. And that's a situation where it's working, where a generic was able to come into the market. The limit on the patent, whether it's the temporal limit because it expired or because it shouldn't have been granted in the first..."
Testimony J. JOHN LEE
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"No. What I'm saying is that relaxing Section 101 limits, relaxing patent eligibility limits, and expecting that that is going to boost U.S. national security, I think it's a tenuous relationship between those because the benefits of the patent system currently, unfortunately, and we should do something about this, are flowing more to foreign patent recipients than to U.S. patent"
Testimony UNKNOWN
Hearings to examine the nominations of Brett Doyle, of Connecticut, Da...
senate Finance Committee · Jun 25, 2026
"even with the amount of time I've spent with him as the chair of ranking member on IP subcommittee, I really had no idea about the depth of his experience going back to a career at the USPTO. He graduated from Georgia Tech, where he focused on embedded systems and semiconductor design. I think he thought he was going to be an engineer, but instead he went over and spent 20 years at the USPTO, starting as a patent examiner for 3D graphics and animation before rising to the roles of primary..."
Testimony SPEAKER_06
China’s Economic Espionage and Subnational Influence in the United Sta...
house Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party · Jun 25, 2026
"The FBI has found that the annual cost to the U.S. economy of counterfeit goods, pirated software, theft of trade secrets to be between $225 billion and $600 billion. Several Chinese companies that the U.S. government has formally designated as national security threats, including Huawei, BOE Technology Group, and Tencent, rank among the top recipients of U.S. patents, receiving thousands each year. These companies have used these patents to sue American firms, transfer rights to patent trolls,..."
Testimony COONS, CHRISTOPHER A.
Hearings to examine proposed budget estimates and justification for fi...
senate Appropriations Committee · Apr 22, 2026
"time since Senator Fischer suffered through me going over in the other hearing and I will do my best Senator. One of the things they drifted into is the manufacturing of biopharmaceuticals where their national hub for that is in Delaware and I believe they've made a dramatic difference. I'll just continue to advocate for NIST. I look forward to hearing from you about how you think they might have drifted but let me move on. Patent and trademark office. I was very encouraged in our last exchange..."
Hearing Business meeting to consider S.365 and H.R.1729, bills to amend the John D. Dingell, Jr. Conservation, Management, and Recreation Act to allow for...
senate Energy and Natural Resources Committee · Jul 29, 2026 · Request transcript
Hearing Business meeting to consider S.365 and H.R.1729, bills to amend the John D. Dingell, Jr. Conservation, Management, and Recreation Act to allow for...
senate Energy and Natural Resources Committee · Jul 16, 2026 · Request transcript
Hearing Business meeting to consider S.140, to address the forest health crisis on the National Forest System and public lands, S.332, to require a study...
senate Energy and Natural Resources Committee · Jun 10, 2026 · Request transcript
Hearing Member Day to examine S.297, to amend title XXVII of the Public Health Service Act to require group health plans and health insurance issuers...
senate Health, Education, Labor, and Pensions Committee · Mar 19, 2026 · Request transcript
Hearing Hearings to examine S.90, to prohibit the use of funds by the Secretary of the Interior to finalize and implement certain travel management plans...
senate Public Lands, Forests, and Mining Subcommittee · Dec 2, 2025 · Request transcript
Hearing American Global Competitiveness at 250: Legislative Proposals to Secure U.S. Technology Leadership.
house Commerce, Manufacturing, and Trade Subcommittee · Jun 30, 2026 · Transcript · 2 transcript matches
SPEAKER_18 "So, I am not a patent attorney and there is a whole bunch of complicated issues around software patents. But the ultimate goal of our copyright and patent systems is to promote the useful arts and sciences. That's the phrase in the Constitution. And so, that has to be the metric by which we measure. Right now, we do not have an innovation problem in AI. The U.S. is driving ahead on that innovation side that I talked about, the three capabilities. That innovation"
Testimony SPEAKER_04
Business meeting to consider S.1782, to prohibit discrimination on the...
senate Health, Education, Labor, and Pensions Committee · Jun 17, 2026
"adopt the manager's amendment in the nature of a substitute and have it considered original text for the purpose of future amendments. All in favor, please say aye. Aye. Opposed, say nay. The ayes have it. The motion is agreed to. Do any members wish to speak on the bill? Seeing none, we shall move on to the Medication Affordability and Patient Integrity Act, which is S-2658. I thank Senators Hassen and Senator Hawley for their work on this legislation. Patents are critical to innovation and..."
Testimony HAWLEY, JOSH
Business meeting to consider S.1782, to prohibit discrimination on the...
senate Health, Education, Labor, and Pensions Committee · Jun 17, 2026
"support. Mr. Chairman. Senator Hawley. Mr. Chairman, I just, I just want to add my voice in support of this legislation, and I want to thank Senator Hassan for her leadership on this. Prescription drugs are just too expensive. I mean, that's the bottom line. They are way too expensive for every family and every individual in this country, and one of the reasons they're too expensive is that the Big Pharma companies game the system. They tell the FDA one thing, and then they tell the Patent..."
Testimony HASSAN, MARGARET WOOD
Business meeting to consider S.1782, to prohibit discrimination on the...
senate Health, Education, Labor, and Pensions Committee · Jun 17, 2026
"to end this Big Pharma loophole, which is exactly what my bipartisan bill with Senator Hawley will accomplish. I, too, acknowledge that we need to continue to work with Senator Cornyn and the Judiciary Committee moving forward, but this would be a very good start, and I appreciate the Chair and Ranking Member's yield back. I appreciate Senator Banks, your concern about the Chinese Communist Party. It is the concern I share. But the Patent Office already has procedures for the handling of trade..."
Testimony HAWLEY, JOSH
Business meeting to consider S.1782, to prohibit discrimination on the...
senate Health, Education, Labor, and Pensions Committee · Jun 17, 2026
"bill that would put a stop to that chicanery. We should have done it a long time ago. I look forward to doing it today. Thank you, Mr. Chairman. Anyone Mr. Chairman. Senator Hawley. I just want to add one thing to that. Senator Hassen's exactly correct. This bill actually expands the protection for trade secrets at the Patent Office. And I just want to note that that's what the pharma companies asked for last time we introduced this bill. Last time we introduced this bill, they were opposed to..."
Testimony ISSA, DARRELL
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"will be discussed. Over the last nearly two years, year and a half, almost half of all the examiners at the Patent and Trademark Office that do PTAB, those judges have been dismissed or allowed to leave. As a result, what we're seeing is a systematic disabling of a process that was outside of Article III that often cleared up discrepancy about whether a portion of a patent was valid or not. There will be questions before all four of our witnesses, at least by the chair, as to whether or not..."
Testimony JOHNSON, HENRY C. "HANK"
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Patents have been at the heart of America's greatest innovation moments. The Industrial Revolution, the Innovation Age, the biotech and mobile telecommunications revolutions in the 21st century were all driven by transformative breakthroughs backed by patent law. By encouraging investment in new ideas, a patent must be reliable enough for an inventor to be able to convince the investors to help transform a sketch on a napkin to a product that changes the world. But it is not always easy. Anyone..."
Testimony RASKIN, JAMIE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"to personally benefit the sitting president is a dangerous abuse of power. And while facially, one might expect patents for medical innovation to be somehow an opaque or esoteric or inaccessible topic, in fact, all of us have benefited from the medical patent system. As small children, we got a polio vaccine, a smallpox vaccine, a measles vaccine, among others. When we cut our fingers, we got a tetanus shot. When we were sick, we enjoyed access to antibiotic treatments. And when we were hit by..."
Testimony MS. KRISTA HESSLER CARVER
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"These advances can improve safety, enhance effectiveness, and expand treatment options for patients – including those with unmet medical needs. So it is not unusual – and it is certainly not problematic – for a single medicine to be associated with multiple patents – those patents reflect the real innovations that benefit patients. As a prime example, as many as 60-75% of oncology drugs are later approved to treat additional types of"
Testimony MS. KRISTA HESSLER CARVER
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Third, proposals based on the concept of so-called patent thickets are based on flawed premises. As the U.S. Patent and Trademark Office has concluded, the number of patents does not, by itself, determine when generic or biosimilar competition will occur. Nor does that number establish a causal link to the prices that patients"
Testimony MS. KRISTA HESSLER CARVER
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Major legislative changes grounded in these incorrect premises would discourage investments in pharmaceutical innovation to the detriment of patients. Some of these proposals would force innovators to relinquish valid patent rights or limit their ability to enforce valid patent rights. These proposals represent a significant departure from long-standing principles of American patent law and encourage new kinds of"
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"So it's well known that not all patents are valid. Patent examiners only have a limited amount of time to review each patent application, and peer-reviewed data shows that about a quarter of pharmaceutical patents are later invalidated and canceled after being challenged and litigated to a final court"
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Generic and biosimilar companies challenge low-quality patents to help bring affordable drugs to market sooner. The problem is that the branded drug companies, the ones that own the patents, can litigate duplicative and repetitive patents on the same feature of the drug. This is driving up litigation"
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"This bureaucracy is slowing down getting affordable drugs to patients. So when I say duplicate patent, I'm referring to something called obviousness-type double patenting, which is exactly what it sounds like. This type of double patenting is when a company has two or more patents on the same invention. This type of double patenting is when a company has two or more patents on the same"
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"But in the United States, a company can overcome a rejection from the patent office against this type of double patenting by filing routine paperwork called a terminal disclaimer, which is a formal statement that the duplicate patents will expire on the same day. The problem is if one of those duplicates is defeated and canceled in litigation, the other duplicate sister patents stay in force and can be litigated again. Now, the correct name for these types of patents is terminally disclaimed..."
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"They have been proven to exist by numerous pieces of empirical research that have been rigorously peer-reviewed and published in highly reputable journals. Peer-reviewed data shows that the ratio of these duplicate patents being litigated against by the pharmaceutical industry is increasing over time compared to the ratio of unique patents litigated on drugs, which is decreasing over time. This is also a problem for innovation. The solution is the Ethic Act, which is also a pro-innovation..."
Testimony MR. MICHAEL CARRIER
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"And Chair Issa, I completely agree with you. If we were to sum up the Hatch-Waxman Act in one word, it is balance. The problem now is that there isn't balance because the stuff that was in there for generics is no longer there. The skinny label pathway is drying up. Patent thickets are arising in ways that they were not at the time of the Hatch-Waxman Act. And so let me briefly talk about skinny labels, patent thickets, and the patent office. First, in terms of skinny labels, there are a couple..."
Testimony MR. MICHAEL CARRIER
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Compare pharma to electronics, semiconductors, computers. In those industries, companies collect patents. Why? Because they cross-license. They all come to the table, and they say, I have a patent, you have a patent, let's trade. That's different in pharma. In pharma, the brand firm doesn't need to collect patents to negotiate with the generic. It's not like the generic has patents that the brand firm needs. So there's something unique about thickets in the pharmaceutical industry. In pharma,..."
Testimony MR. MICHAEL CARRIER
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"are a lot more frequent in the pharma industry than other settings. The Ethic Act would be a very effective way of dealing with anti-competitive thickets. Finally, with the patent office, there are many patents that are issued that are not valid. Interpartis review was essential to the America Invents Act, which said that the patent system needed to reflect the constitutional"
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"This is about getting the timing right and making sure that there are no inappropriate delays or extra monopolies being eked out. And so the reason we need patent system reform is because we've got a lot of peer-reviewed data that links patent thickets to delayed access to generics, especially in this country. So I co-authored a paper with Professor Chow, and it was peer-reviewed, so it was rigorously studied. We counted patents, and we compared how many patents were litigated in Canada, the..."
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"more unique patents, looking for new uses of these drugs. So this would incentivize them more, because under the ETHIC Act, if a drug had 50 patents on it, and 20 of them were duplicates, and 30 were unique, under the ETHIC Act, they could litigate those 30 unique patents, and they could still litigate one duplicate from each cluster. So the more patents that they innovate, the more unique inventions, then the more patents they can litigate against competition. So the more patents that they..."
Testimony JOHNSON, HENRY C. "HANK"
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Thank you, Mr. Chairman. Dr. Good, in a 2024 research letter, you wrote, quote, although the U.S. Patent and Trademark Office is required to reject patents that are obvious follow-ons from earlier versions, they may grant such patents when applicants file terminal"
Testimony JOHNSON, HENRY C. "HANK"
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Prior art? Well, let me ask you, Ms. Simpson, in some situations, a patent applicant can receive a patent that is an obvious variant when compared to a portion of its own work that isn't in the prior art. So long as a terminal disclaimer is filed, how is this different from what Ms. Good, Dr. Good, has"
Testimony MS. JAMIE SIMPSON
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"If they have a small overlap that the patent applicant doesn't think is worth fighting over, they'll agree to this. The second thing to bear in mind is that terminal disclaimers, they're a valuable tool for the patent office to help manage the process of patent prosecution. It helps the office and the applicants kind of break it down into bite-sized"
Testimony MS. JAMIE SIMPSON
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Well, thank you for the question, Congresswoman. I think what that law did, as many have mentioned, is that it created a balance between respecting the patent rights of the innovators and providing a pathway to resolve disputes over the patents that still cover drugs once the regulatory exclusivity expires. I think it's been particularly effective because it encourages all the disputes to be litigated together in one forum. Congresswoman, could I"
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"where the first litigation was in 2016. There were subsequent litigations starting with duplicate patents in 2020. And in the end, a three-year litigation took nine years, because patents can keep issuing even during and after. Not exactly, because we like the unique"
Testimony MS. KRISTA HESSLER CARVER
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"and major improvements in cardiovascular health. Sure, so the patent dance is a phrase that's used to refer to the patent provisions of the Biologics Price Competition and Innovation Act that were enacted by Congress in 2010. As described in the"
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"When we talk about China, we should think not about the quantity of American patents, but we should measure American innovations by the quality of its patents. And this is what the Ethic Act goes"
Testimony LOFGREN, ZOE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"but I think it's important to describe what is a skinny label. It allows a generic company to compete for uses of a drug that are no longer under patent while leaving the patented uses protected. It's interesting that the court decided this morning it was good to see it. So, Professor Carrier, do you think, you addressed this a little bit, but the bill that we've introduced is partly solved by what the court did this morning, but would it add certainty to make this bill law? Because as you..."
Testimony MS. RACHEL GOODE
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Yes, it would. Because what it does is it puts a safe harbor around the label itself. So as long as so it's also incentivizing good behavior. So as long as you do the label carve out and you don't mention the patented disease in any promotional material, then you're safe. So that incentivizes by similar and generic drugs to stay in their lane and stay away from the patented material, which is the exact same compromise that was made in 1984 that works so well for four decades until the recent..."
Testimony MR. MICHAEL CARRIER
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"No, it is not. Sure. So the patent system is designed to promote innovation, and we should be grateful for all that the pharmaceutical industry has done to promote innovation, but when you collect a whole bunch of patents and then use it in an abusive way, I think that is a problem. If I can take just a second, we've heard a lot about terminal disclaimers. It's a bit wonky. So ILEA is a drug that treats an eye disease, and Regeneron here sued Amgen in a patent over ILEA. The patent had a buffer..."
Testimony GRASSLEY, CHUCK
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"Thank you very much. Our nation's founders understood the importance of patent protection to the economy and growth of our newborn nation. They guaranteed this protection in our Constitution. And then at the earliest time in 1790, the first patent law was passed. The task before us today isn't an easy one. Patent eligibility is a multilayered legal issue with detailed tests and case-by-case rules created by the Supreme Court. This law must be called and gleaned from many pages of the Court's..."
Testimony COONS, CHRISTOPHER A.
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"Developments in artificial intelligence, in blockchain, in medical diagnostics, in 5G are patentable in China and in Europe and not patentable here. And I view this as critical for us to address in order to restore American leadership and innovation and to advance our national"
Testimony J. JOHN LEE
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"Communications Industry Association. Our members include some of the most innovative and prolific patent owners in the world, and they depend on a strong, balanced patent system to support innovation, protect IP, and encourage economic growth. It's a great privilege to be invited to testify here today, and I appreciate this opportunity to share our insights on this important"
Testimony J. JOHN LEE
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"That brings me to my third point, protection. One of the ways patent eligibility rules contribute to innovation is by shielding innovative US businesses from low-quality patents. Without reasonable limits on patent eligibility, litigation brought by rent-seeking patent assertion entities is likely to rise. Without reasonable limits on patent eligibility, litigation brought by rent-seeking patent assertion entities is likely to rise. Patent assertion entities often wield low-quality patents on..."
Testimony J. JOHN LEE
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"and the world. Section 101 is part of that success due to the three key points about patent eligibility that I described, predictability, which boosts innovation, including by protection of US businesses, all creating the balance that the patent system needs to continue promoting these and future innovations as it has for well over a century. I commend the committee for taking a thoughtful approach to understanding patent"
Testimony SUE PESCHIN
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"The bill would restore clarity to the eligibility section of the Patent Act so that inventors of medical discoveries can reliably make their way from the lab to doctors and their patients. And I want to note that patent eligibility doesn't guarantee patent approval. It just lets the Patent Office consider an"
Testimony SUE PESCHIN
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"Sequinom developed a non-invasive prenatal test that could detect fetal abnormalities from a simple maternal blood sample, sparing moms and babies the risk of amniocentesis. It was a genuine scientific breakthrough, yet the federal circuit invalidated the patents. Judge Richard Lynn stated in his concurrence that the invention was exactly the kind of advance the patent system is meant to encourage and protect. But the Mayo decision compelled him to strike it down, and he actually called on..."
Testimony J. JOHN LEE
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"Because of that, those things have been restricted from patenting by the Supreme Court's Section 101 law. If that has changed and more of that material is allowed to be patented and thus owned exclusively by one patent owner, then it's going to be much harder to use those building blocks for further"
Testimony ANDREI IANCU
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"And if anything, we want more transparency in artificial intelligence development, not less. And the patent system, a patent means to lay open. That's what the word patent means. The patent system encourages public disclosures. For all of those reasons, Pera would help enable the United States innovation system That's what the word patent means. The patent system encourages public disclosures. For all of those reasons, Pera would help enable the United States innovation"
Testimony SUE PESCHIN
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"However, the inventor of those tests that devoted time and money and had investors that also devoted time and money into the invention should be able to license it to her in order to use it. And the very fact that she is able to recreate it is due to the patent system and the transparency within the patent system. So PARA, and the reason why it's so important, is because what the Supreme Court cases have done is they've muddied the waters by broadening these exceptions and making it harder for..."
Testimony ANDREI IANCU
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"There is, as you indicate, Senator, the potential for a research exemption. There are other ways to address medical pricing and pricing for the diagnostics that have nothing to do with the patent system. But the threshold question for creating the innovation in the first place, the first leg of that balance needs to be a reliable patent system. That's absolutely"
Testimony COONS, CHRISTOPHER A.
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"And you said in passing earlier, but it bears repeating for folks who don't spend their lives on this. A company has a choice between keeping something secret, protecting it as a trade secret, or publishing it for the world, laying it open as a patent. And that choice is in part driven by whether or not there is predictability in patent eligibility jurisprudence. Is that correct? Thank you very"
Testimony WELCH, PETER
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"Yonku, okay. Thank you very much. We have enormous experience here with patent holders abusing the patent system. They create patent thickets. And there's just overwhelming evidence that, while I'm a strong supporter of the patent system, I'm well aware of the abuse of the patent system. And you said that there are ways which some of these could be worked"
Testimony DEBRA G.B. LEONARD
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"And that's what it became at the University of Pennsylvania. Because of genetic sequences that were patented, we didn't need the patents for protection. Companies"
Testimony BLUMENTHAL, RICHARD
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"I know very little about patent law, I have to acknowledge. But I do know that our patent system can impact the prices that people pay for pharmaceutical drugs and I think we can all agree that we need a patent system that works for our innovators, our companies, for their investors and researchers, but also for the everyday American who wants"
Testimony DEBRA G.B. LEONARD
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"And when I was stopped from doing APOE genotyping in my laboratory at the University of Pennsylvania for Alzheimer disease, by Athena Diagnostics, they charged twice the price to do that test than I was currently charging in my laboratory. So patents do increase the cost of care, rightfully so when there is a huge investment like creating a new diagnostic that will, is able to treat pancreatic cancer or other cancers or things like that, or the CRISPR technology that treats a baby in utero for..."
Testimony J. JOHN LEE
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"So, I think, you know, I don't know if this was intentional or just an oversight but just one example as to why there might be some confusion about this. So you had noted that in the summary of the Myriad case, the Supreme Court ruled that isolating a gene makes it, does not make it patent eligible. It is still a human gene, a product of nature and can't be patented. In the portion of Pura, for example, that talks about human genes, it says that something that's purified or enriched counts as..."
Testimony DEBRA G.B. LEONARD
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"modified if it is purified or enriched. So that means that it becomes patent eligible as soon as you take it out of the human body. I can't practice medicine to look at the genes in a patient when they remain in the patient. So I need to be able to purify or isolate. And if that then makes it patent eligible, that means I will be stopped from doing that by some patent holder on that genetic sequence. cDNA is a little more complicated in that cDNA is copies of messenger RNA, which is made from..."
Testimony SUE PESCHIN
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"Sure. Thank you. I don't disagree with what you put up at all. We care a lot at the Alliance for Aging Research about affordability, particularly for older adults, and I would love to meet with you and talk about the work that we've previously done on affordability and prescription drugs. Patents generally aren't the reason that prescription drugs cost so much. In fact, without them, a lot of treatments wouldn't exist, so we wouldn't really have anything to argue about if we didn't have the..."
Testimony HAWLEY, JOSH
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"Anybody else want to comment on this? But don't you think that we can find a way to protect our patent system, which I'm all for doing, provided that it's not gamed any further by the pharma companies to keep prices high? Let's be clear, the pharma companies are absolutely gaming the patent system in order to keep prices high. I think there's no doubt about that. You can't look at these numbers and not think that our pharma companies are not ripping off consumers in the United States of..."
Testimony COONS, CHRISTOPHER A.
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"you said this is off the topic. My core assertion would be that in terms of the patentability or patent eligibility of drugs, of pharmaceuticals, PARA has almost no impact. There is a separate issue, which is patent thicketing, patent hopping. I support it, but these are, am I correct that these are unrelated, what we're trying to do here in eligibility reform and legislation to do here in eligibility reform and legislation that would address abuses of the patent system to raise patent prices?..."
Testimony COONS, CHRISTOPHER A.
Hearings to examine genes to machines, focusing on the patent eligibil...
senate Judiciary Committee · Jul 14, 2026
"In terms of the possibility of patenting human genes, we want to make sure we're not harming your work. Let me put it that narrowly. Is your argument that we should weaken the American patent system so that exclusively they can patent them"
Testimony MR. JAMES GELFAND
“Direct Contracting: A Prescription for Lower Health Care Costs”
house Education and Workforce Committee · Jul 1, 2026
"We also have been very supportive of a number of changes related to big pharma and the way that they extend their patents. For instance, the Ethic Act, in which we would eliminate these patent thickets in which a drug might have five or six patents in Europe and 500 in the United States. There's a lot of little things that we could do to make prescription drugs more"
Testimony SPEAKER_18
American Global Competitiveness at 250: Legislative Proposals to Secur...
house Energy and Commerce Committee · Jun 30, 2026
"So, I am not a patent attorney and there is a whole bunch of complicated issues around software patents. But the ultimate goal of our copyright and patent systems is to promote the useful arts and sciences. That's the phrase in the Constitution. And so, that has to be the metric by which we measure. Right now, we do not have an innovation problem in AI. The U.S. is driving ahead on that innovation side that I talked about, the three capabilities. That innovation"
Testimony SPEAKER_07
American Global Competitiveness at 250: Legislative Proposals to Secur...
house Energy and Commerce Committee · Jun 30, 2026
"We try to expand online and show people... your take on that? So, thank you for the question. I agree it's a complicated issue. I do see that patents as a sort of living protection and it changes over time. Anything under the sun that is made by man used to be the standard for something that could be protected with a patent. Beyond that, it must be new, useful, non-obvious. And so, patents that could cover AI"
Hearing Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role in Advancing U.S. Drug Development.
house Health Subcommittee · Jul 15, 2026 · Transcript
OCASIO-CORTEZ, ALEXANDRIA "Dr. Wang, when it comes to pharmaceuticals, the federal government reviews a company's patent application and determines whether or not it meets specific standards, like creating a brand-new drug to treat a specific disease. Is that correct? And when patents, and these patents, when a drug company earns a patent for a new drug, they get a period of protection from competition when no other company can sell that same"
Hearing Hearings to examine the nominations of Brett Doyle, of Connecticut, David Foley, Jr., of Virginia, Samuel Negatu, of the District of Columbia,...
senate Finance Committee · Jun 25, 2026 · Transcript
UNKNOWN "even with the amount of time I've spent with him as the chair of ranking member on IP subcommittee, I really had no idea about the depth of his experience going back to a career at the USPTO. He graduated from Georgia Tech, where he focused on embedded systems and semiconductor design. I think he thought he was going to be an engineer, but instead he went over and spent 20 years at the USPTO, starting as a patent examiner for 3D graphics and animation before rising to the roles of primary patent examiner, supervisory patent examiner, and eventually branch chief at the Patent Trial and Appeal..."
Hearing China’s Economic Espionage and Subnational Influence in the United States
house Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party · Jun 25, 2026 · Transcript
SPEAKER_06 "The FBI has found that the annual cost to the U.S. economy of counterfeit goods, pirated software, theft of trade secrets to be between $225 billion and $600 billion. Several Chinese companies that the U.S. government has formally designated as national security threats, including Huawei, BOE Technology Group, and Tencent, rank among the top recipients of U.S. patents, receiving thousands each year. These companies have used these patents to sue American firms, transfer rights to patent trolls, and, as in the ongoing YMTC versus Micron case, compel disclosure of sensitive trade secrets..."
Hearing Hearings to examine proposed budget estimates and justification for fiscal year 2027 for the Department of Commerce.
senate Commerce, Justice, Science, and Related Agencies Subcommittee · Apr 22, 2026 · Transcript
COONS, CHRISTOPHER A. "time since Senator Fischer suffered through me going over in the other hearing and I will do my best Senator. One of the things they drifted into is the manufacturing of biopharmaceuticals where their national hub for that is in Delaware and I believe they've made a dramatic difference. I'll just continue to advocate for NIST. I look forward to hearing from you about how you think they might have drifted but let me move on. Patent and trademark office. I was very encouraged in our last exchange that you were no longer considering values-based patent fees but we are about to see the expiration..."
Hearing “Direct Contracting: A Prescription for Lower Health Care Costs”
house Health, Employment, Labor, and Pensions Subcommittee · Jul 1, 2026 · Transcript
MR. JAMES GELFAND "We also have been very supportive of a number of changes related to big pharma and the way that they extend their patents. For instance, the Ethic Act, in which we would eliminate these patent thickets in which a drug might have five or six patents in Europe and 500 in the United States. There's a lot of little things that we could do to make prescription drugs more"