August Highlights: Setting the Record Straight on the DOJ/FTC Listening Sessions
The Department of Justice and Federal Trade Commission recently hosted listening sessions on “Lowering Americans’ Drug Prices Through Competition.” While aimed at exploring ways to expand generic and biosimilar availability, the sessions amplified misleading claims about the patent system — such as allegations of “low-quality” patents, “patent thickets,” and “product hopping.”
In August, C4IP submitted a letter correcting the record, emphasizing that U.S. patents are overwhelmingly high-quality, that multiple patents on complex medicines reflect genuine innovation, and that improvements like new insulin formulations deliver life-saving benefits. C4IP noted that existing laws already ensure robust generic and biosimilar competition, with these products filling 90% of U.S. prescriptions. We also warned that legislative proposals built on these myths — including the Affordable Prescriptions for Patients Act, the ETHIC Act, and the Drug Competition Enhancement Act — would weaken innovation incentives and slow medical progress.
- C4IP’s letter was covered in an IPWatchdog article, which highlighted the Council’s warning to avoid enacting measures that would weaken patent rights under “the false premise of improving affordability.”
Read It Now: “C4IP Letter to FTC & DOJ RE Drug Pricing Listening Sessions”
Additional Coalition Updates
- On September 15-17, C4IP Chief Policy Officer and Counsel Jamie Simpson will speak at the Trade Secret Legal Protection 2025 conference in Boston. Jamie will join a panel on “IP Monetization: Trade Secret – Harmonization or Counteraction?” discussing the legal and strategic challenges of licensing and commercializing trade secrets, balancing confidentiality with partnerships, and weighing trade secret protection against patent exclusivity. Learn more and register here.
- On September 15-17, IPWatchdog will host its Second Annual Women’s IP Forum at IPWatchdog Studios in Ashburn, VA. The event will feature an all-women lineup of expert speakers in the IP field — including Board Member and former Federal Circuit Judge Kathleen O’Malley, as well as C4IP Chief Policy Officer and Counsel Jamie Simpson. Learn more and register here.
- On August 29, C4IP Co-Chair Andrei Iancu and former U.S. Secretary of the Navy and U.S. Ambassador to the Kingdom of Norway Kenneth Braithwaite published an opinion essay in Fortune underscoring how U.S. national security depends on the administration’s commitment to fostering investment in new technologies by ensuring strong, reliable, and enforceable intellectual property rights.
- On August 27, C4IP Co-Chair Andrei Iancu and former NATO Deputy Secretary General Mircea Geoană published an opinion essay in Newsweek arguing that Western governments must band together to protect IP to compete technologically with adversaries like China.
“Each lost patent, each stolen trade secret, and each weakened protection is not just an economic loss; it is a strategic setback, ceding ground in the race to develop the technologies that will define the future of global power.”
- On August 26, C4IP and We Work for Health hosted a roundtable in Raleigh, North Carolina, highlighting the critical role of intellectual property in fueling innovation, economic growth, and patient care. The event, “Catalyzing North Carolina’s Innovation Ecosystem,” featured Congresswoman Deborah Ross (NC-2) and other leading voices from the state’s life sciences sector.
- On August 19, C4IP Executive Director Frank Cullen issued a statement urging Congress to oppose the recently reintroduced Medication Affordability and Patent Integrity Act, warning that the bill would jeopardize trade secrets, weaken patents, and delay patient access to breakthrough treatments.
- On August 13, C4IP Executive Director Frank Cullen was quoted in a Law360 article emphasizing that the federal government has never exercised Bayh-Dole Act march-in rights.
- On August 11, C4IP Executive Director Frank Cullen issued a statement raising concerns about the Commerce Department’s letter to Harvard University initiating the “march-in” process under Bayh-Dole. The statement warned that such a step could deter investment in federally funded discoveries and undermine public-private partnerships.
- C4IP’s statement was quoted in articles in IPWatchdog and Legal Era, and was also featured in IAM’s coverage of the letter.
- On August 11, C4IP Chief Policy Officer and Counsel Jamie Simpson was quoted in a Bloomberg Law article commending ongoing changes to the Patent Trial and Appeal Board petition process, which will limit duplicative challenges and protect innovators from potential abuses of the system by competitors.
- On August 5, C4IP Executive Director Frank Cullen issued a statement opposing the newly introduced Eliminating Thickets to Increase Competition (ETHIC) Act, warning that the bill would erode enforcement of patents and thereby destabilize innovation.
- C4IP’s statement opposing ETHIC was the subject of articles in IPWatchdog and Law360.
- On August 4, C4IP issued a statement applauding the European Commission’s decision to withdraw its proposed regulation for standard-essential patents, which would have undermined free-market-based FRAND licensing principles in favor an onerous, centralized bureaucratic process to set licensing rates.
- On August 3, C4IP was quoted in IPWatchdog’s article on the European Commission’s withdrawal of proposed SEP regulation, expressing approval of the decision.
Government Rundown
USPTO Webinar: USPTO Hour: Patent Trial and Appeal Board Updates:
On August 13, the USPTO held a webinar to provide an overview of the new interim processes at the Patent Trial and Appeal Board, introduced by Acting Director Coke Stewart in March. The reforms include changes to the process by which the Director decides whether to institute a PTAB proceeding, a key step in determining whether the Board will revisit the agency’s earlier grant of an issued patent. (USPTO, 8/13)
USPTO Webinar: USPTO Hour: IT and Innovation:
On August 6, the USPTO hosted a webinar in its “USPTO Hour” series highlighting the agency’s ongoing efforts to modernize its technology systems. The event, moderated by USPTO Chief Information Officer Jamie Holcombe, showcased how the agency is integrating new technologies, such as artificial intelligence, to streamline the patent examination process, increase efficiency, and better support American innovators. (USPTO, 8/6)
Fact Check
Myths about how patent rights affect competition within the drug industry remain a pressing issue for innovators. Although strong patents play a crucial role in promoting innovation — both in the drug industry and in other sectors — lawmakers and activists cite these myths as evidence of the need for legislation that would limit or weaken patents.
During the recent Federal Trade Commission and Department of Justice listening sessions on drug pricing, for instance, several panelists amplified false claims that the current patent system stifles competition and keeps drug prices high. These arguments reflected disproven narratives about how drug patents influence the development of generic and biosimilar medicines.
In reality, research shows that patents are not a barrier to the development and manufacturing of generics and biosimilars, which is why America’s generic and biosimilar industries are thriving and account for the vast majority of U.S. prescriptions. Additionally, industry leaders with firsthand experience have gone through lengths to explain why patents do not impede competition. For example, earlier this year, Amgen — a manufacturer of both biosimilar and biologic drugs – published a rebuttal to numerous patent myths in Nature Biotechnology.
Policymakers must reject false narratives about drug patents to avoid enacting unnecessary, overly burdensome policies that could undermine innovation. Below, we set the record straight on three of the most common false claims regarding patenting in the drug industry:
| Claim: Patents on drugs and drug manufacturing processes are often weak or frivolous. |
| In reality: The notion that companies frequently file “bad” patents does not fit with data. A recent analysis by the nonpartisan Sunwater Institute found that patents granted by the USPTO are overwhelmingly of high quality, with the USPTO’s success at filtering out invalid applications comparing favorably to patent offices in places such as the European Union, Japan, and South Korea. Further, while patent critics sometimes characterize improvements to manufacturing processes as undeserving of patent protection owing to the alleged prior use of the process in question, Amgen’s response in Nature Biotechnology debunks this claim. Amgen clarifies that not only do these process changes represent valid, patentable improvements, but that they are rarely found invalid when subjected to closer scrutiny — and that among the numerous patent portfolios the company has litigated, it “did not find any manufacturing patents invalid owing to prior commercial use of the process.” Recognizing the fact that patents are rarely granted in error is crucial to counter potentially harmful legislative proposals such as the Interagency Patent Coordination and Improvement Act, which would force the FDA and USPTO to share substantial clinical and manufacturing data in order to ensure that drug patents meet statutory requirements. Contrary to what advocates of this bill argue, existing evidence indicates that the existing severe penalties for fraudulent misrepresentation — such as telling the FDA one thing and the USPTO another — already operate as intended to check bad actors. The burdensome requirements proposed by the legislation would harm innovators without a corresponding upside. |
| Claim: Makers of brand-name drugs seek to block competition by filing large numbers of patents on the same medicine and by patenting improvements to drugs already on the market. |
| In reality: Claims like these are among the most common myths about patents, but they do not hold up under scrutiny. For one, drug innovators have good reason to file multiple patents on the same medicine. The reason is that, like other complex technologies — including smartphones and other electronics — drugs comprise a variety of distinct innovations, each of which merit a patent to protect the R&D behind that invention. Drugmakers also have reason to continue improving their products — and filing patents on those improvements — after the products have been released on the market. As Amgen explains in its piece, these innovations, which range from improved formulas and dosing methods to improved manufacturing processes that speed production and lower costs, represent real quality of life improvements for patients and sources of cost savings. A recent report by the Information Technology and Innovation Foundation (ITIF) further detailed how “follow-on” research improves patients’ quality of life, promotes better health outcomes by making it easier for patients to keep to their treatment regimens, and often reduces healthcare costs in the long term. Finally, while patent critics often point to data from the Initiative for Medicines, Access, and Knowledge (I-MAK) as evidence that filing greater numbers of patents helps drugmakers block competition and extend their market exclusivity, this data has been repeatedly shown to be flawed. C4IP, for example, has compared I-MAK’s data on drug patenting with official data from the U.S. Patent and Trademark Office and found that I-MAK significantly overstates both the number of patents filed on individual drugs and the effective duration of drugs’ market exclusivity. |
| Claim: Excessive patenting is preventing biosimilar and generic drugs from entering the market in a timely fashion. |
| In reality: Contrary to what many people claim, patents on brand-name drugs do not serve to unreasonably extend the period of market exclusivity — research has repeatedly found that average periods of drug exclusivity are approximately seven to eight years less than the 20-year statutory length of a patent. This is supported by USPTO data: A study conducted by the USPTO found no correlation between the number of patents on a product and the length of time before generic or biosimilar entry. It also noted that the effective period of exclusivity for drugs is typically less than 12 years. Furthermore, the fact that patents are not a barrier to generic and biosimilar competition is evident in the thriving generic and biosimilar markets. In the United States, nine of every 10 prescriptions are filled by generics. Likewise, the development of biosimilars — cheaper alternatives to brand-name “biologic” drugs derived from living organisms — continues at a steady pace. Since 2015, the FDA has approved more than 60 biosimilars, with 18 approvals coming in 2024 alone. As Amgen’s piece highlights, while some biosimilars and generics may still face delays in reaching the market, this is primarily driven by the complexity of the science behind these drugs rather than by patents. These facts underscore the baselessness of calls for legislative changes like the Affordable Prescriptions for Patients Act and the ETHIC Act, which both seek to restrict the number of patents on which innovators can assert infringement claims if another company attempts to sell the same product. These bills are premised on the false assumption that excessive numbers of patents are driving delays in biosimilar and generic development. However, this legislation would only weaken inventors’ incentives to develop the next generation of cutting edge treatments, to the detriment of future patients. |
Celebrating American Innovation
Inventor Spotlight
This month, C4IP is honoring John B. Goodenough (1922-2023), whose work on the invention of the lithium-ion battery powers billions of high-tech devices and is reshaping renewable energy.
- Born in Germany and raised in Connecticut, Goodenough earned his Ph.D. in physics from the University of Chicago after serving in World War II and went on to teach at Oxford University.
- Goodenough and his colleagues developed the first lithium-ion battery, offering an unprecedented combination of high capacity and voltage, lightweight design, rechargeability, and a long life cycle.
- Goodenough’s invention was patented in 1982 and earned him the Nobel Prize in Chemistry in 2019.
- Lithium-ion batteries are integral to nearly all of today’s electronic technologies, including cell phones, power tools, and even electric vehicles.
- The market for these batteries is estimated to be worth nearly $200 billion today, driven largely by growing demand for electric vehicles.
- In the United States alone, increasing battery production could create 125,000 manufacturing jobs by 2032.
- And lithium-ion batteries aren’t only driving economic growth — they’re also helping address climate challenges by storing energy from solar and wind sources and offering recycling opportunities to reduce their environmental footprint.
(PHOTO: The Nobel Foundation)
What’s Happening in Congress
With the 119th Congress underway, Democratic and Republican lawmakers are weighing legislation to prioritize strengthening IP protections, including the recent reintroduction of several significant bills from the previous Congress:
- The Patent Eligibility Restoration Act (PERA), which would revitalize innovation and investment in crucial high-tech sectors by reversing arbitrary, judicially created exceptions to patent eligibility.
- The Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act, which would level the legal playing field for inventors and give them a fair chance to defend their patents from unauthorized infringement by larger competitors.
- The Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act, which was reintroduced in both the House and Senate. This bipartisan, bicameral legislation would reestablish injunctive relief as the primary legal remedy for patent infringement, reaffirming innovators’ constitutional rights to the exclusive ownership of their inventions.
- The Nurture Originals, Foster Art, and Keep Entertainment Safe (NO FAKES) Act, which would protect all individuals from having their voice and visual likeness copied by generative AI without consent.
We will continue to track movement on these bills and provide updates on legislative developments in upcoming editions. In the interim, you can find resources on these key issues here.