August Highlights: Supporting the RESTORE Patent Rights Act
Inventors depend on strong patent rights to ensure that they can invest in research and development and know that their innovations – once successful – won’t be immediately copied and sold by others without permission. In the court system, the best way to meaningfully guarantee this kind of protection is through injunctions – legal orders that require adjudged infringers to stop utilizing the patented invention. However, inventors’ right to an injunction has eroded over the past two decades. Monetary damages have replaced injunctions as the main legal remedy for patent infringement, allowing large companies to steal patents without significant consequences. The difficulty of obtaining injunctions today has weakened patent rights and made innovation much riskier, especially for small inventors – putting our entire innovation system at risk.
In late July, a bipartisan group of senators and representatives led by Senators Chris Coons (D-DE) and Tom Cotton (R-AR) introduced the RESTORE Patent Rights Act, which would codify that injunctions should be routinely granted as a final remedy after a patent is found valid and infringed in court. Throughout August, C4IP was heavily involved in advocating for this reform:
- Former U.S. Commerce Secretary Gary Locke published an opinion essay in the Financial Times explaining how PERA, the PREVAIL Act, and the RESTORE Patent Rights Act would modernize our patent system to help innovative companies thrive.
“[M]any of our patent laws are in dire need of an update… Without a patent system that can keep pace with technological progress, we risk ceding the innovation high ground to China, the EU, and other rivals.”
- Netlist founder and CEO Chuck Hong published an opinion essay in Fortune detailing his experience of having patents stolen by Google and advocating for the PREVAIL Act and RESTORE Patent Rights Act as ways to prevent future predatory infringement.
“Congress has shown an interest in regulating Big Tech on matters of antitrust, privacy, misinformation, and child protection. They should also add patent infringement to this list.”
- Colorado College Professor Kristina M. L. Acri published an opinion essay in the Denver Post spotlighting the alarming decline in injunctions since eBay v. MercExchange, which the passage of the RESTORE Patent Rights Act would rectify.
- C4IP Chief Policy Officer and Counsel Jamie Simpson was quoted in a Bloomberg Law article on the importance of passing the RESTORE Patent Rights Act and reversing the eBay v. MercExchange
Additional Coalition Updates
- On August 22, C4IP Board Member Judge Kathleen O’Malley () published an opinion essay in the World Intellectual Property Review arguing that, in the digital age, the NO FAKES Act would preserve the incentives that drive creative expression – while ensuring that our identities, our art, and our innovations remain our own.
- On August 16, C4IP Co-Chair and former USPTO Director David Kappos published an opinion essay in the San Francisco Chronicle explaining how strong patent protections have been responsible for the continuous improvement of GLP-1 drugs.
- On August 14, C4IP Chief Policy Officer and Counsel Jamie Simpson was quoted in a Bloomberg Law article on a recent lawsuit involving voice actors that exemplifies the need for the NO FAKES Act.
- On August 5, IP attorney and expert Michael Gulliford published an opinion essay in Law360 underscoring the confusion caused by unpredictable patent eligibility criteria and urging the passage of PERA as a solution.
- On August 2, C4IP Executive Director Frank Cullen issued a statement endorsing the NO FAKES Act of 2024 and explaining how it would uphold the intellectual property rights of artists and creators.
Read it Now: “Council for Innovation Promotion Statement on the NO FAKES Act of 2024”
- On August 1, former USPTO Deputy Director Coke Stewart published an opinion essay in RealClearHealth exploring how a second Trump administration’s patent policies would help protect the rights of inventors.
Government Rundown
USPTO Convention: Invention-Con 2024: Expanding your intellectual property potential:
On August 16 and 17, the USPTO held an in-person convention at its headquarters in Alexandria, VA, to educate inventors about the benefits of IP rights, train them to make use of USPTO resources, and help them develop commercialization strategies for their inventions. The event also included a USPTO open house, resource fair, and tours of the National Inventors Hall of Fame museum. (USPTO, 8/16-8/17)
USPTO Roundtable: Public roundtable: AI and protections for use of an individual’s name, image, likeness, or reputation:
On August 5, the USPTO held a roundtable discussion on how artificial intelligence technology intersects with copyright and trademark protections surrounding individuals’ name, image, and likeness (NIL) rights. The roundtable took place both online and in Alexandria, VA, and featured remarks from USPTO Director Kathi Vidal. (USPTO, 8/5)
Fact Check
The Medication Affordability and Patent Integrity Act, introduced by Senators Maggie Hassan (D-NH) and Mike Braun (R-IN), would require life sciences innovators to share volumes of unnecessary and confidential information related to drug approval with the USPTO. Under the bill, firms would also have to provide lengthy certifications stating that all information submitted to the FDA and USPTO is consistent.
Proponents of the bill argue that such disclosures would help prevent drug companies from manipulating the patent system, keep weak patents from being issued, and lower drug costs for patients. A recent statement published by AARP exemplifies this mistaken line of thought.
Lawmakers are contemplating a major overhaul of a well-functioning system because of false narratives – not because of rigorous analysis of facts. The arguments used by proponents of the bill are unsupported by evidence and fail to recognize the larger problems that would arise from the legislation’s passage:
| Claim: “[D]rugmakers ‘game the system’ by submitting only partial information” to the USPTO and FDA. |
| In reality: Drug companies submit different information to the USPTO and FDA due to the agencies’ differing purposes and requirements. Obtaining a patent at the USPTO mainly hinges on determining whether the invention is new, useful, and non-obvious, so patent applications require inventors to describe and diagram the function of their invention. In contrast, the FDA’s drug approval process requires the disclosure of other information, such as clinical data – which is both confidential and not necessarily relevant to patentability. Where it may be relevant, there are already strict penalties at both the USPTO and FDA for applicants who falsify information, and there is no evidence to suggest that providing differing information to both agencies is routinely abused in a way that benefits drug innovators or harms patients. The effect of the proposed bill, therefore, would not solve any existing problem but create several other problems by needlessly forcing the publication of confidential trade secrets and adding to both agencies’ administrative workload. |
| Claim: By filing new patents on a drug, companies “can extend a drug’s exclusivity on the market.” |
| In reality: The pervasive belief that life science companies can extend the period of exclusivity on drugs by filing for additional, obvious patents is known as “evergreening,” and it is a myth. “Secondary” or “follow-on” patents related to existing inventions must pass the same, rigorous standards as other patents, meaning that only real and non-obvious innovations are able to be patented – such as a formulation that doesn’t cause painful injection-site reactions, in the case of medicine. However, regardless of the type of improvement being patented, new patents have no effect on the expiration of the original patent. Once the original patent term ends, competitors and generic manufacturers are free to copy the original form or formulation of the drug, so it is impossible for companies to “extend” the period of exclusivity on their invention. Attacks on follow-on patents amount to attacks on improvements that will improve patient health and outcomes, rather than actions that will improve patient access to drugs. |
| Claim: The proposed bill would “increas[e] access to safe, affordable prescription drugs and lower drug costs for consumers and taxpayers.” |
| In reality: The proposed bill is unlikely to reduce drug prices, as there is no evidence to show that widespread deception of the USPTO or FDA is taking place or contributing to high prices. However, aspects of the bill do threaten to hinder drug accessibility. Under the requirements of the bill, both the USPTO and FDA would receive much more information to sift through, potentially extending both agencies’ already-lengthy approval processes – currently, it takes about 10 months to get a drug approved at the FDA and nearly 26 months to receive a final patent decision at the USPTO. The bill’s new rules could also provide an opportunity for unscrupulous competitors or patent infringers to challenge innovative companies’ patents in court, which would then consume even more time and resources. If these changes are passed into law, it’s likely that patients would be forced to wait even longer for new treatments – or be deprived of them completely. |
Celebrating American Innovation
Inventor Spotlight
This month, C4IP is recognizing Frederic Eugene Ives, whose prolific inventions pioneered several technological leaps in photography.
- Ives was born in 1856 in Litchfield, Connecticut, and became involved with photography from a young age – first as an apprentice at the Litchfield Enquirer, and later as a leader of the photographic laboratory at Cornell University.
- His first major invention was the half-tone photoengraving process, patented in 1881, which allowed newspapers and magazines to print photographs for the first time.
- The innovative technique is still used in today’s laser printers and copy machines, of which more than 100 million are sold annually.
- Ives later invented and patented the first process for color photography in 1915.
- In total, he amassed 70 patents throughout his career, including numerous improvements to his color photography system.
- Ives’s innovations helped photography become the massive phenomenon it is today, with more than 5 billion photographs being taken around the world each day.
- In the U.S. alone, over 50,000 people earn their livelihoods from photography.
(Photo credit: historiccamera.com)
What’s Happening in Congress
As Democratic and Republican members of Congress continue to weigh legislative priorities during the 118th Congress, top of mind for those who follow intellectual property policy are:
The Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act: In July 2024, Senators Chris Coons (D-DE) and Tom Cotton (R-AR), and Representatives Nathaniel Moran (R-TX), Madeleine Dean (D-PA), and Hank Johnson (D-GA) introduced legislation that aims to realign patent law with the U.S. Constitution and the Patent Act’s promise of “exclusive rights” to inventors. This bipartisan bill seeks to restore injunctive relief – court orders that stop infringers from utilizing patented technology – in response to the Supreme Court’s 2006 eBay v. MercExchange. That ruling substantially curtailed the granting of such injunctions, undermining the exclusive rights set forth in the U.S. Constitution to many inventors. C4IP strongly supports this legislation, viewing it as a pivotal moment for American innovation.
The Nurture Originals, Foster Art, and Keep Entertainment Safe (NO FAKES) Act of 2024: In August 2024, Senators Chris Coons (D-DE) and Thom Tillis (R-NC), along with Senators Amy Klobuchar (D-MN) and Marsha Blackburn (R-TN), introduced bipartisan legislation intended to protect all individuals from having their voice and visual likeness copied by generative AI without consent. The bill would ensure that entities that produce or share a non-consensual digital replica of another person’s image or voice, such as an AI-generated “deepfake,” can be held liable for damages. It also provides a mechanism to hold platforms hosting user-generated content liable for the same, if they do not remove such unauthorized material after receiving notice. By safeguarding all individuals from exploitation, this legislation would ensure that music, videos, and other forms of content feature only individuals who agree to it, strengthening the rights of artists and actors, and preventing the exploitation of them and everyone else.
The Stopping Harmful Offers on Platforms by Screening Against Fakes in E-Commerce (SHOP SAFE) Act: In September 2023, Senators Chris Coons (D-DE) and Thom Tillis (R-NC) introduced legislation designed to protect online consumers from harmful counterfeit products. By establishing trademark infringement liability for e-commerce platforms that allow the sale of dangerous counterfeit items, requiring brand owners to notify platforms of their mark(s) in advance, and providing safety from liability to platforms that appropriately vet and remove counterfeit sellers, the SHOP SAFE Act will protect American families as well as businesses and IP holders. Representatives Darrell Issa (R-CA), Jerry Nadler (D-NY), Ben Cline (R-VA), and Hank Johnson (D-GA) introduced the House companion to this bill in June 2024.
The Patent Eligibility Restoration Act of 2023: In June 2023, Senators Thom Tillis (R-NC) and Chris Coons (D-DE) reintroduced legislation aimed at restoring patent eligibility for important categories of inventions – including life sciences diagnostics, gene therapies, and computer-implemented inventions – as well as resolving questions regarding the scope of patent eligibility. In so doing, the Patent Eligibility Restoration Act will foster the development of next-generation technologies across innovative industries.
The Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act: In July 2023, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) – joined by Deborah Ross (D-NC), and later cosponsored by Nathaniel Moran (R-TX), on the House side – introduced legislation that will eliminate redundant patent invalidity challenges and safeguard Americans’ right to participate in a fair and accessible patent system. The PREVAIL Act contains important reforms to the Patent Trial and Appeal Board, which will return the body to its original purpose of providing an efficient alternative to district court litigation, and will curtail the practice by patent infringers of forcing inventors to defend their patents repeatedly and in multiple fora.
The Medication Affordability and Patent Integrity Act: In September 2023, Senators Maggie Hassan (D-NH) and Mike Braun (R-IN) introduced legislation that would require life sciences innovators to disclose vast amounts of confidential data to the USPTO. In addition, firms would also have to provide lengthy certifications stating that all information submitted to the FDA and USPTO is consistent. Proponents of the bill argue that such disclosures would help prevent drug companies from manipulating the patent system, keep weak patents from being issued, and lower drug costs for patients. However, there is no evidence that these problems exist. Rather than benefit patients, the requirements imposed by this bill would likely compromise the confidentiality of trade secrets and make it easier for companies to have their competitors’ patents invalidated. It would also drain USPTO resources and make the drug approval process even more burdensome for innovative companies. Due to these problems, as well as the lack of empirical support for the bill, C4IP opposes this legislation.
The Prohibiting Adversarial Patents (PAPA) Act: In September 2023, Representatives Scott Fitzgerald (R-WI), Mike Gallagher (R-WI), Darrell Issa (R-CA), and Blaine Luetkemeyer (R-MO) introduced legislation that raises a number of concerns. With the well-intended goal of protecting U.S. national security, the PAPA Act has the potential to trigger significant unintended consequences. These include potential retaliatory moves by China and other nations to suspend or render unenforceable patents owned by American companies, further enabling the theft of American IP overseas. The actions called for by the bill may well violate U.S. treaty obligations, which would, in turn, embolden other nations to violate IP-related treaties in various ways. In addition, confiscating patents, or rendering them unenforceable, violates basic principles of property, and therefore could weaken the concept of patents as property rights. These and other considerations are of the utmost importance as U.S. lawmakers study the full scope of the PAPA Act. C4IP stands ready to work with Members of Congress to address the threat posed by foreign entities, while maintaining the integrity of the U.S. patent system.
The Improving Efficiency to Increase Competition Act: In January 2024, Senators Thom Tillis (R-NC) and Chris Coons (D-DE) introduced legislation intended to reduce the administrative burden on universities and other institutions that receive federal research grants so that they can focus more intently on producing new innovations. Specifically, the legislation would direct the Government Accountability Office (GAO) to conduct a study on intellectual property reporting requirements under the Bayh-Dole Act, which vary between federal agencies. Such a study will offer important insights into how the government can make the reporting process more efficient and remove barriers that may have inhibited the development of new inventions.
The Interagency Patent Coordination and Improvement Act of 2023: In January 2023, Senators Dick Durbin (D-IL), Chris Coons (D-DE), Thom Tillis (R-NC), and Chuck Grassley (R-IA) introduced the Interagency Patent Coordination and Improvement Act of 2023. The bill would create an interagency task force to share patent filing information and technical assistance between USPTO and FDA officials. IP experts warn that interagency entanglement could weaken the patent system by inserting officials from multiple federal agencies – without patent law expertise – into the examination process. They submit that it is premature to implement such substantial changes without conducting a thorough evidence-based study.