February Highlights: Protecting the Bayh-Dole Act
February 6 concluded NIST’s public comment period for the newly proposed “march-in” framework, which would twist the Bayh-Dole Act into a mechanism for government price control. If implemented, such government intervention would distort the commercial investment landscape for new innovation across all areas of technology receiving government funding, introducing significant uncertainties and risks for inventors and investors. The framework would lead to the breakdown of public-private partnerships, and the fruitful innovation emanating from them over the past 40+ years.
This month, C4IP actively engaged in and supported initiatives advocating for the withdrawal of this ill-conceived and legally unsupported framework:
- Nine former Commerce Department officials, including C4IP Co-Chairs Andrei Iancu and David Kappos and former Commerce Secretaries Gary Locke and Carlos Gutierrez, penned a joint letter to President Biden strongly opposing the framework.
- Bloomberg Law and IP Watchdog each highlighted the letter from the former Commerce Department officials in articles chronicling the widespread opposition to the Biden administration’s proposal.
- Two email newsletters also circulated the letter: Politico’s West Wing Playbook and STAT’s C. Diagnosis.
“We emphasize in the strongest possible terms: the proposed framework poses a major threat to America’s prosperity. And it undermines numerous other initiatives by the Biden administration to improve America’s economy.”
- C4IP Executive Director Frank Cullen submitted comments to NIST opposing the framework and highlighting the devastating effects that it would have on the U.S. innovation ecosystem.
- IPWatchdog featured the public comments in a recent article.
- Many other pro-innovation organizations representing manufacturers, small businesses, university tech transfer offices, and more also submitted powerful comments advocating against the framework.
- C4IP compiled excerpts from 32 of them in a “What They’re Saying” document.
Read it Now: “What They Are Saying About the Biden Administration’s Draft Framework for March-In Rights”
- C4IP Co-Chairs Andrei Iancu and David Kappos expanded on the reasoning for opposing the march-in framework in an opinion essay published in World Intellectual Property Review.
- Life Sciences Intellectual Property Review also published the piece.
“In suddenly declaring pricing fair grounds for compulsory relicensing, the administration’s proposal seeks to rewrite four decades of understanding between government and private sector partners. Doing so would jeopardise wide swaths of America’s innovation ecosystem—including in fields far beyond pharmaceuticals.”
- C4IP Co-Chair David Kappos was quoted in an opinion essay published by the Detroit News Editorial Board, which criticized the Biden administration’s radical reinterpretation of Bayh-Dole and underscored its devastating impact on innovation coupled with other continuing attacks on the patent system, such as PTAB abuse and patent ineligibility for emerging technologies.
Additional Coalition Updates
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- On February 21, C4IP Co-Chair David Kappos published an opinion essay in the Brussels Times underscoring how the European Commission’s proposal to micromanage standard-essential patent licensing would devastate European innovation.
“Approving the [EU Standard Essential Patents] proposal — which is designed to solve a problem that the European Commission’s own study admitted does not exist — would harm European companies without any offsetting benefits for consumers.”
- On February 20, C4IP hosted a roundtable at the University of Texas at Tyler, where Congressman Nathaniel Moran (R-TX), C4IP Co-Chair Andrei Iancu and Executive Director Frank Cullen, and several local business leaders discussed East Texas’s path to becoming a national innovation hub.
- On February 12, C4IP released a statement officially opening applications for its summer internship program in Washington, D.C. C4IP is accepting applications from law students through March 31.
- On February 6, C4IP Executive Director Frank Cullen sent a letter to the Senate IP Subcommittee expressing strong support for the Patent Eligibility Restoration Act in the wake of the subcommittee’s Jan. 23 hearing on the bill.
Government Rundown
USPTO Webinar: Unleashing Creativity in the Classroom: Empowering Teachers with SCAMPER for Invention and Intellectual Property Education:
On February 27, the USPTO hosted a virtual teacher development session to provide educators with new tools and strategies to teach about intellectual property. Educational consultants and former teachers Kathy Hoppe and Christine Lawlor-King led the session, which focused on teaching the “SCAMPER” (Substitute, Combine, Adapt, Modify, Put to another use, Eliminate, and Reverse) framework. (USPTO, 2/27)
USPTO Program: 2024 Black Innovation and Entrepreneurship Program: Innovate, elevate, and empower:
On February 22, the USPTO hosted a program to help Black entrepreneurs, small business owners, and inventors learn about intellectual property and make connections in the innovation space. The event was held in person in St. Louis, Missouri, and included panels led by numerous USPTO officials, local startup founders, and leaders of small business organizations. (USPTO, 2/22)
USPTO Program: Women’s Entrepreneurship Series – Leading with Purpose: Women making a difference:
On February 21, the USPTO hosted another program in its Women’s Entrepreneurship series in St. Louis, Missouri, with local women entrepreneurs gathering to discuss their experiences building their businesses and overcoming challenges. Speakers included entrepreneurs Kimberly Adeyinka of Kimtique Eyewear, Shanae Chapman of Nerdy Diva, Keisha Mabry Haymore of Heydays, and Natalie King of Florae. (USPTO, 2/21)
House Committee on the Judiciary, Subcommittee on Courts, Intellectual Property, and the Internet Hearing: Artificial Intelligence and Intellectual Property: Part II – Identity in the Age of AI:
On February 2, the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet held its second in a series of hearings on how Congress can foster “responsible innovation” in artificial intelligence. The hearing was located in Los Angeles, California, and its witnesses included recording artist Lainey Wilson, Recording Academy President and CEO Harvey Mason Jr., Software and Information Industry Association President Christopher Mohr, and University of Pennsylvania law professor Jennifer Rothman. (House Judiciary Committee, 2/2)
Fact Check
America’s strong intellectual property system played a pivotal role in the rapid global response to the COVID-19 pandemic. Patents provided crucial incentives for the development of life-saving vaccines, therapies, and diagnostic tests, all of which were distributed globally. However, despite these successes, there are ongoing efforts by certain global leaders to pursue an international agreement at the World Health Organization (WHO) that would erode essential patent rights. Such a move would jeopardize our ability to effectively address future global health crises.
On February 3, WHO Director-General Tedros Adhanom Ghebreyesus delivered a speech presenting several arguments in favor of this draft treaty. However, closer examination discredits these claims.
| Claim: “A lack of sharing of information and a lack of sharing of resources and tools” left developing nations behind during the pandemic response. |
| In reality: Patents are publicly disclosed, meaning that they encourage rather than inhibit the sharing of information. Contrary to the claim, vaccine hesitancy and distribution issues within developing countries were the major barriers to uptake in low and middle income countries, rather than a lack of cooperation from wealthier nations. |
| Claim: The proposed WHO draft treaty would only encourage countries to “share information.” |
| In reality: The way the draft treaty would require the sharing of information would discourage investment in responses to global health emergencies. The draft treaty’s mandatory data sharing and limitations on royalty collections for pandemic-related patents would chill the critical private investment that brought about the rapid response to the COVID-19 pandemic, including the immediate development of new vaccines created and manufactured in record time. Strong intellectual property rights protecting inventions and trade secrets are vital to incentivize innovation, as they allow companies to risk investments with the promise of recovering it, if successful. Proposals like this draft treaty, which effectively allow others to copy without compensation, turn this incentive system on its head, imperiling future pandemic readiness. |
| Claim: “If [the draft treaty] had been in place before Covid-19, we would not have lost so much.” |
| In reality: The existing system of strong intellectual property rights meant that at the onset of COVID-19, life-saving technologies — such as N95 masks, ventilators, and the cutting-edge mRNA platform — had already been developed. Medical treatments specifically targeting COVID-19 were developed in record time. If the draft treaty had been in place during the years prior to the pandemic, its weaker patent protections would have hindered the development of these critical interventions — likely causing the world to suffer greater losses of life and productivity than it actually did. |
Celebrating American Innovation
Inventor Spotlight
This month, C4IP is recognizing Mark Dean, a pioneer of personal computers.
Dean was born in Jefferson City, Tennessee, in 1957, and studied electrical engineering at the University of Tennessee and Florida Atlantic University before becoming chief engineer of IBM’s personal computers division at the age of 25.
He led the team behind IBM’s first personal computer and holds three of its foundational nine patents.
- The groundbreaking device was named TIME Magazine’s 1982 “Machine of the Year,” made over $1 billion in revenue in its first year, and catapulted IBM to become the most profitable company in the world by 1983.
His major invention was the Industry Standard Architecture bus — an internal structure for computers that allowed visual, audio, and memory data to be transferred between devices, which he patented with colleague Dennis Moeller in 1985.
- Dean is also known for creating the first color PC monitor and the first gigahertz computer chip.
- He currently holds over 40 patents.
Dean’s impact is felt across the world: As of 2019, nearly half of households worldwide owned a computer — a total of over 1.3 billion units — and roughly 95% of U.S. households are currently estimated to own one.
(Photo credit: Florida Inventors Hall of Fame)
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 Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act:
In June 2023, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) – joined by Representatives Ken Buck (R-CO) and Deborah Ross (D-NC) 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 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 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 theft of American IP overseas. The actions called for by the bill could also 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 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.
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.