Coalition Updates
- On April 17, C4IP will host a webinar clarifying the purpose of Section 1498 and explaining why the DOJ’s interpretation would decimate American innovation. To join us for this webinar, please register here.
- On April 10, C4IP will co-host a roundtable discussion with The Stanford Biodesign Policy Program focused on the role that IP law and policy play in supporting the innovation ecosystem. To join us for this discussion, please register here (in-person and remote options available).
- On March 29, C4IP Executive Director Frank Cullen testified at the USITC hearing held as part of the Commission’s investigation into the proposed TRIPS waiver expansion.
- “Stripping developers of the internationally recognized IP protections that underpin their products and processes will not lower barriers to access. However, it will create new ones in the form of stifled investment, innovation, and U.S. competitiveness.”
- On March 29, C4IP board members Judge Paul Michel (Ret.) and Judge Kathleen O’Malley (Ret.) published an opinion essay in RealClearPolicy arguing that the Supreme Court’s decision in eBay Inc. v. MercExchange, L.L.C. is allowing corporations to violate the IP rights of their rivals.
- “Letting this precedent stand any longer would discourage America’s innovators, and by extension, harm our economy and our competitive standing in the world…It’s long past time for Congress to clarify that injunctions are often the most appropriate response in cases of proven patent infringement, not money damages.”
- On March 24, C4IP co-chairs Andrei Iancu and David Kappos published an opinion essay in The Hill arguing that the Federal Trade Commission’s proposal to ban all non-compete agreements would hurt U.S. companies and workers.
- “The FTC proposal would effectively greenlight corporate espionage, all to ‘solve’ a problem that’s already easily — and regularly — handled by the courts. The rule would make it much harder for companies to stop trillions of dollars’ worth of IP from walking out the door…Workers and consumers can only hope that an outpouring of opposition causes the agency to rethink its rash proposal before it’s too late.”
- On March 17, C4IP Executive Director Frank Cullen sent a letter to Senators Bernie Sanders (D-VT) and Bill Cassidy (R-LA) expressing concerns over calls to misuse the Bayh-Dole Act and 28 U.S.C. §1498(a) for purposes they were never intended to authorize.
- “…while advocates of these radical interpretations of the Bayh-Dole Act and 28 U.S.C. §1498(a) have framed their arguments around drug prices, such actions would upend the reliability of all patent rights. If the government could suddenly nullify a patent because a medicine is priced above some arbitrary threshold, all patent protections would rightly be called into question.”
- On March 10, C4IP submitted a response to the USPTO’s request for comment on Joint USPTO-FDA Collaboration Initiatives.
- “The current proposal will lead to an interagency entanglement that will likely exceed the bounds of permissible agency action and will undermine the patent system by interjecting the voices of numerous federal agencies — none of which have patent-law expertise — into the patent examination and review process.”
- On March 10, C4IP board members Judge Paul Michel (Ret.) and Judge Kathleen O’Malley (Ret.) published an opinion essay in the New York Daily News detailing why juries are expertly equipped to adjudicate patent validity.
- “Juries are among our country’s oldest and most important symbols of civic duty, fairness, and equal access to justice for all. They are the proper forum for all manner of criminal and civil disputes — including patent cases.”
- On March 6, former Congressman Lamar Smith (R-TX) published an opinion essay in the Dallas Morning News explaining how misusing the Bayh-Dole Act’s march-in provision to relicense patents will jeopardize cutting-edge industries in Texas.
- “…the entire model depends on universities retaining the rights to their discoveries, then licensing them to companies that can count on secure patents. If the federal government decides to effectively disregard intellectual property protections, it will deter entrepreneurship and research investments for decades to come.”
- On March 2, C4IP published a blog spotlighting a Welcome Reception for the 118th Congress that the Coalition co-hosted — with nearly 50 other pro-innovation organizations — in collaboration with the Creative Rights Caucus.
- “The event, which drew nearly 200 attendees, underscored the depth of bipartisan support for a strong and reliable intellectual property system. C4IP stands as a trusted resource — and partner — to the Creative Rights Caucus as lawmakers work together to advance policies that prioritize U.S. creative industries and copyright protections in the 118th Congress.”
Media Rundown
- USITC Holds Public Hearing in Connection with TRIPS Waiver Expansion Investigation: The U.S. International Trade Commission held a public hearing on March 29-30 as part of its fact-finding investigation into the proposed WTO TRIPS waiver expansion. Beyond the hearing, written comments will be accepted until May 5 and the USITC will submit a final report, conveying the investigation’s findings, to the USTR by October 17. (USITC, 03/29-3/30)
- U.S. Chamber of Commerce’s Global Innovation Policy Center Publishes 2023 Patient Access Report: The GIPC’s report profiles the effect of varying legal and regulatory frameworks on patient access to lifesaving medicines in nine OECD economies. Among the key findings, countries with market restrictive policies — namely artificial price controls — had “fewer biopharmaceutical product launches” and “delayed access to treatments.” (U.S. Chamber, 3/21)
- U.S. Copyright Office Offers Guidance on Artificial Intelligence: The U.S. Copyright Office issued new guidance on determining whether AI-generated art is copyright eligible. According to the Copyright Office, copyright eligibility hinges on whether the “‘work” is one of human authorship, with the computer [or other device] merely being an assisting instrument, or whether the traditional elements of authorship in the work were actually conceived and executed not by man but by a machine.” (USCO, Reuters 03/15)
- USPTO Begins New Program for Patent Applications: The U.S. Patent and Trademark Office announced a plan to accelerate the patent application process for first-time filers. The project aims to benefit first-time filers and inventors from underrepresented communities by providing expedited feedback on patent applications. In its pilot program, the USPTO will allow up to 1,000 first-time filers to receive accelerated review. (USPTO, 03/8)
Fact Check
Claim: Senator Bernie Sanders (D-VT), the newly minted Chairman of the Senate Health, Education, Labor, & Pensions HELP) Committee, hosted a hearing on March 22 entitled “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” The hearing was predicated on Sen. Sanders’ belief that the government shouldered the burden of researching and developing Moderna’s Covid-19 vaccine.
Correction: This fundamentally misrepresents the nature of public-private partnerships and the government’s role in the creation of life-saving breakthroughs — including Moderna’s vaccine. More than a decade before Covid-19, University of Pennsylvania scientists — with support from federal funding — uncovered the therapeutic potential of mRNA molecules and licensed their research to Moderna. Moderna invested $3.8 billion in private capital to translate this basic research into the refined mRNA technology underpinning its eventual Covid-19 vaccine, and has taken on the substantial risks of late-stage development and commercialization. While the company received $1.7 billion from the government to support clinical trials, it has provided $2.9 billion in return through discounted prices.
Across the industry, the vast majority of R&D investments come from the private sector. Indeed, in a study of 18 approved drugs receiving NIH grants, the private sector provided 98.5% of the funding required to bring the drugs to market. But private sector investment only occurs when the ecosystem supports and appropriately values patented medicines entering the commercial market.
By suggesting that the private sector played a minimal role, Sen. Sanders is devaluing the expensive and risky efforts that brought a Covid-19 vaccine to the world in record time. Propagating this narrative will only discourage future R&D ventures and rob patients of breakthrough medical advancements.
Bottom Line: This claim is false.
What’s Happening in Congress:
Intellectual property has long been an area of bipartisan consensus in the United States. Now, more than ever, it’s critical that U.S. policymakers work together to advance pro-innovation measures that uphold — even bolster — trust in our nation’s intellectual property system.
As Democratic and Republican congressmen continue to weigh legislative priorities for the 118th session, top of mind for those who follow intellectual property policy are:
- 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), 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 an interagency entanglement could weaken the patent system by inserting officials from multiple federal agencies — without patent law expertise — into the patent examination process. They submit that it is premature to implement such substantial changes without conducting a thorough evidence-based study.
- Patent Eligibility Restoration Act of 2022: In August 2022, Senator Thom Tillis (R-NC) introduced legislation aimed at restoring patent eligibility for important categories of inventions — including life sciences diagnostics, gene therapies, and artificial intelligence — as well as resolving questions regarding the scope of patent eligibility. Some version of this legislation is expected to be reintroduced in the 118th Congress.
- STRONG and STRONGER Patents Acts: In his keynote speech for the IPOwners Spring Summit, Senator Chris Coons (D-DE) announced his intention to reintroduce his legislation, previously known as the STRONG Patents Act and the STRONGER Patents Act, as two separate bills. One will reinstate a presumption of irreparable harm once patent infringement is shown, and the other will focus on balancing the process for post-grant PTAB proceedings.
Celebrating American Innovation
Inventor Spotlight
This month, C4IP is recognizing Wilbur and Orville Wright, better known as the “Wright Brothers,” for inventing the airplane.
The Wright Brothers grew up in Dayton, Ohio, in the late 1800s. Neither brother attended university, they opted to launch the West Side News, a local newspaper company, in 1889. The two ultimately opened up a bike shop in 1892 amid their growing popularity. German aviator Otto Lilinethal’s death in a glider crash inspired the brothers to begin flight experiments of their own in Kitty Hawk, North Carolina. Finally, on December 17, 1903, the brothers soared through the skies in their first successful flight.
In 1906, the brothers received a patent for their unique flying method. By 1908, the Wright Brothers began selling planes to the U.S. War Department. They launched the Wright Company just a year later and built a manufacturing facility in their hometown of Dayton, Ohio. Today, commercial aviation supports more than 10 million American jobs and generates around $1.25 trillion for the U.S. economy each year.