On October 8, the Senate Judiciary Subcommittee on Intellectual Property held a hearing on the Patent Eligibility Restoration Act (PERA) to examine how the bill would clarify patent eligibility under Section 101 and its implications for U.S. innovation and competitiveness.
C4IP Co-Chairs Andrei Iancu and David Kappos were among the witnesses. C4IP also submitted a letter ahead of the hearing, in support of the legislation, underscoring that a predictable patent system is vital to the United States’s innovative strength.
Here are some key takeaways from the written testimonies submitted by several witnesses:
Andrei Iancu, C4IP Co-Chair and Former Under Secretary of Commerce for Intellectual Property and Director of the USPTO
“Over the past decade, judicial decisions have extended limited exceptions into sweeping doctrines that Congress never authorized, producing jurisprudence so unstable that even federal judges admit it cannot be consistently applied…
The costs of inaction are significant and mounting. Innovation thrives only when the rules are predictable and inventors and their investors can rely on the protections our system promises. When the law is unpredictable, investment dries up. The U.S. is losing its competitive edge in sectors where reliable patent protection matters most: diagnostics, artificial intelligence, biotech, and advanced manufacturing, among others.”
“By defining in statute which categories of invention are in and which are out, and by eliminating the extra-statutory judicial exceptions that have sown confusion for more than a decade, PERA offers the reliable foundation our patent system urgently needs.”
You can read his full testimony here.
David Kappos, C4IP Co-Chair and Former Under Secretary of Commerce for Intellectual Property and Director of the USPTO
“PERA’s approach is measured, codifying a sensible, technology-neutral framework that I am confident will allow our judiciary to deliver much more consistent results than what we’ve seen under the current patchwork.
The Patent Eligibility Restoration Act is aptly named. It is not a radical overhaul but a restoration of clarity, Congress’s intent and the vitality of the U.S. patent system. By enacting this law, Congress will send a resounding message: the United States is committed to being the most innovative nation on Earth, and our laws will reflect that commitment.”
“Crucially, PERA also realigns the U.S. with its peers. Today, a biotech or AI inventor can obtain meaningful protection in Europe and China, yet face uncertainty here — even when the invention was made in America. That tilts the playing field against U.S. innovators, encourages moving R&D overseas and ultimately risks a brain drain in strategic fields like 5G, advanced computing, AI and medical diagnostics.”
You can read his full testimony here.
Sue Peschin, President and CEO of the Alliance for Aging Research
“The Supreme Court has narrowed patent eligibility in many areas, but what most concerns me is how the Court has explicitly restricted protection for medical diagnostics.”
“In fact, in the four years after Mayo, investment in diagnostics fell more than $9 billion short of what it otherwise would have been. The startups and companies that rely on this sort of venture capital suffered, and the United States became more reliant on other countries for diagnostic technologies.”
“For example, researchers at numerous top American universities have left behind novel
diagnostics for lupus, Alzheimer’s, major depressive disorder, cancer, including metastatic
cancers, schizophrenia, and rare pediatric disorders, after the USPTO rejected or weakened their patents because of the eligibility rules in Mayo.”
“This is not a failure of science. It is a failure of our patent system. And for patients and their families, the price of that failure is measured in lost time, diminished health, and lives cut short.”
You can read her full testimony here.
Steven Caltrider, C4IP Advisory Board Member and Vice President and Chief Intellectual Property Officer at Dana-Farber Cancer Institute
“The current law of eligibility is often justified in the life science sector as an issue of patient access. I wholeheartedly agree that patient access is critical. It is why Dana-Farber and other innovators and caregivers do what we do. Our mission is to help patients with innovative patient therapies and scientific discoveries. The ultimate barrier to patient access, however, is a medicine or diagnostic never being discovered, developed, or commercialized.”
“While the legal landscape for treatment-related patents is not yet as dire as for medical diagnostics, defending against patent eligibility challenges creates a strong headwind against innovation and remains only one adverse court decision away from being catastrophic for patients awaiting cures.
The question for the Subcommittee today is whether the country should have sound IP policy, which includes PERA as a solution to the eligibility crisis, that supports these breakthroughs? In my opinion, the answer is clearly ‘yes.’ Again, patients are waiting.”
You can read his full testimony here.