The U.S. Patent and Trademark Office (“USPTO”) Acting Director’s recent decision to deny institution of inter partes review (“IPR”) in iRhythm Technologies Inc. v. Welch Allyn Inc. offers valuable lessons for both patent owners and patent challengers navigating the PTAB’s approach to discretionary denials.
A New Dawn for Patent Owners? Breaking Down the PERA and PREVAIL Acts of 2025
In a move that could reshape the U.S. patent landscape, Congress has reintroduced two major pieces of legislation: the Patent Eligibility Restoration Act (PERA) of 2025 and the Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL) Act. Both bills purport to restore clarity, strength and global competitiveness to the U.S. patent system—longstanding priorities for patent owners across industries.
Here we break down what each bill proposes and what it could mean for innovators if passed in its current form.
Ingenico Inc. v. IOENGINE, LLC: Federal Circuit Resolves the IPR Estoppel Split
In what is certain to become a landmark decision, the Federal Circuit has resolved a long-standing question that divided patent litigators and judges alike: does IPR estoppel apply to physical systems (“system art”) described in patents or printed publications? The Court answered with a resounding “no.” See Ingenico Inc. v. IOENGINE (“Op.”). While such systems may qualify as prior art under 35 U.S.C. §§ 102 or 103, the Court reaffirmed that “Congress excluded [them] in IPR proceedings.” Id. at 13.
Amazon Patent Evaluation Express (APEX): Personal Jurisdiction Considerations
The Supreme Court recently declined to review a Federal Circuit decision that could have significant implications for patent owners that rely on the Amazon Patent Evaluation Express (“APEX”) program.
The APEX program offers a streamlined way for utility patent owners to request removal of allegedly infringing product listings on Amazon.com, without filing a suit in district court. To initiate the process, the patent owner identifies up to 20 product listings that allegedly infringe one claim of a patent. Amazon then notifies the sellers, who may (1) agree to an independent infringement analysis by a neutral third party, (2) engage with the patent owner directly to resolve the dispute, (3) file a declaratory judgment action in U.S. district court, or (4) do nothing—at which point Amazon removes the product listings.
Federal Circuit Affirms Stem Cell Product-by-Process Claims: Lessons in Claim Construction and Inherency from Restem LLV v. Jadi Cell LLC
The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell, LLC, the Court affirmed the Patent Trial and Appeal Board’s inter partes review final written decision in favor of the patent owner, Jadi Cell, LLC, upholding claims in U.S. Patent No. 9,803,176 (the “ ’176 Patent”) directed to stem cells derived from umbilical cord subepithelial layer (“SL”) tissue with specific cell marker expressions (“Claimed Cells”).
Litigating Patents in the ITC: When and Why Companies Take the Section 337 Route
Formerly a niche venue for trade-related matters, the International Trade Commission (“ITC”) has emerged as a battleground for many high stakes intellectual property disputes, particularly in the technology, life sciences, and consumer electronics industries. With the power to block infringing products from entering the U.S., the ITC has become an increasingly attractive option for patent holders seeking swift and decisive remedies.
The Uncertain Future of Section 101: Patent Eligibility in the Wake of Recent Supreme Court (In)Action
Patent eligibility under 35 U.S.C. § 101 remains one of the most hotly contested and unpredictable areas of U.S. patent law. In the years following the Supreme Court’s landmark decisions in Alice Corp. v. CLS Bank Int’l (2014) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012), lower courts, the USPTO, and the Federal Circuit have wrestled with the proper application of the two-step framework for determining whether an invention is directed to an abstract idea, law of nature, or natural phenomenon—and, if so, whether it includes an inventive concept sufficient to transform it into patent-eligible subject matter.
Further Shifts in Patent Office Guidance for Discretionary Denials Signal Uphill Battles for Patent Challengers
On the heels of the rescission of the Fintiv guidance memorandum, the U.S. Patent and Trademark Office has again reshaped the PTAB’s approach to discretionary denials. On March 26, 2025, the Acting Director issued a new memorandum that fundamentally changes how the PTAB will handle inter partes review and post grant review petitions
A Looming En Banc Decision with Potentially Damaging Consequences – EcoFactor v. Google
For anyone following the evolving admissibility standards for expert opinions relating to patent damages, the EcoFactor v. Google case is one to watch. In December 2024, the Federal Circuit granted Google’s petition for rehearing en banc to address the effect of amended Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals as they relate to admissibility of damages expert testimony—particularly when a per-unit royalty rate is derived from three allegedly comparable lump-sum licenses.
Focus on Fintiv: Shift in Patent Office Guidance for Discretionary Denials of Patent Challenges
On February 28, 2025, the U.S. Patent and Trademark Office announced that it was rescinding a 2022 memorandum that provided guidance regarding the application of the Apple v. Fintiv decision to the Patent Trial and Appeal Board’s discretion to deny patent challenges with pending parallel district court litigation. The PTO has referred parties back to precedent for guidance including Apple Inc. v. Fintiv, Inc. Rescinding the 2022 memorandum also has the effect of effectively removing the proposed rules related to discretionary denial that were under consideration as recently as last year.