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.
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”).
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
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.
When Is Less Really More for a Patent Licensee?
In Apple v. Qualcomm, Federal Circuit Finds No Standing to Challenge Validity of a Few Patents When Many Were Licensed
The development timeline for small-molecule drugs and biologics is lengthy, estimated to take between 10 and 15 years. As a result, pharmaceutical companies need to consider freedom to operate issues long before they receive FDA approval or market their new product. These considerations might lead a company to take a license, seek to invalidate a competitor’s patent, or some combination of the two. The Patent Trial and Appeal Board (“PTAB”) is a popular venue for challenging patent validity and in 2020, Bio/Pharma and Chemical Patents accounted for 12% of petitions filed at the PTAB.
I’ve Been Sued for Patent Infringement… Is an IPR Worthwhile?
Recent Precedential Decisions Applying Fintiv
When a company is sued for patent infringement, often one early strategic consideration is whether to counterattack the patent’s validity at the Patent Trial and Appeal Board (PTAB) in a parallel post-grant proceeding such as inter partes review (IPR) or post-grant review (PGR). Although the PTAB has recently conformed certain practices more closely to litigation—notably, its claim construction and indefiniteness standards—it remains a valuable venue for patent challengers seeking a relatively speedy, predictable, and cost-effective process.