On June 6, 2025, the Acting Director of the Patent Trial and Appeal Board (“the PTAB”) denied five petitions filed by iRhythm Technologies, Inc. (“iRhythm”) for inter partes review of four related patents (“the Petitions”). In a three-page ruling (“the Ruling”), the Acting Director exercised her discretion to deny the petitions because iRhythm was aware of the first of the four patents to issue (“the ‘007 patent”). The decision has far-reaching implications for IPR practice and management and enforcement of patent portfolios. This advisory explains both the Ruling and some of its implications.
In February 2024, the patent owner, Welch Allyn, Inc. sued iRhythm in Delaware federal court alleging that iRhythm’s heart monitor products, mainly the Zio Monitor, infringed four physiological monitoring patents. Within eleven months of service of the complaint, iRhythm filed the Petitions. Under the America Invents Act, 35 U.S.C. § 311, a party accused of infringement in a federal action has one year from service of the action to file an IPR unless the party had previously filed a declaratory judgment action regarding the patentability of the patent.
Welch Allyn persuaded the Acting Director to exercise its discretion not to institute a trial based Fintiv. The Ruling found that the most important fact in the record was that iRhythm had been aware of the ‘007 patent at least since May 2015, when iRhythm listed it with over 900 patents on an Information Disclosure Statement in iRhythm’s prosecution of its own patent application. According to the Acting Director, the twelve-year intervening period from when the ‘007 patent issued and the filing of the Petitions created a “settled expectation” that no IPR would be filed, which in turn favored denial of the Petitions. Such a circumstance had never been adopted as a Fintiv factor. Yet the Ruling states, “Petitioner’s awareness of Patent Owner’s applications and failure to seek early review of the patents favors denial and outweighs the [first three Fintiv factors, which favor institution].” Ruling at 3 (emphasis added). In essence the ruling creates a “laches” Fintiv factor.
One significant consequence of the Ruling is that a party that becomes aware of a patent, but fails to pursue an IPR, jeopardizes the party’s ability to obtain relief in an IPR proceeding after being sued. This result seems at odds with the one-year deadline to file an IPR petition upon being sued and the total lack of any other time bar to filing an IPR petition more than nine months after a post-AIA patent issues. Without probing into any other facts as to why no IPR is filed after learning of a patent also appears inequitable given, as iRhythm argued, that a long delay in enforcing a patent against a product can create a settled expectation that no suit will ever be brought. Indeed, this expectation is more reasonable given that approximately 98% of all patents are never litigated.
The Ruling is also inconsistent with the Supreme Court decision that eliminated the laches defense to an infringement action. SCA Hygiene Prods. Aktiebolag v. First Quality Baby Prods., L.L.C., 580 U.S. 328 (2017). The Supreme Court relied on Congressional intent expressed in the six-year statute of limitations on damages. Thus, the Ruling creates an asymmetry in the remedies available to patent owners and petitioners: patent owners can bring suit at any time, but petitioners might lose the right to pursue an IPR by waiting to file. There is no evidence in the legislative history of the AIA that Congress intended such an asymmetry in the assertion of laches.
The record underlying the iRhythm decision gives rise to many questions that the Ruling fails to analyze. For example, the four patents at issue were issued twelve, eight, seven, and six years before the Petitions were filed in response to allegations the patents were infringed. The Acting Director relied on the twelve-year gap between issuance and petition, but the record established only that iRhythm was aware of the ‘007 patent no later than 2015, a gap of nine years for the ‘007 patent. How long a gap is necessary before it will justify denial? Is evidence of intent, namely, that the petitioner consciously decided not to file a petition, important in deciding whether to deny institution?
At bottom, the Ruling means that more petitioners will be denied the ability to invoke IPR proceedings to streamline patent litigation. To bring more certainty to the process, the leadership of the PTAB should provide more guidance about when this new laches Fintiv factor will be invoked. For example, is there a minimum delay that is more likely to trigger the factor; is the intent of the petitioner relevant, especially because any third party can bring an IPR; and what is the impact of having multiple patents in a family issued over a period of years? In particular, must the petitioner be aware of all the patents in the family to trigger Fintiv laches? How relevant is the date that a potentially infringing product is released relative to when the petitioner learns of the challenged patent? Given the significant impact that Fintiv laches is likely to have on PTAB practice going forward, and the growing role of Fintiv in general, it is important that the USPTO consider a rulemaking proceeding to elicit meaningful comments from all constituents in resolving these issues.
In a speech on Tuesday, June 10, 2025, the Acting Director stated that petitioners need to focus on tools like post-grant reviews brought early in the life of a patent, rather than filing IPRs as a defense to being sued. Prominent former USPTO officials have called out the Acting Director on her contradictory statements: on the one hand, the agency advising parties to file IPRs preemptively, on the other, the agency focusing on discretionary denials to manage the surge of IPRs. In the end, Congress structured the AIA to strike a balance between immediate review (post-grant) and longer-term review (inter partes review) that could be sought within one year of suit. Only time will tell the extent to which the Ruling undermines this carefully forged balance.
* This article also includes contributions by Samantha Galinson, Summer Associate (a Michael Best professional not admitted to practice law).