Ingenico Inc., et al. v. IOENGINE, LLC, No. 2023-1367 (Fed. Cir. (D. Del.) May 7, 2025). Opinion by Hughes, joined by Dyk and Prost.
Ingenico filed a declaratory judgment action against IOENGINE relating to two patents owned by IOENGINE. Ingenico also filed IPR petitions challenging the asserted patents, which resulted in final written decisions holding most challenged claims unpatentable.
At summary judgment, IOENGINE moved to preclude Ingenico from relying on documentation related to prior art “DiskOnKey” software under 35 U.S.C. § 315(e)(2) because Ingenico reasonably could have been expected to raise it during the IPR proceedings. The district court ruled that Ingenico was estopped from relying on those documents to prove invalidity except to the extent that they form “part of a substantively different combination of references that could not reasonably have been raised in the IPRs.”
At trial, Ingenico introduced evidence of the DiskOnKey device, which was offered with various software applications, including a Firmware Upgrader. The jury found the claims infringed but invalid as anticipated and obvious because of the DiskOnKey system. The district court denied IOENGINE’s post-trial motions, and IOENGINE appealed.
In the appeal, IOENGINE challenged the jury’s implicit finding that the Firmware Upgrader portion of the DiskOnKey system was either “on sale” or “in public use” under 35 U.S.C. § 102(b) (pre-AIA) or “known or used by others … before the invention” under 35 U.S.C. § 102(a) (pre-AIA). The Federal Circuit disagreed, ruling that “substantial evidence supports the finding that the Firmware Upgrader was accessible to the public.” In particular, there was “substantial circumstantial evidence that would allow a reasonable jury to conclude that a user downloaded and actually used the Firmware Upgrader with the DiskOnKey Device.”
Next, the Federal Circuit discussed IOENGINE’s various challenges to the district court’s jury instructions on conception and diligence, public use, and on sale, as well as the court’s decision not to instruct the jury on the presumption of validity. The Federal Circuit saw no error in the court’s instructions. And there was no error in the district court’s decision not to instruct the jury on the presumption of validity because the court had “properly and repeatedly instructed the jury on the clear and convincing standard” of proof for invalidity.
Lastly, the Federal Circuit addressed IOENGINE’s argument that under § 315(e)(2), Ingenico should have been estopped from presenting the Firmware Upgrader at trial. IOENGINE argued that IPR estoppel applies because the Firmware Upgrader was cumulative and substantively identical to certain printed publications that reasonably could have been raised during the IPR.
Addressing that argument, the Federal Circuit interpreted the term “ground” in § 315(e)(2) to mean a “theor[y] of invalidity available to challenge a claim under §§ 102 and 103.” The court noted that “Congress intentionally limited an IPR’s scope to invalidity challenges based on ‘prior art consisting of patents or printed publications,’” giving petitioners “no opportunity to challenge that the claimed invention was known or used by others, on sale, or in public use at IPR.” The court also clarified that “a ground is not the prior art asserted during an IPR.” Rather, “prior art is evidence of a ground, not coextensive with a ground.”
The Federal Circuit then held that “IPR estoppel applies only to a petitioner’s assertions in district court that the claimed invention is invalid under 35 U.S.C. §§ 102 or 103 because it was patented or described in a printed publication (or would have been obvious only on the basis of prior art patents or printed publications). IPR estoppel does not preclude a petitioner from asserting that a claimed invention was known or used by others, on sale, or in public use in district court. These are different grounds that could not be raised during an IPR.”
In this case, Ingenico challenged that the DiskOnKey system was known or used by others, on sale, or in public use, which “are grounds that could not have been raised during the IPR.” The printed publications that Ingenico relied on at trial were evidence to support these grounds, and “to the extent that Ingenico reasonably could have raised [these] during the IPR, it would only be to challenge that the claimed invention was described in a printed publication—a separate ground not raised at trial.” Thus, a new trial was unwarranted “because IPR estoppel did not preclude Ingenico from relying on the DiskOnKey System with related printed publications at trial to prove the claimed invention was known or used by others, on sale, or in public use.”
Incyte Corp. v. Sun Pharmaceutical Industries, Inc., No. 2023-1300 (Fed. Cir. (PTAB) May 7, 2025). Opinion by Moore, joined by Cunningham. Concurring opinion by Hughes.
Sun owns a patent that “teaches a method of treating hair-loss disorders like alopecia areata using precise dosages of deuterated analogs of ruxolitinib.” Incyte filed a PGR petition challenging claims 1–21. Sun disclaimed claim 8, and the Board held that Incyte failed to show the remaining claims were unpatentable. Incyte appealed.
The Federal Circuit dismissed the appeal because Incyte failed to establish Article III standing based on its potential infringement liability or the competitor standing doctrine.
The Federal Circuit ruled that for Incyte to have standing based on its potential infringement liability, “it must establish that it has concrete plans for future activity that creates a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement.” The court determined that when Incyte filed this appeal, it “faced significant manufacturing, formulation, testing, and regulatory hurdles to bring either product to market.” Incyte’s development plans were “too speculative to show concrete plans to develop a deuterated ruxolitinib product to treat hair loss at specific dosages.” At best, the record demonstrated “a wish to enter the market with no concrete plan how to do so,” leaving “too much to the imagination.” Thus, Incyte did not demonstrate Article III standing based on potential infringement liability.
Next, under the competitor standing doctrine, the Federal Circuit ruled that “it is not enough to show a benefit to a competitor to establish injury in fact; the party seeking to establish standing must show a concrete injury to itself.” Because “Incyte has not shown it is currently engaging in, or has nonspeculative plans to engage in, conduct covered by the claims of the … patent,” the court ruled that Incyte cannot rely on the competitor standing doctrine to confer standing.
Judge Hughes concurred “because [he] is bound by [the court’s] existing precedent,” but he explained that the precedent “is too restrictive and creates a special standing rule for patent cases.” The precedent “dictates an outcome inconsistent with the spirit of Article III standing,” and in this case, “absent our existing caselaw, [Judges Hughes] would conclude that Incyte has established Article III standing to appeal the Board’s adverse decision.”
Incyte Corp., et al. v. Sun Pharmaceutical Industries, Ltd., et al., No. 2025-1162 (Fed. Cir. (D.N.J.) May 7, 2025). Opinion by Moore, joined by Prost and Hughes.
Incyte owns a patent that “claims deuterated versions of ruxolitinib, a Janus kinase (JAK) modulator used to treat diseases associated with autoimmune disorders.” Sun obtained FDA approval for an oral deuterated ruxolitinib product to treat alopecia areata. Before Sun launched its product, Incyte sued Sun for patent infringement and moved for a preliminary injunction. The district court granted the preliminary injunction, and Sun appealed.
The Federal Circuit reversed, ruling that the district court clearly erred in finding that Incyte established irreparable harm.
The district court had granted the preliminary injunction based on the idea that a patentee can be irreparably harmed by an alleged infringer’s improper “head start” and the loss of the “first mover advantage” because the alleged infringer can capture market share and secure a competitive lead. The district court agreed with Incyte’s head start theory, explaining that but for Sun’s product, Incyte’s patent “would provide it with the ability to bring a deuterated ruxolitinib AA treatment first to market.”
The Federal Circuit ruled that “there is no question this is a clearly erroneous fact finding.” Incyte will not launch its product “until at least several years after its … patent expires,” and Incyte cannot enjoin Sun from launching its own product after the patent expires. Thus, the court determined that “Sun’s multi-year head start is inevitable regardless of any injunction.” The Federal Circuit therefore concluded “it was clearly erroneous for the district court to find that Incyte would be first to market if its preliminary injunction were granted.”
In re: Kostic, et al., No. 2023-1437 (Fed. Cir. (PTAB) May 6, 2025). Opinion by Cunningham, joined by Stoll and Clevenger.
Kostic and Vandevelde are the owners and listed inventors of a patent directed to certain methods implemented on an online network connecting websites to users’ computers “for buying and selling of click-through traffic.” Claim 1 requires “conducting a pre-bidding trial of click-through traffic” as well as “conducting a bidding process after the trial period is concluded.” Dependent claim 3 recites the method of claim 1 with an exchange of click-through traffic “without a trial process.”
About six years after the patent issued, the inventors filed a reissue application. They stated that claim 3 “expressly excludes the trial bidding process referred to in the method of claim 1,” which would make it invalid under 35 U.S.C. § 112. Thus, they sought to rewrite claim 3 in independent form and claim a method that omits a trial process.
The examiner rejected the application as a broadening reissue application outside the two-year period permitted by 35 U.S.C. § 251(d). The examiner also rejected reissue claim 3 as obvious over cited prior art. The Patent Trial and Appeal Board affirmed the rejection on both grounds, and the inventors appealed.
The Federal Circuit affirmed. In the appeal, the inventors argued that the proper inquiry is not whether the scope of reissue claim 3 is broader than the scope of original claim 3, but whether the scope of reissue claim 3 is broader than the “intended scope” of original claim 3. The Federal Circuit disagreed because the court’s “precedent counsels in favor of comparing the scope of a reissue claim to the actual scope of an original claim, rather than what the inventors subjectively intended to claim.” Also, “the text, history, and purpose of 35 U.S.C. § 251 all support looking at the actual scope of the original claim language, not the intended scope.”
The Federal Circuit noted that “looking to the intended scope rather than the actual scope of the original claim would prejudice competitors who had reason to rely on the implied disclaimer involved in the terms of the original patent.” Thus, because the reissue application was filed more than two years after the grant of the original patent and broadens the scope of the original patent claims, the Federal Circuit held that “the reissue application is statutorily barred.”
Jazz Pharmaceuticals, Inc., et al. v. Avadel CNS Pharmaceuticals, LLC, Nos. 2024-2274, -2277, -2278 (Fed. Cir. (D. Del.) May 6, 2025). Opinion by Lourie, joined by Reyna and Taranto.
Jazz manufactures and sells two sodium oxybate products. Jazz’s competitor, Avadel, submitted a New Drug Application to the FDA seeking approval of its own sodium oxybate product, Lumryz. After Avadel submitted its NDA, Jazz filed a patent application that issued as the ’782 patent.
Because neither of Jazz’s sodium oxybate products practice the ’782 patent, Avadel’s NDA did not need to make (and did not make) any patent certifications under 21 U.S.C. § 355(b)(2)(A) as to the ’782 patent.
Jazz sued Avadel for infringement of the ’782 patent based on Avadel’s FDA submission. The FDA eventually approved Avadel’s NDA, and Avadel commercially launched Lumryz. Jazz then amended its complaint to remove any allegations of “artificial” infringement based on Avadel’s FDA submission and replaced them with affirmative allegations of infringement based on making and selling the now-FDA-approved Lumryz.
The parties stipulated that Lumryz would infringe if the asserted claim of the ’782 patent is not found to be invalid. At trial, a jury found that Avadel failed to prove invalidity and awarded Jazz a reasonable royalty for Avadel’s past infringement. The district court then awarded Jazz a “limited permanent injunction,” and Avadel appealed.
On appeal, Avadel challenged three of the activities that the district court enjoined: (1) initiating new clinical trials for Lumryz, (2) offering open-label extensions (OLEs) in ongoing clinical trials, and (3) applying for FDA approval of Lumryz for treating idiopathic hypersomnia (IH). The Federal Circuit addressed each of these in turn.
First, the Federal Circuit ruled that “the plain language and purposes of the Hatch-Waxman Act make it clear that enjoining Avadel from initiating new clinical trials for Lumryz (for IH or otherwise) until expiration of the ’782 patent is unlawful and, therefore, an abuse of discretion.” The court explained that this activity “is statutorily non-infringing under § 271(e)(1) and statutorily precluded from being enjoined under § 271(e)(3).” Thus, this part of the injunction was “overbroad as a matter of law.”
Second, the Federal Circuit reversed the part of the injunction enjoining Avadel from offering OLEs to trial participants. The court noted that “OLEs allow clinical trial participants to continue taking the drug after their trial participation is complete,” but Jazz had never accused this activity of infringement. The court stated: “Only if and when that activity is adjudicated to fall outside the protection of the safe harbor, and only if and when the district court finds the eBay factors to favor an injunction, may it be permanently enjoined.”
Lastly, the Federal Circuit vacated and remanded the part of the injunction enjoining Avadel from applying for FDA approval of Lumryz for any indication that was not part of its label as of March 4, 2024. The Federal Circuit held that “the submission of an application to the FDA is not infringement under § 271(a),” and “because applicability of the safe harbor is dependent on there being a predicate infringing activity …, submitting an application for FDA approval is not an activity that triggers the safe harbor.” In the end, the Federal Circuit determined that “the district court’s analysis is simply too speculative and tenuous to reasonably conclude from its findings that enjoining Avadel from applying for FDA approval is necessary to prevent future infringement.” The court therefore vacated and remanded.
Hulu, LLC v. Piranha Media Distribution, LLC, Nos. IPR2024-01252, -01253 (PTAB Director Review) (Apr. 17, 2025) (designated informative on May 7, 2025).
After Piranha sued Hulu for patent infringement in district court, Hulu moved to dismiss under Rule 12(b)(6), asserting that the claims are invalid as reciting ineligible subject matter under 35 U.S.C. § 101. The district court granted the motion and dismissed Piranha’s infringement claim with prejudice.
Separately, Hulu filed IPR petitions challenging the claims of Piranha’s patent. The Patent Trial and Appeal Board granted institution, and Piranha then filed a request for Director Review arguing that a district court final judgment of invalidity favors denial of IPR under Fintiv.
The Acting Director agreed and thus vacated the Board’s institution decision and ordered that no IPR trial is instituted. She noted that “the Fintiv framework emphasizes efficiency concerns.” Thus, she ruled that “because the patent claims already stand invalid, it is unnecessary to institute another proceeding to review them for patentability under other grounds. In the event the Federal Circuit reverses the district court’s decision, [Hulu] may raise such invalidity arguments in the district court on remand. Under these circumstances, that is the better and more efficient approach.” The Acting Director reiterated that in this case, “the efficiency and integrity of the patent system is best served by denying institution.”