Apple Inc., et al. v. Gesture Technology Partners, LLC, Nos. 2023-1501, -1554 (Fed. Cir. (PTAB) Jan. 27, 2025). Opinion by Dyk, joined by Lourie and Hughes.
Apple filed an IPR petition challenging certain claims of a patent owned by Gesture relating to a portable device that uses an electro-optical sensor to scan the field of vision and detect a user’s gesture. The Patent Trial and Appeal Board issued a final written decision determining that claims 1–3 and 5–7 were unpatentable as obvious but that claim 4 was not unpatentable as obvious. Apple appealed, and Gesture cross-appealed.
In the appeal, Gesture argued that the Board could not exercise jurisdiction over the IPR because the patent had expired before Apple filed its IPR petition. The Federal Circuit noted that while “prior cases have not squarely addressed whether the Board may institute IPRs for patents after they have expired,” the court had reviewed IPR decisions involving expired patents.
In this case, the Federal Circuit “confirm[ed] here that the Board had jurisdiction over IPRs concerning expired patents.” The court explained that the review of an earlier grant of a patent “inherently involves the adjudication of a public right, and it is irrelevant whether the patent has expired, since the patent itself continues to confer a limited set of rights to the patentee,” such as the right to bring an action for past damages. Thus, the court rejected Gesture’s challenge to the Board’s jurisdiction.
On the merits, Gesture argued that the Board’s finding of unpatentability was not supported by substantial evidence. In particular, Gesture argued that the Board incorrectly found a motivation to combine one of the prior art reference’s third, fifth, and eighth embodiments, each of which has a specialized processing unit. The Federal Circuit disagreed with Gesture because “Apple was not required to identify embodiments with identical processing units, since the obviousness inquiry looks to the ‘combined teachings of the references’ and ‘does not require an actual, physical substitution of elements.’” Also, the Board had sufficiently explained “how a person of ordinary skill in the art would understand how to combine these embodiments.” Thus, the Federal Circuit affirmed the unpatentability of claims 1–3 and 5–7.
As to claim 4, the sole issue presented by Apple was whether the Board properly determined that claim 4’s “fixed” limitation was not obvious. The Board had ignored Apple’s expert’s testimony relating to the fixed limitation because the IPR petition did not reference the expert’s analysis in connection with claim 4. The Federal Circuit disagreed with the Board’s approach, ruling that “under our precedent, Apple’s expert’s testimony was sufficiently confined to the argument made in Apple’s IPR petition to warrant consideration by the Board, since a party is not barred from elaborating on its arguments on issues previously raised.” Apple’s expert “simply expanded upon” an argument expressly raised in Apple’s IPR petition.
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., et al., Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. (N.D.W. Va.) Jan. 29, 2025). Opinion by Taranto, joined by Moore and Reyna.
Regeneron holds a Biologics License Application (BLA) for EYLEA®, a therapeutic product that contains the fusion protein aflibercept, and Regeneron owns a patent directed to certain formulations and methods for making and using the formulations. Samsung Bioepis (SB) and several other companies filed abbreviated Biologics License Applications (aBLAs) seeking approval to market EYLEA® biosimilars. Regeneron sued each of the applicants for patent infringement, and the actions were consolidated in the Northern District of West Virginia.
The district court held that it had personal jurisdiction over SB and that Regeneron established entitlement to a preliminary injunction. As part of the latter finding, the court ruled that SB had not raised a substantial question of invalidity. SB appealed as to both issues.
Addressing the district court’s exercise of personal jurisdiction over SB, the Federal Circuit affirmed because “the record as a whole supports the district court’s finding that SB intends to distribute [SB’s FDA-approved EYLEA® biosimilar] SB15 nationwide, including in West Virginia.” For instance, SB’s filing of its aBLA constituted “an action that reliably confirms a plan to engage in real-world marketing of SB15 within the U.S.” SB also served Regeneron with a Notice of Commercial Marketing, and SB “engaged several manufacturing, testing, labeling, and/or packaging partners within the U.S.” and “entered into an elaborate distribution agreement … to commercialize SB15 in the U.S.”
SB argued that there is “a crucial, bright-line constitutional difference” between SB doing its own distribution and SB contracting with a national distributor, but the Federal Circuit rejected that view. The court also rejected SB’s assertion that Regeneron needed affirmative evidence calling express attention to West Virginia as a target market. The Federal Circuit ruled “there is simply no good reason, under the constitutional standard, for demanding such singling-out evidence as a substitute for persuasive evidence of nationwide targeting without a carve-out.”
Next, SB argued that the district court abused its discretion in granting the preliminary injunction because, according to SB, it had raised a substantial question as to invalidity based on obviousness-type double patenting (ODP). Comparing the claims of the later and earlier patents, the district court found that three claim limitations were patentably distinct over the claims of the earlier patent. The Federal Circuit analyzed those limitations and concluded that “two claim differences—‘at least 98%’ stability and glycosylation—render the [later] and [earlier] claims patentably distinct.” Thus, the Federal Circuit agreed with the district court that SB had not presented a substantial question of invalidity under the ODP doctrine.
SB also argued that it had raised a substantial question of invalidity for lack of an adequate written description, but the Federal Circuit again disagreed. In its analysis, the Federal Circuit explained that the district court’s ODP and written description findings were not contradictory: “The ODP analysis is focused on the earlier patent’s claims, and what a relevant artisan would find obvious based on them, whereas the written-description analysis is focused on what is disclosed in the specification.”
Lastly, SB argued that the district court erred in finding that Regeneron had established a causal nexus between SB’s infringement and the irreparable harm Regeneron would incur without injunctive relief. The Federal Circuit rejected the argument because there was “no evidence that SB possesses or plans to sell or offer to sell a noninfringing biosimilar under its approved aBLA.” SB also argued that Regeneron had to establish a causal nexus between the irreparable harms and the unique limitations of the patent (as opposed to the limitations also present in the earlier reference patent). The Federal Circuit rejected the argument and noted that “if SB produces a noninfringing product within the scope of its aBLA, it may seek modification of the injunction from the district court.”