Precedential and Key Federal Circuit Opinions
1. STEUBEN FOODS, INC. v. SHIBUYA HOPPMANN CORPORATION [OPINION] (2023-1790, 1/24/2025) (Moore, Hughes, Cunningham)
Moore, Chief J. The Court reversed the district court’s findings for judgment as a matter of law (“JMOL”) of noninfringement because it determined that the reverse doctrine of equivalents (“RDOE”) did not apply and, therefore, the patents were infringed. Steuben Foods, Inc. (“Steuben”) sued Shibuya Hoppmann Corporation (“Shibuya”) for patent infringement resulting in a jury verdict of infringement. Following the verdict, Shibuya moved for, and the district court granted, JMOL of noninfringement under RDOE.
On appeal, Steuben argued that the district court erred by relying on RDOE to overturn the jury’s verdict. The Court explained that RDOE “can be traced back to at least the 1800s,” and allows an alleged infringer to avoid a judgment of infringement by “showing the accused ‘product has been so far changed in principle [from the asserted claims] that it performs the same or similar function in a substantially different way.’” For RDOE to apply, if the patentee establishes literal infringement, then an accused infringer bears the burden of establishing a prima facie case of noninfringement under RDOE. If the accused infringer meets this burden, then the burden shifts back to the patentee to rebut the prima facie case. In this case, there was substantial evidence to rebut any prima facie case of RDOE, because the district court failed to consider Steuben’s expert testimony that showed Shibuya’s infringement.
In addition, Steuben argued that RDOE is not a viable defense to infringement because it was eliminated by the 1952 Patent Act. Specifically, Congress wrote out any RDOE exception to infringement when defining infringement in the Act because the plain language of 35 U.S.C. § 271(a), “[e]xcept as otherwise provided in this title,” requires that exceptions to infringement must be expressly identified in Title 35. Steuben argued this elimination was intentional because RDOE was subsumed by 35 U.S.C. § 112. Specifically, if a device literally falls within the scope of a claim, but the accused infringer believes the claim is too broad and its device should not infringe, the appropriate recourse is a § 112 challenge, not a claim of noninfringement under RDOE. The Court “[found] Steuben’s arguments compelling,” but did not need to decide this issue.
The Court noted that it had previously described RDOE as an “anachronistic exception, long mentioned but rarely applied,” and that the Court had never “affirmed a decision finding noninfringement based on [RDOE].”
2. REGENERON PHARMACEUTICALS, INC. v. MYLAN PHARMACEUTICALS INC. [OPINION] (2024-1965, 2024-1966, 2024-2082, 2024-2083, 1/29/2025) (Moore, Reyna, Taranto)
Taranto, J. The Court affirmed the district court’s decision to enter a preliminary injunction preventing the sale of a biosimilar product approved by the U.S. Food and Drug Administration (“FDA”), finding that the application for a biosimilar drug approval that Samsung Bioepis Co. Ltd.’s (“SB”) filed with the FDA provided sufficient minimum contacts to support personal jurisdiction in West Virginia.
SB is a biosimilar-products company headquartered in Incheon, South Korea. While SB declared that it was not registered to do business in West Virginia, did not designate an agent for service of product in West Virgina, did not do business with West Virginia entities, and sold its finished drug product to Biogen in a state other than West Virginia, SB’s involvement with commercialization activities did not terminate upon SB’s sale of its product to Biogen.
On appeal, SB challenged the district court’s exercise of personal jurisdiction over it arguing that it lacked sufficient direct contacts with West Virginia to satisfy the Constitutional standard required for the exercise of personal jurisdiction. Ultimately, the Court explained that FDA filing and commercialization activities satisfy the minimum contacts inquiry for purposes of personal jurisdiction. The Court reached its decision by applying its reasoning from Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., 817 F.3d 755 (Fed. Cir. 2016), which dealt with similar issues related to Abbreviated New Drug Applications (“ANDA”) filed under the Hatch-Waxman Act. The Court explained that much like the ANDA filing in Acordia, SB filed an application with the FDA that confirms its intent to market its product “within the U.S.”; it entered into “an elaborate distribution agreement with Biogen” to commercialize in the U.S.; and that agreement did not carve any states out of the U.S. market.
3. APPLE INC. v. GESTURE TECHNOLOGY PARTNERS, LLC [OPINION] (2023-1501, 2023-1554, 1/27/2025) (Lourie, Dyk, Hughes)
Dyk, J. The Court affirmed the Patent Trial and Appeal Board’s determination finding claims unpatentable in an inter partes review proceeding (“IPR”), finding that the Board has jurisdiction over IPRs concerning expired patents.
The challenged patent expired before the IPR petition was filed. The patentee argued that since the patentee’s right becomes limited to collecting damages that formerly existed through an infringement action in an Article III court, jurisdiction over the expired patent becomes limited to the Article III courts.
The public-rights doctrine recognizes that Congress may assign some matters either to the Article III judiciary or to a non-Article III forum. The Supreme Court has thus long held that Congress has the authority to assign to non-Article III forums those matters arising between the government and others, which from their nature do not require judicial determination and yet are susceptible of it. In Oil States, the Supreme Court held that the Board’s jurisdiction over IPRs does not run afoul of Article III under the public-rights doctrine. Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, 584 U.S. 325, 334–35 (2018). Because an IPR is a second look at an earlier administrative grant of a patent, it involves the public’s same interest in seeing that patent monopolies are kept within their legitimate scope. Id. at 336–37. Recognizing that a public franchise can be qualified by an agency’s authority to cancel it outside of an Article III court, IPRs fall within the public-rights doctrine and do not violate Article III. Id. at 337.
The Court found that patentee’s argument that the public franchise ceases to exist after a patent expires is incompatible with Oil States. There, that an IPR falls under the public-rights doctrine was based on the fact that the procedure involves a “second look” at the earlier determination of granting a public right in the first place. The review of an earlier grant of a patent thus 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. Although a patentee has fewer rights when its patent expires, it nevertheless maintains some rights, such as bringing an action for past damages, which creates a live case or controversy that can be adjudicated by an IPR and in proceedings before the Court.
