Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

Duke University and Allergan Sales, LLC own a patent relating to methods for treating hair loss using certain prostaglandin F (PGF) analogs. The patent describes a method of growing hair by topically applying a composition containing a PGF analog with specific structural features. Allergan markets Latisse®, a product containing bimatoprost, a PGF analog, for eyelash hair growth. Sandoz manufactures a generic version of Latisse®. Allergan sued Sandoz for patent infringement, specifically asserting claim 30 of the patent, which covers a subgenus of PGF analogs with defined chemical characteristics.In the United States District Court for the District of Colorado, Sandoz stipulated to infringement but challenged the validity of claim 30, arguing it lacked adequate written description, was obvious, and not enabled. After a jury trial, the jury found in favor of Allergan on all grounds, concluding Sandoz had not proven invalidity and awarding damages. Sandoz moved for judgment as a matter of law and for a new trial, both of which the district court denied. Sandoz then appealed.The United States Court of Appeals for the Federal Circuit reviewed the district court’s denial of judgment as a matter of law de novo, applying Tenth Circuit standards. The Federal Circuit held that no reasonable jury could have found that claim 30 was adequately described in the patent specification. The court found that the specification broadly described billions of compounds, while claim 30 covered a much narrower subgenus, and the patent failed to provide sufficient guidance (“blaze marks”) to direct a skilled artisan to the claimed compounds. The court concluded that the written description requirement of 35 U.S.C. § 112(a) was not met and reversed the district court’s judgment, holding claim 30 invalid for lack of adequate written description. View "DUKE UNIVERSITY v. SANDOZ INC. " on Justia Law

Turkish steel producers, including Kaptan Demir Celik Endustrisi ve Ticaret A.S., were subject to a countervailing duty (CVD) order after the U.S. Department of Commerce determined that the Turkish government subsidized steel rebar exports. During an administrative review, Commerce found that Kaptan sourced steel scrap, a key input for rebar, from several affiliates, including Nur, a shipbuilder. Commerce initially determined that Nur’s steel scrap was primarily dedicated to Kaptan’s rebar production, making Nur a cross-owned input supplier whose subsidies should be attributed to Kaptan, thereby increasing Kaptan’s CVD rate.The United States Court of International Trade (CIT) reviewed Commerce’s decision after Kaptan challenged the cross-attribution of Nur’s subsidies. The CIT found that Commerce had not adequately explained whether steel scrap was merely a link in the rebar production chain or addressed prior cases treating steel scrap as a byproduct. The CIT remanded the case for further explanation. On remand, Commerce developed a multi-factor analysis and ultimately reversed its position, finding that Nur’s steel scrap was a common, unprocessed input used in various products and industries, and that Nur’s primary business activity—shipbuilding—was not dedicated almost exclusively to producing rebar. As a result, Commerce concluded that Nur was not a cross-owned input supplier, and Kaptan’s CVD rate was reduced to a de minimis level. The CIT sustained Commerce’s remand decision.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the CIT’s decision for abuse of discretion and Commerce’s remand findings for substantial evidence. The Federal Circuit affirmed, holding that Commerce’s determination that Nur’s steel scrap was not primarily dedicated to Kaptan’s rebar production was adequately explained, supported by substantial evidence, and consistent with the applicable regulation. View "KAPTAN DEMIR CELIK ENDUSTRISI VE TICARET A.S. v. US " on Justia Law

Nutricia North America, Inc. imported five products from the United Kingdom that the Food and Drug Administration (FDA) classified as “medical foods” under the Federal Food, Drug, and Cosmetics Act. These products are specially formulated for individuals with specific metabolic or medical conditions, such as phenylketonuria, intractable epilepsy, and other disorders that require nutritional therapy not achievable through ordinary diet modification. The products are administered enterally, contain no active pharmacological ingredients, and are intended for use under medical supervision.Upon importation in 2014, U.S. Customs and Border Protection classified these products under subheading 2106.90.99 of the Harmonized Tariff Schedule of the United States (HTSUS), which covers “food preparations not elsewhere specified” and imposes a duty. Nutricia protested, arguing that the products should be classified as “medicaments” under heading 3004 of chapter 30, which would allow duty-free entry, or alternatively under a duty-free provision for articles for handicapped persons in chapter 98. Customs denied the protests, and Nutricia filed suit in the United States Court of International Trade (CIT). The CIT granted summary judgment for the government, holding that the products were excluded from chapter 30 by note 1(a) and thus properly classified under chapter 21.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the CIT’s decision de novo. The Federal Circuit held that Nutricia’s medical foods are properly classified under heading 3004 as “medicaments” because they are specially formulated for therapeutic or prophylactic uses under medical supervision. The court found that chapter 30 note 1(a) does not exclude these medical foods from heading 3004. Accordingly, the Federal Circuit reversed the CIT’s judgment and remanded for determination of the appropriate subheading under heading 3004. View "NUTRICIA NORTH AMERICA, INC. v. US " on Justia Law

This case concerns a dispute between two companies over alleged infringement of two patents related to illuminated school bus signs. The plaintiff, Smartrend Manufacturing Group (SMG), Inc., claimed that Opti-Luxx Inc. infringed both a design patent (D930) and a utility patent (’491) with its single-piece illuminated school bus sign, which features a rigid plastic housing, an LED light board, and a yellow lens with black lettering. The design patent describes certain features as “transparent,” while the utility patent claims a sign with a “frame” that is separate from the sign panel.The United States District Court for the Western District of Michigan held a jury trial, where the jury found that Opti-Luxx infringed both patents. The district court denied Opti-Luxx’s motion for judgment as a matter of law (JMOL) and issued a permanent injunction against Opti-Luxx. The court construed the term “transparency” in the design patent to mean both “transparent” and “translucent,” and determined that the “frame” in the utility patent must be a separate and distinct component. The trial on the utility patent proceeded under the doctrine of equivalents, as the accused product did not literally have a separate frame.On appeal, the United States Court of Appeals for the Federal Circuit found that Opti-Luxx had forfeited its objection to the plaintiff’s expert testimony regarding the design patent. However, the appellate court held that the district court erred in construing “transparency” to include “translucent,” and ordered a new trial on infringement of the design patent. Regarding the utility patent, the appellate court concluded that no reasonable jury could have found infringement under the doctrine of equivalents, as the accused product did not perform the required functions of a separate frame. The Federal Circuit reversed the judgment of infringement for the utility patent, vacated the judgment and injunction for the design patent, and remanded for further proceedings. View "SMARTREND MANUFACTURING GROUP (SMG), INC. v. OPTI-LUXX INC. " on Justia Law

Canatex Completion Solutions, Inc. owns a patent for a “releasable connection” device used in oil and gas wells, which consists of two parts that can be disconnected downhole if necessary. Canatex alleged that several companies infringed its patent, specifically claims 1, 4–13, and 15–19. The dispute centered on the claim language “the connection profile of the second part,” which appears in the independent claims and the specification. Canatex argued that this was a clerical error and that a person skilled in the art would recognize the intended meaning as “the connection profile of the first part,” since only the first part’s connection profile is described and depicted in the patent.The United States District Court for the Southern District of Texas reviewed the case. During claim construction, the defendants argued that the claims were indefinite due to the lack of an antecedent basis for the disputed phrase. The district court agreed, finding the error was not evident from the face of the patent and that the correction was not as simple as Canatex suggested. The court held all asserted claims invalid for indefiniteness and entered final judgment based on a joint stipulation.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the district court’s claim construction de novo. The appellate court held that the error in the claim language was evident on the face of the patent and that the only reasonable correction, based on the intrinsic evidence, was to change “second” to “first.” The Federal Circuit reversed the district court’s judgment, ruling that judicial correction of the claim was appropriate under the demanding standard for such corrections, and remanded the case for further proceedings consistent with the corrected claims. View "CANATEX COMPLETION SOLUTIONS, INC. v. WELLMATICS, LLC " on Justia Law

The case concerns the validity of certain claims in two patents owned by a pharmaceutical company, which relate to methods of treating multiple sclerosis (MS) using oral administration of cladribine according to a specific dosing regimen. Before the patents’ priority date, cladribine was already known as a treatment for MS, but was typically administered intravenously or subcutaneously due to safety concerns. The patent owner, in partnership with another company, developed an oral formulation and dosing schedule for cladribine. During this collaboration, confidential information was exchanged, and a third party later filed a patent application (the Bodor reference) disclosing a similar dosing regimen. Another prior publication (Stelmasiak) described different cladribine regimens for MS.The Patent Trial and Appeal Board (PTAB) reviewed two inter partes review petitions challenging the patents’ claims as obvious over the combination of the Bodor and Stelmasiak references. The Board determined that the Bodor reference qualified as prior art, finding no complete overlap in inventors between the patents and the reference, and concluded that the patent owner failed to show that all named inventors of the patents contributed to the relevant disclosure in Bodor. The Board also found that the combination of Bodor and Stelmasiak rendered all challenged claims obvious, and rejected arguments that the claims required weight-based dosing or that the prior art failed to teach the claimed regimen.On appeal, the United States Court of Appeals for the Federal Circuit affirmed the Board’s decisions. The court clarified that, under pre-AIA law, a reference is “by another” and thus prior art unless the inventive entity is identical to that of the challenged patent. The court held that the Board did not err in its legal analysis, factual findings, or claim construction, and that substantial evidence supported the Board’s obviousness determination. The Board’s unpatentability findings were affirmed. View "MERCK SERONO S.A. v. HOPEWELL PHARMA VENTURES, INC. " on Justia Law

Aortic Innovations LLC owns four related patents concerning devices used in transcatheter aortic valve replacement, a procedure for treating diseased aortic valves. The patents share a common specification and claim priority to the same provisional applications. The claims focus on a transcatheter valve assembly featuring an “outer frame” and an “inner frame.” Aortic alleged that Edwards Lifesciences’ SAPIEN 3 Ultra valve, which uses a single balloon-expandable frame, infringed these patents.The United States District Court for the District of Delaware presided over the initial litigation. Edwards Lifesciences petitioned for inter partes review before the Patent Trial and Appeal Board, which instituted review for three of the patents but not the ’735 patent. The district court stayed the case except for the ’735 patent. During claim construction, the parties disputed the meaning of “outer frame.” The district court found that the patentee had acted as their own lexicographer, redefining “outer frame” to mean “a self-expanding frame.” The court applied this construction to all asserted patents and, following a joint stipulation, entered judgment of non-infringement because Edwards’ accused product did not have a self-expanding frame.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the district court’s claim construction de novo. The Federal Circuit agreed with the district court’s construction, holding that the specification consistently and interchangeably used “outer frame” and “self-expanding frame,” thereby redefining the term. The court affirmed the judgment of non-infringement for three patents and dismissed the appeal as to the fourth patent (’538) for lack of jurisdiction, as its claims had been cancelled by the Patent Office. The Federal Circuit also found that Aortic’s judicial estoppel argument was forfeited. View "AORTIC INNOVATIONS LLC v. EDWARDS LIFESCIENCES CORPORATION " on Justia Law

Centripetal Networks LLC owns a patent related to rule-based network threat detection for encrypted communications. In November 2021, Palo Alto Networks petitioned for inter partes review (IPR) of certain claims of Centripetal’s patent. The Patent Trial and Appeal Board (PTAB) instituted the IPR with a panel of three administrative patent judges (APJs). Subsequently, Cisco Systems and Keysight Technologies filed similar petitions and sought to join the proceedings. During the process, Centripetal discovered that one APJ, McNamara, owned Cisco stock and moved for the recusal of the panel and vacatur of the institution decision, arguing a conflict of interest. After rehearing requests and additional disclosures, APJ McNamara and another APJ withdrew from the panel, but the Board denied Centripetal’s recusal motion as untimely and found no violation of ethics rules or due process.The PTAB, in its final written decision, held claims 1, 24, and 25 of Centripetal’s patent unpatentable as obvious. Centripetal appealed to the United States Court of Appeals for the Federal Circuit, challenging both the merits of the Board’s obviousness determination and the handling of the recusal issue. The Federal Circuit reviewed the Board’s recusal analysis for abuse of discretion and its legal conclusions de novo, finding that Centripetal’s recusal motion was untimely and that the APJ’s stock ownership did not violate applicable ethics regulations. The court also determined that Centripetal’s due process rights were not infringed and that the Board’s actions did not warrant vacatur based on recusal concerns.However, the Federal Circuit found that the PTAB failed to adequately consider evidence of copying presented by Centripetal as part of the obviousness analysis. The court vacated the Board’s final written decision and remanded the case for further proceedings, instructing the Board to properly address the evidence of copying. The disposition by the Federal Circuit was “vacated and remanded.” View "CENTRIPETAL NETWORKS, LLC v. PALO ALTO NETWORKS, INC. " on Justia Law

Barrette Outdoor Living, Inc. owns several related patents describing fencing assemblies that use connectors to attach pickets to rails, allowing the pickets to pivot and slide for easier installation and improved racking ability. The patents describe connectors with “bosses,” “projections,” “nubs,” or “series of axles” that engage holes in the pickets, purportedly providing a fastener-less, pivotal connection. Barrette alleged that products sold by Fortress Iron, LP and Fortress Fence Products, LLC infringed claims of these patents.The United States District Court for the Northern District of Texas construed the terms “boss,” “projection,” and related terms as requiring the structures to be both integral and fastener-less, based on the patent specification and prosecution history. The court also found that the claim terms related to “sliding” and “causes” were not indefinite, concluding that the specification and prosecution history provided sufficient guidance for a skilled artisan to understand the scope of the claims. Following these constructions, Barrette stipulated it could not prove infringement, and the court entered judgment of non-infringement and no invalidity for indefiniteness.On appeal, the United States Court of Appeals for the Federal Circuit affirmed the district court’s judgment of non-infringement, but clarified that while the claims should not be limited to fastener-less bosses, Barrette had clearly disclaimed non-integral bosses during prosecution. The Federal Circuit also affirmed the district court’s finding that the claims were not indefinite, holding that the specification and prosecution history provided reasonable certainty as to the meaning of the “sliding” and “causes” terms. The court thus affirmed the district court’s judgment of non-infringement and no invalidity for indefiniteness. Each party was ordered to bear its own costs. View "BARRETTE OUTDOOR LIVING, INC. v. FORTRESS IRON, LP " on Justia Law

A federally recognized Indian tribe in northern Nevada, whose lands were set aside by the federal government in the early 20th century, experienced a leadership dispute after the death of its council chairman in 2000. Two factions claimed to be the legitimate tribal government, leading to litigation in tribal courts and a prolonged refusal by the Bureau of Indian Affairs (BIA) to recognize either group. Eventually, the BIA recognized the results of a 2014 tribal election favoring one faction, but disputes over land occupation and government recognition persisted.The faction recognized by the 2014 election filed suit in the U.S. District Court for the District of Nevada, seeking injunctive and declaratory relief regarding tribal leadership and alleging unauthorized occupation of tribal lands. The district court initially ruled in favor of the plaintiffs, but the U.S. Court of Appeals for the Ninth Circuit later vacated those orders, holding that the district court lacked subject matter jurisdiction and remanded with instructions to dismiss. The BIA continued to recognize the election results unless a tribal remedy required otherwise.Before the Ninth Circuit issued its mandate, the tribe filed suit in the United States Court of Federal Claims, alleging statutory violations and breaches of trust related to land and water rights. The Claims Court dismissed the case for lack of jurisdiction, finding that some claims failed to identify a money-mandating source of law, others were time-barred, some were barred by 28 U.S.C. § 1500 due to the pending Nevada action, and some sought equitable relief outside its jurisdiction.On appeal, the United States Court of Appeals for the Federal Circuit affirmed the Claims Court’s dismissal. The court held that the tribe’s claims either lacked a money-mandating source of law, were time-barred, or were barred by § 1500 because they were based on substantially the same operative facts as the earlier Nevada action. The court also affirmed that the Claims Court lacked jurisdiction over the equitable relief requested. View "WINNEMUCCA INDIAN COLONY v. US " on Justia Law