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

Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively, "Jazz") manufacture and sell sodium oxybate products, Xyrem and Xywav, for treating narcolepsy and idiopathic hypersomnia (IH). Avadel CNS Pharmaceuticals, LLC ("Avadel") sought FDA approval for Lumryz, a sodium oxybate product, for treating narcolepsy. Jazz sued Avadel, alleging that Avadel's FDA submission infringed Jazz's U.S. Patent 11,147,782. The district court found in favor of Jazz, issuing a permanent injunction against Avadel from seeking FDA approval for Lumryz for IH and from marketing Lumryz for that indication.The U.S. District Court for the District of Delaware initially ruled that Avadel's submission of its New Drug Application (NDA) constituted infringement under 35 U.S.C. § 271(e)(2). The court issued a permanent injunction prohibiting Avadel from seeking FDA approval for Lumryz for IH, offering open-label extensions (OLEs) to clinical trial participants, and initiating new clinical trials. Avadel appealed, arguing that the injunction was overly broad and that certain activities were protected under the safe-harbor provision of 35 U.S.C. § 271(e)(1).The United States Court of Appeals for the Federal Circuit reviewed the case. The court reversed the injunction prohibiting Avadel from initiating new clinical trials and offering OLEs, finding these activities to be protected under the safe-harbor provision. The court vacated the injunction preventing Avadel from seeking FDA approval for new indications of Lumryz, remanding the issue to the district court for further consideration. The court instructed the district court to determine whether Avadel's submission of a paper NDA for additional indications would constitute an act of infringement under 35 U.S.C. § 271(e)(2) and to reassess the eBay factors if necessary. View "JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC " on Justia Law

Edward Amezquita, a U.S. Navy veteran, appealed a decision denying service connection for his left shoulder disability. Prior to his service entrance examination in June 2003, Amezquita had undergone Bankart repair surgery on his left shoulder due to a motor vehicle accident. The service entrance examination noted the surgery but stated he was asymptomatic with no physical limitations. Amezquita served from July 2003 to March 2005. Shortly before his separation, he reported a shoulder injury, which was diagnosed as a sprain. In June 2005, he filed a claim for service connection for his left shoulder disability, which was denied by the VA in September 2005, citing no evidence of aggravation due to service.The Board of Veterans’ Appeals denied Amezquita’s claim in August 2021, finding that the presumption of soundness did not apply because his preexisting condition was noted upon service entry. The Board analyzed the claim under the aggravation standard and found no evidence of in-service aggravation. Amezquita appealed to the U.S. Court of Appeals for Veterans Claims, arguing that his asymptomatic condition should not be considered a noted defect. The Veterans Court affirmed the Board’s decision, relying on precedent that an asymptomatic condition can be noted as a preexisting defect.The United States Court of Appeals for the Federal Circuit reviewed the case. The court affirmed the Veterans Court’s interpretation that an asymptomatic condition can be noted as a preexisting defect under 38 U.S.C. § 1111. The court dismissed Amezquita’s arguments regarding the factual determination that his condition was resolved upon service entry, as it lacked jurisdiction to review factual findings. The decision was affirmed in part and dismissed in part. View "AMEZQUITA v. COLLINS " on Justia Law

A group of landowners in Indiana, who own land adjacent to the former Indiana Nickel Plate Line, sued the United States in the Court of Federal Claims. They sought compensation for an alleged taking under the Fifth Amendment, arguing that the issuance of Notices of Interim Trail Use (NITUs) under the National Trails System Act Amendments of 1983 constituted a taking of their property.The Court of Federal Claims rejected the plaintiffs' request to certify a question to the Indiana Supreme Court. It held that the plaintiffs lacked a compensable property interest because the releases signed by their predecessors-in-interest conveyed fee simple estates to the Peru and Indianapolis Railroad Company. The court granted summary judgment in favor of the United States.The United States Court of Appeals for the Federal Circuit reviewed the case. The court affirmed the lower court's decision, holding that under Indiana law, the releases conveyed fee simple titles to the railroad company. The court relied on the Indiana Supreme Court's decisions in Newcastle & Richmond Railroad Co. v. Peru & Indianapolis Railroad Co. and Indianapolis, Peru, & Chicago Railway Co. v. Rayl, which established that releases executed under the railroad's legislative charter conveyed fee simple estates. The court also declined to certify a question to the Indiana Supreme Court, finding that the relevant Indiana law was clear and controlling. View "ATS FORD DRIVE INVESTMENT, LLC v. US " on Justia Law

The veteran served in the U.S. Army from March 1944 to May 1945 and was diagnosed with Hodgkin’s lymphoma in 1978. He received radiation therapy at a VA facility, which successfully treated the lymphoma but led to his death in early 1979 due to pulmonary complications. The veteran’s wife, Hatfield, filed a claim for dependency and indemnity benefits, which was denied by the Regional Office (RO) for lack of service connection. Hatfield appealed to the Board of Veterans’ Appeals (the Board), asserting that the veteran’s death was due to negligent VA medical care. In 1980, the Board denied the appeal, finding the VA provided adequate care and the veteran’s reaction was a recognized complication of radiation therapy.Hatfield later filed an application to reopen her claim in 2010, arguing entitlement to compensation under a 2004 regulation requiring informed consent for VA-administered medical care. The Board denied the application, but the Veterans Court reversed, granting benefits from August 1, 2010, due to the VA’s failure to obtain informed consent. In 2020, Hatfield filed a motion to revise the 1980 Board decision, claiming clear and unmistakable error (CUE) for not considering informed consent under 38 U.S.C. § 4131. The Board denied the motion, and the Veterans Court affirmed, stating there was no indication in 1980 that failure to obtain informed consent amounted to a compensable negligence claim.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the Veterans Court’s decision. The court held that Hatfield did not demonstrate that the 1980 Board committed CUE, as there was no undebatable error in the application of the law at that time. The court found no evidence that the failure to obtain informed consent under 38 U.S.C. § 4131 was considered a compensable negligence claim under 38 U.S.C. § 351 in 1980. View "HATFIELD v. COLLINS " on Justia Law

Kevin Steele, a Marine veteran, filed an original claim in 1991 for a head injury sustained during service, which he attributed to a 1980 training incident. The Department of Veterans Affairs (VA) examiner noted that Steele experienced occasional headaches as a residual of the head injury but deemed them non-disabling. The VA Regional Office (RO) granted service connection for the scar on Steele's scalp but did not explicitly address the headaches in its decision. Steele did not appeal this decision.In 2013, Steele filed a new claim for various conditions, including traumatic brain injury (TBI), and was awarded a 50% disability rating effective from March 6, 2013. In 2016, he filed a claim for service connection for headaches, which the RO granted with an effective date of October 14, 2015. The Board of Veterans Appeals later adjusted the effective date to March 6, 2013. Steele appealed, arguing that his 1991 claim for headaches remained open and should entitle him to an earlier effective date.The United States Court of Appeals for Veterans Claims affirmed the Board's decision, holding that Steele's 1991 claim for headaches was implicitly denied and thus finally adjudicated in 1991. The court applied the implicit denial rule, which provides that a claim can be deemed denied if the VA's decision provides sufficient notice that the claim was considered and rejected. The court found that the 1991 RO decision and notice letter provided Steele with reasonable notice that his claim for headaches was denied.The United States Court of Appeals for the Federal Circuit affirmed the Veterans Court's decision, agreeing that the Board and the Veterans Court did not legally err in their application of the implicit denial rule. The court held that the reasons provided for the explicit denial of Steele's head injury claim in 1991 were sufficient to implicitly deny the related claim for headaches, thus closing off the earlier filing date. View "STEELE v. COLLINS " on Justia Law

Fintiv, Inc. sued PayPal Holdings, Inc. for patent infringement in the U.S. District Court for the Western District of Texas, asserting four patents related to a cloud-based transaction system. The district court determined that certain claim terms in the asserted patents were subject to 35 U.S.C. § 112 ¶ 6 and held the asserted claims invalid as indefinite.The district court found that the payment-handler terms in the patents invoked § 112 ¶ 6 because they recited function without sufficient structure. The court noted that the terms were drafted in a format consistent with traditional means-plus-function limitations and merely replaced the term "means" with "payment handler" or "payment handler service." The court also found that the specifications of the asserted patents failed to disclose adequate structure corresponding to the claimed functions, rendering the claims indefinite.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the district court's indefiniteness determination. The Federal Circuit agreed that the payment-handler terms invoked § 112 ¶ 6 because they recited function without sufficient structure. The court also agreed that the specifications did not disclose any algorithm to perform the recited functions, and thus, the claims were indefinite. The Federal Circuit concluded that the payment-handler terms were no more than a "black box recitation of structure" and that a person of ordinary skill in the art would not have understood how to implement the recited functions based on the specifications. View "FINTIV, INC. v. PAYPAL HOLDINGS, INC. " on Justia Law

PT Medisafe Technologies, a medical glove manufacturer, applied to the United States Patent and Trademark Office (PTO) for registration of a color mark for use on medical examination gloves. The proposed mark was described as the color dark green (Pantone 3285 c) applied to the entire surface of chloroprene examination gloves. The PTO’s examining attorney found the color was not inherently distinctive and could not be registered without showing acquired distinctiveness. Medisafe attempted to prove acquired distinctiveness but was ultimately rejected by the examining attorney, who determined the mark was generic and had not acquired distinctiveness.The Trademark Trial and Appeal Board (Board) reviewed the examining attorney’s decision. The Board applied a modified version of the H. Marvin Ginn test, tailored for color marks, as set out in Milwaukee Electric Tool Corp. v. Freud America, Inc. The Board defined the genus of goods as all chloroprene medical examination gloves and found the relevant public to include all purchasers of such gloves. The Board agreed with the examining attorney that the dark green color was common in the industry and could not identify a single source, thus deeming the mark generic. The Board also found Medisafe’s evidence of acquired distinctiveness unconvincing and affirmed the refusal to register the mark.The United States Court of Appeals for the Federal Circuit reviewed the Board’s decision. The court affirmed the Board’s application of the Milwaukee test and found substantial evidence supporting the Board’s determination that the mark was generic. The court held that the dark green color was so common in the industry that it could not serve as a source indicator, making it ineligible for registration on either the principal or supplemental registers. The court did not address the issue of acquired distinctiveness, as a generic mark cannot acquire distinctiveness. View "In Re PT MEDISAFE TECHNOLOGIES " on Justia Law

Qualcomm Incorporated owned U.S. Patent No. 8,063,674, which relates to integrated circuit devices using multiple power supplies. Apple Inc. filed two petitions for inter partes review (IPR) challenging various claims of this patent as unpatentable due to obviousness. Each petition included a ground that relied on applicant admitted prior art (AAPA) in combination with other prior art patents. The Patent Trial and Appeal Board (PTAB) initially determined that the use of AAPA complied with 35 U.S.C. § 311(b), which allows IPR petitions to be based only on prior art consisting of patents or printed publications. Qualcomm appealed this decision.The United States Court of Appeals for the Federal Circuit previously held that the PTAB misinterpreted § 311(b) because AAPA is not considered prior art consisting of patents or printed publications. The case was remanded for the PTAB to determine whether the AAPA in Apple's petitions formed the basis of the ground at issue in violation of § 311(b). On remand, the PTAB concluded that the AAPA did not form the basis of the ground because it was used in combination with prior art patents, thus complying with § 311(b).The United States Court of Appeals for the Federal Circuit reviewed the PTAB's decision and held that the PTAB erred in its interpretation of § 311(b). The court clarified that the statute's plain meaning does not permit AAPA to form the basis of an IPR ground, even if used in combination with prior art patents or printed publications. The court found that Apple's petitions expressly included AAPA in the basis of the ground, violating § 311(b). Consequently, the court reversed the PTAB's decision, determining that the challenged claims of the '674 patent are not unpatentable as obvious. View "QUALCOMM INCORPORATED v. APPLE INC. " on Justia Law

The case involves a breach of contract action brought by socially disadvantaged farmers against the United States Department of Agriculture (USDA) regarding Farm Service Agency (FSA) loans. The plaintiffs, Lester Bonner and Princess Williams, claimed that the USDA breached an express or implied-in-fact contract by failing to provide debt relief after the Inflation Reduction Act repealed a provision of the American Rescue Plan Act (ARPA) that mandated such relief.The United States Court of Federal Claims dismissed the plaintiffs' complaint for failure to state a claim upon which relief could be granted. The court found that the plaintiffs did not plausibly allege the formation of a contract, as they failed to demonstrate mutuality of intent, lack of ambiguity in offer and acceptance, consideration, and a government representative with actual authority to bind the United States.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the lower court's decision. The appellate court held that the plaintiffs did not plausibly allege mutuality of intent to contract, which is a threshold condition for contract formation. The court found that the language of ARPA § 1005, which directed the Secretary of Agriculture to provide payments, did not create a contractual obligation. The court also determined that the FSA-2601 form, which informed recipients of their eligibility for payment, did not demonstrate the government's intent to contract. The court concluded that the statutory grant of payment under ARPA was a gratuity and not a contractual right. Consequently, the Court of Federal Claims' dismissal of the complaint was affirmed. View "BOYD v. US " on Justia Law

Marmen Inc., Marmen Énergie Inc., and Marmen Energy Co. (collectively, “Marmen”) appealed the U.S. Court of International Trade’s (CIT) decision that sustained the U.S. Department of Commerce’s (Commerce) final determination of a 4.94% dumping margin for utility-scale wind towers from Canada. Commerce had initiated an antidumping (AD) investigation in July 2019, and in June 2020, issued its final AD determination. Marmen challenged Commerce’s decision on three grounds: the weight-averaging of steel plate costs, the rejection of a USD-to-CAD cost reconciliation, and the use of the average-to-transaction (A-to-T) methodology based on Cohen’s d test.The CIT affirmed Commerce’s weight-averaging of Marmen’s steel plate costs but remanded the case on the other two issues. Commerce again rejected the USD-to-CAD cost reconciliation on remand, arguing it would double count an exchange-rate adjustment. Commerce also maintained its use of Cohen’s d test, despite concerns raised by the Federal Circuit in Stupp Corp. v. United States. The CIT sustained Commerce’s determination on both issues, leading to Marmen’s appeal.The United States Court of Appeals for the Federal Circuit reviewed the case. The court found that Commerce’s rejection of the USD-to-CAD cost reconciliation was not supported by substantial evidence, as the proposed adjustment did not duplicate other adjustments and was reliable. The court also concluded that Commerce’s use of Cohen’s d test was unreasonable because the data did not meet the necessary assumptions of normal distribution, equal variability, and sufficient size. The court vacated Commerce’s calculated dumping margin and remanded for further proceedings consistent with its opinion. View "MARMEN INC. v. US " on Justia Law