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

Incyte Corporation and Incyte Holdings Corporation (collectively, Incyte) own U.S. Patent No. 9,662,335, which claims deuterated versions of ruxolitinib, a Janus kinase (JAK) modulator used to treat autoimmune disorders. Sun Pharmaceutical Industries, Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, Sun) secured FDA approval for an oral deuterated ruxolitinib product, branded as Leqselvi, to treat alopecia areata (AA) and planned to launch it in October 2024. Incyte sued Sun for allegedly infringing the ’335 patent and moved for a preliminary injunction to prevent Sun from launching Leqselvi.The United States District Court for the District of New Jersey granted Incyte’s motion for a preliminary injunction, finding that Incyte would suffer irreparable harm if Sun launched Leqselvi. The district court based its decision on the theory that Sun’s launch would give it an unjust head start in the AA market, diminishing the value of Incyte’s investments in developing its own topical deuterated ruxolitinib product.Sun appealed the district court’s decision to the United States Court of Appeals for the Federal Circuit. The Federal Circuit reviewed the grant of the preliminary injunction for an abuse of discretion, focusing on whether the district court made a clear error in its irreparable harm analysis. The Federal Circuit found that the district court clearly erred in its finding of irreparable harm, as it was based on the incorrect assumption that Incyte would be first to market if the injunction were granted. The court noted that Sun’s multi-year head start was inevitable regardless of the injunction, as Incyte’s product would not launch until several years after the ’335 patent expired.The Federal Circuit reversed the district court’s order granting the preliminary injunction, concluding that Incyte failed to provide non-speculative evidence of irreparable harm. View "INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, LTD. " on Justia Law

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

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

Daniel R. Smith, who is currently blind, underwent medical examinations upon entering military service in August 1964 and upon leaving in June 1965. Both examinations noted poor night and color vision, with vision correctable in both eyes. After his discharge, Smith filed several claims with the U.S. Department of Veterans Affairs (VA) for benefits based on retinitis pigmentosa, an eye disease causing vision loss. An ophthalmologist opined that Smith's condition preexisted his service and did not worsen during service. The VA denied his claim, and the Board of Veterans’ Appeals agreed, finding clear and unmistakable evidence rebutting the presumption of sound health upon entry into service. The Court of Appeals for Veterans Claims affirmed this decision.The United States Court of Appeals for Veterans Claims reviewed the case and affirmed the Board's decision, finding that Dr. Wilson's opinion constituted clear and unmistakable evidence that Smith's retinitis pigmentosa did not increase in severity during service. Smith appealed, arguing that Dr. Wilson's opinion did not meet the clear and unmistakable evidence standard and that it improperly relied on the absence of evidence.The United States Court of Appeals for the Federal Circuit reviewed the case and dismissed Smith's appeal. The court held that it lacked jurisdiction to review the factual determination that Dr. Wilson's opinion met the clear and unmistakable evidence standard. The court also found that the Veterans Court did not rely on an absence of evidence but rather on affirmative evidence comparing Smith's vision tests at entry and separation from service. Therefore, the Federal Circuit concluded that it could not address Smith's legal contention regarding the sufficiency of the evidence. View "SMITH v. COLLINS " on Justia Law

Regeneron Pharmaceuticals, Inc. holds a Biologics License Application (BLA) for EYLEA®, a therapeutic product containing aflibercept, a VEGF antagonist used to treat angiogenic eye diseases. Regeneron also owns U.S. Patent No. 11,084,865, which covers VEGF-trap formulations suitable for intravitreal injection. Several companies, including Samsung Bioepis Co., Ltd. (SB), filed abbreviated Biologics License Applications (aBLAs) seeking approval to market EYLEA® biosimilars. Regeneron sued these companies, including SB, for patent infringement in the Northern District of West Virginia.The district court consolidated the cases and granted Regeneron’s motion for a preliminary injunction against SB, enjoining it from marketing its biosimilar product in the U.S. without a license from Regeneron. The court found it had personal jurisdiction over SB based on SB’s aBLA filing and its distribution agreement with Biogen, which indicated plans for nationwide marketing, including West Virginia. The court also found that Regeneron was likely to succeed on the merits, as SB had not raised a substantial question of invalidity of the ’865 patent for obviousness-type double patenting or lack of written description.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the district court’s decision. The appellate court agreed that the district court had personal jurisdiction over SB, as SB’s actions indicated plans to market its biosimilar nationwide. The court also upheld the district court’s findings that SB had not raised a substantial question of invalidity for the ’865 patent. The court found that the patent’s specific stability and glycosylation requirements were patentably distinct from the reference patent and adequately supported by the specification. The court also agreed that Regeneron had established a causal nexus between SB’s infringement and the irreparable harm it would suffer without an injunction. View "REGENERON PHARMACEUTICALS, INC. v. MYLAN PHARMACEUTICALS INC. " on Justia Law

Galderma Laboratories, L.P. and TCD Royalty Sub LP (collectively, Galderma) own and market Oracea®, a doxycycline-based treatment for rosacea. They hold U.S. Patent Nos. 7,749,532 and 8,206,740 (the Asserted Patents), which cover a specific formulation of doxycycline. Lupin Inc. and Lupin Ltd. (collectively, Lupin) filed an abbreviated new drug application (ANDA) to market a generic version of Oracea®, claiming bioequivalence. Galderma sued Lupin for patent infringement under the Hatch-Waxman Act, asserting that Lupin’s product infringed the Asserted Patents.The United States District Court for the District of Delaware held a three-day bench trial and found that Lupin’s ANDA product did not infringe the Asserted Patents. The court concluded that Galderma failed to prove that Lupin’s product met the specific formulation requirements of the Asserted Patents, particularly the immediate release (IR) and delayed release (DR) portions of doxycycline. The court also found that Galderma did not demonstrate infringement under the doctrine of equivalents.The United States Court of Appeals for the Federal Circuit reviewed the case. Galderma argued that the district court erred in disregarding dissolution test data from Lupin’s ANDA, admitting evidence from a rebuttal batch, imposing additional claim limitations, and not finding infringement under the doctrine of equivalents. The Federal Circuit found no clear error in the district court’s findings. It held that the district court correctly determined that the two-stage dissolution test did not represent in vivo behavior and that Galderma did not prove its theory of infringement. The court also found no abuse of discretion in admitting the rebuttal batch evidence and no imposition of additional claim limitations. Finally, the court upheld the district court’s finding that Galderma did not prove infringement under the doctrine of equivalents.The Federal Circuit affirmed the district court’s decision, concluding that Lupin’s ANDA product did not infringe the Asserted Patents. View "Galderma Laboratories, L.P. v. Lupin, Inc." on Justia Law

Chad Sheller, as the personal representative of the estate of his son Daniel Elias Sheller, sought attorneys' fees after voluntarily dismissing a Vaccine Act petition. Daniel passed away at two months old, two days after receiving several vaccinations. Sheller filed for compensation under the National Childhood Vaccine Injury Compensation Program, relying on the "Triple Risk Model" of vaccine-triggered sudden infant death syndrome (SIDS) proposed by Dr. Douglas Miller. This model had previously been accepted in another case, Boatmon v. Secretary of Health & Human Services.The Special Master denied Sheller's request for attorneys' fees, concluding that the Triple Risk Model did not provide a reasonable basis for the claim. The United States Court of Federal Claims affirmed this decision. The Special Master also struck certain medical articles from the record, which were submitted after the petition was dismissed, deeming them irrelevant.The United States Court of Appeals for the Federal Circuit reviewed the case. The court found that the Special Master abused his discretion by not considering whether the Triple Risk Model was a reasonable basis at the time of filing, given its prior acceptance in the Boatmon case. The court noted that the model was plausible and had succeeded before another special master, making it a reasonable basis for the petition when filed. The court also found that the Special Master did not abuse his discretion in striking the medical articles, as he assessed their relevance appropriately.The Federal Circuit vacated the decision and remanded the case for the Special Master to determine, in his discretion, whether attorneys' fees should be granted, considering the Vaccine Act's objective of maintaining access to qualified legal assistance. View "SHELLER v. HHS " on Justia Law

Nevada Health CO-OP, a health insurance provider, received two loans from the Centers for Medicare & Medicaid Services (CMS) under the Affordable Care Act’s CO-OP program. These loans included a start-up loan and a solvency loan. In 2015, Nevada Health faced financial difficulties and was placed into receivership by the Nevada Commissioner of Insurance. CMS subsequently terminated the loan agreement and began offsetting payments owed to Nevada Health against the start-up loan debt.The United States Court of Federal Claims reviewed the case and granted summary judgment in favor of the Nevada Commissioner of Insurance, acting as the receiver for Nevada Health. The court found that the government improperly withheld statutory payments owed to Nevada Health under the ACA. The court also held that the government could not invoke 31 U.S.C. § 3728 to withhold these payments in the future.The United States Court of Appeals for the Federal Circuit reviewed the case. The court affirmed the lower court’s judgment that the government improperly withheld payments owed to Nevada Health. The court held that the loan agreement subordinated the government’s claim to those of policyholders and basic operating expenses, thus precluding the government from asserting offset rights to jump ahead of these senior creditors. However, the appellate court vacated the portion of the lower court’s order that addressed the government’s ability to invoke 31 U.S.C. § 3728, ruling that the lower court exceeded its jurisdiction by addressing this issue, which was not raised by the parties. View "Richardson v. United States" on Justia Law

The case involves Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Limited, and Mochida Pharmaceutical Co., Ltd. (collectively, “Amarin”) and Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC (collectively, “Hikma”). Amarin markets and sells icosapent ethyl, an ethyl ester of an omega-3 fatty acid commonly found in fish oils, under the brand name Vascepa®. In 2012, the U.S. Food and Drug Administration (“FDA”) approved Vascepa for the treatment of severe hypertriglyceridemia. In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: as a treatment to reduce cardiovascular risk in patients having blood triglyceride levels of at least 150 mg/dL.In the United States District Court for the District of Delaware, Hikma moved to dismiss Amarin’s complaint for failure to state a claim. The court granted Hikma’s motion, concluding that Amarin’s allegations against Hikma did not plausibly state a claim for induced infringement.The United States Court of Appeals for the Federal Circuit reversed the decision of the district court. The court held that Amarin had plausibly pleaded that Hikma had induced infringement of the asserted patents. The court noted that the case was not a traditional Hatch-Waxman case or a section viii case, but rather a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b). The court concluded that the totality of the allegations, taken as true, plausibly plead that Hikma “actively” induced healthcare providers’ direct infringement. View "AMARIN PHARMA, INC. v. HIKMA PHARMACEUTICALS USA INC. " on Justia Law

Insulet Corp. and EOFlow are medical device manufacturers that produce insulin pump patches. Insulet began developing its OmniPod product in the early 2000s, and EOFlow started developing its EOPatch product after its founding in 2011. Around the same time, four former Insulet employees joined EOFlow. In 2023, reports surfaced that Medtronic had started a process to acquire EOFlow. Soon after, Insulet sued EOFlow for violations of the Defend Trade Secrets Act (DTSA), seeking a temporary restraining order and a preliminary injunction to enjoin all technical communications between EOFlow and Medtronic in view of its trade secrets claims.The U.S. District Court for the District of Massachusetts temporarily restrained EOFlow from disclosing products or manufacturing technical information related to the EOPatch or OmniPod products. The court then granted Insulet’s request for a preliminary injunction, finding strong evidence that Insulet is likely to succeed on the merits of its trade secrets claim, strong evidence of misappropriation, and that irreparable harm to Insulet crystallized when EOFlow announced an intended acquisition by Medtronic. The injunction enjoined EOFlow from manufacturing, marketing, or selling any product that was designed, developed, or manufactured, in whole or in part, using or relying on alleged trade secrets of Insulet.The United States Court of Appeals for the Federal Circuit reversed the district court’s order. The court found that the district court had failed to address the statute of limitations, lacked a tailored analysis as to what specific information actually constituted a trade secret, and found it hard to tell what subset of that information was likely to have been misappropriated by EOFlow. The court also found that the district court had failed to meaningfully engage with the public interest prong. The court concluded that Insulet had not shown a likelihood of success on the merits and other factors for a preliminary injunction. The case was remanded for further proceedings consistent with the opinion. View "INSULET CORP. v. EOFLOW, CO. LTD. " on Justia Law