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

The case involves a patent interference proceeding between the Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively “Regents”) and the Broad Institute, Massachusetts Institute of Technology, and the President and Fellows of Harvard College (collectively “Broad”). The dispute centers on the priority of invention for a CRISPR-Cas9 system that edits DNA in eukaryotic cells using a single-guide RNA.The Patent Trial and Appeal Board (PTAB) issued a final decision concluding that Broad has priority over Regents for the CRISPR-Cas9 system. The PTAB determined that Broad reduced the invention to practice by October 5, 2012, when Broad's scientist, Feng Zhang, submitted a manuscript to Science. The PTAB rejected Regents' earlier asserted dates of conception and reduction to practice, which were based on various disclosures and experiments conducted by Regents' scientists. The PTAB also denied Regents' motion to be accorded the benefit of the filing date of its first and second provisional patent applications, determining that they lacked written description support for the claimed invention.The United States Court of Appeals for the Federal Circuit reviewed the case. The court held that the PTAB legally erred by conflating the standards for conception and reduction to practice, requiring Regents' scientists to know their invention would work to prove conception. The court vacated the PTAB's decision on conception and remanded for reconsideration under the correct legal framework. The court affirmed the PTAB's decision on written description, finding no legal error in the PTAB's analysis. The court dismissed Broad's cross-appeal on claim construction as moot, as the PTAB's denial of Broad's preliminary motions was based on independently sufficient grounds unrelated to claim construction. View "THE BROAD INSTITUTE, INC. v. THE REGENTS OF THE UNIVERSITY OF CALIFORNIA " on Justia Law

Incyte Corporation appealed a post-grant review (PGR) final written decision from the Patent Trial and Appeal Board (Board) which held that Incyte failed to prove claims 1–7 and 9–21 of U.S. Patent No. 10,561,659 were unpatentable. The '659 patent, owned by Sun Pharmaceutical Industries, Inc., discloses a method of treating hair-loss disorders using deuterium-modified ruxolitinib. Incyte petitioned for PGR, arguing the claims were obvious, but the Board found Incyte's arguments unpersuasive and upheld the claims. Incyte's request for rehearing was also denied.The United States Court of Appeals for the Federal Circuit reviewed the case. Sun argued that Incyte lacked Article III standing to appeal. The court noted that standing is a threshold jurisdictional issue that must be addressed before reaching the merits of an appeal. To establish standing, Incyte needed to demonstrate an injury in fact, which it attempted to do by claiming potential infringement liability and invoking the competitor standing doctrine.The court found that Incyte's plans to develop a deuterated ruxolitinib product were too speculative to establish concrete plans for future activity that would create a substantial risk of future infringement. The court also determined that Incyte's reliance on the competitor standing doctrine was insufficient because Incyte did not show it was currently engaging in or had nonspeculative plans to engage in conduct covered by the claims of the '659 patent.Ultimately, the United States Court of Appeals for the Federal Circuit dismissed the appeal for lack of jurisdiction, concluding that Incyte failed to establish an injury in fact sufficient to confer Article III standing. View "INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, INC. " on Justia Law

Ingenico Inc. filed a declaratory judgment action against IOENGINE, LLC, in the District of Delaware, asserting that IOENGINE's patents were invalid. The patents in question, U.S. Patent No. 9,059,969 and U.S. Patent No. 9,774,703, relate to a portable device, such as a USB thumb drive, that includes a processor for network communication. IOENGINE counterclaimed, alleging infringement. Ingenico argued that the patents were invalid due to prior art, specifically a USB device known as the DiskOnKey System, which included a Firmware Upgrader.The District Court for the District of Delaware held a jury trial, which resulted in a verdict finding the claims of the patents invalid as anticipated and obvious. IOENGINE filed a motion for judgment as a matter of law (JMOL) and a motion for a new trial, both of which were denied by the district court. IOENGINE then appealed the decision, challenging the jury's findings and the district court's rulings on jury instructions and the introduction of prior art.The United States Court of Appeals for the Federal Circuit reviewed the case. The court found that substantial evidence supported the jury's verdict that the DiskOnKey System, including the Firmware Upgrader, was in public use before the critical date, thus invalidating the patents. The court also held that the district court did not err in its jury instructions or in allowing Ingenico to introduce the prior art at trial. The court clarified that IPR estoppel under 35 U.S.C. § 315(e)(2) did not preclude Ingenico from using the DiskOnKey System to argue that the claimed invention was known or used by others, on sale, or in public use, as these grounds could not have been raised during the IPR.The Federal Circuit affirmed the district court's judgment, upholding the jury's verdict of invalidity. View "INGENICO INC. v. IOENGINE, LLC " on Justia Law

Thomas D. Foster, APC (Foster) sought to register the trademark "US SPACE FORCE" for various goods and services. The application was filed on March 19, 2018, shortly after President Donald J. Trump announced the creation of a new military branch called the Space Force. The United States Patent and Trademark Office (USPTO) examining attorney refused the registration, citing a false suggestion of a connection with the United States under § 2(a) of the Lanham Act.The Trademark Trial and Appeal Board (Board) affirmed the examining attorney’s refusal, concluding that the mark falsely suggested a connection with the United States. Foster requested reconsideration, arguing that the Board erred by not crediting the filing date of the intent-to-use application as the constructive use date and by relying on evidence post-dating the filing date. The Board denied reconsideration, maintaining that Foster was not the prior user and that there was ample evidence supporting the false connection analysis.The United States Court of Appeals for the Federal Circuit reviewed the case. The court held that the appropriate timing for assessing a false suggestion of a connection includes evidence up to the time of examination, which in this case extended through the Board’s December 12, 2022 decision. The court found substantial evidence supporting the Board’s findings that the mark "US SPACE FORCE" was the same as or a close approximation of a name or identity used by the United States and that it pointed uniquely and unmistakably to the United States. The court affirmed the Board’s decision, concluding that the mark falsely suggested a connection with the United States and was therefore unregistrable under § 2(a) of the Lanham Act. View "In Re FOSTER" on Justia Law

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

Miodrag Kostic and Guy Vandevelde, owners and listed inventors of U.S. Patent No. 8,494,950, appealed a decision by the Patent Trial and Appeal Board (PTAB) that sustained the examiner’s rejection of claim 3 of their Reissue Application No. 16/667,530. The '950 patent is directed to methods for buying and selling click-through traffic on internet websites, involving a trial process to measure traffic before a bidding process. Claim 3 of the original patent allowed for a direct exchange of click-through traffic without a trial process.The examiner rejected the reissue application, finding that the reissue claim 3 was broader than the original claim 3 and thus constituted an improper broadening reissue application filed outside the permissible two-year period. The examiner also found the reissue claim 3 to be obvious over prior art. The PTAB affirmed these rejections, agreeing that reissue claim 3 improperly broadened the scope of the original claim by making the trial process optional, which was not allowed under 35 U.S.C. § 251(d).The United States Court of Appeals for the Federal Circuit reviewed the case. The court held that the scope of reissue claim 3 was indeed broader than the original claim 3 because it allowed for either a trial process or a direct exchange without a trial process, whereas the original claim 3 required both. The court emphasized that the proper inquiry under 35 U.S.C. § 251(d) is whether the reissue claim is broader than the actual scope of the original claim, not the intended scope. Consequently, the court affirmed the PTAB’s decision, finding that the reissue application was statutorily barred as it broadened the scope of the original patent claims beyond the permissible period. View "In Re KOSTIC " 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

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