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

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

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

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

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