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

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Arbutus's patent, directed to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP,” describes the invention as “novel, serum-stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles (e.g., for the treatment of a disease or disorder)”; “[t]he present invention is based, in part, upon the surprising discovery that lipid particles comprising … provide advantages when used for the in vitro or in vivo delivery of an active agent, such as a therapeutic nucleic acid (e.g., an interfering RNA)”; the particles are “stable in circulation, e.g., resistant to degradation by nucleases in serum and are substantially non-toxic” to humans.On inter partes review, the Patent Trial and Appeal Board held that the claims of the patent are not unpatentable as obvious. The Federal Circuit affirmed, first holding that that Moderna could pursue its appeal based on the risk of an infringement suit. Substantial evidence—including prior art and expert testimony—supports a finding that optimizing the four interdependent lipid components in prior art nucleic acid-lipid particles would not have been routine, and Moderna’s proposed adjustments to the lipid components are hindsight driven. View "ModernaTx, Inc. v. Arbutus Biopharma Corp." on Justia Law

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Arbutus’s 435 patent, directed to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP,” issued in 2016. The patent recognized that there remained “a strong need in the art for novel and more efficient methods and compositions for introducing nucleic acids such as siRNA into cells.” On inter partes review (IPR), the Patent Board found that Moderna proved by a preponderance of the evidence that 10 claims were anticipated by a formulation in a publication but that Moderna failed to prove that the remaining claims were anticipated, or that those claims would have been obvious over the prior art.The Federal Circuit dismissed Moderna’s appeal and otherwise affirmed. Under the IPR statute, there is no standing requirement for petitioners to request the institution of IPR by the Board; the statute does not eliminate the Article III injury-in-fact requirement for appeal. Moderna lacked standing at the time the appeal was filed. Moderna conceded that the basis for its standing shifted during the pendency of this appeal, i.e., from the financial burdens of its sublicenses to a potential infringement suit for the COVID-19 vaccine. Moderna did not present evidence to demonstrate the necessary continuity of jurisdiction. View "ModernaTx, Inc. v. Arbutus Biopharma Corp." on Justia Law

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Biogen’s 514 Patent claims a method of treating multiple sclerosis with a drug called dimethyl fumarate. Mylan filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to manufacture, use, and market a generic dimethyl fumarate product for the treatment of multiple sclerosis before the expiration of the 514 Patent. Biogen sued Mylan alleging patent infringement. Mylan sought a declaratory judgment that the patent was invalid and not infringed. The district court determined that the asserted claims of the 514 Patent were invalid for lack of written description.The Federal Circuit affirmed. The district court did not clearly err in determining that Mylan has established its burden of showing, by clear and convincing evidence, that the asserted 514 Patent claims are invalid for lack of written description under 35 U.S.C. 112. View "Biogen International GmbH v. Mylan Pharmaceuticals, Inc." on Justia Law

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Indivior’s patent, which generally describes orally dissolvable films containing therapeutic agents, was issued as the fifth continuation of the 571 application, which was filed in 2009. DRL petitioned for inter partes review of claims 1–5 and 7–14. alleging that the polymer weight percentage limitations, added to the claims by amendment, do not have written description support in the 571 application as filed and thus are not entitled to the benefit of its filing date.The Patent Trial and Appeal Board held that several challenged claims are unpatentable as anticipated, but that DRL failed to demonstrate that claim 8 is anticipated. The Federal Circuit affirmed, upholding the Board’s finding as to claim 8. The Board properly determined that claims 1, 7, and 12 do not have written description support in the 571 application; the remaining challenged claims were anticipated by prior art published in 2011. View "Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A." on Justia Law

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In 2015, JKB and the Army entered into a three-year indefinite-delivery, indefinite-quantity contract. JKB agreed to provide instructional services up to 14 classes per year. The contract incorporates Federal Acquisition Regulation (FAR) 52.212-4, which includes a termination for convenience clause for the government, and incorporates Defense Federal Acquisition Regulation Supplement (DFARS) 252.216-7006, which requires all supplies and services furnished under the contract to be ordered by issuance of delivery or task orders. The Army issued three year-long task orders, each listing one lot of training-instructor services, the price per class, and a total price corresponding to the price of 14 classes. Each year, the Army used JKB for fewer than 14 classes and paid for each class actually taught, refusing to pay the total price listed in the task orders.JKB sued for breach of contract. The Claims Court ultimately granted the government summary judgment based on FAR 52.212-4 and the doctrine of constructive termination for convenience. The Federal Circuit vacated. FAR 52.212-4 governs the termination of commercial item contracts for the government’s convenience; it does not apply to service contracts, such as the contract at issue. On remand, the Claims Court may consider whether the “Christian doctrine” applies to incorporate a termination for convenience clause and whether the doctrine of constructive termination for convenience applies. View "JKB Solutions and Services, LLC v. United States" on Justia Law

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For more than 30 years, Brewery has used the marks BROOKLYN and BROOKLYN BREWERY in connection with the advertising, promotion, and sale of Brewery’s beer and beer-related merchandise. Brewery owns Registration No. 3,186,503 for BROOKLYN BREWERY for beer in Class 32,1 registered in 2006. Brewery petitioned to cancel BBS’s subsequent registration of the mark “BROOKLYN BREW SHOP,” in standard characters, for goods identified as “Beer making kit[s]” in Class 32 and opposed BBS’s application to register a stylized version of the same mark for beer-making kits in Class 32 and sanitizing preparations for household use in Class 5.The Federal Circuit affirmed the Trademark Trial and Appeal Board’s denial of Brewery’s petition for cancellation. The court dismissed the appeal regarding the Class 5 goods for lack of standing. The court vacated in part; the Board erred by not entering judgment in favor of Brewery on the Class 32 goods deleted from BBS’s application. As to the remaining goods in Class 32 (beer-making kits), the court affirmed the Board’s dismissal of the claim that, under Section 2(d), the mark is likely to cause confusion. The court vacated with respect to the descriptiveness issue under Section 2(e)(1); the Board erred by not reaching Brewery’s claim that the applied-for mark lacked acquired distinctiveness under Section 2(f) as to the beer-making kits. The court affirmed the Board’s refusal to consider geographic descriptiveness.. View "Brooklyn Brewery Corporation v. Brooklyn Brew Shop, LLC" on Justia Law

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Valles began working for the State Department as a passport specialist in 2011. In 2016, Valles served a three-day suspension for charges concerning inappropriate sexual and political comments made to co-workers and customers. In 2018, Valles served a five-day suspension for failure to follow instructions and failure to protect personally identifiable information. In 2019, Valles received a performance appraisal of “Fully Successful” for 2018.The agency nonetheless proposed Valles’ removal based on four charges from 18 specifications dating between July 2018 and February 2019. Some of the alleged conduct occurred during the 2018 evaluation period. The charges included failure to follow instructions, failure to properly move along applications and provide updates, leaving a passport application on a photocopier, failure to follow policies concerning the handling of fees, not maintaining control over applications, leaving his adjudication stamp unsecured, and drinking from a wine glass at his workstation in the public counter.An administrative judge upheld the termination. The Federal Circuit affirmed. The agency proved all the charges and established a nexus between the proven misconduct and the agency’s ability to carry out its mission. The penalty was reasonable, considering all the relevant “Douglas” factors, including the repeated nature and seriousness of the misconduct, Valles’ prior discipline, his seven years of federal service and job performance, the consistency of the penalty with similar cases, and the lack of rehabilitation potential on Valles’ part. View "Valles v. Department of State" on Justia Law

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A 2005 Customs ruling letter stated that Kent’s imported bicycle seats would be classified as “accessories of bicycles” under HTSUS heading 8714, with a 10% ad valorem duty. In 2008, after Customs classified a competitor’s bicycle seats as “seats” under duty-free heading 9401. Kent started filing protests, post-entry amendments, and an application for further review. Customs approved the protests and reliquidated Kent’s merchandise under heading 9401. Kent sought revocation of the 2005 Ruling but continued to make entries through New York and lodged protests for each. Customs stopped granting those protests. Kent began to import the same merchandise through Long Beach under heading 8714. Long Beach Customs treated these entries as bypass entries and liquidated them under heading 8714 without examination or Customs officer review. Kent protested. Although the New York protests were granted, Kent’s Long Beach protests were denied. In 2014, Customs revoked its earlier decisions classifying Kent’s competitors’ merchandise under heading 9401, concluding that the merchandise would be classified under heading 8714. Customs declined to revoke the 2005 Ruling.The Trade Court rejected Kent’s claims that the classification violated 19 U.S.C. 1625(c) by departing from a “treatment previously accorded” and was contrary to a de facto “established and uniform practice” (EUP) under section 1315(d). The Federal Circuit reversed. The Trade Court erred in approving Customs’ use of bypass entries to show the absence of treatment previously accorded but properly found no de facto EUP. View "Kent International, Inc. v. United States" on Justia Law

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Celgene markets pomalidomide as a multiple-myeloma drug under the brand name Pomalyst. Many drug companies questioned the validity or applicability of Celgene's patents and sought to bring generic pomalidomide to market. The defendants submitted an abbreviated new drug application (ANDA) to the FDA. Celgene filed suit in New Jersey. Celgene is headquartered there, but no defendant is. MPI is based in West Virginia, Mylan Inc. in Pennsylvania, and Mylan N.V. in Pennsylvania and the Netherlands. The district court dismissed the case for improper venue (MPI; Mylan Inc.) and for failure to state a claim (as to Mylan N.V.).The Federal Circuit affirmed. Under the Hatch-Waxman Act, 21 U.S.C. 355(j)(5)(B)(iii), venue was improper in New Jersey for the domestic corporation defendants, MPI and Mylan Inc. Celgene did not show that those defendants committed acts of infringement in New Jersey and have a regular and established place of business there. The court rejected Celgene’s argument that receipt of the ANDA notice letter is an infringing act in New Jersey. Under section 271(e)(2), submitting an ANDA is the act of infringement; although the ANDA applicant must later send a notice letter that happens after the infringing submission. As to the foreign-corporation defendant, Mylan N.V., Celgene’s pleadings failed to state a claim upon which relief could be granted. View "Celgene Corp. v. Mylan Pharmaceuticals Inc." on Justia Law

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Methicillin-resistant Staphylococcus aureus (MRSA), and other Gram-positive bacteria that have developed resistance to antibiotics cause health problems, particularly in the hospital environment. TheUniversity of Strathclyde’s 706 patent addresses problems resulting from the “availability of few effective sterili[z]ation methods for environmental decontamination” of air and surfaces and discloses photoinactivation as a method that has emerged for killing harmful bacteria like MRSA and describes a method for photo-inactivating antibiotic-resistant bacteria like MRSA without using a photosensitizing agent.In inter partes review, the Patent Trial and Appeal Board found claims 1–4 of the 706 patent unpatentable as obvious, 35 U.S.C. 103. The Federal Circuit reversed. Neither the Board’s finding that the prior art disclosed all claim limitations nor its finding of a reasonable expectation of success is supported by substantial evidence. No reasonable factfinder could have found that the combination of the prior art discloses inactivating one or more Gram-positive bacteria without using a photosensitizer. In this case, where the prior art establishes only failures to achieve that at which the inventors succeeded, no reasonable factfinder could find an expectation of success based on the teachings of that same prior art. View "University of Strathclyde v. Clear-Vu Lighting, LLC" on Justia Law