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

Tolliver had a contract with the United States under which Tolliver was obliged to write technical manuals for government-used equipment. The government was obliged to supply Tolliver information relevant to that task. When the government failed to obtain and therefore failed to supply that information, the parties modified the contract. Tolliver ultimately produced the manuals. After the modification, however, a third party sued Tolliver in the name of the government under the False Claims Act, alleging that Tolliver had made a false certification of compliance with the original contract. The government, rather than intervening in the qui tam case and then dismissing it, allowed it to proceed. With evidentiary help from the government, Tolliver prevailed after incurring substantial legal fees.The contracting officer denied Tolliver's claim under the Contract Disputes Act, 41 U.S.C. 7101, for an “equitable adjustment” for reimbursement of “allowable legal fees.” The Claims Court entered judgment for Tolliver, concluding that the United States had breached an implied warranty of performance. The Federal Circuit vacated. Because Tolliver never submitted a claim of breach of that warranty to the contracting officer, the Claims Court lacked jurisdiction to adjudicate such a claim. The claim that Tolliver presented to the contracting officer was, on its face, based on legal fees, not on a breach of the implied warranty of performance. View "Tolliver Group, Inc. v. United States" on Justia Law

Former and current Drug Enforcement Agency (DEA) employees were relocated to Puerto Rico or the U.S. Virgin Islands at the DEA’s request for two to five years. Each received a one-time relocation incentive bonus under 5 U.S.C. 5753(b), which provides that “[t]he Office of Personnel Management may authorize the head of an agency to pay a [relocation incentive] bonus” to an individual who relocates to accept a position. Each bonus was equivalent to 25% of each employee’s yearly salary. The employees allege they are entitled to a relocation incentive bonus for each year of their relocation, rather than the one-time bonus they received.The Federal Circuit affirmed the Claims Court’s dismissal of that claim, for lack of subject matter jurisdiction. The claim was not based on a statute or regulations that are money mandating, as required for jurisdiction under the Tucker Act, 28 U.S.C. 1491(a)(1). The statute and implementing regulations use discretionary language. View "Bell v. United States" on Justia Law

In an administrative review of an antidumping duty order on welded line pipe from the Republic of Korea, the Department of Commerce found that a “particular market situation” (PMS) existed in the Korean market for welded line pipe. Commerce made an upward adjustment in its calculation of the costs of production of the subject welded line pipe for the two selected respondents, which resulted in enhanced antidumping duties. The Trade Court overturned Commerce’s determination holding that Commerce was not statutorily authorized to adjust the exporters’ costs of production to account for the existence of a PMS; “there is nothing in the statutory scheme which can be read to grant Commerce the authority to modify the [sales-below-cost] test to account for a PMS.” On remand, Commerce acquiesced under protest.The Federal Circuit agreed that the 2015 Trade Preferences Extension Act, which amended the constructed value calculation statute, 19 U.S.C. 1677b(e), does not authorize Commerce to use the existence of a PMS as a basis for adjusting a respondent’s costs of production to determine whether a respondent has made home market sales below cost. The court did not address whether Commerce’s finding of a PMS was supported by substantial evidence. View "Hyundai Steel Co. v. United States" on Justia Law

AstraZeneca’s asserted patents are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book), as covering AstraZeneca’s Symbicort® pressurized metered-dose inhaler (pMDI). The Symbicort® pMDI is approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD). AstraZeneca has marketed a dry powder inhaler version of Symbicort® (Symbicort® Turbuhaler) since the early 1990s. Both the Symbicort® pMDI and the Symbicort® Turbuhaler administer two active ingredients to the lungs—formoterol, a bronchodilator that opens the airway, and budesonide, a steroid that reduces inflammation in the lungs. Mylar's predecessor submitted an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to manufacture and sell a generic version of Symbicort® pMDI.AstraZeneca sued Mylan for infringement. After claim construction, Mylan stipulated to infringement. The district court entered judgment accordingly, then held a bench trial and determined that Mylan failed to prove that the asserted claims are invalid as obvious. The Federal Circuit vacated the judgment of infringement, disagreeing with the district court’s claim construction of “0.001%,” the claimed amount of the excipient PVP, on which the stipulated judgment of infringement was based. The court affirmed the determination of nonobviousness, finding no clear error in the district court’s finding that the prior art taught away from the claimed invention. View "AstraZeneca AB v. Mylan Pharmaceuticals Inc." on Justia Law

U.S. Customs and Border Protection (CBP) controls and monitors traffic at the borders, including the flow of vehicles, cargo, and people. CBP’s Cargo Systems Program Directorate (CSPD) manages a commercial trade processing system, the Automated Commercial Environment (ACE), which provides automated tools and information for making admissibility decisions before shipments reach U.S. borders and supports cargo revenue collection. ACE “is not a single operating system but a collection of applications built on diverse multivendor technological platforms.” In 2018, CBP issued a solicitation requesting quotes for “application development and operation and maintenance support services” as part of CSPD’s effort to develop and support cargo systems applications. Harmonia submitted an unsuccessful pre-award agency-level protest to CBP concerning amendments to the solicitation and CBP’s limitation of bid revisions.The Claims Court rejected Harmonia’s subsequent suit on the Administrative Record. The Federal Circuit reversed in part. The Claims Court erred in determining that Harmonia waived its right to assert before the court the same challenges that it asserted in its pre-award protest. The Federal Circuit vacated a holding that CPD did not act in an arbitrary or capricious manner in evaluating Harmonia’s proposal and in making an award decision. The Claims Court must determine the merits of Harmonia’s pre-award protest and what relief, if any, Harmonia is entitled to based on that protest. View "Harmonia Holdings Group, LLC v. United States" on Justia Law

In the 1980s, researchers suggested using mifepristone to treat Cushing’s syndrome, a disease caused by excessive cortisol levels. More than 20 years later, Corcept initiated the first major clinical trial of mifepristone and obtained FDA approval for Korlym, a mifepristone tablet, with postmarketing requirements (21 U.S.C. 355(o)(3)), including a drug-drug interaction clinical trial involving co-administration of ketoconazole. The FDA approved the prescribing information for Korlym on its label, which warned against using mifepristone “with strong CYP3A inhibitors” and limited the “mifepristone dose to 300 mg per day when used with strong CYP3A inhibitors.” Corcept conducted the drug-drug interaction study, then obtained the 214 patent relating to methods of treating Cushing’s syndrome by co-administering mifepristone and a strong CYP3A inhibitor.Corcept asserted the 214 patent against Teva, Teva sought post-grant review, arguing that certain claims would have been obvious in light of Korlym’s label and the FDA memo describing the required drug interaction study (Lee). The Federal Circuit affirmed the Patent Trial and Appeal Board’s rejection of the obviousness claims. The Board did not err by requiring Teva to show a reasonable expectation of success for a specific mifepristone dosage. The general working conditions disclosed in Lee did not encompass the claimed invention. A skilled artisan would not have expected monotherapy and coadministration dosages to behave similarly. View "Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc." on Justia Law

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

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

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

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