Justia Government & Administrative Law Opinion Summaries

Norwich Pharmaceuticals sought to market a generic version of Xifaxan, a drug invented by Salix Pharmaceuticals for treating irritable bowel syndrome with diarrhea and hepatic encephalopathy. Norwich submitted an Abbreviated New Drug Application (ANDA) to the FDA, identified as number 214369. Salix believed this ANDA infringed its patents and sued Norwich in the United States District Court for the District of Delaware. That court found Norwich’s ANDA infringed Salix’s patents related to hepatic encephalopathy, while the patents for irritable bowel syndrome were invalid as obvious. The court’s final judgment barred FDA approval of Norwich’s ’369 ANDA until Salix’s hepatic encephalopathy patents expired in October 2029.Following the judgment, Norwich amended its ’369 ANDA to remove the indication for hepatic encephalopathy and requested the Delaware District Court modify its judgment to allow immediate FDA approval of the amended ANDA. The court denied this motion, reasoning that Norwich could not change its ANDA after final judgment to circumvent the prior ruling. Norwich appealed to the United States Court of Appeals for the Federal Circuit, which agreed the judgment restricted approval of the entire ANDA, including non-infringing indications, until 2029, and affirmed the Delaware District Court’s decision.After the FDA declined to grant final approval of Norwich’s amended ANDA, instead issuing only tentative approval, Norwich sued in the United States District Court for the District of Columbia, arguing the FDA acted arbitrarily and capriciously. The court granted summary judgment to the FDA and Salix. On appeal, the United States Court of Appeals for the District of Columbia Circuit held that the Delaware District Court’s judgment applied to Norwich’s ANDA as amended, so the FDA correctly delayed final approval until October 2029. The appellate court affirmed the district court’s judgment. View "Norwich Pharmaceuticals, Inc. v. Kennedy" on Justia Law

The dispute centers on the HAVANA CLUB trademark, originally registered in the United States in 1976 by a Cuban state-owned company, Cubaexport. Due to changes in U.S. law, renewal of the trademark registration required a specific license from the Treasury’s Office of Foreign Assets Control (OFAC) after 1998. In December 2005, Cubaexport submitted its renewal application and payment to the United States Patent and Trademark Office (PTO) without the required OFAC license. OFAC later notified the PTO that the payment was unauthorized, leading to the PTO’s refund of the fee and refusal to renew the registration. Cubaexport unsuccessfully litigated against OFAC and, in 2015, reapplied for the license, which OFAC granted retroactively in 2016, authorizing the 2005 payment.After the PTO Director accepted Cubaexport’s renewal filing based on the retroactive OFAC license, Bacardi sued the PTO and its Director in the United States District Court for the Eastern District of Virginia. Bacardi argued the PTO lacked statutory authority to renew the expired registration and acted arbitrarily and capriciously. The district court initially dismissed the case, finding judicial review precluded by the Lanham Act, but the United States Court of Appeals for the Fourth Circuit reversed and remanded. On remand, Cubaexport intervened, and after cross-motions for summary judgment, the district court granted judgment for the defendants, finding the OFAC license validated the payment and that any deficiency was cured during the petition process.Reviewing the district court’s summary judgment de novo, the United States Court of Appeals for the Fourth Circuit held that the PTO Director acted within statutory authority, as the retroactive OFAC license validated the 2005 payment, satisfying the renewal requirements. The court also held the Director’s explanation for the renewal was reasonable and not arbitrary or capricious. The Fourth Circuit affirmed the district court’s judgment. View "Bacardi and Company Limited v. Squires" on Justia Law

A volunteer affiliated with a nonprofit focused on innovation requested documents under the Freedom of Information Act (FOIA) from the United States Patent and Trademark Office (PTO). The request sought information related to an adversary proceeding before the Patent Trial and Appeal Board (PTAB), particularly concerning the panel of judges assigned, changes to the panel, and drafts of the written decision. The proceeding involved a motion for recusal due to a judge’s stock ownership and subsequent reassignment of panel members. The FOIA request specifically targeted documents reflecting the identities and opinions of involved judges, membership of the Circulation Judge Pool, legal bases for judge participation, and information about stock holdings.The PTO produced about 1,500 pages of documents but withheld drafts of decisions and related communications, citing FOIA Exemption 5, which covers predecisional and deliberative documents. The United States District Court for the Eastern District of Virginia reviewed cross-motions for summary judgment and ruled in favor of the PTO, finding that the withheld documents were both predecisional and deliberative. The court rejected arguments that the communications constituted unlawful ex parte communications or government misconduct, determining there was no basis under FOIA to compel disclosure. The court also concluded that the plaintiff’s broader claims were not appropriately raised in a FOIA action.On appeal, the United States Court of Appeals for the Fourth Circuit affirmed the district court’s judgment. The appellate court held that the PTO properly withheld the drafts and related communications under Exemption 5, finding them categorically predecisional and deliberative. The court further determined that intra-agency circulation of draft opinions among judges did not constitute ex parte communications and that FOIA does not provide a government misconduct exception for Exemption 5. View "Malone v. United States Patent & Trademark Office" on Justia Law

Several technology companies challenged instructions issued by the Director of the United States Patent and Trademark Office (PTO) that guided the Patent Trial and Appeal Board (Board) in deciding whether to institute inter partes review (IPR) proceedings. These instructions, known collectively as the NHK-Fintiv instructions, outlined factors for the Board to consider when parallel patent litigation was occurring in district court. The challengers argued that these instructions resulted in too many denials of IPR petitions and were contrary to law, arbitrary and capricious, and issued without the required notice-and-comment rulemaking under the Administrative Procedure Act (APA).The United States District Court for the Northern District of California initially found all challenges to the PTO’s instructions to be judicially unreviewable. On appeal, the United States Court of Appeals for the Federal Circuit previously held that while the challenges based on statutory and arbitrary-and-capricious grounds were unreviewable, the claim regarding the lack of notice-and-comment rulemaking could proceed. On remand, the district court determined that the instructions were exempt from notice-and-comment requirements because they were “general statements of policy,” not substantive or legislative rules.The United States Court of Appeals for the Federal Circuit reviewed the district court’s decision de novo. The court agreed that the Director’s instructions were general statements of policy exempt from notice-and-comment rulemaking under 5 U.S.C. § 553(b). It emphasized that there is no statutory right to IPR institution, that the instructions do not bind the Director, and that the Director retains unreviewable discretion to institute or deny IPR. The court found that none of the legal standards or precedents cited by the challengers required a different result, and it affirmed the district court’s judgment rejecting the APA-based challenge. View "APPLE INC. v. SQUIRES " on Justia Law

The plaintiffs in this case are the sons of Roberto Clemente, a renowned Puerto Rican baseball player, and two corporations they control. The dispute centers on the Commonwealth of Puerto Rico’s use of Clemente’s name and image on commemorative license plates and vehicle registration tags. Proceeds from these items were designated to fund a new “Roberto Clemente Sports District,” a public project that would replace an earlier initiative, Ciudad Deportiva, originally founded by Clemente. The plaintiffs allege that they hold trademark rights in Clemente’s name and that the Commonwealth’s actions were unauthorized and caused public confusion, with many mistakenly believing the Clemente family benefited financially from the program.The plaintiffs brought suit in the United States District Court for the District of Puerto Rico against the Commonwealth, several high-ranking officials, and the Puerto Rico Convention Center District Authority. Their claims included trademark infringement, false association, false advertising, and trademark dilution under the Lanham Act, as well as a takings claim under the Fifth and Fourteenth Amendments. The Commonwealth and the Authority moved to dismiss, arguing sovereign and qualified immunity and failure to state a claim. The district court granted both motions, dismissing all federal claims on immunity and merits grounds, and declined to exercise jurisdiction over non-federal claims.On appeal, the United States Court of Appeals for the First Circuit reviewed the dismissal de novo. The court affirmed the dismissal of all claims against the Authority and all claims against the Commonwealth and its officials in their official capacities. It also affirmed dismissal of the false advertising and takings claims. However, the court vacated the dismissal of the Lanham Act claims for trademark infringement, false endorsement, and dilution against the Commonwealth officials in their personal capacities, holding those claims were plausibly alleged and not barred by qualified immunity at this stage, and remanded for further proceedings. View "Clemente Properties, Inc. v. Pierluisi-Urrutia" on Justia Law

Causam Enterprises, Inc. owns several patents related to “demand response” technology, which allows electrical utilities to reduce power demand in response to certain conditions. Causam filed a complaint with the United States International Trade Commission (ITC), alleging that Resideo Smart Homes Technology (Tianjin) and its affiliate Ademco, Inc. were importing and selling internet-connected smart thermostats that infringed method claim 1 of U.S. Patent No. 10,394,268, which Causam claimed to own. Causam sought to exclude these products from importation. During the ITC investigation, respondents argued that Causam did not own the patent and that Resideo’s products did not infringe the asserted claims.The assigned administrative law judge (ALJ) at the ITC found that Causam did not own the ’268 patent and that Resideo’s products did not infringe the claims. The full Commission, upon review, adopted only the noninfringement finding and did not address the ownership issue. Causam appealed to the United States Court of Appeals for the Federal Circuit, challenging the noninfringement determination and seeking a ruling on ownership. Meanwhile, the Patent Trial and Appeal Board (PTAB) held, in a separate inter partes review, that claim 1 of the ’268 patent was unpatentable, and the Federal Circuit affirmed that decision in a companion case.The United States Court of Appeals for the Federal Circuit held that Causam owns the ’268 patent, interpreting the relevant assignment agreements to exclude continuations-in-part from a prior assignment, thus leaving ownership with Causam. However, the court did not reach the noninfringement issue because its affirmance of the PTAB’s finding that claim 1 is unpatentable rendered the appeal moot. The court therefore dismissed the appeal as moot. View "CAUSAM ENTERPRISES, INC. v. ITC " on Justia Law

Two advocacy organizations submitted a petition to the United States Patent and Trademark Office (PTO) seeking a rule that would limit the PTO’s discretion to institute inter partes review (IPR) and post-grant review (PGR) proceedings under the America Invents Act. Their proposed rule would have prevented institution of such proceedings in certain circumstances when the patent owner objected and met specific criteria, such as being the original applicant and having small entity status. The PTO denied the petition, stating that the issues overlapped with topics already under consideration in a separate request for public comment and that the suggestions would be considered in any future rulemaking.After the denial, the organizations filed a lawsuit in the United States District Court for the District of Columbia, alleging that the PTO’s denial violated the Administrative Procedure Act and the America Invents Act. They argued that the PTO failed to act within a reasonable time, did not provide adequate reasons for denial, and was required to engage in notice-and-comment rulemaking. The PTO moved to dismiss the complaint for lack of standing. The district court granted the motion, finding that the organizations lacked both organizational and associational standing because they failed to show that any member faced a concrete, non-speculative injury as a result of the PTO’s denial.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the dismissal de novo. The court held that the organizations lacked associational standing because they did not demonstrate that any member suffered an actual or imminent injury traceable to the PTO’s denial of the petition. The court found the alleged injury too speculative, relying on a chain of uncertain future events involving third-party actions. The Federal Circuit affirmed the district court’s dismissal for lack of standing. View "US INVENTOR, INC. v. PTO " on Justia Law

A state port authority and a group of related companies entered into a series of letters of intent (LOIs) regarding the possible expansion and operation of a port facility. The final LOI, signed in December 2019, included provisions for confidentiality, exclusivity, and certain legally binding terms, but also stated that it was not a binding agreement to consummate the potential transaction. The port authority’s board approved the LOI and several subsequent extensions, but the board minutes did not include the terms or conditions of the LOI. After negotiations failed, the port authority terminated the LOI. The companies claimed significant losses and alleged the port authority had breached the LOI and misused confidential information.The Harrison County Circuit Court found that the LOI was unenforceable under Mississippi’s “minutes rule,” which requires that public board contracts be sufficiently detailed in the board’s official minutes. The court dismissed all claims based on the LOI, including breach of contract and quantum meruit, but allowed claims for unjust enrichment and misappropriation of trade secrets to proceed. Both parties sought interlocutory appeal, and the appeals were consolidated.The Supreme Court of Mississippi affirmed the lower court’s ruling that the LOI was unenforceable because the board minutes did not contain enough terms to determine the parties’ obligations, and held that the minutes rule was not superseded by the Open Meetings Act. The court also held that unjust enrichment, as an implied contract claim, was barred by the minutes rule and reversed the trial court’s denial of summary judgment on that claim. However, the court affirmed that the companies’ notice of claim regarding misappropriation of trade secrets was sufficient under the Mississippi Tort Claims Act. The case was remanded for further proceedings on the remaining claim. View "The Mississippi State Port Authority at Gulfport v. Yilport Holding A.S." on Justia Law

CPI Security Systems, Inc. filed a lawsuit against Vivint Smart Home, Inc., alleging that Vivint engaged in deceptive practices to lure away CPI’s customers. Vivint sales representatives falsely claimed that Vivint had acquired CPI, that CPI was going out of business, or that Vivint needed to upgrade CPI’s equipment. These tactics led many CPI customers to switch to Vivint, causing significant losses for CPI. A jury found Vivint liable for violating the Lanham Act, the North Carolina Unfair and Deceptive Trade Practices Act (UDTPA), and for committing the common-law torts of unfair competition and tortious interference with contracts. The jury awarded CPI $49.7 million in compensatory damages and $140 million in punitive damages.The United States District Court for the Western District of North Carolina upheld the jury’s verdict. Vivint appealed, raising several issues, including the requirement of CPI’s reliance on false statements for the UDTPA claim, the sufficiency of evidence supporting the damages award, the application of North Carolina’s cap on punitive damages, and the admission of prejudicial evidence.The United States Court of Appeals for the Fourth Circuit reviewed the case and found no reversible error. The court held that CPI was not required to prove its own reliance on Vivint’s false statements to establish a UDTPA claim, as the claim was based on unfair competition rather than fraud. The court also found that the evidence presented by CPI was sufficient to support the jury’s damages award. Additionally, the court ruled that the district court correctly applied North Carolina’s cap on punitive damages by considering the total compensatory damages awarded. The court further held that the district court did not abuse its discretion in denying Vivint’s motion to bifurcate the trial or in its evidentiary rulings. The reassignment of the trial judge post-trial did not warrant a new trial. Consequently, the Fourth Circuit affirmed the district court’s judgment. View "CPI Security Systems, Inc. v. Vivint Smart Home, Inc." on Justia Law

The case involves Bacardi & Company Limited and Bacardi USA, Inc. (collectively, Bacardi) and the United States Patent and Trademark Office (PTO). Bacardi claimed that the PTO violated Section 9 of the Lanham Act and its own regulations by renewing a trademark registration ten years after it expired. The trademark in question is the "HAVANA CLUB," originally registered by a Cuban corporation, José Arechabala, S.A. In 1960, the Cuban government seized the corporation's assets, and by 1974, the U.S. trademark registrations for HAVANA CLUB rum had expired. Later, a company owned by the Cuban government registered the HAVANA CLUB trademark in the U.S. for itself. Bacardi, which had bought the interest in the mark from Arechabala, filed its own application to register the HAVANA CLUB mark and petitioned the PTO to cancel the Cuban government-owned company's registration.The PTO denied Bacardi's application due to the Cuban government-owned company's preexisting registration, and the Trademark Trial and Appeal Board (TTAB) denied Bacardi's cancellation petition. Bacardi then filed a civil action challenging the TTAB's denial of cancellation. Meanwhile, the Cuban government-owned company's registration was set to expire in 2006, unless it renewed its trademark. However, due to a trade embargo, the company was not permitted to pay the required renewal fee without first obtaining an exception from the Department of the Treasury’s Office of Foreign Assets Control (OFAC). OFAC denied the company's request for an exception, and the PTO notified the company that its registration would expire due to the failure to submit the renewal fee on time.The United States Court of Appeals for the Fourth Circuit reversed the district court's judgment that dismissed Bacardi's lawsuit for lack of subject matter jurisdiction. The court concluded that the Lanham Act does not foreclose an Administrative Procedure Act (APA) action for judicial review of the PTO’s compliance with statutes and regulations governing trademark registration renewal. The court found that the Lanham Act does not expressly preclude judicial review of PTO registration renewal decisions or fairly implies congressional intent to do so. Therefore, the APA’s mechanism for judicial review remains available. The case was remanded for further proceedings. View "Bacardi and Company Limited v. United States Patent & Trademark Office" on Justia Law