Justia Patents 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

Seed Company Limited, a Japanese company, is led by Shigeru Tamai. Tamai invented a dispenser of correctional tape enabling users to correct printed documents by rolling white tape over errors. Seed and Tamai applied for patents but the application was denied because of legal counsel’s noncompliance with Patent Office regulations when filing a motion related to the application. As a result of the error, another inventor obtained the patent for the same invention. Seed and Tamai filed a legal malpractice suit against counsel. The district court subsequently granted summary judgment for defendants. The court concluded that the statute of limitations had elapsed with respect to the malpractice claims against one group of defendants - those who ceased working on behalf of Seed and Tamai when the law firm engaged in the representation split into two firms. With regard to the remaining defendants - those who continued to represent Seed and Tamai after the breakup of the firm - the court found that the statute of limitations poses no bar to the malpractice action. On the merits of the claims against those defendants, the court concluded that there is a genuine dispute of material fact about whether the alleged error is one of professional judgment, and whether defendants exercised reasonable care in making the judgment. Accordingly, the court reversed and remanded as to this issue. View "Seed Co. Ltd. v. Westerman" on Justia Law