Justia Intellectual Property 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

A computer scientist, Dr. Stephen Thaler, created an artificial intelligence system called the "Creativity Machine," which autonomously generated an artwork titled "A Recent Entrance to Paradise." Dr. Thaler submitted a copyright registration application to the United States Copyright Office, listing the Creativity Machine as the sole author and himself as the owner. The Copyright Office denied the application, citing its policy that only works authored by humans are eligible for copyright protection.Dr. Thaler sought review of the Copyright Office's decision in the United States District Court for the District of Columbia. The district court affirmed the Copyright Office's denial, holding that human authorship is a fundamental requirement under the Copyright Act of 1976. The court also rejected Dr. Thaler's argument that he should own the copyright under the work-made-for-hire doctrine, as the work was never eligible for copyright protection in the first place. Additionally, the court found that Dr. Thaler had waived his argument that he should be considered the author because he created and used the Creativity Machine.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and affirmed the district court's decision. The court held that the Copyright Act requires all eligible works to be authored by a human being. Since Dr. Thaler listed the Creativity Machine, a non-human entity, as the sole author, the application was correctly denied. The court did not address the argument that the Constitution requires human authorship, nor did it consider Dr. Thaler's claim that he is the author by virtue of creating and using the Creativity Machine, as this argument was waived before the agency. View "Thaler v. Perlmutter" on Justia Law

SoundExchange, a nonprofit entity, charged with the responsibility of collecting royalties for performing artists and copyright owners of music, filed suit under the Copyright Act, 17 U.S.C. 101 et seq., against Muzak, a company that supplies digital music channels to satellite television networks who, in turn, sell to subscribers. SoundExchange alleged that Muzak underpaid royalties owed. The district court dismissed the complaint. The court concluded that the better interpretation of the statute is that the term "service" under section 114(j)(11) contemplates a double limitation; both the business and the program offering must qualify before the transmissions are eligible for the favorable rate. Accordingly, the court reversed the district court. View "SoundExchange, Inc. v. Muzak LLC" on Justia Law