On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s grant of an injunction directing Jazz Pharmaceuticals, Inc. (“Jazz”) to delist U.S. Patent 8,731,963 (“the ’963 patent”) from the Orange Book.
REGENTS OF THE UNIVERSITY OF MINNESOTA V. GILEAD SCIENCES, INC.
Before Lourie, Dyk, and Stoll. Appeal from the Patent Trial and Appeal Board.
Summary: For drug patents, adequate written description of a broad genus claim requires (1) description of the outer limits of the genus and (2) a representative number of genus members or description of structural features common to genus members such that a skilled artisan can visualize or recognize genus members.
JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC
Before Lourie, Reyna, and Taranto. Appeal from the United States District Court for the District of Delaware.
Summary: A patent directed to a system to reduce the misuse of a drug is not a listable patent in the FDA’s Orange Book because the patent does not claim a method of using the drug.
LINE-NETICS, LLC v. NU TSAI CAPITAL LLC
Before Lourie, Taranto, and Stark. Appeal from the U.S. District Court for the District of Nebraska.
Summary: Courts cannot enjoin speech by patentholders to third parties alleging infringement where there is an objectively reasonable basis for the allegations.
HAWKS TECHNOLOGY SYSTEMS, LLC v. CASTLE RETAIL, LLC
Before Reyna, Hughes, and Cunningham. Appeal from the United States District Court for the Western District of Tennessee.
Summary: A court’s failure to exclude extraneous evidence submitted with a motion to dismiss was harmless error where the evidence was immaterial to the court’s invalidity ruling under 35 U.S.C. § 101.
SSI TECHS., LLC v. DONGGUAN ZHENGYANG ELECTRONIC MECHANICAL LTD.
Before Reyna, Bryson, and Cunningham. Appeal from the United States District Court for the Western District of Wisconsin.
Summary: The district court correctly construed the claim of one patent in view of the prosecution history but erred in construing a second patent by limiting the claimed “filter” to specification examples.
On January 31st, 2023, a jury awarded $42 million to medical device company TissueGen in a patent infringement case against Boston Scientific for infringement of U.S. Patent No. 6,596,296, titled “Biodegradable Drug-Releasing Implant.” The ’296 patent relates to a drug releasing biodegradable fiber implant which allows for controlled delivery of therapeutic agents.
Bringing a medical device to market relies on a broad understanding of IP, explain Sabing Lee and Kregg Koch of Knobbe Martens.
The medical device industry is driven by innovation, where great ideas are developed into successful businesses and products to improve patient care and outcomes. As patent attorneys, we witness many different pathways to innovation and guide IP strategies for innovators of all types. From garage start-ups that become global industry leaders to incubators and university-funded research programs, innovation has no common starting point.
In a move that may substantially increase healthtech companies’ exposure to monetary damages, the U.S. Supreme Court agreed to weigh in on the key standard for fraud lawsuits under the False Claims Act (“FCA”). On January 13, 2023, the Supreme Court granted petitions for writs of certiorari in two now-combined 7th Circuit Court whistleblower fraud lawsuits that address the fraud standard– Schutte v. Supervalu Inc. and Proctor v. Safeway.
PERSONALIZED MEDIA COMMUNICATIONS, LLC V. APPLE INC.
Before Reyna, Chen, and Stark. Appeal from the United States District Court for the Eastern District of Texas.
Summary: The district court did not abuse its discretion by holding that Personalized Media Communication’s patent was unenforceable based on prosecution laches.
