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.
Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda. According to BioNTech’s press release, the modular factory consists of six ISO-sized shipping containers that will arrive in Rwanda sometime in early 2023. Reports indicate that the modular units were manufactured in Germany and will be filled and finished by local partners in Ghana and South Africa.
GRACE INSTRUMENT INDUS. V. CHANDLER INSTRUMENTS CO.
Before Chen, Cunningham, and Stark. Appeal from the United States District Court for the Southern District of Texas.
Summary: Terms of degree are not indefinite when the specification provides guidance as to their meaning.
In Re Google LLC
Before: Moore, Lourie, and Prost. Appeal from the Patent Trial and Appeal Board.
Summary: The PTO’s arguments on appeal did not reflect the record below.
IN RE: STINGRAY IP SOLUTIONS, LLC
Before Lourie, Taranto, and Stark. Appeal from the United States District Court for the Eastern District of Texas.
Summary: A defendant’s post-suit, unilateral consent to suit in another state cannot defeat personal jurisdiction under Fed. R. Civ. P. 4(k)(2).
DIONEX SOFTRON GMBH v. AGILENT TECHNOLOGIES, INC.
Before: Reyna, Chen, and Stark. Appeal from the Patent Trial and Appeal Board.
Summary: The PTAB did not err in considering evidence corroborating actual reduction to practice when determining priority in an interference proceeding.
Cochlear implant developer Advanced Bionics LLC will pay about $12 million to resolve allegations that it misled federal health care programs, the United States Department of Justice (DOJ) announced. The allegations were in connection with information provided within pre-market approval (PMA) applications to the FDA for cochlear implant processors, as reported by a DOJ press release dated December 20, 2022.
