Florida is more than just the home of alligators and presidential candidates. The state was recently ranked as the fourth largest “medical device state” in the U.S., after California, Minnesota, and Massachusetts. It was estimated to have the third largest “total medical technology employment, with nearly 24,000 jobs, and No. 7 in total revenue generated in the sector, with $6.09 billion.” Florida has also recently been recognized as having the nation’s “second-largest pharmaceuticals manufacturing industry” and “the fourth-largest biotech R&D industry.”
Quest Diagnostics recently announced a multi-faceted collaboration with PathAI to improve diagnoses in cancer and other diseases using AI pathology innovations.
LKQ Corp. v. GM Glob. Tech. Operations LLC [EN BANC OPINION]
Before Moore, Lourie, Dyk, Prost, Reyna, Taranto, Chen, Hughes, Stoll, and Stark. Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board.
Summary: Sitting en banc, the Federal Circuit overruled the Rosen-Durling test for determining whether a design patent is invalid as obvious, instead adopting “a more flexible” approach
Core Optical Technologies, LLC v. Nokia Corporation
Before Dyk, Mayer, and Taranto. Appeal from the Central District of California.
Summary: Applying California law, the phrase “entirely on my own time” in an employment agreement was found ambiguous and therefore precluded summary judgment of no standing to sue for patent infringement.
IOENGINE, LLC v. Ingenico Inc.
Before Lourie, Chen, and Stoll. Appeal from the Patent Trial and Appeal Board.
Summary: Claim limitations requiring communications to be “encrypted” or to deliver “program code” were not subject to the printed matter doctrine.
PACKET INTELLIGENCE LLC v. NETSCOUT SYSTEMS, INC.
Before Lourie, Hughes, and Stark. Appeal from the U.S. District Court for the Eastern District of Texas.
Summary: An infringement judgment is only sufficiently “final” to be immune from a later finding of unpatentability if the litigation has moved to a stage that leaves nothing for the court to do but execute the judgment.
LUV N’ CARE, LTD. v. LAURAIN
Before Reyna, Hughes, and Stark. Appeal from the Western District of Louisiana.
Summary: The district court correctly found unclean hands, but erred by finding no inequitable conduct without addressing the collective weight of the evidence of prosecution misconduct.
Profound Medical (Nasdaq: PROF) has received FDA 510(k) clearance for its second AI model aimed at treating prostate cancer. Profound Medical is a Toronto-based company, which specializes in developing and marketing customizable, non-invasive therapies for tissue ablation. The newly cleared AI model, called the Contouring Assistant, complements Profound Medical’s TULSA-Pro system, which is designed for transurethral ultrasound ablation (TULSA) procedures.
On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs).[1] The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are within the purview of the FDA.[2] The final rule will publish on May 6, 2024.[3] Until then, the unpublished version is available. [4]
Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties. The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently released a dataset to assist medical device firms in this process. The information addresses capabilities of third-party analytical chemistry labs.
