The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek a breakthrough device designation prior to requesting market approval regardless of the classification of the device. In order to qualify as a breakthrough device, the device must (1) provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition and (2) meet at least one of: (a) represents a breakthrough technology; (b) no approved or cleared alternatives exist, (c) offers significant advantages over existing approved or cleared alternatives, or (d) device availability is in the best interest of patients.
Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel and bladder control issues. After California-based Axonics Inc. (“Axonics”) entered the sacral neuromodulation market in late 2019, MedTronic sued for patent infringement. Axonics filed for inter partes review (IPR) of the asserted patents at the Patent Trial and Appeal Board (PTAB). Although MedTronic initially prevailed in the IPR, Axonics has now succeeded on appeal at the Federal Circuit.
Trinity Info Media, L.L.C. v. Covalent INC.
Before STOLL, BRYSON, and CUNNINGHAM. Appeal from the United States District Court for the Central District of California.
Summary: Patents directed to connecting users based on their polling answers are abstract because the patents simply use generic computer components without adding more to the abstract idea.
SNIPR Technologies Ltd v. Rockefeller University
Before Chen, Wallach, and Hughes. Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board.
Summary: Patents whose priority is governed exclusively by the AIA are not subject to interference proceedings.
As retailers or distributors that are not manufacturers of a product, companies may believe they cannot infringe a patent claiming how the product is made. After all, the retailers or distributors are not performing any steps of the patented manufacturing process. The companies may have no say in, or even be aware of how the product is manufactured. The companies may conclude they are insulated from liability based simply on being downstream from the manufacturing process.
On August 22-23, 2023, the FDA will conduct an Advisory Committee Meeting to discuss, make recommendations, and vote on renal denervation devices (e.g., devices indicated to reduce blood pressure in patients with hypertension).
INGURAN, LLC, DBA STGENETICS v. ABS GLOBAL, INC., GENUS PLC
Before Lourie, Bryson, and Reyna. Appeal from the United States District Court for the Western District of Wisconsin.
Summary: Claim preclusion does not bar an induced infringement claim that did not exist at the time of the earlier action.
Presidio Medical, Inc. announced that the company successfully concluded a Series C funding round, raising a total of $72 million. The round was led by Deerfield Management, Invus Opportunities, Action Potential Venture Capital, and ShangBay Capital. David Neustaedter, venture partner at Deerfield, joined Presidio’s board in connection with the financing.
On June 5, 2023, Conformal Medical Inc., developer of a left atrial appendage occlusion system, announced a successful Series D funding round, raising a total of $35 million. The round was led by SPRIG Equity with participation from all major Series C investors.
Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device. Recruitment for the clinical trial has not yet started.
