AXONICS, INC. v. MEDTRONIC, INC.

Before Dyk, Lourie, and Taranto. Appeal from the Patent Trial and Appeal Board.

Summary: Where a patent owner in an IPR proposes a claim construction for the first time in a patent owner response, a petitioner must be given the opportunity in its reply to argue and present evidence of anticipation or obviousness under the new construction.

The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD). According to the FDA’s press release, the draft guidance aligns with the FDA’s Overdoes Prevention Framework and aims to advance evidence-based treatment for individuals with substance use disorders.

The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products. This comes as supply chain issues from the COVID-19 pandemic continues to improve, albeit at different speeds around the globe. Non-continuous ventilators had been in short supply since at least August of 2020, according to Medical Design & Outsourcing.

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.