SANDERLING MANAGEMENT LTD. v. SNAP INC.
Before Chen, Cunningham, and Stark. Appeal from the United States District Court for the Central District of California.
Summary: The district court properly found that digital imaging processing method claims were patent ineligible under 35 U.S.C. §101.

HEALTHIER CHOICES MANAGEMENT CORP. V. PHILIP MORRIS USA, INC.
Before Taranto, Stoll, and Cunningham. Appeal from the United States District Court for the Northern District of Georgia.
Summary: A plaintiff can sufficiently disavow statements contained in attachments to a complaint by making specific, targeted contentions in the complaint to contradict such statements.

On April 21, 2023, the Supreme Court granted a stay in Alliance for Hippocratic Medicine v. FDA, a case concerning the Food and Drug Administration’s approval of and access to the widely used abortion pill mifepristone. The stay preserves access to mifepristone as the Biden administration and Danco Laboratories, the drug’s manufacturer, appeal a lower court ruling that would greatly limit the availability of the drug.

The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to analyze vast amounts of patient data and provide diagnoses as well as personalized treatment recommendations. In recent years, the FDA has approved various AI-enabled medical devices, some of which are discussed below.

The “Orange Book”, more formally known as Approved Drug Products with Therapeutic Equivalence Evaluations, identifies U.S. Food and Drug Administration (FDA) approved drug products as well as any related patent and exclusivity information. After FDA approval of a New Drug Application (NDA) filed on a drug, pharmaceutical patents are only listable in the Orange Book if they claim either a method of using the drug or the drug product itself. Once a patent is listed in the Orange Book, the NDA filer can gain a number of regulatory benefits under the Hatch-Waxman Act, including the possibility of preventing FDA approval of potentially infringing products by generic manufacturers.

Occurring Milk ComponentsIn ChromaDex, Inc. v Elysium Health, Inc., Appeal No. 2022-1116, the Federal Circuit upheld the invalidity of a claim reciting a supplement comprising nicotinamide riboside (“NR”), a component found in cow’s milk, under 35 U.S.C. § 101, finding that the claim read on a product of nature.

SALAZAR V. AT&T MOBILITY LLC
Before Stoll, Schall, and Stark. Appeal from the United States District Court for the Eastern District of Texas.
Summary: While the indefinite article “a” means “one or more” in open ended claims, use of the term “said” indicates that the portion of the claim limitation is a reference back to the previously claimed term, and thus may require a single claim element to be capable of performing all the recited functionality.

ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.
Before Reyna, Schall, and Chen. Appeal from the Patent Trial and Appeal Board.
Summary: Arbutus’ patent was anticipated by an earlier Arbutus patent that incorporated the same references to describe methods of producing stable nucleic acid lipid particles (SNALPs).

Cranial Technologies, Inc. sued Ottobock SE & Co. KGaA and Active Life LLC in the U.S. District Court for the Central District of California on March 29, 2023. The lawsuit alleges that Ottobock’s MyCRO Band and iFab system infringe U.S. Patent No. 7,242,798, titled “Automatic Selection of Cranial Remodeling Device Configuration,” which issued in 2007; and U.S. Patent No. 7,227,979, titled “Automatic Selection of Cranial Remodeling Device Trim Lines,” which issued in 2007.

On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva could be held liable for inducement based on language in its “skinny label” and reinstated a $235 million jury award to GSK that the district court had set aside. The question at the heart of the case—as framed by Teva—is: “If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses?”