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?”

The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as their devices transition from Emergency Use Authorizations (EUAs). Just over three hundred EUAs were issued for diagnostic devices during the COVID-19 pandemic. In the announcement, the FDA characterized the issuance of EUAs as “proactive steps to help facilitate the availability of critical medical devices, including in vitro diagnostic tests.” Draft versions of the guidance documents were made available for public comment in December 2021.

BERTINI v. APPLE INC.
Before Moore, Taranto and Chen. Appeal from the Patent Trial and Appeal Board.
Summary: Tacking a mark for one good or service does not grant priority for every other good or service in the trademark application.

IRONBURG INVENTIONS LTD. v. VALVE CORP.
Before Lourie, Clevenger, and Stark. Appeal from the United States District Court for the Western District of Washington.
Summary: The patentee has the burden of proving that invalidity grounds not raised in a petition for inter partes review could reasonably have been raised.

ROKU, INC. v. UNIVERSAL ELECTRONICS, INC.
Before Newman, Reyna, and Stoll. Appeal from the Patent Trial and Appeal Board.
Summary: When an appeal from the PTAB addresses only a factual issue, the substantial evidence standard of review applies.