The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of which is intended for “Advancing Medical Product Availability.” The portion of the requested budget directed to advancing access to safe and effective medical products would be used toward various initiatives, three of which are highlighted in the FDA’s announcement.

INTEL CORP. V. PACT XPP SCHWEIZ AG

Before Newman, Prost, and Hughes. Appeal from the Patent Trial and Appeal Board.

Summary: Under the “known-techniques” rationale, a motivation to combine two prior art references exists when the references address the same problem and one of the references provides a known technique that would suitably address that problem.

ALTERWAN, INC. V. AMAZON.COM, INC., AMAZON WEB SERVICES, INC.

Before Lourie, Dyk, and Stoll. Appeal from the United States District Court for the District of Delaware.

Summary: The Federal Circuit declined to reach the merits of a claim-construction appeal after finding the parties’ stipulation of non-infringement did not provide sufficient detail.

APPLE INC. v. VIDAL

Before Lourie, Taranto, and Stoll. Appeal from the United States District Court for the Northern District of California.

Summary: Judicial review is available to determine whether the PTO Director’s instructions regarding Fintiv IPR dismissals required notice-and-comment rulemaking.

Health Tracker Systems LLC (“Health Tracker”) sued Garmin International, Inc. (“Garmin”) for patent infringement in the Central District of California on March 6, 2023. The lawsuit alleges that Garmin’s Forerunner 45/45S smartwatch infringes U.S. Patent No. 6,582,380, entitled “System and Method of Monitoring and Modifying Human Activity-Based Behavior,” which issued in 2003, and expired in June 2021.

On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s grant of an injunction directing Jazz Pharmaceuticals, Inc. (“Jazz”) to delist U.S. Patent 8,731,963 (“the ’963 patent”) from the Orange Book.

REGENTS OF THE UNIVERSITY OF MINNESOTA V. GILEAD SCIENCES, INC.
Before Lourie, Dyk, and Stoll. Appeal from the Patent Trial and Appeal Board.
Summary: For drug patents, adequate written description of a broad genus claim requires (1) description of the outer limits of the genus and (2) a representative number of genus members or description of structural features common to genus members such that a skilled artisan can visualize or recognize genus members.

JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC
Before Lourie, Reyna, and Taranto. Appeal from the United States District Court for the District of Delaware.
Summary: A patent directed to a system to reduce the misuse of a drug is not a listable patent in the FDA’s Orange Book because the patent does not claim a method of using the drug.

LINE-NETICS, LLC v. NU TSAI CAPITAL LLC
Before Lourie, Taranto, and Stark. Appeal from the U.S. District Court for the District of Nebraska.
Summary: Courts cannot enjoin speech by patentholders to third parties alleging infringement where there is an objectively reasonable basis for the allegations.

HAWKS TECHNOLOGY SYSTEMS, LLC v. CASTLE RETAIL, LLC
Before Reyna, Hughes, and Cunningham. Appeal from the United States District Court for the Western District of Tennessee.
Summary: A court’s failure to exclude extraneous evidence submitted with a motion to dismiss was harmless error where the evidence was immaterial to the court’s invalidity ruling under 35 U.S.C. § 101.