SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of smallpox. The U.S., Canada, and Europe have approved an oral formulation for treating smallpox, and Europe has also approved it for treating monkeypox and cowpox. The newly approved intravenous formulation provides an option for patients who are unable to swallow.
KAUFMAN v. MICROSOFT CORPORATION
Before Dyk, Reyna, and Taranto. Appeal from the District Court for the Southern District of New York
Summary: An “automatic” method does not require all steps in the method to be performed without user input and five years delay in bringing a suit is not an undue delay.
MITEK SYS., INC. V. UNITED SERVS. AUTO. ASS’N
Before Dyk, Taranto, and Cunningham. Appeal from the U.S. District Court for the Eastern District of Texas.
Summary: Declaratory judgment plaintiffs must identify particular facts supporting standing and defendants must clearly state whether Rule 12(b)(1) motions to dismiss are facial or factual challenges.
GOOGLE LLC v. IPA TECHNOLOGIES INC.
Before Dyk, Schall, and Taranto. Appeal from the Patent Trial and Appeal Board.
Summary: For purposes of determining whether a reference was prior art, the Board has an obligation to resolve fundamental testimonial conflicts.
On May 13, 2022, Medtronic, Inc. announced that it completed the acquisition of Intersect ENT, Inc. The transaction was only able to gain approval of the Federal Trade Commission (FTC) upon the agreement that Medtronic sell the assets of Fiagon NA Corp., a key subsidiary of Intersect ENT. Medtronic sold Fiagon to Hemostasis LLC and was thereupon able to finalize the acquisition of Intersect ENT.
ATLANTA GAS LIGHT COMPANY v. BENNETT REGULATOR GUARDS, INC.
Before Newman, Lourie, and Stoll
Summary: Termination decision made by the Board in part based on the time-bar was “intimately related” to the institution decision, and therefore not reviewable by the Federal Circuit under 35 U.S.C. §314(d).
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, can be found here.
SOUND VIEW INNOVATIONS, LLC v. HULU, LLC
Before Prost, Mayer, and Taranto. Appeal from the United States District Court for the Central District of California.
Summary: It was improper to find a claim limitation was missing without affirmatively construing the limitation and instead relying on its relation to a term not shown to have a sufficiently uniform meaning in the art.
On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The draft guidance covers a wide range of issues, including cybersecurity device design, labeling, and documentation. The guidance is intended to provide medical device makers a road map on how to satisfy the FDA’s quality system and patient safety regulations and how to address cybersecurity considerations within their premarket submissions.
AURIS HEALTH, INC., v. INTUITIVE SURGICAL OPERATIONS, INC.,
Before Dyk, Prost, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB).
Summary: Evidence of generic industry skepticism cannot, by itself, form the basis to preclude a finding of motivation to combine.
