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On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, can be found here.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 The draft guidance covers a wide range of issues, including cybersecurity device design, labeling, and documentation.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.

SUNOCO PARTNERS MARKETING v. U.S. VENTURE, INC.

Before Prost, Reyna, and Stoll. Appeal from the United States District Court for the Northern District of Illinois.

Summary: References to testing in an offer for sale do not necessarily trigger application of the experimental use exception to the on-sale bar defense.

ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of approximately AUD $100 million. ResApp directors announced a unanimous recommendation to sell, and their intent to vote their own shares accordingly. A shareholder vote is scheduled for June.

Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.” The company’s website states that their “mission is to enable manufacturers and their suppliers to develop and maintain products that aren’t just safe, but are also secure.”

APPLE INC. v. ZIPIT WIRELESS, INC. [OPINION]- PRECEDENTIAL
Before Hughes, Mayer and Stoll. Appeal from the United States District Court for the Northern District of California.

Summary: Notice letters and related communications may be sufficient to establish personal jurisdiction within a given forum.