For good reasons, including product safety, quality assurance, development of delivery procedures and instructions, it has been a common practice for medical device companies and innovators to consult with physicians during innovation. In a 2021 posting citing an analysis published in the journal Health Affairs, MedTech Dive states that payments to physicians from medical device companies during between 2014 and 2021 totaled $3.6 billion, coming out to $904 million per year.

In Baxalta Incorporated v. Genentech, Inc., 2022-1461, the Federal Circuit affirmed the district court’s decision granting Genentech’s motion for summary judgment that claims 1-4, 9, and 20 of U.S. Patent No. 7,033,590 (“the ’590 patent”) are invalid for lack of enablement.
The ’590 patent is directed to resolving a known issue in treating Hemophilia A, a blood clotting disorder. Previously, to treat Hemophilia A, a patient was often intravenously administered Factor VIII. However, some patients cannot be effectively treated with Factor VIII because their bodies develop Factor VIII inhibitors.

Elekta Limited v. Zap Surgical Systems, Inc.

Before: Reyna, Stoll, and Stark. Appeal from the Patent Trial and Appeal Board.

Summary: Patentee’s failure during prosecution to distinguish relevant art provided support for motivation to combine.

On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving technology.” As stated on the FDA website: “[E]ach person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless” the device meets certain limited exemptions. A 510(k) submission provides, for the FDA’s review, safety and effectiveness data to show that a new device is substantially equivalent to a legally marketed predicate device.

APPLE INC. v. COREPHOTONICS, LTD.

Before Stoll, Linn, and Stark. Appeal from the Patent Trial and Appeal Board.

Summary: An IPR final written decision based on a party’s brief mention of an error in an expert declaration did not satisfy the notice requirements of the APA, where neither party suggested the error was material or dispositive.

NETFLIX, INC. v. DivX, LLC

Before Hughes, Stoll, and Stark. Appeal from the Patent Trial and Appeal Board.

Summary: Petitioner was not required to explicitly identify secondary reference’s “field of endeavor” using specific language when briefing sufficiently communicates the field of endeavor.

On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC (collectively, “Shire”) asked the Supreme Court to review an Eleventh Circuit ruling involving the interplay between state tort law and FDA regulations regarding drug labels. As framed by Shire, the question presented to the Supreme Court is: “Whether a state-law claim is preempted if it places a duty on a drug manufacturer to unilaterally change FDA-approved language that appears in the Highlights section of a drug label.” In order to appreciate what is at stake in this case, a brief summary of the key facts and procedural posture is necessary.

Medtronic Minimed, Inc. and Minimed Distribution Corp. (“Medtronic”) were sued in a class action complaint in the Central District of California on August 30, 2023, by users of Medtronic’s InPen® system. The lawsuit alleges that Medtronic engaged in “transmission and disclosure of Plaintiff’s and Class Members’ personally identifiable information (‘PII’) and protected health information (‘PHI’) [collectively, ‘Private Information’]… to Google[] and other third parties via tracking and authentication technologies – including Google Analytics (and others).”

On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors. Informed consent enables prospective subjects to understand the relevant information concerning a clinical investigation while also providing them the opportunity to pose questions, deliberate on participation, and grant voluntary agreement.

Recent reports, including one by PitchBook, indicate that both venture capitalist funding for medtech companies and the variety of medtech companies receiving venture capitalist funding has increased since the first quarter of 2023.