Manufacturers of e-cigarettes find themselves in a challenging regulatory environment to obtain U.S. Food and Drug Administration (FDA) marketing approval of flavored products. On October 12, 2023, the FDA denied premarket authorization of flavored e-cigarette products from R.J. Reynolds Vapor Company under its Vuse Alto brand. This follows on the heels of the U.S. Supreme Court’s denial of e-cigarette manufacturer Avail Vapor’s challenge to the FDA’s rejection of premarket authorization of Avail Vapor’s flavored e-cigarette products, which was affirmed earlier by the U.S. Court of Appeals for the 4th Circuit. This is the latest case in a series of legal setbacks for the vaping industry, which has ballooned into an $8.2 billion market in less than a decade.
Enovis Corporation (“Enovis”) announced on September 25, 2023, that it has agreed to acquire LimaCorporate S.p.A (“LimaCorporate”).
Haemonetics Corporation announced on October 10th that it would be acquiring OpSens, Inc. The deal between the companies is expected to close by the end of January 2024, according to the press release.
The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event of a shutdown, 19% of FDA employees would be furloughed immediately.
On September 26, 2023, Nexus Pharmaceuticals, LLC announced that it had received approval from the U.S. Food and Drug Administration (FDA) for Fluorescein Injection, USP. Nexus Pharmaceuticals is a maker of generic drugs.
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.
