In a recent precedential opinion, the Court of Appeals for the Federal Circuit vacated an infringement judgement against Mylan (Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 2022-1889, Fed. Cir. Nov. 6, 2023). This Abbreviated New Drug Application (ANDA) litigation involved Actelion’s patents related to epoprostenol formulations, which cover Actelion’s brand name product, Veletri®, an injectable drug for treatment of severe pulmonary arterial hypertension.

Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius Sleep device with relation to treatment of insomnia and/or anxiety. The clearance was supported by data collected from a Phase III/pivotal clinical trial carried out in the UK and Ireland by Ulster University and in Hong Kong by PolyU University, Medical Device Network reports.

Cleerly, a digital healthcare company offering artificial-intelligence-based software to identify and measure atherosclerosis from Coronary Computed Tomography Angiography (CCTA) imaging tests, was awarded Best in Class for the Best Use of AI in Health Tech at the 2023 Digital Health Hub Foundation Awards.

IP rights can be vital to the success of medical device companies. Significant legislative changes governing some of these rights may be on the horizon. Senators Coons (Delaware), Durbin (Illinois), Hirono (Hawaii), and Tillis (North Carolina), along with Congressman Ken Buck (Colorado) and Representative Deborah Ross (North Carolina) have introduced the bipartisan, bicameral PREVAIL Act to Congress. The bill is awaiting committee consideration. And like all bills, the PREVAIL Act is subject to amendment prior to passing either chamber of Congress. The bill purports to remedy “[u]nintended consequences of the comprehensive 2011 reform of patent laws [such as] the strategic filing of post-grant review proceedings to depress stock prices and extort settlements, the filing of repetitive petitions for inter partes and post grant review . . . and the unnecessary duplication of work by the district courts” and PTAB. The bill has attracted high profile support, including former Federal Circuit Chief Judge Radar and former Director of the USPTO Andrei Iancu. The PREVAIL Act proposes several significant changes to PTAB proceedings that medical device companies should be aware of.

The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s Automated Impella Controller (AIC), which is part of a medical device system that provides temporary ventricular support to help a patient’s heart to pump blood in a critical care setting.

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.