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.

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.