Managing Partner, Hoffmann & Baron, LLP Featured In Law 360
Daniel A. Scola Jr., Managing Partner at Hoffmann & Baron, LLP, was recently quoted in Law360
- (1888PressRelease) April 12, 2024 - The article, "Judge Lourie's Dissent Revives Debate Over FDA Safe Harbor," by reporter Dani Kass, explores the recent ruling by the Federal Circuit and the dissenting opinion of the U.S. Circuit Judge Alan Lourie regarding the interpretation and application of the safe harbor provision for companies developing products regulated by the U.S. Food and Drug Administration (FDA).
The article highlights Judge Lourie's suggestion that the Federal Circuit review its previous decisions regarding the safe harbor. He believes that the court's broadening of the provision has weakened its original purpose. Several legal professionals, such as Dan Scola, have similar concerns over the wide interpretation of the safe harbor and its impact on patent owners and innovators.
Scola expressed support for an en banc hearing in the Edwards case, stating the court has veered from Congress' intent. He continued, “The investigation of this safe harbor has been slow but very well-defined.”
He further explained, “You start off first with [the safe harbor] applies to drugs, then medical devices, then to people making ingredients for research tools, and then to information that is solely reasonably related.”
To read the article in its entirety, please click here.
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ABOUT DAN SCOLA:
Daniel A. Scola, Jr. is the managing partner of Hoffmann & Baron, LLP, and also manages the chemical, pharmaceutical/biochemical and medical device practice group in the New Jersey office. He has extensive experience in polymers, pharmaceuticals and medical devices. He specializes in building IP portfolios and designing strategies to protect and enhance company value. He also practices extensively in Post Grant Proceedings at the USPTO and has argued Post Grant Proceedings at the appellate level, before the CAFC. Previously, he was Counsel, patents, and trademarks as well as Assistant Corporate Secretary at The Warner-Lambert Co. and Intellectual Property Attorney at Loctite Corporation.
Prior to earning his law degree, Scola was a chemist with particular experience in material science including polymers, adhesives and biodegradable approaches to material engineering. He was a scientist at the Pratt & Whitney Division of United Technologies.
ABOUT HOFFMANN & BARON, LLP:
Hoffmann & Baron is a full-service IP law firm specializing in all areas of intellectual property, both domestically and internationally. Their services include IP procurement as well as litigation, counseling, licensing, and post-grant proceedings. With an entrepreneurial spirit, not usually seen in the legal industry, the firm attracts world-class attorneys. For almost four decades, the practice has become known for its unparalleled ability to protect intellectual property and transform ideas into assets.
Hoffmann & Baron, LLP provides cost-effective intellectual property and business strategies tailored to individual client needs to enhance commercial outcomes. Efficiency, discipline and focus on our client’s commercial success are the governing guides. Established in 1984 by co-founders Charles R. Hoffmann and Ronald J. Baron, the firm has offices in New York, New Jersey, and Washington, D.C. The firm is proud to serve clients around the globe in all scientific and engineering fields, from start-ups to Fortune 500 companies, as well as some of the most respected research institutions.
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