Foley & Lardner LLP partner David Rosen is featured across the media for his perspective on the U.S. Supreme Court case Hikma Pharmaceuticals v. Amarin Pharma.
The case centers on whether generic drug makers using ‘skinny labels’ encourage patent infringement. Rosen told Law360 that the several of the justices’ comments during oral arguments suggest patent owners will have to demonstrate more than simply that a generics maker described its skinny label product as a generic version of a branded drug.
“I don’t think…in their minds, that that in itself was inducement,” he explained, adding that what is less clear is if the court will agree that additional marketing materials are enough to let the case proceed.
In IP Watchdog, Rosen said “Amarin is not challenging the statutory provision providing for skinny labeling,” but instead challenging Hikma’s motion for summary judgment motion which alleged certain advertising induced patent infringement.
Rosen noted the key question is whether Hikma’s advertising “is actively or passively inducing infringement.” He emphasized the significance for the generic pharmaceutical industry and the public, explaining that an overly broad passive inducement standard “will have a chilling effect on generic companies seeking to obtain FDA approval.”
Rosen shared a final takeway in the STAT News article, “Supreme Court to hear case about ‘skinny labeling’ and generic access.”
“This has been going on for quite some time now…The question is what’s the best way to provide better health care for the American public,” he concluded.
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