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What is at the heart of the GSK skinny-label standoff at the CAFC?
I previously blogged about the surprising case, GlaxoKlineSmith v. Teva (GSK), where the Federal Circuit held that a generic pharmaceutical company can, under the right circumstances, be liable for inducing infringement of a method-of-use pharmaceutical patent despite carving out the patented indication from its label. The decision at first spooked the generic pharmaceutical industry, but was then followed by two additional opinions—one related to a panel rehearing, followed by another one, which issued on February 11, 2022, denying a hearing en banc, which included a fiery dissent. These decisions show clear disagreements among the Judges at the Federal Circuit. What is at the heart of this dispute?
Can Amarin benefit from the GSK v. Teva decision regarding induced infringement for off-label sales?
Just when you think the Amarin saga to keep out generic competition is over, something else happens. In the latest development, the Federal Circuit issued a precedential decision in an unrelated case (GlaxoSmithKline v. Teva) that suggests that a generic could potentially be liable for inducing infringement of a patented indication, even though that indication has been carved out of the generic’s label. Will this decision benefit Amarin?
Does Alice require fact questions or not? The Federal Circuit appears split.
Earlier this year, the Federal Circuit issued two precedential decisions that were predicted to stem the tide of early dismissals based upon Alice motions. The cases were Berkheimer v. HP and Aatrix Software v. Green Shades Software, and there were both deemed precedential by the Federal Circuit. A recent concurrence at the Federal Circuit, however, shows that the Court may be splitting over the rationale underpinning Berkheimer and Aatrix, and that split may be heading for the Supreme Court.