Amarin Corp Plc (AMRN)

[HDGabor]

H-

A follow-up ... Acc. to Markman:

Q: What is your view about the Astra Zeneca LP v. Apotex Inc. (Nos. 2009-1381, 1424 (Fed. Cir. Nov. 1, 2010) [see also: https://www.fr.com/news/skinny-labeling-and-the-inducement-of-patent-infringement-12-09-2010/]

A: HDGABOR – The Astrazeneca case did not address the issue of induced infringement of a patent covering an off-label indication. The Fish article by Terry Mahn suggests that certain reasoning from Astrazeneca’s opinion could, theoretically, be extended to hold generics liable for induced infringement of patents covering off-label indications. But more recent Federal Circuit cases, which are more on point, have held otherwise. See Takeda v. West-Ward, 785 F.3d 625 (Fed. Cir. 2015). There are always circumstances where a generic could be liable for induced infringement of a patent covering an off-label indication. But that typically requires conduct outside of the label, such as active promotion by Hikma or Dr. Reddy’s of the cardiovascular effects of generic Vascepa. But they are unlikely to do that.

Best,
G