Amarin Corp Plc (AMRN)

[HDGabor]

g- (&Piyao)

Something like:

a) Motivation to Combine

Federal Circuit “case law does not require that a particular combination must be the preferred, or the most desirable, combination described in the prior art in order to provide motivation for the current invention.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (internal quotation omitted). “The question is whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination, not whether there is something in the prior art as a whole to suggest that the combination is the most desirable combination available.” Id. (citation omitted). “[T]here is no requirement that the prior art contain an express suggestion to combine known elements to achieve the claimed invention.” Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1472 (Fed. Cir. 1997).

“Conclusive proof of efficacy is not necessary to show obviousness. All that is required is a reasonable expectation of success.” Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014) (citation omitted). Difficulties in receiving FDA approval “are not particularly probative with respect to obviousness” because “[t]here is no requirement that one of ordinary skill have a reasonable expectation of success in developing” the FDA approved drug. Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1292 (Fed. Cir. 2013).

Best,
G