Amarin Pharma, Inc., et al. v. Hikma Pharmaceuticals USA Inc., et al.

In Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966), this Court established four factors that a court must consider in determining whether a patent is obvious and therefore unpatentable under 35 U.S.C. § 103. Three of those factors relate to technical differences between the invention and the prior art. The fourth factor concerns objective facts indicating that the field of art did not treat the claimed invention as obvious. These objective indicia include long-felt but unresolved needs ultimately addressed by the invention, failure of others to make the invention, and commercial success of products embodying the invention. This Court has made clear that objective indicia must be considered along with the other factors before concluding that any invention is obvious, so that real world indicators—which are often the strongest evidence of nonobviousness—may guard against the risk that patents will incorrectly appear obvious in hindsight. The Federal Circuit has improperly relegated objective indicia of nonobviousness to a secondary role. Under the Federal Circuit’s framework, a court first considers only the three technical Graham factors and reaches a conclusion of “prima facie” obviousness. Only then does the court consider objective indicia, merely as a basis for rebutting a conclusion already reached. The result is over-invalidation of patents through hindsight bias and the suppression of innovation. The question presented is: Whether a court must consider objective indicia of nonobviousness together with the other factors bearing on an obviousness challenge before making any obviousness determination. (i)