March 23, 2021 Articles

The Role of Objective Indicia of Nonobviousness When Evaluating Whether a Patent Claim Is Obvious

Amarin Pharma, Inc.’s certiorari petition to the Supreme Court raises the question of whether objective indicia of nonobviousness should be evaluated using a “totality of the evidence” approach or as part of a “prima facie” framework.

By Isaac Kim and Richard Kurz

For patent claims, the obviousness question under 35 U.S.C. § 103 has been the most common invalidity issue litigated in both district court and post-grant proceedings before the PTO. Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1074 (Fed. Cir. 2016) (en banc) (Dyk, J., dissenting). When conducting an obviousness analysis, the Supreme Court in Graham v. John Deere Co., 383 U.S. 1 (1966), instructs courts to consider: (1) “the scope and content of the prior art”; (2) “differences between the prior art and the claims at issue”; (3) “the level of ordinary skill in the pertinent art”; and (4) “secondary considerations,” which are also known as objective indicia of nonobviousness. Id. at 17–18. A critical inquiry en route to making a determination on obviousness is how objective indicia may “give light to the circumstances surrounding the origin of the subject matter sought to be patented.” Id. Such objective indicia may include commercial success, long felt but unresolved needs, failure of others, industry praise, and unexpected results. See id.; Apple, 839 F.3d at 1052; In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1075 (Fed. Cir. 2012).   

Amarin’s certiorari petition raises the question of “[w]hether a court must consider objective indicia of nonobviousness together with the other factors bearing on an obviousness challenge before making any obviousness determination.” Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., petition for cert., Case No. 20-1119 (U.S. Feb. 11, 2021) (hereinafter “Amarin Petition”), at i, Question Presented. Amarin argues in the affirmative—that is, the Supreme Court has instructed courts to use a “totality of the evidence” approach when conducting an obviousness analysis, where all Graham factors are given “full and fair consideration” prior to making any obviousness conclusion. Amarin Petition at 2–4, 27. As discussed below, federal circuit panels have decided that this is the correct approach. Nonetheless, according to Amarin, the federal circuit has also authorized the use of a prima facie framework when considering objective evidence. Id. at 3. In the prima facie framework, objective indicia are considered as rebuttal evidence after a prima facie determination of obviousness has been made by the court. Id. at 2–3. This, Amarin asserts, departs from the instructions set forth in Graham and erroneously shifts a burden of proof to the patent owner when defending against obviousness allegations. Id. at 3–4. Amarin contends that the prima facie framework ultimately leads to over-invalidation of patents and suppression of innovation. Id. at i. While at the time of this writing it is unknown whether the Supreme Court will grant the petition, this article in the meantime explores case law setting forth the potentially different treatments given to objective indicia of nonobviousness in courts today.

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