Federal Circuit Endorses District Court’s Prima Facie Approach to Obviousness on Summary Judgment

For several years now, the Federal Circuit has seemingly struggled to articulate the proper role of objective evidence of non-obviousness, often referred to as secondary considerations, in obviousness determinations. In accordance with the Supreme Court’s decision in Graham v. John Deere Co., 383 U.S. 1 (1966), the Federal Circuit requires that legal determinations of obviousness be based on factual inquiries regarding: (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) any objective indicia of non-obviousness, such as commercial success, long-felt but unsolved need, failure of others, industry praise, unexpected results, and copying. On one hand, the Federal Circuit has appeared to reject a formal burden-shifting framework under the Graham factors, directing courts to consider all evidence relevant to obviousness or non-obviousness, and to consider it collectively, before reaching a conclusion of obviousness. See, e.g., In re Cyclobenzprine, 676 F.3d 1063, 1077-78 (Fed. Cir. 2012). On the other hand, the Federal Circuit also has held that, in particular cases, a patent owner’s objective evidence failed to overcome a prima facie case of obviousness based on the first three factors. See, e.g., Cubist Pharm., Inc. v. Hospira, Inc., 805 F.3d 1112, 1130 (Fed. Cir. 2015).

On September 7, 2017, in Intercontinental Great Brands LLC v. Kellogg North America Co., a 2-1 panel decision of the Federal Circuit again endorsed the latter approach, affirming a district court’s summary judgment of obviousness. Nos. 2015-2082, 2015-2084, majority slip op. at 1, 14-19 (Fed. Cir. Sept. 7, 2017). Continue reading

Federal Circuit Rejects PTAB’s Articulation of Obviousness Rationale, Disregard for Evidence, and Burden Shifting

On August 25, 2017, a 2-1 Federal Circuit panel vacated and remanded the Patent Trial and Appeal Board’s affirmance of an examiner’s obviousness rejection of Stepan Company’s herbicide formulation patent claims, holding that the Board “failed to adequately articulate its reasoning, erroneously rejected relevant evidence of nonobviousness, and improperly shifted to Stepan the burden of proving patentability.” In re Stepan Co., No. 2016-1811, slip op. at 6 (Fed. Cir. Aug. 25, 2017). Continue reading

Eyes on Alice: Improved Computer Memory System Patent Eligible

In the wake of the Supreme Court’s decision in Alice Corp. v. CLS Bank International, 134 S. Ct. 2347 (2014), the Federal Circuit has issued a series of precedential decisions attempting to delineate between patent-eligible and patent-ineligible improvements in computer-related technology.  On August 15, 2017, the Federal Circuit issued another important precedential decision on the subject, concluding that U.S. Patent No. 5,953,740, which claims computer memory systems having certain features, is directed to patent eligible subject matter under 35 U.S.C. § 101.  Continue reading

Federal Circuit Clarifies Boundaries of Discovery During Litigation Under the BPCIA

This week, the Federal Circuit issued a much-anticipated precedential decision in Amgen, Inc. v. Hospira, Inc., No. 2016-2179 (Fed. Cir. Aug. 10, 2017), rejecting Amgen’s efforts to compel discovery regarding aspects of Hospira’s biosimilar application relevant to patents Amgen chose not to identify during the “patent dance” established by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). While much of the court’s discussion is dictum, the opinion nonetheless provides important guidance to reference product sponsors regarding what patents can and should be identified under 42 U.S.C. § 262(l)(3)(A). Continue reading

PTAB Obviousness Determination Vacated and Remanded for Flawed Analysis of Unexpected Results

When a patent claims an invention directed toward a combination of previously known elements, evidence that the combination produced unexpected results can often play a critical role in rebutting a challenge to the patent’s validity based on obviousness. On August 1, 2017, in Honeywell International Inc. v. Mexichem Amanco Holdings S.A. DE C.V., the Federal Circuit rejected a Patent Trial and Appeal Board obviousness determination that failed to properly consider such evidence in two merged inter partes reexaminations. No. 2016-1996, slip op. (Fed. Cir. Aug. 1, 2017). Continue reading

Federal Circuit Affirms Inequitable Conduct Ruling Imposed in Part as Sanction for Litigation Misconduct

On July 27, 2017, a Federal Circuit panel affirmed 2-1 a district court’s determination that Regeneron Pharmaceuticals, Inc.’s patent on genetically modified mice is unenforceable due to inequitable conduct during prosecution of the patent. In Regeneron Pharmaceuticals, Inc. v. Merus N.V., the Federal Circuit upheld the district court’s unconventional approach to finding inequitable conduct, holding that the district court did not clearly err in finding the prior art Regeneron withheld from the Patent Office to be “but-for material” to patentability and did not abuse its discretion by drawing an adverse inference of specific intent to deceive the Patent Office as a sanction for Regeneron’s misconduct during litigation, and therefore, the district court did not abuse its discretion in holding the patent unenforceable due to inequitable conduct. No. 2016-1346 (Fed. Cir. July 27, 2017) (precedential).

During prosecution of Regeneron’s patent-in-suit, and only days before its allowance, a third-party submitted three relevant prior art references to the Patent Office during prosecution of another application related to the patent-in-suit. Regeneron’s in-house counsel admittedly knew of these references, as well as a fourth reference authored by a member of Regeneron’s scientific advisory board. Regeneron disclosed the references in other related Regeneron patent applications after the patent-in-suit was allowed but never disclosed them during prosecution of the patent-in-suit. Continue reading

Federal Circuit Rejects District Court’s Invalidity Finding Based on Key Tenets of Non-Obviousness

On July 17, 2017, the Federal Circuit issued a precedential decision heavily criticizing the district court’s obviousness analysis invalidating U.S. Patent No. 7,713,446, directed toward a product for the treatment of oncology disease.

In Millennium Pharmaceuticals, Inc., v. Sandoz, Inc., a Hatch-Waxman litigation, the Federal Circuit reversed the United States District Court for the District of Delaware’s finding of invalidity and vacated judgment that was entered based on collateral estoppel.  Nos. 2016-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1109, 2016-1110, 2016-1283, 2016-1762, slip op. at 3 (Fed. Cir. July 17, 2017).  The Federal Circuit held that the district court clearly erred in a number of its legal conclusions in its determination of obviousness under 35 U.S.C. § 103. Continue reading