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

Join us for the Complimentary Webinar “SaaS Agreements – A View from the Customer’s Perspective”

Please join us on Tuesday, July 25 at 12:00 p.m. Central for the first session in Michael Best’s 2017 intellectual Property Webinar series “SaaS Agreements – A View from the Customer’s Perspective.”

By 2020, nearly 80 percent of all software will be provided as a service rather than as a copy with a license. Companies that are not already operating in the cloud, will be. In this complimentary webinar, attorneys Derek Stettner and Gregory Helding will discuss key points to consider when negotiating a Software as a Service (SaaS) contract, mainly from a customer’s perspective. Continue reading

Genband v. Metaswitch Outlines Permanent Injunction Standards for Infringing Sales of Multicomponent Products

This week the Federal Circuit issued its decision in Genband US LLC v. Metaswitch Networks Corp., No. 2017-1148 (Fed. Cir. July 10, 2017) (precedential), which vacated a district court’s order denying a request for a permanent injunction in a case involving two competitors in the telecommunications industry. The opinion synthesizes and clarifies a prior series of rulings regarding the proper standards for evaluating irreparable harm in requests for injunctive relief regarding sales of multicomponent products. Continue reading

Federal Circuit Reverses Eastern District of Texas Denial of Attorneys’ Fees Motion

A little over three years ago, the Supreme Court’s decisions in Octane Fitness, LLC v. Icon Health & Fitness, Inc., 134 S. Ct. 1749 (2014) and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., 134 S. Ct. 1744 (2014) drastically changed the Federal Circuit’s standards governing the award of attorneys’ fees under 35 U.S.C. § 285, making attorneys’ fees easier to recover in district court patent litigation and increasing deference toward fee decisions on appeal. In Highmark, the Supreme Court held that “an appellate court should review all aspects of a district court’s § 285 determination for abuse of discretion.” 134 S. Ct. at 1747. And in Octane, the Supreme Court explained that § 285 “imposes one and only one constraint” on that discretion—“[t]he power is reserved for ‘exceptional’ cases,” which the Supreme Court characterized as those standing out from others “with respect to the substantive strength of a party’s litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated.” 134 S. Ct. at 1755-56. Since that time, the Federal Circuit has had a number of occasions to address § 285 determinations by the district courts and generally recognized the deference owed to the district courts in deciding fee motions. However, it also has recognized that deference is not absolute. Continue reading