Federal Circuit Remands Inter Partes Review Decision Invalidating NuVasive Patent

Federal CircuitIn re NuVasive, Inc., (Fed. Cir. Dec. 7, 2016) (Before Moore, Wallach, and Taranto, J.) (Opinion for the court, Wallach, J.).

NuVasive owns a patent relating to spinal fusion implants. Medtronic petitioned the Patent Trial and Appeal Board (the “Board”) to institute an inter partes review challenging the validity of NuVasive’s patent over several references. The Board instituted the IPR and found the challenged claims obvious over a combination of references.

NuVasive appealed, challenging first that the Board erred in concluding that the references were prior art and second that the Board erred in concluding that Claim 1 of NuVasive’s patent was obvious. The Court vacated and remanded the Board’s decision.

The Court found that NuVasive failed to preserve its challenge to the prior art status of the cited references for appeal. NuVasive waived this challenging when it failed to make this defense to the Board. While NuVasive questioned the prior art status of the references in the preliminary stages of the IPR, it explicitly declined to address the issue later on. Consequently, the Board did not address this issue in its final decision. This resulted in a failure to preserve the issue for appeal.

Recording obviousness, the Court found that the Board’s reasons for finding a motivation to combine the references was deficient, leaving the Court unable to review the Board’s obviousness ruling. Two principles guided this decision: 1) “the [Board] must make the necessary findings and have an adequate evidentiary basis for its findings;” and 2) the [Board] must examine and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made.”

The Board’s obviousness analysis did not comport with these principles. Specifically, the Board failed to articulate why a person of ordinary skill would be motivated to combine the prior art references. Instead, the Board relied on a conclusory statement by Medtronic’s expert and merely summarized the parties’ arguments. Because the Court could not reasonably discern the Board’s reasoning, it could not engage in meaningful judicial review of the obviousness decision. The Court vacated and remanded the decision on obviousness for further clarification by the board.

Arguments not made during an IPR trial before the Board are waived and not preserved for appeal. The Board must provide well-reasoned and non-conclusory explanations for its findings, e.g. re obviousness.

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Robert Schaffer

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

Robert Schaffer

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

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There are currently 1 Comment comments.

  1. Paul Cole December 17, 2016 5:06 am

    As I have noted elsewhere, this is an important and helpful decision with wide implications.

    Vice-Admiral Grace Hopper memorably said: “Leadership is a two-way street, loyalty up, loyalty down. Respect for one’s superiors, care for one’s crew.” It is a pleasure to remember that distinguished lady, whose brilliant work in the field of computers throughout her long lifetime and whose public service could usefully be the subject of a future article on this blog.

    In our field, this can easily and directly be translated. Patentability is also a two-way street, calling for common sense up and common sense down. Common sense in formulating objections and common sense in responding to them. The requirement for common sense was identified in KSR but should not be the monopoly of applicants and patentees: if common sense has to be used in the formulation of patentability arguments, it should also surely be used by patent examiners and judges in the formulation of objections.

    In the context of section 101 eligibility in particular I fear that this maxim is often lost sight of on both sides of the argument. Similarly often on the issue of obviousness.