Ameritox, Ltd. v. Millennium Health, LLC

101 F. Supp. 3d 800, 2015 U.S. Dist. LEXIS 51205, 2015 WL 1866085
District Court, W.D. Wisconsin·Decided April 17, 2015·No. No. 13-cv-832-wmc·Published·Cited by 2 cases

Opinion

[802]*802OPINION AND ORDER

WILLIAM M. CONLEY, District Judge.

Defendant Millennium Health, LLC moved in limine for an order excluding any evidence of willful infringement on the basis that Ameritox cannot show by clear and convincing evidence that Millennium “acted despite an objectively high likelihood that its actions constituted infringement of a valid patent.” In re Seagate Technology, LLC, 497 F.3d 1360, 1371 (Fed.Cir.2007)(en banc). The court declined to decide the issue on the eve of trial, opting instead to hear the evidence submitted in the invalidity phase before deciding the objective prong of the willful infringement claim. (4/3/15 Op. & Order (dkt. # 380) 50.)

Having now had the benefit of hearing that evidence, as well as additional arguments and proffers by counsel for the parties, the court finds that Millennium’s invalidity defense under § 103 is objectively reasonable. In particular, for reasons explained below, while the jury had sufficient evidence to find that the combination of the elements of claims 1, 2, 4-7, 10, and 16-18, of the '608 patent were not obvious, the court finds this was a “substantial question” and, therefore, plaintiffs have not met their burden of establishing that Millennium willfully infringed the patent. Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc., 776 F.3d 837, 844 (Fed.Cir.2015) (“Bard II”). The court further finds a substantial question with respect to Millennium’s defense under § 101, although this a closer question given the treatment of patent eligibility at the time of infringement.1

Despite this ruling, the court has also decided to permit the jury to resolve the so-called “subjective” prong of the willfulness standard. This is being done solely to avoid the necessity of an additional trial should the Federal Circuit disagree with this court’s conclusion as to the objective prong, now that the jury has heard substantially, if not all, of the evidence necessary to reach this fact question. This opinion, therefore, further elaborates on the limits of admissible evidence and argument with respect to this question.

OPINION

I. Objective Test

A. § 103 Defense

As Millennium argued to the jury, it believes that the '608 patent is invalid as obvious under 35 U.S.C. § 103. As an initial matter, the court may consider arguments developed during the course of litigation. See Halo Elecs., Inc. v. Pulse Elecs., Inc., 769 F.3d 1371, 1382 (Fed.Cir.2014) (“The court properly considered the totality of the record evidence, including the obviousness defense that Pulse developed during the litigation, to determine whether there was an objectively-defined risk of infringement of a valid patent.” (internal citations and quotations omitted)). The court finds all of the essential elements were present in the prior art, or at least that such a belief was objectively reasonable. The court also finds objectively reasonable the argument that one skilled in the art would make the step of combining these elements using Kell, and substituting creatinine for specific weight. See Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341, 1348 (Fed.Cir.2009) (affirming district court’s finding that the patent was obvious because it would have been “obvious to try” the invention).

[803]*803In no way does this finding upend the jury’s rejection of defendant’s obviousness defense&emdash;the jury had a sound basis for finding that Larson should have been given credit for taking the additional step of identifying a meaningful comparison between an individual’s metabolic urine concentration to a normative data set, notwithstanding persuasive expert testimony to the contrary. The court simply finds that defendant raised a “substantial question” of obviousness to warrant dismissal of plaintiffs’ willful infringement claim on the objective prong. See Bard II, 776 F.3d at 844; see also Spine Solutions, Inc. v. Medtronic Sofamor Danek USA, Inc., 620 F.3d 1305, 1319 (Fed.Cir.2010) (“Although we hold that the record contains substantial evidence to support the jury’s implicit finding that one of skill in the art would not have found the combination obvious, Medtronic was not objectively reckless in relying on this defense.”).

B. § 101 Defense

Given the developing law with respect to § 101, the court also finds a substantial question exists as to how the Supreme Court and Federal Circuit will ultimately land on the patenting of the advancement of combining basic and well-known scientific steps to achieve marginal advance, although highly marketable, in an existing medical product.2 First, as to 35 U.S.C. § 101, the Supreme Court’s holding that the patent considered in Mayo Collaborative Services v. Prometheus Laboratories, Inc., - U.S. -, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012), was invalid under § 101, is supportive of plaintiffs’ position, at least on a facial level. There is substantial evidence that each element (a) through (f) of the claims in the '680 patent were known. Only when one looks more closely at the combination of element (e) and element (f)- and whether there were disputed facts as to whether that combination existed-did the court find the present case distinct from Mayo, at least in the context of summary judgment.3 Given this finer line of distinction between Mayo and the instant case, plaintiffs face a difficult hurdle and cannot discharge their burden of proving by clear and convincing evidence that the objective prong is met. Second, instead of acting like the coarse “filter” it once was, § 101 is considered a strong shield in defending against patent infringement claims, particularly in the post-Alice landscape. Alice Corp. v. CLS Bank Int’l, - U.S. -, 134 S.Ct. 2347, 189 L.Ed.2d 296 (2014). Indeed, § 101 now arguably imposes a “higher bar,” invalidating numerous patents in district courts and inter partes proceedings before the Patent Office. See Cal. Inst. of Tech. v. Hughes Commc’n, 59 F.Supp.3d 974, 978-80 (C.D.Cal.2014). Because of this reinvigoration of the § 101 defense, and the developing case law that will no doubt receive greater elaboration and guidance by the Federal Circuit, if not the United States Supreme Court, Mil[804]*804lennium’s reliance on this defense is objectively reasonable.

II. Subjective Prong

A. Standard

Free access — add to your briefcase to read the full text and ask questions with AI

Ameritox, Ltd. v. Millennium Health, LLC, 101 F. Supp. 3d 800, 2015 U.S. Dist. LEXIS 51205, 2015 WL 1866085 (W.D. Wis. 2015).

101 F. Supp. 3d 800 (Ameritox, Ltd. v. Millennium Health, LLC) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

Related

Wisconsin Alumni Research Foundation v. Apple, Inc.
140 F. Supp. 3d 791 (W.D. Wisconsin, 2015)