Ameritox, Ltd. v. Millennium Health, LLC

• Decision Date: 18 February 2015
• Docket Number: No. 13–cv–832–wmc.,13–cv–832–wmc.
• Citation: 88 F.Supp.3d 885
• Parties: AMERITOX, LTD., and Marshfield Clinic, Inc., Plaintiffs, v. MILLENNIUM HEALTH, LLC, Defendant.
• Court: U.S. District Court — Western District of Wisconsin

88 F.Supp.3d 885

AMERITOX, LTD., and Marshfield Clinic, Inc., Plaintiffs

v.MILLENNIUM HEALTH, LLC, Defendant.

No. 13–cv–832–wmc.

United States District Court, W.D. Wisconsin.

Signed Feb. 18, 2015.

Filed Feb. 19, 2015.

James P. Ulwick, Kramon and Graham PA, Baltimore, MD, Adam Louis Marchuk, Mark T. Smith, Matthew F. Carmody, Michael R. Osterhoff, Tiffany Patrice Cunningham, Timothy J. Carroll, Perkins Coie LLP, Chicago, IL, David Edwin Jones, Perkins Coie LLP, Madison, WI, for Plaintiffs.

Robert Benjamin Wolinsky, Rebecca Cheryl Mandel, Steven P. Hollman, Hogan Lovells U.S. LLP, Washington, DC, Arlene L. Chow, Bonnie Chen, Hogan Lovells U.S. LLP, New York, NY, Douglas Maynard Poland, Jennifer Lynn Gregor, Godfrey & Kahn S.C., Madison, WI, for Defendant.

OPINION AND ORDER

WILLIAM M. CONLEY, District Judge.

This patent dispute presents a question of first impression with respect to the subject matter eligibility of a urine or other biological sample for drug screening and compliance protocols under 35 U.S.C. § 101, as well as related issues of enablement under § 112. The analysis is made more challenging by the state of flux in the treatment of competing goals inherent in § 101 challenges in recent years, and even in recent months. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., ––– U.S. ––––, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012) ; In re BRCA1– & BRCA2–Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed.Cir.2014) ; DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed.Cir.2014) ; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed.Cir.2014). Of course, this debate reflects a broader tension in patent law between what is legitimate invention in need of the incentives of patent law and what is merely description of the natural world for which no further incentive is required than our desire to understand it better—a tension recognized virtually from the outset of the American patent system. See Le Roy v. Tatham, 55 U.S. 156, 159, 14 How. 156, 14 L.Ed. 367 (1852). Justice Breyer's relatively recent opinion in Mayo attempts to reconcile the goal of ensuring that patents do not “impede innovation more than it would tend to promote it,” and the axiomatic notion that “all inventions, at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” Id. at 1293. Thus, Justice Breyer cautions that “too broad an interpretation of the exclusionary principle could eviscerate patent law.” Id.

Here, plaintiffs Ameritox, Ltd., and Marshfield Clinic, LLC allege that defendant Millennium Health, LLC infringes two of their patents: U.S. Patents No. 7,585,680 (“the '680 patent”), purporting to describe a method for drug screening and compliance protocols for one sample of urine from a patient on a prescribed medication regimen; and 7,785,895 (“the '895 patent ”), purporting to describe a similar method for one biological sample generally. (See Am. Compl., Exs. A, B (dkt. 106–1, 106–2).) Defendant Millennium seeks summary judgment of non-infringement and invalidity as to both patents. (Dkt. # 126.) The parties also ask the court to construe various terms common to both patents, including most notably “known normative data” and “quantifying the concentration.” (Def.'s Opening Br. (dkt. # 130); Pl.'s Opp'n (dkt. # 172).) For the reasons that follow, the court will deny Millennium's motion for summary judgment of non-infringement and invalidity with respect to the '680 patent and grant the motion with respect to the '895 patent, finding the patent invalid for lack of enablement under § 112. For many of the same reasons, the court finds the '895 patent is vulnerable to the application of the exclusionary principle under § 101, while the '680 patent is substantially less so.

UNDISPUTED FACTS

I. The Licensing Agreement

Plaintiff Marshfield Clinic is a health care and research organization. Marshfield is also the assignee of the patents-in-suit from the inventors, Dr. Michael Larson and Dr. Thomas Richards.

Plaintiff Ameritox Ltd. is in the field of pain medication monitoring, including a provider of urine drug testing (“UDT”) services. Ameritox is the exclusive licensee of the patents-in-suit pursuant to an exclusive license agreement between Ameritox and Marshfield dated March 15, 2010. In exchange for an exclusive license, Ameritox agreed to make certain royalty payments to Marshfield and to use good faith commercial efforts to develop, market, and sell a drug testing service based on the asserted patents.

II. The Testing Protocols

Ameritox tests urine samples on behalf of doctors, nurses, and other health-care providers who prescribe pain medications to treat chronic pain. (Am. Compl. (dkt. # 106) ¶¶ 7.) Ameritox describes its UDT service as being able to “help clinicians assess whether patients are correctly taking medications and whether the prescription should be adjusted.” (Dr. Paul J. Orsulak Infringement Report (“Orsulak Infringement Rept.”) (dkt. # 117) ¶¶ 27.) Healthcare professionals periodically use Ameritox's services to monitor drug levels in their patients in order to help assess their patients' therapeutic response to medications and adherence to the treatment plan, as well as to detect aberrant behaviors (e.g., illegal drug use) that may complicate treatment. ('680 patent at 2:17–20.)¹

On May 16, 2011, Ameritox launched its current Rx Guardian CD service, which Ameritox asserts is based on the patents-in-suit.² The testing protocol for Rx Guardian CD has three phases. (Dr. Paul J. Orsulak Rebuttal Report (“Orsulak Rebuttal Rept.”) (dkt. # 118) ¶¶ 246–56.) First, Ameritox performs a series of laboratory tests to detect and measure the amount of drug and drug metabolites in a patient's urine sample (the “detection” steps, which are reflected in steps (a)-(d) of the '680 patent ). Second, Ameritox “normalizes” or “adjusts” urine drug levels for a patient's hydration status by determining the metabolite/creatinine

ratio of the patient (the “normalization” step, as reflected in step (e) of the '680 patent ).³ Third, the Rx Guardian CD protocol compares a patient's normalized test results to a range of “normative data” collected from other clinical patients on the same medication, who Marshfield carefully monitored to insure adherence to their prescribed opioid regimen (the “determining” step, as reflected in step (f) of the '680 patent ).

By comparing the patient's normalized value to a range of values for other clinical patients believed to be prescribed and taking the same medication properly, the health care provider can better assess whether a patient is likely to be taking the prescribed drug in a manner consistent with the prescribed regimen. The three steps outlined above largely truncate the steps outlined in claim 1 of the '680 patent, which states:

1. A method for quantifying at least one metabolite in a biological sample comprising the steps of:

(a) providing one biological sample obtained from a patient on a prescribed medication regimen, wherein the sample comprises at least one test metabolite, wherein in the sample is urine;

(b) providing one set of known normative data specific to a reference metabolite, wherein the set of data is collected from a population that is on a prescribed medication regimen;(c) contacting the biological sample with an analytical device;

(d) detecting the presence of at least one test metabolite in the biological sample with the device, wherein the device is capable of measuring the concentration of the test metabolite in the sample;

(e) normalizing the biological sample to adjust for changes in the patient's hydration status by determining the metabolite/creatinine ratio of the patient; and

(f) quantifying the concentration of at least one test metabolite in the biological sample by comparing a ratio between the concentration of the test metabolite from the patient to the set of known normative data specific to the reference metabolite concentration.

('680 patent at 21:9–32.)

III. The Specification, Prosecution History and Reexamination Certificates

The patents-in-suit have a priority date of August 28, 2003, and cover a method to monitor medication usage and to detect aberrant drug usage patterns, including overuse and under-use of prescribed medications. ('680 patent at ABSTRACT.) The patents share the same specification, which states that adherence to a prescribed medication regimen is important to the success of most treatments, “particularly in patients in drug abuse or chronic pain programs.” (Id. at 1:21–24.) The specification further describes a number of sources used by health care professionals to monitor medication usage, including interviews with patients, medical records, pill counts, prescription monitoring programs, and testing of biological samples, such as urine. (Id. at 1:42–48, 15:11–15.) The specification also states that urine drug screens available in 2003 were limited to reporting a positive or negative result because of “the large amount of variability in urine drug concentrations, mostly due to variations in hydration and urinary output volume.” (Id. at 1:50–53.)

Both patents highlight problems with purely “up or down” test results. In particular, so long as patients took some amount of medication, their test results were positive and patients who overused or underused their medications continued to receive the same prescription:

To date, a test is purely negative or positive as to the presence or absence of a drug metabolite in the urine. Accordingly, it would be useful to develop a method to assess with confidence patient adherence to prescribed drug treatment regimens.

(Id. at 2:61–3:3 (emphasis added).) In light of the problems in the prior art, the specification goes on to state that:

[t]he method of the present invention enables improved clinical accuracy of protocols used in testing biological samples, such as, urine testing [and] the present invention can substantially improve the ability of a

...