Ameritox, Ltd. v. Millennium Health, LLC
Filing
256
OPINION AND ORDER: Partial summary judgment is AWARDED in plaintiff's favor with respect to its claim that Millennium infringed claims 1, 2, 4-7, 10 and 16-18 of the '680 patent. Signed by District Judge William M. Conley on 3/6/15. (jat)
IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF WISCONSIN
AMERITOX, LTD., and
MARSHFIELD CLINIC, INC.,
Plaintiffs,
OPINION AND ORDER
v.
13-cv-832-wmc
MILLENNIUM HEALTH, LLC.,
Defendant.
In this case, plaintiffs Ameritox, Ltd., and Marshfield Clinic, LLC, claim that
defendant Millennium Health, LLC infringes two of their patents: (1) 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 (2) 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).)
On February 19, 2015, the court granted Millennium’s motion for summary judgment as
to the '895 patent and denied as to the ’680 patent. (2/19/15 Op. & Order (dkt. #215).)
Pursuant to Federal Rule of Civil Procedure 56(f), the court also directed Millennium to
serve and file a response on or before March 2, 2015, as to why summary judgment
should not be entered against it on the question of infringement of the ’680 patent.
Because Millennium’s response offers no viable argument of law or fact that “all of the
limitations” of claim 1 of the ’680 patent are not found in Millennium’s RADAR Report,
Innovention Toys, LLC v. MGA Entm’t, Inc., 637 F.3d 1314, 1319-20 (Fed. Cir. 2011), the
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court will now grant summary judgment in favor of plaintiffs on their claim that
Millennium infringes the ’680 patent.
The court’s summary judgment opinion observed the likelihood that “a trained
toxicologist . . . familiar with clinical laboratory science” would find the comparative data
in the RADAR Report as “falling within the plain and ordinary meaning of element (f).”
(2/19/15 Op. & Order (dkt. #215) 74.)
The court came to this conclusion because
Millennium contracts for and produces RADAR Reports “that provide[] a comparison of
the ratio between the concentration of a test metabolite from a patient to a set of
normative data.”
(Id.)
Indeed, Millennium’s sample RADAR Report provides a
comparison for oxycodone use, which is one of the specific drugs noted in the ’680
patent specification. (’680 patent (dkt. #106-1) 12:18-13:48.)
Millennium’s arguments to the contrary are wholly unpersuasive.
First,
Millennium repeats its already rejected argument for construing away from the plain and
ordinary meaning of element (f) of claim 1. (Def.’s Resp. (dkt. #218) 1-2.) Contrary to
Millennium’s proposed narrow construction of element (f), the court found that element
(f) should be given its broad meaning, which is consistent with a plain reading of the
patents claims, as well as the varied aspects set forth in the patent’s embodiments and
described in its numerous and varied examples. (2/19/15 Op. & Order (dkt. #215) 2427.) In particular, the court expressly rejected the notion that element (f) required use of
known normative data from a population that is on the exact same regimen for a
prescribed medication, much less that all members of the population actually adhered to
that prescription regimen. Not prevailing in the construction debate on element (f) (as
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well as element (b)) effectively foreclosed Millennium’s only arguments against a finding
of infringement of the ‘680 patent.1
As explained in the court’s summary judgment decision, from the perspective of a
person having ordinary skill in the art (a toxicologist), there is no reasonable factual
dispute that the RADAR Report -- as best evidenced by the graph below -- reads upon
element (f).
(Declaration of Rebecca C. Mandel (dkt. #129-29) p.4.)
Millennium regularly uses the word “dose,” rather than “prescribed medication” used in the
patent claims themselves. The distinction is significant, since “dose” can refer to both “a quantity
of medicine taken or recommended to be taken at a particular time,” while “prescribed” is merely
the act of a medical practitioner authorizing, usually in writing, “a patient to be provided a
medicine or treatment.” New Oxford American Dictionary pp. 518, 1381 (3rd ed. 2010).
Millennium’s own Rule 56(f) response recognizes this distinction itself by using the adjective
“prescribed” or “actual” before dose when wanting to be more precise. To the extent that this
extrinsic evidence from a dictionary adds to the reasoning of the court’s earlier claim construction,
it is entirely consistent with that reasoning:
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Language in the embodiment above tracks key language in claim 1 of the ’680 patent as
demonstrated here, only strengthening Ameritox’s construction -- i.e., data that is not
unknown, and certainly not limited to data that is dose specific. The view is fortified by
the fact that when inventors knew how to specify dose in one of the patents’ embodiments
(Example 1), they did so. And by not doing the same in the claims, this tends to end the
debate over the disputed term. (Compare ’680 patent at 9:65-66 (specification using the
term “prescribed dosage regimen”), with id. at 21:16-1 (claim 1 using the phrase
“prescribed medication regimen”).)
(2/19/15 Op. & Order (dkt. #215) 23-24.)
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Indeed, this is precisely what Millennium’s product does as represented by the bell
curve reflected in the RADAR Report and internal correspondence of its employees.
Millennium never controverts the fact that the comparative graph in the RADAR Report
is based on statistical analysis (i.e. frequency distribution). Indeed, in its response to
Ameritox’s proposed findings of facts, infringement of claim 1 is arguably best reflected
in Millennium’s own description:2
The cited RADAR Report merely states that graph “present[ing] the current
UDT results[] in relation to the frequency distribution of positive UDT
values for all patients with a reported prescription tested by Millennium”
and “[s]et against the bell curve is the patient’s individual creatininecorrected concentration for the given drug indicated by a single vertical line
labeled ‘Result.’”
(Def.’s Resp. to Pl.’s PFOFs (dkt. #185) ¶ 240 (quoting Mandel Decl., Ex. 29 (dkt.
#129-29) pp.4, 9.) In short, the RADAR Report quantifies a patient’s likely adherence to
(i.e., whether it is consistent with) a prescription medication regimen by comparing his or
her test results to a set of known normative data.
Although less than clear in its Rule 56(f) response, Millennium nevertheless seems
to argue that its product falls outside the claim scope because its putative normative data
is based on “both adherent and non-adherent” usage and, therefore, the graphical data
cannot assess appropriate or inappropriate drug usage. (Def.’s Resp. (dkt. #218) 3). In
Of course, this acknowledgment was made well before the court rejected Millennium’s narrow
construction of the claim terms -- suggesting that all their eggs relevant to the infringement
defense were placed in the legal basket (i.e. claim construction) -- nevertheless, the
acknowledgement above only further supports that the RADAR Report falls within a broad
reading of the claim terms.
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making this argument, Millennium ignores its own internal emails stating unambiguously
that:
(1) One of the benefits of the graphed results added to the RADAR report is that it
provides “the vertical lines labeled ‘Lower’ and ‘Upper’ indicat[ing] the 95%
inclusion interval. The inclusion interval represents the universe of patients tested
for the named medication. Ninety-five percent of the patients in the ML database
who tested positive for the named drug (with a reported prescription) fall within
the lower and upper limits shown. Two and a half percent of patients fall below
the lower limit and another 2.5% of patients fall above the upper limit shown . . .
A result closer to the middle of the frequency distribution indicates that the
patient’s urinary concentration is comparable to the bulk of ML patients with a
reported prescription that was tested for the named medication . . . Atypical
urinary concentrations, those found at the low or high end of the range may
motivate clinicians to investigate anomalies in the way a patient is taking their
medications.” (Mandel Decl., Ex. 29 (dkt. #129-29) p.9.);
(2) “The Comparative Results graph [in the RADAR Report] assists clinicians with
determining whether the patient’s result is consistent with or similar to those of
other patients prescribed and taking the same medication, unrelated to dosage.”
(Id., Ex. 33 (dkt. #129-33) p.3.).
(3) “An individual patient’s test result below the ‘Lower Limit’ of the 95% inclusion
range can show possible ‘[m]edication non-adherence,’ including ‘hoarding’ or
‘diversion.’” (Id. at p.4.).
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In the end, Millennium’s argument for non-infringement is nothing more than
another attempt to read back into element (f) a limitation that is just not in the patent
claims. Indeed, elements (b) and (f) merely refer to a “set of known normative data”
from a population prescribed the subject medication, not that the data reflects a
population prescribed the same dose -- and certainly not data where each person’s
adherence to the dose prescribed is confirmed. While these shortcomings in the data
used in Millennium’s RADAR Report may well make for an inferior product, they do not
render the product non-infringing.
Once Millennium’s “specific dosage” construction is rejected, all that remains is a
plain and ordinary meaning of the claim language -- a set of known normative data that
(1) is “specific to the reference metabolite” and (2) allows for “compari[son]” with a “test
metabolite” drawn from a creatinine-normalized biological sample.
(Id. at 21:28-32.)
Since Millennium offers no material facts undermining the court’s finding of
infringement consistent with the court’s expressed claim construction, after having been
given an opportunity to do so pursuant to Rule 56(f), the court now finds that
Millennium infringes all of the asserted claims of the ‘608 patent.3
Of course, as Millennium points out, this still leaves its invalidity defenses to be decided during
the liability phase of the upcoming trial. Millennium also appears to suggest that it lacked an
opportunity pursuant to Fed. R. Civ. P. 56(f) to respond fully on the issues of enablement and
utility before having summary judgment entered against it. On this, it is simply mistaken since
the court only denied defendant’s motion.
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ORDER
IT IS ORDERED that partial summary judgment is AWARDED in plaintiff’s
favor with respect to its claim that Millennium infringed claims 1, 2, 4-7, 10 and 16-18
of the ‘680 patent.
Entered this 6th day of March, 2015.
BY THE COURT:
/s/
________________________________________
William M. Conley
District Judge
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