Teva Pharmaceuticals USA Inc. et al v. Sandoz Inc. et al.

Filing 214

ORDER CONSTRUING THE TERMS of U.S. Patent Nos. 8,232,250, 8,399,413, 8,969,302, and 9,155,776. Signed by Judge Gregory M. Sleet on 3/7/2016. (mdb)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

IN RE COPAXONE 40 MG
CONSOLIDATED CASES

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Civil Action No. 14-1171-GMS
(CONSOLIDATED)

ORDER CONSTRUING THE TERMS OF U.S. PATENT NOS. 8,232,250, 8,399,413,
8,969,302, .and 9,155, 776

After considering the submissions of the parties and hearing oral argument on the· matter,
IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted claims of
U.S. Patent Nos. 8,232,250 (''the '250 patent"), 8,399,413 ("the '413 patent"), 8,969,302 ("the
'302 patent"), and 9,155,776 ("the '776 patent"):
1.

The terms the defendants contend are non-limiting 1 are construed to be non-limiting

1 The terms the defendants contend are non-limiting are: "alleviating a symptom of relapsingremitting multiple sclerosis;" "reducing [the] frequency ofrelapses;'? "therapeutically effective;"
"regimen being sufficient to alleviate the symptom of the patient;" "wherein alleviating a symptom
comprises reducing the frequency ofrelapses;" "wherein alleviating a symptom comprises reducing the
mean cumulative number of Gd-enhancing lesions, reducing the mean number of new T 2 lesions,
reducing the total volume ofT2 lesions, or reducing the cumulative number of enhancing lesions on T1weighted images in the brain of the patient;" "wherein alleviating a symptom comprises reducing brain
atrophy in the patient;" "wherein alleviating a symptom comprises illcreasing the time to a confirmed
relapse in the patient;" "wherein alleviating a symptom comprises reducing the total number of confirmed
relapses in the patient;" "wherein alleviating a symptom comprises reducing the progression ofMRImonitored disease activity in the patient;" "wherein alleviating a symptom comprises reducing the
number of new hypointense lesions on enhanced T 1 scans in the patient or reducing the total volume of
pypointense lesions on enhanced T1 scans in the patient;" "wherein alleviating a symptom comprises
reducing a level of disability as measured by EDSS Score, by the work productivity and activities
impairment-General Health (WP AI-GH) questionnaire, or by EuroQoL (EQ5D) questionnaire in the
patient;" "wherein alleviating a symptom comprises reducing a change in EDSS Score in the patient or
reducing a change in Ambulation Index in the patient;" "wherein the regimen is therapeutically effective;"
"the regimen being sufficient to reduce frequency of relapses in the human patient;" "further comprising
reducing the mean cumulative number of Gd-enhancing lesions in the brain of the patient;" "further
comprising reducing the mean number of new T1 lesions in the brain of the patient;" "further comprising
reducing the cumulative number of enhancing lesions on Ti-weighted images;" "so as to treat the human
patient;" "reducing the frequency of relapses by 30% or more as compared to placebo in a human

statements of intended effect. 2

population, for reducing brain atrophy, for reducing the cumulative number of enhancing lesions on Tlweighted images, or for reducing the level of disability as measured by EDSS Score;" "so as to thereby
reduce the frequency of relapses by 30% or more as compared to placebo in a human population, reduce
brain atrophy, reduce the cumulative number of enhancing lesions on Tl-weighted images, or reduce the
level of disability as measured by EDSS Score of the human patient;" "which reduces brain atrophy and
for reducing the frequency of relapses by 30% or more as compared to placebo in a human population;"
"which reduces the cumulative number of enhancing lesions on Tl-weighted images;" "which reduces the
level of disability of the human patient as measured by EDSS Score;" "which is as effective as
administration of 20 mg of glatiramer acetate s.c. daily;" "so as to thereby treat the human patient as
effectively as by administration of 20 mg glatiramer acetate s.c. daily;" "reducing the frequency of
relapses, reducing brain atrophy, reducing the cumulative number of enhancing lesions on Tl-weighted
images, o_r reducing the level of disability as measured by EDSS Score;" "so effectively as administration
of 20 mg of glatiramer acetate s.c. daily;" "so as to thereby reduce the frequency ofrelapses, reduce brain
atrophy, reduce the cumulative number of enhancing lesions on Tl-weighted images, or reduce the level
of disability as measured by EDSS Score, of the human patient as effectively as by administration of 20
mg of glatiramer acetate s.c. daily;" "which reduces the frequency of relapses as effectively as
administration of 20 mg of glatiramer acetate s.c. daily;" "which reduces brain atrophy as effectively as
administration of 20 mg of glatiramer acetate s.c. daily;" which reduces the cumulative number of
enhancing lesions on Tl-weighted images as effectively as administration of 20 mg of glatiramer acetate
s.c. daily;" and "which reduces the level of disability as measured by EDSS Score as effectively as
administration of 20 mg of glatiramer acetate s.c. daily."
2

These terms are strikingly similar to those in the patents in Bristol-Myers Squibb Co. v. Ben Venue
Laboratories, Inc., 246 F.3d 1368 (Fed. Cir. 2001). Those patents also covered a method of administering
a drug. The Federal Circuit upheld.the district court's interpretation of the preambles, "for reducing
hematologic toxicity" and "[a] method for treating a cancer patient to effect regression of a taxol-sensitive
tumor, said method being associated with reduced hematologic toxicity," as non-limiting statements of
-intended outcome. Id. at 1375-76. These statements had no bearing on the claimed methods. Id. at 1375
(''The steps of the three-hour infusion method are performed the same way regardless whether or not the
patient experiences a reduction in hematologic toxicology."). The court also concluded that the statement
"an antineoplastically effective amount" was a statement of intended result because it duplicated the dosage
amounts recited in the claims. Id. ("The express dosage amounts are material claim limitations; the
statement of the intended result of administering those amounts does not change those amounts or otherwise
limit the claim.").
The prosecution history in Bristol-Myers Squibb also did not support construing the contested terms
as limitations. It was "not a case in which a new use of a process should be considered to be a limitation
because the new use distinguishes the process over the prior art." Id. at 13 7 6. Further, "unsolicited assertions
of patentability made during prosecution" such as voluntarily adding the phrase "antineoplastically
effective amount" did not "create a material claim limitation where ... the language does not create one."
-Id. The plaintiff in Bristol-Myers Squibb argued that claim differentiation required the terms to be
limitations, because holding otherwise would cause several of the independent claims to have identical
scope. The Federal Circuit disagreed, "declin[ing] to blindly apply the doctrine in this case to supplant other
canons of claim construction" that compelled the conclusion that those terms were not limitations.
The same principles apply here. Just as in Bristol-Myers Squibb, these claim terms do not "result
in a manipulative difference in the steps of the claim[s]." See id. at 1376. Rather, terms such as "alleviating
a symptom of relapsing-remitting multiple sclerosis" and "further comprising reducing the ... lesions in
the brain of the patient" list the intended outcome from following the claimed steps. Other terms, such as
2

2.

The regimen terms 3 are construed to mean "a continuous treatment requiring three
and only three subcutaneous injections each and every week [with at least one day
between every injection]."4

3.

The term "brain atrophy" is construed to mean a reduction in gray matter and white
matter volume over time. 5

"therapeutically effective;'' duplicate the dosage requirements and do not provide any additional required
structure or condition for the claims. Here, there is also no evidence that these terms are central to
patentability or were used to meaningfully distinguish the claims from the prior art. It is true that the court's
ruling eviscerates many of the dependent claims, which only contain these non-limiting terms to distinguish
them from their independent claims. But just as in Bristol-Myers Squibb, the doctrine of claim
differentiation alone cannot save claims that do not contain any true limitations. The court agrees with the
defenqants that these numerous claim terms are not limitations .
3

The regimen terms are: "comprising administering ... regimen of three subcutaneous injections
... over a period of seven days with at least one day between every subcutaneous injection;" "comprising
administration of three subcutaneous injections ... per week;" and "comprising subcutaneous injection ..
. three times per week [with at least one day between every subcutaneous injection]."
.

4

The parties' dispute centers on whether the terms contemplate a fourth injection every other
week-in other words, whether the patent allows an alternate-day dosing regimen. The defendants argue
that the use of the open ended term "comprising" means that additional doses may be added, as long as
there is a day between every injection. Ordinarily, the court would agree because comprising is an open
ended transition. The language of the claims does not preclude an alternate-day dosing regimen. But in this
case, the prosecution history limits the scope of these claims. The court finds the patentee clearly disclaimed
an alternate-day dosing regimen to distinguish the inventions from the prior art. (D.I. 104 at JA218, JA223,
JA1766, JA1761).
5

The court recognizes that based on its construction that the preamble terms are nonlimiting, "brain
atrophy" does not need to be construed. Nevertheless, the court construes the term out of an abundance of
caution. Here, the task is simple because the specification clearly defines the term. The patent repeatedly
defines brain atrophy as the percent change in brain volume over time-more specifically, the change "in
normalized gray matter volume and in normalized white matter volume." 250 patent at 12:19-20, 12:4649, 13:66-14:5, 14:62-15:4.

3

4.

The reduced severity terms6 are construed to have their plain and ordinary meaning. 7

Dated: March l_, 2016

6

The reduced severity terms are: "reduced severity of injection site reactions" and "reduced
frequency and severity of immediate post injection site reactions and injection site reactions."
7

Paradoxically, the court adopts the plaintiffs' proposed construction, but the defendants'
interpretation for these terms. The defendants' proposed construction is "a reduction in the intensity of a
patient's injection site reactions." The plaintiffs correctly note that this is redundant, because the claims
explicitly state they are methods for treating a human patient. But this clear indication that the claims are
directed to "a human patient" informs the plain meaning of this term. Contrary to the plaintiffs' assertions,
the court finds that in context of the claims, the plain meaning of these terms requires reduced severity of
a patient's injection site reactions.

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