Case 1:14-cv-01171-GMS Document 214 Filed 03/07/16 Page 1 of 4 PageID #: 4075
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE COP AXONE 40 MG
`CONSOLIDATED CASES
`
`)
`)
`)
`)
`)
`)
`
`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-limiting1 are construed to be non-limiting
`
`1 The terms the defendants contend are non-limiting are: "alleviating a symptom of relapsing(cid:173)
`remitting 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 T1-
`weighted 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 ofMRI(cid:173)
`monitored 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
`
`MYLAN PHARMS. INC. EXHIBIT 1136 PAGE 1
`
`

`
`Case 1:14-cv-01171-GMS Document 214 Filed 03/07/16 Page 2 of 4 PageID #: 4076
`
`statements of intended effect.2
`
`population, for reducing brain atrophy, for reducing the cumulative number of enhancing lesions on Tl(cid:173)
`weighted 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
`
`MYLAN PHARMS. INC. EXHIBIT 1136 PAGE 2
`
`

`
`Case 1:14-cv-01171-GMS Document 214 Filed 03/07/16 Page 3 of 4 PageID #: 4077
`
`2.
`
`The regimen terms3 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, 12:46-
`49, 13:66-14:5, 14:62-15:4.
`
`3
`
`MYLAN PHARMS. INC. EXHIBIT 1136 PAGE 3
`
`

`
`Case 1:14-cv-01171-GMS Document 214 Filed 03/07/16 Page 4 of 4 PageID #: 4078
`
`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.
`
`4
`
`MYLAN PHARMS. INC. EXHIBIT 1136 PAGE 4