Case 1:14-cv-01171-GMS Document 139 Filed 12/18/15 Page 1 of 15 PageID #: 2947
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`
`C.A. No. 1:14-1171-GMS
`(CONSOLIDATED)
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`
`
`
`
`
`IN RE COPAXONE 40 MG
`CONSOLIDATED CASES
`
`DEFENDANTS’ OPENING CLAIM CONSTRUCTION BRIEF
`REGARDING U.S. PATENT NO. 9,155,776
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`Mylan Pharms. Inc. Exhibit 1013 Page 1
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`Case 1:14-cv-01171-GMS Document 139 Filed 12/18/15 Page 2 of 15 PageID #: 2948
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`TABLE OF CONTENTS
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`INTRODUCTION AND SUMMARY OF THE ARGUMENT ........................................ 1
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`I.
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`II. NATURE AND STAGE OF PROCEEDINGS ................................................................... 1
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`III. BACKGROUND ................................................................................................................... 2
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`IV. ARGUMENT ......................................................................................................................... 2
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`A.
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`“SEVERITY” IS INDEFINITE .................................................................................... 2
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`1.
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`2.
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`Legal Standards ........................................................................................ 2
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`A Skilled Artisan Cannot Know the Meaning of “Severity” in
`the Claims with Reasonable Certainty .................................................... 3
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`B.
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`CLAIM CONSTRUCTION .......................................................................................... 7
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`1.
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`2.
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`Legal Standards ........................................................................................ 7
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`The Claims Recite A Patient, and Not an Entire Population, as
`their Subject .............................................................................................. 8
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`V. CONCLUSION ................................................................................................................... 10
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`i
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`Mylan Pharms. Inc. Exhibit 1013 Page 2
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`Case 1:14-cv-01171-GMS Document 139 Filed 12/18/15 Page 3 of 15 PageID #: 2949
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`TABLE OF AUTHORITIES
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`CASES
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`ACTV, Inc. v. Walt Disney Co.,
`346 F.3d 1082 (Fed. Cir. 2003) .................................................................................................. 8
`
`Bayer Intellectual Prop. GmbH v. Warner Chilcott Co.,
`No. 12-1032-GMS (D. Del. Apr. 21, 2015) ............................................................................... 3
`
`Biosig Instruments, Inc. v. Nautilus, Inc.,
`783 F.3d 1374 (Fed. Cir. 2015) .................................................................................................. 3
`
`Dow Chem. Co. v. NOVA Chems. Corp.,
`803 F.3d 620 (Fed. Cir. 2015) .................................................................................................... 7
`
`Haemonetics Corp. v. Baxter Healthcare Corp.,
`607 F.3d 776 (Fed. Cir. 2010) .................................................................................................... 8
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`134 S. Ct. 2120 (2014) ................................................................................................................ 2
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., Ltd.,
`521 F.3d 1351 (Fed. Cir. 2008) .................................................................................................. 8
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .................................................................................................. 8
`
`Praxair, Inc. v. ATMI, Inc.,
`543 F.3d 1306 (Fed. Cir. 2008) .................................................................................................. 3
`
`United Carbon Co. v. Binney & Smith Co.,
`317 U.S. 228 (1942) .................................................................................................................... 3
`
`STATUTES
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`35 U.S.C. § 112 ............................................................................................................................... 7
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`ii
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`Mylan Pharms. Inc. Exhibit 1013 Page 3
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`Case 1:14-cv-01171-GMS Document 139 Filed 12/18/15 Page 4 of 15 PageID #: 2950
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`I.
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`INTRODUCTION AND SUMMARY OF THE ARGUMENT
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`U.S. Patent No. 9,155,776 (“’776 patent”) concerns a dosing regimen in which 40 mg of
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`glatiramer acetate administered three times per week is said to “reduce[] severity of injection site
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`reactions in the human patient relative to administration of 20 mg of glatiramer acetate s.c. daily.”
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`The ’776 patent’s specification, which was borrowed from an application filed six years earlier,
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`says precious little about the severity of injection reactions (and nothing about how to measure a
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`reduction in severity). This has given rise to two claim construction disputes. First, Defendants
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`submit that the “reduced severity” terms are indefinite. Because the ’776 patent is silent about
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`how severity is defined and measured, no common art-recognized meaning existed, and the
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`relevant art teaches numerous incompatible ways of measuring it, a skilled artisan cannot know
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`with reasonable certainty whether “reduced severity” has been achieved. Second, Defendants
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`maintain that the claimed methods require reducing the severity of injection reactions in a patient,
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`not in the aggregate. The claims are directed to a method of treating “a human patient” and recite
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`reduced severity of injection reactions “in the human patient,” and the methods are directed to
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`administering treatment to a particular patient, not an entire population. Therefore, Defendants
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`ask that (1) the Court hold that the “reduced severity” terms are indefinite, and (2) if construed,
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`the Court interpret the “reduced severity” terms to mean reduced severity of a patient’s injection
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`reactions.
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`II.
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`NATURE AND STAGE OF PROCEEDINGS
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` Markman briefing for the first three patents-in-suit concluded on October 2, 2015. The
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`’776 patent issued on October 13, 2015 and was formally added to the case on November 9, 2015.
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`Defendants are filing this opening Markman brief for the ’776 patent pursuant to the schedule
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`entered by the Court that same day, as modified by the stipulation filed with the Court on December
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`1
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`10, 2015.
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`Mylan Pharms. Inc. Exhibit 1013 Page 4
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`III. BACKGROUND
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`The ’776 patent shares a common specification with the other three patents-in-suit and
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`similarly purports to claim a method of treating multiple sclerosis (“MS”) with intermittent dosing
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`of 40 mg of glatiramer acetate (“GA”). The ’776 patent has 30 claims. Independent claims 1, 5,
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`12, and 16 are directed to a method of treating a patient suffering from a form of MS. Each
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`independent claim recites that the claimed method achieves “reduced severity of injection site
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`reactions in the human patient relative to administration of 20 mg of glatiramer acetate s.c. daily.”
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`Dependent claims 2, 9, 13, and 21-24 further recite that the claimed method induces “reduced
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`frequency and severity of immediate post injection reactions and injection site reactions [in the
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`human patient] relative to administration of 20 mg of glatiramer acetate s.c. daily.” (Emphasis
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`added). This brief refers to these terms as “the ‘reduced severity’ terms.”
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`IV. ARGUMENT
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`A.
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`“Severity” is Indefinite
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`In initial Markman briefing, the parties debated whether intended results—here, for
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`example, reducing the severity of injection reactions—operate as claim limitations. Defendants
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`contend they do not. See Defendants’ Opening Claim Construction Br., D.I. 92 at 3–11;
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`Defendants’ Responsive Claim Construction Br., D.I. 99 at 2–13. Teva insists that treatment
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`effects are limitations. See, e.g., Teva’s Opening Claim Construction Br., D.I. 91 at 12–20.
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`Irrespective of that dispute, however, the “reduced severity” terms are indefinite.
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`1.
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`Legal Standards
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`“[A] patent is invalid for indefiniteness if its claims, read in light of the specification
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`delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those
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`skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 134
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`S. Ct. 2120, 2124 (2014). While “[s]ome modicum of uncertainty . . . is the price of ensuring the
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`2
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`Mylan Pharms. Inc. Exhibit 1013 Page 5
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`appropriate incentives for innovation,” “a patent must be precise enough to afford clear notice of
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`what is claimed, thereby apprising the public of what is still open to them.” Id. at 2128–29. “And
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`absent a meaningful definiteness check . . . patent applicants face powerful incentives to inject
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`ambiguity into their claims.” Id. at 2129. “Otherwise there would be ‘[a] zone of uncertainty
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`which enterprise and experimentation may enter only at the risk of infringement claims.’” Id.
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`(quoting United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236 (1942)).
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`“Indefiniteness is a matter of claim construction, and the same principles that generally
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`govern claim construction are applicable to determining whether allegedly indefinite claim
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`language is subject to construction.” Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1319 (Fed. Cir.
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`2008); see also Bayer Intellectual Prop. GmbH v. Warner Chilcott Co., No. 12-1032-GMS, slip
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`op. at 4 (D. Del. Apr. 21, 2015). Definiteness, like claim construction, is a question of law
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`sometimes involving subsidiary factual determinations. Biosig Instruments, Inc. v. Nautilus, Inc.,
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`783 F.3d 1374, 1382 (Fed. Cir. 2015). “[I]n assessing definiteness, claims are to be read in light
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`of the patent’s specification and prosecution history.” Nautilus, 134 S. Ct. at 2128. Finally,
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`“definiteness is measured from the viewpoint of a person skilled in the art at the time the patent
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`was filed.” Id. (alterations and quotation omitted).
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`2.
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`A Skilled Artisan Cannot Know the Meaning of “Severity” in the
`Claims with Reasonable Certainty
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`The “reduced severity” claim terms are indefinite because the ’776 patent does not inform
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`a skilled artisan how to identify a reduction in the severity of injection site reactions (“ISRs”) and
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`immediate post injection reactions (“IPIRs”) with reasonable certainty, and “severity” has no
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`established meaning in the art.
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`The parties agree that severity refers to the intensity of ISRs and IPIRs. But that alone
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`cannot inform a skilled artisan of the claims’ bounds. A skilled artisan—as well as the Court—
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`3
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`Mylan Pharms. Inc. Exhibit 1013 Page 6
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`Case 1:14-cv-01171-GMS Document 139 Filed 12/18/15 Page 7 of 15 PageID #: 2953
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`would turn first to the ’776 patent and its prosecution history to discern the patent’s approach to
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`defining and measuring reductions in severity. However, the intrinsic evidence uses the word
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`severity only once in the context of ISRs and IPIRs,1 and does not explain how severity is defined
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`or measured. The sole reference in the specification simply states that “[t]olerability is associated
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`with the frequency and severity of post injection reactions and injection site reactions. Tolerability
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`influences the period that a patient can follow GA treatment.” ’776 patent col. 7 ll. 39–42. This
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`single reference tells an ordinarily skilled artisan nothing about how to determine, let alone
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`measure, whether the claimed dosage regimen has reduced the severity of ISRs and IPIRs. The
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`prosecution history does not discuss severity at all. As the patent drafter, Teva was “in the best
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`position to resolve the ambiguity” by providing some indication of how one is to measure and
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`grade severity in the context of the claims. Nautilus, 134 S. Ct. at 2129 (quotations and citation
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`omitted). But it chose not to. See id. (“[A]bsent a meaningful definiteness check . . . patent
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`applicants face powerful incentives to inject ambiguity into their claims.”).
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`Analysis of the claims only increases the ambiguity. Various dependent claims recite a
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`reduction in the severity of ISRs and IPIRs relative to administration of 20 mg GA daily, “wherein
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`the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.”
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`’776 patent, col. 16 ll. 55–60 (claims 3 and 4); col. 17 ll. 31–36 and ll. 59–64 (claims 10, 11, 14,
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`and 15); col. 18 l. 53–col. 19 l. 3 (claims 25-30). All independent claims of the ’776 patent,
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`however, are comparative to a GA patient taking 20 mg daily—they claim “reduced severity of
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`injection site reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.” See,
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`e.g., id. at col. 16 ll. 49–50 (emphasis added). Thus, for the dependent claims requiring patients
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`1 Other references to “severity” in the specification are to the severity of MS relapses, see
`’776 patent col. 1, ll. 23–26, and the severity of MS symptoms, id. at col. 12, ll. 52–55.
`4
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`naïve to GA therapy to make sense, the severity measurement is necessarily hypothetical—a
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`patient receiving the claimed 40 mg low frequency dosing regimen must experience less severe
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`injection reactions as compared to a 20 mg daily regimen she has never taken. But the ’776 patent
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`does not describe how a person of ordinary skill can conduct this hypothetical inquiry—an inquiry
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`that is pivotal for determining whether a claim is infringed.
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`Extrinsic evidence confirms the claims’ indefiniteness. At the time the patent was filed,
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`there was no consensus among skilled artisans about how severity should be measured and defined
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`in this context. Declaration of Dr. Samuel J. Pleasure ¶¶ 26-27, 30, 38-40 (“Pleasure Decl.”). In
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`fact, even today, no accepted meaning of “severity” of ISRs and IPIRs or how to measure it
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`exists—and certainly none existed at the time the ’776 patent was filed. One article summarized:
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`“[a]lthough ISRs are universally recognized to be an issue with the use of injectable DMTs
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`[disease-modifying therapies] for MS [multiple sclerosis], the term currently has no standard
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`definition, nor is there any widely accepted method for grading the severity of ISRs.” Id. at Ex.
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`B., 47; see also id. at Ex. H, 187 (“[B]etter, standardized methods of assessing ISRs [are needed]
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`to improve the ability of MS nurses to recognize and report consistently on ISRs.”). For example,
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`severity could be measured subjectively—based on a patient’s personal assessment—or
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`objectively—based on a doctor’s comparison of a patient’s symptoms against set criteria.
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`Moreover, as the patent specification makes clear (see ’776 patent col. 7 ll. 15–37) there are many
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`different types of ISRs and IPIRs, and some, such as induration (hardening of the injection site),
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`are more amenable to objective measurement than others, such as pain, feeling hot, or flushing.
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`Pleasure Decl. ¶¶ 26, 30, 34. Indeed, the large number of different ISRs and IPIRs identified in
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`the specification (ranging from “palpitations” and “chest pain” to “pruritus” and “injection site
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`hemorrhage”) compounds the uncertainty of grading the severity of each.
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`5
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`The imprecision of “severity” is confirmed by the relevant literature, which has used many
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`materially distinct definitions. For instance, one study defined “moderate” ISRs as “possibly not
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`transient, including discomfort, and involving itching, pain, lumps, dimpling, and/or skin sores.”
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`Id. at Ex. B, 48. “Severe” ISRs were those “including scabs, crusting around wound, infection,
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`and/or necrosis.” Id. In contrast, Teva’s GLACIER study simply asked patients to subjectively
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`rate the severity of their own ISRs based on how much they interfered with the patients’ normal
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`daily activities. Id. at Ex. F, 371; Ex. G. Other sources provide still more definitions.2
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`In summary, the intrinsic evidence leaves a person of ordinary skill in the art with
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`absolutely no guidance beyond his background knowledge of the art. And as the term’s meaning
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`in the art was and continues to be unsettled and subject to multiple inconsistent interpretations, the
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`person of ordinary skill cannot determine when reduced severity of any of the numerous ISRs and
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`IPIRs listed in the patent is achieved. See Dow Chem. Co. v. NOVA Chems. Corp., 803 F.3d 620,
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`634–35 (Fed. Cir. 2015) (holding claims indefinite where, as here, there are “multiple
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`[measurement] methods leading to different results without guidance in the patent or the
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`prosecution history as to which method should be used”). The Supreme Court “has warned” that
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`this level of uncertainty “would diminish the definiteness requirement’s public-notice function and
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`foster [an] innovation-discouraging ‘zone of uncertainty’ . . . .” Nautilus, 134 S. Ct. at 2130.
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`Accordingly, the claims fail to “inform those skilled in the art about the scope of the invention
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`2 See, e.g., Pleasure Decl. at Ex. D, 58 (categorizing ISR severity by considering variables
`such as tenderness, pain, warmth, erythema, itching, and tissue damage); id. at Ex. E, 59
`(measuring lipoatrophy severity in GA-treated patients by clinician assessing “surface area
`affected, number of areas in one injection site location, number of overall injection site areas
`affected, length of time on the therapy and stature of the patients”); id. at Ex. C, 3 (measuring ISR
`severity in MS patients treated with GA competitor interferon-β by blinded clinician observing
`size of injection-site redness, injection-site swelling, bruising, and patient-reported itching, among
`other factors).
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`6
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`Mylan Pharms. Inc. Exhibit 1013 Page 9
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`Case 1:14-cv-01171-GMS Document 139 Filed 12/18/15 Page 10 of 15 PageID #: 2956
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`with reasonable certainty,” id. at 2129, and the “reduced severity” terms are indefinite.
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`B.
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`Claim Construction
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`The parties’ positions are as follows:
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`Term
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`Reduced severity of
`injection site reactions.
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`Reduced frequency and
`severity of immediate post
`injection reactions and
`injection site reactions.
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`Plaintiffs
`No construction required;
`plain and ordinary meaning,
`or defined as a reduction in
`the intensity of injection site
`reactions.
`No construction required;
`plain and ordinary meaning,
`or defined as a reduction in
`both the rate of occurrence
`and the intensity of
`immediate post injection
`reactions and injection site
`reactions.
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`Defendants3
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`A reduction in the intensity of
`a patient’s injection site
`reactions.
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`A reduction in both the rate
`of occurrence and the
`intensity of a patient’s
`immediate post injection
`reactions and injection site
`reactions.
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`
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`1.
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`Legal Standards
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`Several claim construction tenets are particularly relevant to the construction of the terms-
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`at-issue. “First and foremost, the analytical focus of claim construction must begin, and remain
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`centered, on the language of the claims themselves.” ACTV, Inc. v. Walt Disney Co., 346 F.3d
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`1082, 1088 (Fed. Cir. 2003). Second, claim terms “are generally given their ordinary and
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`customary meaning,” which “is the meaning that the term would have to a person of ordinary skill
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`in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–
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`13 (Fed. Cir. 2005). Third, courts must “construe claims with an eye toward giving effect to all of
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`their terms . . . .” Haemonetics Corp. v. Baxter Healthcare Corp., 607 F.3d 776, 781 (Fed. Cir.
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`2010). Lastly, “[a] determination that a claim term ‘needs no construction’ or has the ‘plain and
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`3 By proffering these constructions, Defendants do not waive—and indeed expressly preserve—
`any arguments that these terms fail to satisfy the requirements of 35 U.S.C. § 112, including the
`enablement and written description requirements.
`7
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`Mylan Pharms. Inc. Exhibit 1013 Page 10
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`ordinary meaning’ may be inadequate when a term has more than one ‘ordinary’ meaning or when
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`reliance on a term’s ‘ordinary’ meaning does not resolve the parties’ dispute.” O2 Micro Int’l Ltd.
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`v. Beyond Innovation Tech. Co., Ltd., 521 F.3d 1351, 1361 (Fed. Cir. 2008).
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`2.
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`The Claims Recite A Patient, and Not an Entire Population, as their
`Subject
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`At the outset, the parties agree that frequency and severity are separate concepts: severity
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`relates to “intensity,” and frequency relates to rate of occurrence. Rather than adopt plain and
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`ordinary meaning, as Teva proposes, the Court should construe the reduced severity terms to
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`memorialize these agreements and prevent future disputes.
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`One issue remains for resolution: whether the claimed methods recite reduced severity of
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`injection reactions in a patient, or in a population. The claims unambiguously resolve this dispute.
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`Independent claims 1 and 5 recite that the treatment method induces “reduced severity of injection
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`site reactions in the human patient relative to administration of 20 mg of glatiramer acetate s.c.
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`daily . . . .” ’776 patent, col. 16 ll. 36–38; col. 16 l. 67–col. 17 l. 2 (emphasis added). Similarly,
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`the other two independent claims, claims 12 and 16, both refer to “a human patient” and
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`respectively recite treating and reducing the symptoms of “the human patient . . . with reduced
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`severity of injection site reactions relative to administration of 20 mg of glatiramer acetate s.c.
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`daily.” Id. at col. 17 ll. 50–54; col. 18 ll. 15–22.
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`The dependent claims reinforce Defendants’ construction. For example, dependent claims
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`13 and 21-24 connect the reduced frequency and severity of IPIRs and ISRs to a single patient, not
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`a population, because they recite a previously claimed method “which treats the human patient
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`with reduced frequency and severity of immediate post injection reactions and injection site
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`reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.” See, e.g., id. at col.
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`17 ll. 55–58 (emphasis added). Similarly, dependent claims 2 and 9 recite the methods of claim 1
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`8
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`Mylan Pharms. Inc. Exhibit 1013 Page 11
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`Case 1:14-cv-01171-GMS Document 139 Filed 12/18/15 Page 12 of 15 PageID #: 2958
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`and 5 (respectively), “which induces reduced frequency and severity of immediate post injection
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`reactions and injection site reactions in the human patient relative to administration of 20 mg of
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`glatiramer acetate s.c. daily.” See, e.g., id. at col. 16 ll. 51–54 (emphasis added). The limitation
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`added by 10 other dependent claims—“wherein the human patient has not received glatiramer
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`acetate therapy prior to initiation of the treatment”—underscores that a unique individual, not a
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`population, is the subject of the claimed methods.
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`Moreover, only claims 5 and 6 recite an effect across a population. For example, claim 5
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`recites “reducing the frequency of relapses by 30% or more as compared to placebo in a human
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`population.” Id. at col. 16 ll. 61–62; col. 17 ll. 20–22. But these claims also mention “a human
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`patient,” and the claims include “inducing reduced severity of injection site reactions in the human
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`patient.” Id. at col. 16 l. 67–col. 17 l. 1. Claims 5 and 6 thus require both population effects and
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`individual effects. And significantly, the claims state that reduced severity of injection site
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`reactions occurs “in the human patient,” not in the population. Thus, claims 5 and 6 demonstrate
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`that the patentee knew how to claim treatment effects occurring over a population. Yet, in claiming
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`reduced severity of ISRs and IPIRs, the patentee chose to require those effects in an individual
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`patient, not a population.
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`Patentee’s choice makes sense. The ’776 patent claims methods of treating MS by injecting
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`a drug. Doctors do not inject populations; they inject patients. So while large-scale administration
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`of the method could have population-wide effects—such as the reduced population relapse rate as
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`recited by claims 5 and 6—the method itself is directed to a single patient. After all, the claimed
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`“human patient” is singular, not plural. Defendants’ construction is thus most consistent with plain
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`meaning and the claims.
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`Finally, the specification lends further support to Defendants’ construction. The summary
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`9
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`Mylan Pharms. Inc. Exhibit 1013 Page 12
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`Case 1:14-cv-01171-GMS Document 139 Filed 12/18/15 Page 13 of 15 PageID #: 2959
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`of the invention section’s first paragraph could not be any clearer in declaring that a patient is the
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`subject of the described methods:
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`This invention provides a method of alleviating a symptom of relapsing-remitting
`multiple sclerosis in a human patient suffering from relapsing-remitting multiple
`sclerosis or a patient who has experienced a first clinical episode and is determined
`to be at high risk of developing clinically definite multiple sclerosis comprising
`administering to the human patient three subcutaneous injections of a
`therapeutically effective dose of glatiramer acetate over a period of seven days with
`at least one day between every subcutaneous injection so as to thereby alleviate the
`symptom of the patient.
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`Id. at col. 2 ll. 56–65. The remainder of the section’s disclosure is similar. Therefore, as it is
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`consistent with the plain meaning, claims, and specification, the Court should construe the
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`“reduced severity” terms to refer to a patient’s ISRs and IPIRs, not aggregated ISRs and IPIRs.
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`V.
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`CONCLUSION
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`For these reasons, Defendants respectfully request that the Court: (1) Hold that the
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`“reduced severity” terms are indefinite; and (2) Construe:
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`• “reduced severity of injection site reactions” as “a reduction in the intensity of a
`patient’s injection site reactions,” and
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`• “reduced frequency and severity of immediate post injection reactions and injection
`site reactions” as “a reduction in both the rate of occurrence and the intensity of a
`patient’s immediate post injection reactions and injection site reactions.”
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`10
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`Mylan Pharms. Inc. Exhibit 1013 Page 13
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`Case 1:14-cv-01171-GMS Document 139 Filed 12/18/15 Page 14 of 15 PageID #: 2960
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`Dated: December 18, 2015
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`
`
`/s/ Arun J. Mohan
`Frederick L. Cottrell, III (No. #2555)
`Cottrell@rlf.com
`Arun J. Mohan (No. #6110)
`Mohan@rlf.com
`RICHARDS, LAYTON & FINGER, P.A.
`One Rodney Square
`920 North King Street
`Wilmington, Delaware 19801
`Tel: (302) 651-7700
`
`Shannon M. Bloodworth
`Perkins Coie, LLP
`SBloodworth@perkinscoie.com
`700 13th Street, NW
`Washington, DC 20005
`Tel: (202) 654-6204
`
`David L. Anstaett
`DAnstaett@perkinscoie.com
`Emily J. Greb
`EGreb@perkinscoie.com
`Perkins Coie LLP
`1 East Main Street, Suite 201
`Madison, WI 53703
`Tel: (608) 663-7460
`
`Attorneys for Defendants Mylan, Inc., and
`Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
`
`
`
`/s/ David A. Bilson
`John C. Phillips, Jr. (No. 110)
`jcp@pgslaw.com
`David A. Bilson (No. 4986)
`dab@pgslaw.com
`PHILLIPS, GOLDMAN &SPENCE, P.A.
`1200 North Broom Street
`Wilmington, DE 19806
`
`Constance S. Huttner
`Beshoy M. Sharoupim
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`(973) 315-4430
`
`Attorneys for Defendants DRL
`
`
`/s/ Dominick T. Gattuso
`Dominick T. Gattuso (No. 3630)
`DGattuso@proctorheyman.com
`PROCTOR HEYMAN &ENERIO LLP
`300 Delaware Ave., Suite 200
`Wilmington, DE 19801
`(308) 472-7300
`
`William A. Rakoczy
`Deanne M. Mazzochi
`Rachel Pernic Waldron
`RAKOCZY MOLINO MAZZOCHI SIWIK
`LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL 60654
`(312) 222-7543
`wrakoczy@rmmslegal.com
`dmazzochi@rmmslegal.com
`rwaldron@rmmslegal.com
`
`Attorneys for Defendants Sandoz Inc.
`and Momenta Pharmaceuticals, Inc.
`
`11
`
`
`
`Mylan Pharms. Inc. Exhibit 1013 Page 14
`
`

`
`Case 1:14-cv-01171-GMS Document 139 Filed 12/18/15 Page 15 of 15 PageID #: 2961
`
`
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`
`
`
`
`/s/ Richard L. Renck
`Richard L. Renck (No. 3893)
`DUANEMORRIS LLP
`222 Delaware Avenue, Suite 1600
`Wilmington, DE 19801-1659
`(302) 657-4900
`
`Anthony J. Fitzpatrick
`Vincent L. Capuano, Ph.D.
`Christopher S. Kroon
`Carolyn A. Alenci
`DUANEMORRIS LLP
`100 High Street, Suite 2400
`Boston, MA 02110-1724
`(857) 488-4200
`
`Attorneys for Amneal Pharmaceuticals LLC
`and Amneal Pharmaceuticals Company
`GmbH
`
`
`
`
`
`
`12
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Eve H. Ormerod
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`SMITH KATZENSTEIN & JENKINS LLP
`1000 West Street, Suite 1501
`P.O. Box. 410
`Wilmington, DE 19899 (courier 19801)
`(302) 652-8400
`nbelgam@skjlaw.com
`eho@skjlaw.com
`
`E. Anthony Figg
`Sharon L. Davis
`R. Elizabeth Brenner-Leifer
`Seth E. Cockrum
`Jennifer Nock
`ROTHWELL, FIGG, ERNST & MANBECK,
`P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`(202) 783-6040
`
`Attorneys for Synthon Pharmaceuticals Inc.,
`Synthon B.V, Synthon s.r.o., and Pfizer Inc.
`
`Mylan Pharms. Inc. Exhibit 1013 Page 15