Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 1 of 13 PageID: 2663
`
`NOT FOR PUBLICATION
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`_______________________________________________
`:
`:
`
`:
`:
`:
`:
`:
`:
`Defendants.
`_______________________________________:
`:
`:
`
`HORIZON PHARMA, INC., HORIZON
`PHARMA USA, INC., and POZEN INC.,
`
`Plaintiffs,
`
`v.
`
`DR. REDDY’S LABORATORIES, INC.
`and DR. REDDY’S LABORATORIES,
`
`HORIZON PHARMA, INC., HORIZON
`PHARMA USA, INC., and POZEN INC.,
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`MYLAN LABORATORIES LIMITED, and
`MYLAN, INC.,
`
` Civil Action No. 15-3324 (SRC)
`
`
`
` OPINION & ORDER
`
`(consolidated for discovery
`purposes with Civil Action
`Nos. 16-4918, 16-9035,
`15-3327, 16-4921, 15-3326,
`and 16-4920)
`
`::
`
`::
`
`::
`
`::
`
`:
`:
`:
`:
`
`::
`
`:
`Defendants.
`_______________________________________:
`:
`:
`
`::
`
`::
`
`:
`:
`:
`
`::
`
`HORIZON PHARMA, INC., HORIZON
`PHARMA USA, INC., and POZEN INC.,
`
`Plaintiffs,
`
`v.
`
`LUPIN LTD. and LUPIN
`PHARMACEUTICALS INC.,
`
`:
`Defendants.
`_______________________________________:
`CHESLER, U.S.D.J.
`
` EXHIBIT 1045 PAGE 1
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 2 of 13 PageID: 2664
`
`This matter comes before the Court on the application for claim construction by
`
`Plaintiffs Horizon Pharma, Inc., Horizon Pharma USA, Inc., and Pozen Inc. (collectively,
`
`“Horizon”) and Defendants Dr. Reddy’s Laboratories Inc. and Dr. Reddy’s Laboratories Ltd.
`
`(collectively, “DRL”), Mylan Inc., Mylan Laboratories Limited, and Mylan Pharmaceuticals Inc.
`
`(collectively, “Mylan”), and Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively, “Lupin”).
`
`In this patent infringement suit involving eleven pharmaceutical patents related to the drug
`
`Vimovo®, the parties seek construction of claims in three patents. Horizon, DRL and Lupin seek
`
`construction of terms in U.S. Patent No. 8,945,621 (“the ’621 patent”). All parties seek
`
`construction of terms in U.S. Patent Nos. 9,220,698 (“the ’698 patent”) and 9,393,208 (“the ’208
`
`patent”). The Court held a Markman hearing on November 7, 2017.
`
`I.
`
`The law of claim construction
`
`ANALYSIS
`
`A court’s determination “of patent infringement requires a two-step process: first, the court
`
`determines the meaning of the disputed claim terms, then the accused device is compared to the
`
`claims as construed to determine infringement.” Acumed LLC v. Stryker Corp., 483 F.3d 800,
`
`804 (Fed. Cir. 2007). “[W]hen the district court reviews only evidence intrinsic to the patent (the
`
`patent claims and specifications, along with the patent’s prosecution history), the judge’s
`
`determination will amount solely to a determination of law.” Teva Pharms. USA, Inc. v. Sandoz,
`
`Inc., 135 S. Ct. 831, 841 (2015).
`
`
`
`The focus of claim construction is the claim language itself:
`
`It is a bedrock principle of patent law that the claims of a patent define the
`invention to which the patentee is entitled the right to exclude. Attending this
`principle, a claim construction analysis must begin and remain centered on the
`claim language itself, for that is the language the patentee has chosen to
`
`2
`
`EXHIBIT 1045 PAGE 2
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 3 of 13 PageID: 2665
`
`‘particularly point[] out and distinctly claim[] the subject matter which the patentee
`regards as his invention.’
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115-1116 (Fed. Cir.
`
`2004) (citations omitted).
`
`The Federal Circuit has established this framework for the construction of claim language:
`We have frequently stated that the words of a claim ‘are generally given their
`ordinary and customary meaning.’ We have made clear, moreover, that the
`ordinary and customary meaning of a claim term is the meaning that the term
`would have to a person of ordinary skill in the art in question at the time of the
`invention, i.e., as of the effective filing date of the patent application.
`The inquiry into how a person of ordinary skill in the art understands a claim term
`provides an objective baseline from which to begin claim interpretation. . .
`
`In some cases, the ordinary meaning of claim language as understood by a person
`of skill in the art may be readily apparent even to lay judges, and claim
`construction in such cases involves little more than the application of the widely
`accepted meaning of commonly understood words. In such circumstances, general
`purpose dictionaries may be helpful. In many cases that give rise to litigation,
`however, determining the ordinary and customary meaning of the claim requires
`examination of terms that have a particular meaning in a field of art. Because the
`meaning of a claim term as understood by persons of skill in the art is often not
`immediately apparent, and because patentees frequently use terms
`idiosyncratically, the court looks to those sources available to the public that show
`what a person of skill in the art would have understood disputed claim language to
`mean. Those sources include the words of the claims themselves, the remainder of
`the specification, the prosecution history, and extrinsic evidence concerning
`relevant scientific principles, the meaning of technical terms, and the state of the
`art.
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1312-1314 (Fed. Cir. 2005) (citations omitted).
`
`II.
`
`Claim construction of the disputed terms
`
`A.
`
`The ’621 patent
`
`The parties had originally briefed three terms in the ’621 patent: “coordinated release,”
`
`“more effective,” and “reducing the incidence.” Just before the Markman hearing, the parties
`
`agreed that: 1) “coordinated release” should have the same construction as previously established
`
`3
`
` EXHIBIT 1045 PAGE 3
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 4 of 13 PageID: 2666
`
`in regard to the ’907 patent; and 2) “reducing the incidence” need not be construed. This leaves
`
`only “more effective” at issue.
`
`The phrase “more effective” appears toward the end of claim 1 in the ’621 patent:
`
`. . . wherein said pharmaceutical composition in unit dose form reduces the
`incidence of NSAID-associated ulcers in said patient and wherein administration of
`the unit dose form is more effective at reducing the incidence of the
`NSAID-associated ulcers in patients taking LDA than in patients not taking LDA
`who are administered the unit dose form.
`
`At the hearing, it became clear that the parties have no actual dispute about the meaning of the
`
`phrase, “more effective,” and they agree that it should have its ordinary meaning. The dispute
`
`between the parties instead concerned Defendants’ argument that the claim is nonsensical and
`
`therefore indefinite, but these are not issues to address at claim construction. “More effective” has
`
`its ordinary meaning.
`
`B.
`
`The ’698 and ’208 patents
`
`The parties dispute the construction of three terms in the ’698 and ’208 patents: “±20%,”
`
`“target,” and “mean area under the plasma concentration-time curve.” The parties seek
`
`construction of these terms in the two patents, but focused on the ’698 patent in briefing and at the
`
`hearing. The ’698 patent has one independent claim:
`
`1. A method for treating osteoarthritis, rheumatoid arthritis, or ankylosing
`spondylitis comprising orally administering to a patient in need thereof an AM unit
`dose form and, 10 hours (±20%) later, a PM unit dose form, wherein:
`
`the AM and PM unit dose forms each comprises:
`naproxen, or a pharmaceutically acceptable salt thereof, in an
`amount to provide 500 mg of naproxen, and
`esomeprazole, or a pharmaceutically acceptable salt thereof, in an
`amount to provide 20 mg of esomeprazole;
`
`said esomeprazole, or pharmaceutically acceptable salt thereof, is released from
`said AM and PM unit dose forms at a pH of 0 or greater,
`
`4
`
`EXHIBIT 1045 PAGE 4
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 5 of 13 PageID: 2667
`
`the AM and PM unit dose forms target:
`
`i) a pharmacokinetic (pk) profile for naproxen where:
`a) for the AM dose of naproxen, the mean Cmax is 86.2 ng/mL
`(±20%) and the median Tmax is 3.0 hours (±20%); and
`b) for the PM dose of naproxen, the mean Cmax is 76.8 ng/mL
`(±20%) and the median Tmax is 10 hours (±20%); and
`ii) a pharmacokinetic (pk) profile for esomeprazole where:
`a) for the AM dose of esomeprazole, the mean area under the plasma
`concentration-time curve from when the AM dose is administered to
`10 hours (±20%) after the AM dose is administered (AUC0-10,am) is
`1216 hr*ng/mL (±20%),
`b) for the PM dose of esomeprazole, the mean area under the plasma
`concentration-time curve from when the PM dose is administered to
`14 hours (±20%) after the PM dose is administered (AUC0-14,pm) is
`919 hr*ng/mL (±20%), and
`c) the total mean area under the plasma concentration-time curve for
`esomeprazole from when the AM dose is administered to 24 hours
`(±20%) after the AM dose is administered (AUC0-24) is 2000
`hr*ng/mL (±20%); and
`
`the AM and PM unit dose forms further target a mean % time at which intragastric
`pH remains at about 4.0 or greater for about a 24 hour period after reaching steady
`state that is at least about 60%.
`
`A note about terminology: in the art, “PK profile” refers to a pharmacokinetic profile,
`
`basically statements of characteristics of levels of the active ingredient in blood plasma, showing
`
`the absorption of the active ingredient by the body. “PD profile” refers to a pharmacodynamic
`
`profile, basically statements of the resulting effect on the body, such as raising the stomach pH a
`
`certain amount. Claim 1 states targets in terms of certain PK characteristics (plasma levels of
`
`active ingredients) and certain PD characteristics (levels of intragastric pH).
`
`1.
`
`“±20%”
`
`
`
`The parties dispute whether “±20%” in claim 1 has its ordinary arithmetic meaning (plus
`
`or minus 20%), or is a “coefficient of variation” (“CV”), as defined in the specification. The term
`
`“±20%” appears in claim 1 in 10 places: half are time values (hours ±20%), and half are plasma
`
`5
`
` EXHIBIT 1045 PAGE 5
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 6 of 13 PageID: 2668
`
`concentration values (Cmax or AUC ±20%). Defendants propose that “±20%” has its ordinary
`
`arithmetic meaning when modifying time values, but a special meaning (CV) when modifying
`
`plasma concentration values. There is no dispute that, as to the time values, “±20%” has its
`
`ordinary arithmetic meaning.
`
`On first blush, Defendants seem to make a strong case for the CV construction: Defendants
`
`point out that, in a section which states principles of general applicability, the specification states:
`
`“With regard to the pharmacokinetic and/or pharmacodynamic values provided herein, the degree
`
`of variation is reflected in SDs and % CV values. The %CV = SD/mean x 100.” ’698 patent,
`
`col.5 ll.53-56. There is no dispute that Cmax and AUC are pharmacokinetic (“PK”) values.
`
`Defendants, however, have overlooked the full context of that statement in the
`
`specification:
`
`With regard to the pharmacokinetic and/or pharmacodynamic values provided
`herein, the degree of variation is reflected in SDs and % CV values. The %
`CV=SD/mean x 100; the SD=(% CV x mean) divided by 100. It can be expected
`that approximately 68% of patients will be within one SD of the mean and
`approximately 95% of patients will be within two SDs of the mean. The
`pharmacokinetic and pharmacodynamic values presented herein are average values,
`rounded to the nearest whole number, and are based upon results obtained from
`multiple individuals. As a result, the values presented herein may vary from one
`patient to another. This variation is reflected in the term ‘about.’
`
`’698 patent, col. 5 ll.53-64. When the sentence quoted by Defendants is read in context, the
`
`context shows that this applies only “to results obtained from multiple individuals.” ’698 patent,
`
`col.5 ll.61-62. It therefore applies only to PK or PD values that state results from groups of
`
`patients, such as results of research studies. It does not apply to results from a single patient. The
`
`preamble of claim 1 states: “A method for treating osteoarthritis, rheumatoid arthritis, or
`
`ankylosing spondylitis comprising orally administering to a patient in need thereof . . .”
`
`6
`
` EXHIBIT 1045 PAGE 6
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 7 of 13 PageID: 2669
`
`(emphasis added). The PK and PD limitations in claim 1 apply to that single patient, not to results
`
`from multiple individuals.1
`
`Furthermore, as Plaintiffs point out, the prosecution history shows that the applicants
`
`substituted “±20%” in claim 1 (then claim 19) for the word “about.” (Beel Dec. Ex. 5 at 5.) The
`
`applicants stated, in regard to this change: “This amendment is supported Applicants’
`
`specification [sic] at, for example, page 6, lines 17-18.” (Id.) This citation refers to this statement
`
`in the draft specification: “For the values provided herein, the term ‘about’ indicates a given
`
`number may vary by at least 5%, with variations of 10%, 15% or 20% being possible.” (Beel Dec.
`
`Ex.7 at 6.) Note that the applicants did not refer to the next paragraph in the draft specification
`
`which, like the specification in the issued patent, is the paragraph quoted above about PK values
`
`and the coefficient of variation. This statement in the prosecution history supports the
`
`understanding that the applicants intended “±20%” to mean a simple arithmetic percentage –
`
`roughly equivalent to “about” – , rather than a coefficient of variation.
`
`Plaintiffs also point out that claim 1 uses “±20%” in reference not only to PK and PD
`
`values, but also in regard to time periods. In short, the CV concept has no applicability to – and,
`
`rather, makes no sense if applied to – time periods. “[T]he same word appearing in the same
`
`claim should be interpreted consistently.” Dig. Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335,
`
`1 At the hearing, counsel for Plaintiffs argued that the PK and PD profile values in claim
`1 are summary statistics for groups of patients. This position conflicts with the preamble
`language that specifies that what is claimed is a method of treatment for “a patient.” Plaintiffs
`have not pointed to anything in the patent that shows that what the inventors actually invented
`was a method for treating a group of patients. See Renishaw PLC v. Marposs Societa' Per
`Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998) (“Ultimately, the interpretation to be given a term
`can only be determined and confirmed with a full understanding of what the inventors actually
`invented and intended to envelop with the claim.”)
`
`7
`
` EXHIBIT 1045 PAGE 7
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 8 of 13 PageID: 2670
`
`1345 (Fed. Cir. 1998).
`
`Furthermore, in the specification, where the inventors meant to refer to the CV, they wrote
`
`out, “% CV” or “% coefficient of variation.” See, e.g., ’698 patent, Figure 7; col.8 ll.12-13;
`
`Tables 4, 5, 6. Defendants have not pointed to any place in the specification that “±20%” appears
`
`and has the meaning, “a CV of 20.”
`
`
`
`“±20%” has its ordinary meaning, “plus or minus 20 %.”
`
`2.
`
`“target”
`
`Claim 1 contains the term “target” in two places: “the AM and PM unit dose forms target:”
`
`and “the AM and PM unit dose forms further target.” Plaintiffs contend that “target” has its
`
`ordinary meaning, and that that ordinary meaning is “produce.” At oral argument, the Court
`
`inquired as to how “produce” is the ordinary meaning of “target.” In reply, Plaintiffs explained
`
`that what they meant is that “produce” is the meaning that would be understood by the skilled
`
`artisan in the context of this patent. In support, Plaintiffs point to the declaration of their expert,
`
`Dr. Taft, who states that opinion. (Taft Dec. ¶ 28.) Plaintiffs also cite this statement in the ’698
`
`specification: “This, and similar, formulations can be effective in improving NSAID tolerability
`
`through dosages of esomeprazole and naproxen that produce the desired pharmacodynamic
`
`response and pharmacokinetic values.” ’698 patent, col.1 ll.34-37. Plaintiffs also point to a place
`
`in the specification in which an embodiment is said to target a particular PD profile. ’698 patent,
`
`col.6 ll.46-56.
`
`The Court finds Plaintiffs’ proposed construction unpersuasive. At the hearing, Plaintiffs
`
`offered nothing to counter the Court’s suggestion that the ordinary meaning of “target” is not
`
`“produce,” except for the argument, based on extrinsic evidence, that the skilled artisan would
`
`8
`
` EXHIBIT 1045 PAGE 8
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 9 of 13 PageID: 2671
`
`understand it that way. Under Federal Circuit law, “conclusory, unsupported assertions by experts
`
`as to the definition of a claim term are not useful to a court.” Phillips, 415 F.3d at 1318. Dr.
`
`Taft’s assertion is the kind of conclusory, unsupported assertion that, under Phillips, is not useful
`
`in claim construction.
`
`The only intrinsic evidence cited by Plaintiffs is the specification passage in which the
`
`treatment method is described as producing certain PD and PK profiles, as well as one in which
`
`the treatment method is said “to target” a specific PD profile. The Court does not see how this
`
`supports Plaintiffs’ position. For example, if the specification of a car suspension patent states
`
`that the design “delivers” a smooth ride, and also that the design “creates” a smooth ride, that is
`
`not evidence that “deliver” means “create.”
`
`It is certainly clear that the inventors believed that the patented method should, at some
`
`point and in some way, produce the stated PD and PK profiles – as Plaintiffs demonstrate, the
`
`specification makes that clear. But that does not resolve this issue. As the Federal Circuit has
`
`stated, “the claims, not the specification, provide the measure of the patentee’s right to exclude.”
`
`Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d 1046, 1052 (Fed. Cir. 2002). “It is the
`
`claims that define the metes and bounds of the patentee’s invention.” Kara Tech. Inc. v.
`
`Stamps.com Inc., 582 F.3d 1341, 1347 (Fed. Cir. 2009). Thus, an underlying concern in claim
`
`construction is ascertaining the metes and bounds of the patentee’s invention that are stated in the
`
`claim. Plaintiffs’ proposed construction does not appear to clarify how the patentees drew those
`
`boundaries.
`
`During oral argument, this was apparent when Plaintiffs seemed to contend that the PK
`
`and PD profile values in claim 1 are average values that are obtained from some unspecified group
`
`9
`
` EXHIBIT 1045 PAGE 9
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 10 of 13 PageID: 2672
`
`of patients. If this is Plaintiffs’ position, it makes no sense. As already noted, the preamble of
`
`claim 1 states: “A method for treating osteoarthritis, rheumatoid arthritis, or ankylosing
`
`spondylitis comprising orally administering to a patient in need thereof . . .” (emphasis added).
`
`Plaintiffs’ position conflicts with this: how could the treatment of a single patient target PK and
`
`PD values that are averages from some unknown group?2 Moreover, if this is the case, how does a
`
`skilled artisan determine whether or not a particular treatment of a particular individual patient has
`
`met the limitations of claim 1? Does one have to treat a group of patients and then compare the
`
`average values for the group to the values stated in claim 1? Is this a hypothetical group of
`
`patients? In terms of understanding the metes and bounds of the claims, this is a path to
`
`confusion.
`
`In sum, Plaintiffs did not shed light on the meaning of “target” in claim 1.
`
`Defendants contend that “target” is indefinite. This Court considers indefiniteness
`
`arguments on summary judgment or at trial, and not at claim construction. Defendants propose, in
`
`the alternative, that if the Court does not find the term indefinite, it has its ordinary meaning,
`
`which is, “with the goal of obtaining.”
`
`Thus, both sides propose that “target” has its ordinary meaning, but they differ on what
`
`that ordinary meaning is. Defendants point to a number of dictionary definitions of target: “to
`
`establish as a target or a goal” (Beel Dec. Ex. 8), “establish as a goal” (Beel Dec. Ex. 9), and “to
`
`establish as a target, goal, etc.) (Beel Dec. Ex. 10). These three dictionary definitions agree that
`
`2 The Court recognizes that the specification states: “The pharmacokinetic and
`pharmacodynamic values presented herein are average values, rounded to the nearest whole
`number, and are based upon results obtained from multiple individuals.” ’698 patent, col.5 ll.59-
`62. This is clearly true as applied to research results, such as disclosed in Table 6. The parties
`did not address the question of whether this also applies to claim 1.
`
`10
`
` EXHIBIT 1045 PAGE 10
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 11 of 13 PageID: 2673
`
`“target” means “to establish as a goal.” Unlike Plaintiffs’ proposed meaning, this fits with the
`
`Court’s understanding of what “target” ordinarily means. This construction also fits with claim 1
`
`and the patent as a whole: the PK and PD profiles in claim 1 appear to be goals for the treatment
`
`method of claim 1. If Plaintiffs are correct in their contention that the PK and PD values in claim
`
`1 are averages for a group, the claim, using this construction, makes sense: one administers the
`
`method to an individual patient with the goal of obtaining these values, on average, for a group of
`
`patients. From this perspective, the PK and PD profiles in claim 1 do not serve as limitations for
`
`the method, but as statements of a goal aspired to, but not met, for every patient.3
`
`This Court agrees with Defendants’ proposed construction, “with the goal of obtaining.”
`
`In the context in which “target” appears in claim 1, that exact wording has a poor grammatical fit
`
`(since “target” functions as a verb in claim 1, and “with the goal of obtaining” is a prepositional
`
`phrase.) To improve the grammatical fit, this Court construes “target” in claim 1 to mean: “set as
`
`a goal.”
`
`This Court recognizes the general canon of claim construction that claims should be
`
`construed so as to preserve their validity. While this Court today makes no determination about
`
`the validity of claim 1, at the same time, the Court recognizes that this construction of “target”
`
`could conceivably impact the validity of the claim. On this record, however, this Court sees no
`
`alternative. Plaintiffs’ proposed construction makes no sense, and Defendants’ proposed
`
`construction makes sense. Moreover, the Federal Circuit does not apply this canon of
`
`3 Defendants argued separately that the PK and PD values in claim 1 are non-limiting,
`offering a number of arguments in support, including one focused on the relationship between
`claim 1 and Table 6 in the specification. This Court need not reach any of these arguments at
`this juncture in order to construe the claim term, “target.” The Court does not, today, decide the
`question of whether the PK and PD profiles in claim 1 are or are not limiting.
`
`11
`
` EXHIBIT 1045 PAGE 11
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 12 of 13 PageID: 2674
`
`construction in every case, but limits it to certain circumstances:
`
`This court has frequently alluded to the familiar axiom that claims should be so
`construed, if possible, as to sustain their validity. At the same time, however, the
`court has admonished against judicial rewriting of claims to preserve validity.
`Accordingly, unless the court concludes, after applying all the available tools of
`claim construction, that the claim is still ambiguous, the axiom regarding the
`construction to preserve the validity of the claim does not apply.
`
`Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 911 (Fed. Cir. 2004) (citations omitted).
`
`Because this Court does not find the term “target” to be ambiguous, it need not contemplate
`
`rewriting the claim to preserve its validity.
`
`3.
`
`“mean area under the plasma concentration-time curve”
`
`The parties dispute whether “mean area under the plasma concentration-time curve”
`
`(“mean AUC”) is limited to a steady state value. Defendants seek to import a narrowing
`
`limitation from certain embodiments in the specification. There is no basis in the claim language
`
`for Defendants’ proposed narrowing construction. “[A]lthough the specification often describes
`
`very specific embodiments of the invention, we have repeatedly warned against confining the
`
`claims to those embodiments.” Phillips, 415 F.3d at 1323. Claim 1 contains a different limitation
`
`which specifies “after reaching steady state,” and the specification includes examples in which the
`
`steady state characteristic is expressly stated, showing that the patentees knew how to state that
`
`characteristic when they intended it to apply. “Mean area under the plasma concentration curve”
`
`will be given its ordinary meaning, without the narrowing construction Defendants propose.
`
`12
`
`EXHIBIT 1045 PAGE 12
`
` DRL
`
`

`

`Case 2:15-cv-03324-SRC-CLW Document 82 Filed 11/14/17 Page 13 of 13 PageID: 2675
`
`In conclusion, in claim 1 of the ’698 and ’208 patents, “±20%” and “mean area under the
`
`plasma concentration-time curve” have their ordinary meaning, while “target” means, “set as a
`
`goal.” In claim 1 of the ’621 patent, “more effective” has its ordinary meaning.
`
`SO ORDERED.
`
`Dated: November 14, 2017
`
` s/ Stanley R. Chesler
`Stanley R. Chesler, U.S.D.J.
`
`13
`
`EXHIBIT 1045 PAGE 13
`
` DRL
`
`