Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 1 of 21
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`SHIRE LLC and
`SHIRE US INC.,
`
`v.
`
`ABHAI, LLC,
`
`Plaintiffs,
`
`Defendant.
`
` Civil Action No. 1:15-cv-13909
`
`PLAINTIFFS’ REPLY CLAIM CONSTRUCTION BRIEF
`
`KVK-TECH EXHIBIT 1036
`
`

`

`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 2 of 21
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION .............................................................................................................. 1
`
`COLLATERAL ESTOPPEL IS NOT APPLICABLE TO THE DISPUTED
`TERMS ............................................................................................................................... 2
`
`III.
`
`THE DISPUTED CLAIM TERMS .................................................................................... 4
`
`A.
`
`The ’096 Patent ....................................................................................................... 4
`
`1.
`
`“delayed pulsed enteric release” / “delayed pulse enteric release”
`(’096 Patent, Claims 1, 2, 8, 18, 20) ........................................................... 4
`
`B.
`
`The ’148 Patent ....................................................................................................... 7
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`“a delayed enteric release dosage form that provides delayed
`release upon oral administration” (’148 Patent, Claims 1 and 12) ............. 7
`
`“a plasma concentration versus time curve (ng/ml versus hours)
`having an area under the curve (AUC) of about 467 to about 714
`ng hr/ml” (’148 Patent, Claim 1) and .......................................................... 8
`
`“said plasma concentration curve has a maximum concentration
`(Cmax) of about 22.5 to about 40 ng/ml” (’148 Patent, Claim 2) .............. 10
`
`“peak plasma concentration” (’148 Patent, Claims 1 and 12) .................. 11
`
`“a human individual” / “ a human patient” (’148 Patent, Claim 1) .......... 12
`
`IV.
`
`CONCLUSION ................................................................................................................. 15
`
`
`
`
`
`
`
`i
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 3 of 21
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`314 F.3d 1313 (Fed. Cir. 2003)..................................................................................................3
`
`Amgen, Inc. v. Hoffman-La Roche Ltd.,
`494 F. Supp. 2d 54 (D. Mass. 2007) ..........................................................................................3
`
`Braintree Labs., Inc. v. Novel Labs., Inc.,
`749 F.3d 1349 (Fed. Cir. 2014)....................................................................................12, 13, 15
`
`Glycobiosciences Inc. v. Innocutis Holdings, LLC,
`No. 12-1902, 2015 WL 7574749 (D.D.C. Nov. 25, 2015) ......................................................10
`
`Kara Tech. Inc. v. Stamps.com Inc.,
`582 F.3d 1341 (Fed. Cir. 2009)..................................................................................................7
`
`Kollmorgen Corp. v. Yaskawa Elec. Corp.,
`147 F. Supp. 2d 464 (W. Va. 2001) ...........................................................................................3
`
`Merck & Co. v. Teva Pharm. USA,
`395 F.3d 1364 (Fed. Cir. 2005)..................................................................................................7
`
`New Hampshire v. Maine,
`532 U.S. 742 (2001) ...............................................................................................................4, 5
`
`O2 Micro Int’l, Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008)..................................................................................................2
`
`Pall Corp. v. Micron Separations, Inc.,
`66 F.3d 1211 (Fed. Cir. 1995)..................................................................................................10
`
`Parker-Hannifin Corp. v. Baldwin Filters, Inc.,
`724 F. Supp. 2d 810 (N.D. Ohio 2010) ......................................................................................3
`
`Pure Fishing, Inc. v. Normark Corp.,
`No. 10-2140, 2011 WL 5082339 (D.S.C. Oct. 26, 2011) ........................................................10
`
`Regents of Univ. of Cal. v. Dakocytomation Cal., Inc.,
`517 F.3d 1364 (Fed. Cir. 2008)..................................................................................................2
`
`Shire Labs. Inc. v. Impax Labs., Inc.,
`Case No. 03-cv-1164 GMS (D. Del.) ..................................................................................1, 10
`
`ii
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 4 of 21
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`Shire LLC v. Colony Pharms. et al.,
`Case No. 1:07-cv-00718-CCB (D. Md.) ....................................................................................1
`
`Shire LLC v. Amerigen Pharms. Ltd.,
`Civ. A. No. 14-cv-6095 (D.N.J.)................................................................................................5
`
`Shire, LLC v. Neos Therapeutics, Inc.,
`Case. No. 3:13-cv-01452-N (N.D. Tex.) ...................................................................................1
`
`Shire LLC v. Sandoz,
`Case No. l:07-cv-00197-PAB-CAS (D. Col.) ............................................................................1
`
`Tandon Corp. v. Int’l Trade Comm’n,
`831 F.2d 1017 (Fed. Cir. 1987)..................................................................................................7
`
`Teva Pharm. USA, Inc. v. Sandoz, Inc.,
`789 F.3d 1335 (Fed. Cir. 2015)..................................................................................................9
`
`TM Patents, L.P. v. Int’l Bus. Mach. Corp.,
`72 F. Supp. 2d 370 (S.D.N.Y. 1999)..........................................................................................2
`
`Other Authorities
`
`Fed. R. Civ. P. 54(b) ........................................................................................................................2
`
`iii
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 5 of 21
`
`
`I.
`
`
`
`INTRODUCTION
`
`Abhai’s argument that this Court is bound by collateral estoppel to accept the
`
`constructions adopted by the District of New Jersey in the ongoing Amerigen litigation is wrong.
`
`The Amerigen case is still pending, and claim construction may well be refined before final
`
`judgment is entered. Moreover, the disputed terms have been construed multiple times in prior
`
`Hatch-Waxman litigations relating to Adderall XR®, and each Court has applied its own,
`
`different, set of claim constructions. See Shire, LLC v. Neos Therapeutics, Inc., Case. No. 3:13-
`
`cv-01452-N, D.I. 69 (N.D. Tex. Mar. 20, 2014); Shire LLC v. Sandoz, Case No. l:07-cv-00197-
`
`PAB-CAS, D.I. 169 (D. Col. Sept. 24, 2008); Shire Labs. Inc. v. Impax Labs., Inc., Case No. 03-
`
`cv-1164 GMS, D.I. 119, 2005 WL 319983 (D. Del. Feb. 9, 2005) (the “Impax case” or
`
`“Impax”).1 At the end of the day, Abhai is merely cherry-picking the prior constructions it
`
`prefers. But no prior court’s construction can override the claim language, specification, and
`
`prosecution history of the ’148 and ’096 Patents.
`
`
`
`Apart from its flawed collateral estoppel arguments, Abhai’s proposed constructions fail
`
`on the merits. The Court should reject Abhai’s attempts to shape the claims to suit its non-
`
`infringement positions.
`
`
`1 These previous constructions are in Appendices A and B to Shire’s Preliminary Claim
`Construction Brief, D.I. 60 (“Op. Br.”). The District of Maryland, in Shire LLC v. Colony
`Pharm. et al., Case No. 1:07-cv-00718-CCB, also construed certain claims in its memorandum
`order on Colony’s motion to summary judgment of noninfringement. See D.I. 109 (Feb. 1, 2008).
`
`1
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 6 of 21
`
`
`II.
`
`
`
`COLLATERAL ESTOPPEL IS NOT APPLICABLE TO THE DISPUTED TERMS
`
`Abhai is incorrect that Shire is collaterally estopped from disputing the constructions
`
`adopted by the Amerigen Court.2 In the absence of a final judgment, claim construction is an
`
`interlocutory order and “subject to revision at any time before the entry of judgment.” See
`
`Regents of Univ. of Cal. v. Dakocytomation Cal., Inc., 517 F.3d 1364, 1371 (Fed. Cir. 2008);
`
`Fed. R. Civ. P. 54(b). The Amerigen litigation is set for trial in February 2017, and expert
`
`discovery is currently ongoing. Moreover, as Abhai is aware, the parties are continuing to
`
`dispute the interpretation of certain claim terms in the Amerigen litigation that are also at issue in
`
`this case—specifically, the meanings of “peak plasma concentration” and “about” in the
`
`pharmacokinetic terms of the ’148 Patent. Given these issues, it would be unsurprising if the
`
`Amerigen Court further refined its claim constructions. See O2 Micro Int’l, Ltd. v. Beyond
`
`Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008) (“When the parties present a
`
`fundamental dispute regarding the scope of a claim term, it is the court’s duty to resolve it.”).
`
`
`
`Abhai incorrectly contends that courts have found collateral estoppel in the absence of a
`
`final judgment. In TM Patents, the prior constructions were read to the jury on the first day of
`
`trial, which subsequently settled, resulting in a final judgment. See TM Patents, L.P. v. Int’l Bus.
`
`Mach. Corp., 72 F. Supp. 2d 370, 375 (S.D.N.Y. 1999). Because of the advanced stage of the
`
`case at settlement, the subsequent court found the constructions sufficiently final for collateral
`
`estoppel to apply. Id. at 377 (“A verdict would not have changed anything about Judge Young’s
`
`
`2 These terms at issue here, which were also construed by the Amerigen court, are “delayed
`pulsed enteric release,” “delayed enteric release dosage form that provides delayed release upon
`oral administration,” “a plasma concentration versus time curve (ng/ml versus hours) having an
`area under the curve (AUC) of about 467 to about 714 ng hr/ml,” “said plasma concentration
`curve has a maximum concentration (Cmax) of about 22.5 to about 40 ng/ml,” and “a human
`individual.”
`
`2
`
`

`

`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 7 of 21
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`[prior] Markman rulings. Nothing more remained to be adjudicated; nothing more remained to be
`
`decided on the issue of claim construction.”). In Amgen, Inc. v. Hoffman-La Roche Ltd., 494 F.
`
`Supp. 2d 54 (D. Mass. 2007), the prior construction held to have preclusive effect came from a
`
`case that had been extensively litigated—including at least one appeal to the Federal Circuit. See
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003) (affirming the
`
`district court’s claim construction). The Amerigen case is, by comparison, in its infancy. This
`
`Court should reject any argument that collateral estoppel applies here: not only is there a split in
`
`authority regarding the extent to which claim construction has preclusive effect, but none of the
`
`cases Amerigen cites applied collateral estoppel based on a proceeding that was ongoing and in
`
`which further claim construction was possible. See, e.g., Kollmorgen Corp. v. Yaskawa Elec.
`
`Corp., 147 F. Supp. 2d 464, 470 (W.D. Va. 2001) (“Courts need not blindly apply the doctrine of
`
`collateral estoppel to a prior Markman ruling that construes a patent’s scope and claim.”); see
`
`also Parker-Hannifin Corp. v. Baldwin Filters, Inc., 724 F. Supp. 2d 810, 815 (N.D. Ohio 2010)
`
`(refusing to give prior claim constructions preclusive effect).
`
`
`
`Abhai’s argument also fails to acknowledge that the Amerigen Court is the fifth court to
`
`construe the terms of the ’096 and ’148 Patents—and that each Court adopted a different set of
`
`constructions, including constructions that directly conflict with the constructions of another
`
`court. See Op. Br., Appendices A and B (showing prior constructions). In light of these
`
`conflicting constructions, it is unclear how collateral estoppel would (or could) apply. This
`
`Court, like the Amerigen, Neos, Sandoz, Colony, and Impax Courts before it, should
`
`independently analyze the intrinsic and extrinsic evidence, and come to its own conclusions
`
`about claim construction.
`
`
`
`
`
`3
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 8 of 21
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`
`III. THE DISPUTED CLAIM TERMS
`
`A.
`
`The ’096 Patent
`
`1.
`
`“delayed pulsed enteric release” / “delayed pulse enteric release” (’096
`Patent, Claims 1, 2, 8, 18, 20)
`
`Shire’s Proposed Construction
`“rapid and complete release of drug intended to
`be delayed until the drug has passed through
`the stomach”
`
`Abhai’s Proposed Construction
`“rapid and complete release of drug (after a
`first dose by immediate release) designed to be
`delayed until the drug has passed through the
`stomach into the intestines”
`
`
`Abhai argues that Shire should be judicially estopped from advocating its proposed
`
`
`
`construction for these terms, but its analysis fails to engage with the legal test for estoppel and
`
`the particular facts of this case. First, “a party’s later position must be ‘clearly inconsistent’ with
`
`its earlier position.” New Hampshire v. Maine, 532 U.S. 742, 750 (2001). But as explained in
`
`Shire’s Opening Brief, Shire agrees with its earlier position that the immediate release of the
`
`highly soluble amphetamine salts will occur in the stomach, while the enteric release is intended
`
`to occur later in the gastrointestinal tract, in the intestines. However, Shire disagrees to the extent
`
`Abhai is arguing that its construction requires perfect sequencing of the releases. As explained
`
`during the Markman hearing (which Abhai ignores), “[t]here may be . . . a little bit of leakage in
`
`the stomach,” from the enteric release component. See Declaration of William C. Rose (“Rose
`
`Decl.”), Ex. C at 67:5–7 (D.I. 57-3); see also id. at 50:5–12 (“These enteric release coatings, no
`
`matter how good they are, they may not achieve 100 percent perfect release [in the intestine], and
`
`so the way that FDA captures that, captures the reality of science, is using [the] intent
`
`language.”); id. at 63:11–19 (“There may be some small portion of overlap. . . . [T]here may be
`
`some small amount of enteric release during that initial time in the stomach.”). Indeed, the
`
`Amerigen Court itself acknowledged that Shire’s proposed construction of “essentially all” in
`
`that proceeding would allow for a scenario where some small amount of leakage could occur in
`
`4
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 9 of 21
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`the stomach. See id. at 63:11–64:7; 65:14–66:4; 67:23–68:14. The Amerigen Court then rejected
`
`defendant Amerigen’s proposal of “essentially all,” which required “the entire dose” to be
`
`released. See D.I. 100, Civ. A. No. 14-cv-6095 (D.N.J.). Thus, Shire’s positions here are fully
`
`consistent with its positions in the Amerigen case—Shire merely seeks to refine the construction
`
`to avoid confusion and capture the understanding of the Amerigen Court.
`
`
`
`Second, in assessing judicial estoppel, “courts regularly inquire whether the party has
`
`succeeded in persuading a court to accept that party’s earlier position.” See New Hampshire, 532
`
`U.S. at 750. But in Amerigen Shire proposed and argued for the same construction of “delayed
`
`pulse[d] enteric release” that it now advances in this case. The Amerigen Court adopted a
`
`compromise construction, resulting from extensive discussion with counsel at the Markman
`
`hearing. See generally Rose Decl., Ex. C at 51:8–64:8; 65:11–69:19.
`
`
`
`Setting aside Abhai’s estoppel argument, the Court should adopt Shire’s proposed
`
`construction on the merits. While the parties’ constructions are largely in agreement, Shire seeks
`
`to clarify that perfect sequencing of the immediate and enteric release is not required. As
`
`acknowledged by the Amerigen Court itself (see D.I. 100, Civ. A. No. 14-cv-6095 (D.N.J.)),
`
`Claim 1 of the ’096 Patent only requires that “essentially all” of the enteric release component be
`
`released within 60 minutes—allowing for some small amount of leakage in the stomach.
`
`Moreover, the specification makes clear that the immediate and enteric release components act
`
`independently from one another, and release from the enteric component is not contingent on
`
`release from the immediate release component. Op. Br. at 9–10. For this reason, the timing of
`
`each release is defined by a fixed point—the time of oral administration. Davies Rebuttal ¶¶ 7,
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`10; see, e.g., ’096 Patent, col.3 ll.58–59 (“[T]he immediate release component releases the
`
`pharmaceutical agent in a pulsed dose upon oral administration.”); id. at col.4 ll.5–8
`
`5
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 10 of 21
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`(specification describes the “lag time” to the enteric release as measured with respect to “oral
`
`administration of the delivery system”).
`
`
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`The intrinsic evidence is consistent with the understanding of one of ordinary skill in the
`
`art, as it takes into account variability in the release of drug components due to leakage of the
`
`enteric component in the stomach, and variability due to individual factors such as time of day,
`
`stress level, illness, and the effects of medication, all of which may result in limited overlap of
`
`the immediate and enteric releases. See Davies Decl. ¶¶ 42, 44 (D.I. 62); Davies Rebuttal ¶¶ 8–9.
`
`FDA itself defines an enteric coating as one “intended to delay the release of the drug (or drugs)
`
`until the dosage form has passed through the stomach.” Declaration of Erica Andersen, Ex. 7, at
`
`32 (D.I. 61-9) [SHIREAXR67163478] (emphasis added); see also Davies Rebuttal ¶ 11. FDA’s
`
`definition reflects the understanding of one of ordinary skill in the art that no matter how perfect
`
`an enteric coating may be, some small amount of release may still occur in the stomach. The
`
`literature cited by Abhai’s own expert, Dr. Bergstrom, parallels this understanding. See Rose
`
`Decl., Ex. I, at 429 (D.I. 57-9) (“In order to perform adequately, an enteric-coated form should
`
`not allow significant release of the drug in the stomach . . . . It is a fact, however, that all of the
`
`enteric-coating polymers in the hydrated state in the stomach will be permeable to some degree
`
`to a given active material.”) (emphases added). The Court should therefore adopt Shire’s
`
`construction, which avoids any potential confusion created by the phrase “after a first dose by
`
`immediate release.”
`
`6
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`

`

`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 11 of 21
`
`
`B.
`
`The ’148 Patent
`
`1.
`
`“a delayed enteric release dosage form that provides delayed release
`upon oral administration” (’148 Patent, Claims 1 and 12)
`
`Shire’s Proposed Construction
`Requires no construction. Alternatively, the
`term means:
`
`“a dosage form that is intended to delay release
`of drug until the dosage form has passed
`through the stomach after oral administration”
`
`
`
`Abhai’s Proposed Construction
`“a dosage form that provides enteric release of
`drug that is rapid and complete (after a first
`dose by immediate release) designed to be
`delayed until the drug has passed through the
`stomach into the intestines”
`
`Abhai attempts to equate the phrase “delayed pulsed enteric release” in the ’096 Patent
`
`with “delayed enteric release” in the ’148 Patent. But different claim terms are presumed to have
`
`different meanings and scopes. See Tandon Corp. v. Int’l Trade Comm’n, 831 F.2d 1017, 1023
`
`(Fed. Cir. 1987); see also Kara Tech. Inc. v. Stamps.com Inc., 582 F.3d 1341, 1347 (Fed. Cir.
`
`2009). The word “enteric” refers to the location of the release (after the stomach, in the
`
`intestine), whereas the word “pulsed” defines the rate of that release once it reaches the stomach
`
`(rapid). See Op. Br. at 6–8. The inventors chose to define the rate of the release in the ’096
`
`Patent by using the term “pulsed” in the claims of the ’096 Patent, but to omit any reference to
`
`the rate of the release in the claims of the ’148 Patent. That difference must be given effect.
`
`
`
`To justify its construction, Abhai now argues that all “enteric” release is, by definition,
`
`pulsed. But such a definition does not comport with the understanding of a person of ordinary
`
`skill (Davies Rebuttal ¶¶ 14–17), and would render the term “pulsed” in the ’096 Patent
`
`superfluous. See Merck & Co. v. Teva Pharm. USA, 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“A
`
`claim construction that gives meaning to all the terms of the claim is preferred over one that does
`
`not do so.”).
`
`
`
`Moreover, the ’148 Patent does not indicate that a “pulsed” release is a “feature of the
`
`‘present invention’ as a whole,” as Abhai argues. To the contrary, the ’148 Patent specification
`
`7
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`

`

`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 12 of 21
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`provides that the phrase “delayed enteric release,” is broader than “delayed pulsed enteric
`
`release.” For example, the ’148 Patent describes the “delayed release components of the present
`
`invention” in three separate figures. See ’148 Patent, col.6 ll.52–63 (emphasis added); FIGS. 4–6.
`
`And while two of these Figures show a “pulsed” release, occurring in about 30–60 minutes, the
`
`third shows a sustained enteric release, occurring over the course of six hours. Compare FIGS. 4
`
`and 5, with FIG. 6; see also Davies Rebuttal ¶ 15. Thus, contrary to Abhai’s assertions, Shire’s
`
`proposed construction does not “broaden the scope of the claims to include dosage forms where
`
`the delayed enteric release is not ‘rapid and complete’ but slow and incomplete,” see Def.’s Br.
`
`at 14. Rather, Shire’s construction properly accounts for the types of sustained enteric release
`
`described in the specification.
`
`
`
`Further, for the reasons stated in Section III.A.1 above, the Court should again reject
`
`Abhai’s attempt to read the limitation “after a first dose by immediate release” into this claim
`
`term.
`
`2.
`
`“a plasma concentration versus time curve (ng/ml versus hours) having an
`area under the curve (AUC) of about 467 to about 714 ng hr/ml” (’148
`Patent, Claim 1)
`
`Shire’s Proposed Construction
`“a plasma concentration versus time curve
`(ng/ml versus hours) for d-amphetamine
`having an area under the curve (AUC)0-48 of
`467 to 714 ng hr/ml, ± 20%”
`
`Abhai’s Proposed Construction
`“a plasma concentration versus time curve
`(ng/ml versus hours) for amphetamine having
`an area under the curve (AUC) of about 467 to
`about 714 ng hr/ml”
`
`
`
`The parties’ proposed constructions differ from one another in three respects, which are
`
`addressed in turn below.
`
`
`
`First, Abhai argues that because the claimed formulation includes both isomers, the
`
`relevant plasma concentration versus time curve must be of the combination of the two isomers.
`
`Def.’s Br. at 20–21. However, that the claimed formulation contains and releases both isomers
`
`does not address whether the plasma concentration versus time curve shows the concentration of
`
`8
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 13 of 21
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`d-amphetamine, l-amphetamine, or both added together. Because (1) the two isomers are
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`typically measured and plotted separately, (2) d-amphetamine is present in an amount greater
`
`than the amount of l-amphetamine in the claimed formulations, and (3) d-amphetamine is the
`
`more potent enantiomer, a person of ordinary skill in the art would have expected a single
`
`plasma concentration curve to be that of d-amphetamine. See Maggio Decl. ¶¶ 27–34; Maggio
`
`Rebuttal ¶¶ 16–31. And to the extent there was any uncertainty in the mind of such a person, it
`
`would have been eliminated by the statement in the prosecution history that “[t]he values from
`
`Figs. 7 and 8 [which, in turn, are recited in the claims] are d-amphetamine levels to one of
`
`ordinary skill in the art.”3
`
`Second, with respect to the time interval over which the claimed AUC is calculated,
`
`Abhai provides no compelling support for its assertion that there is a “standard” method to
`
`calculate AUC, much less that such a standard method involves time 0 to infinity. Compare
`
`Bergstrom Decl. ¶ 65 with Maggio Rebuttal ¶¶ 40–43. In any event, FIG. 7 and FIG. 8 in the
`
`specification depict AUC from time 0 to 48 hours and dictate the construction here.4 See Maggio
`
`Decl. ¶¶ 35–37.
`
`Third, with respect to the term “about,” Abhai ignores the prosecution history, in which
`
`the patentee explicitly stated that “[t]he term ‘about’ has its usual meaning in the field, e.g.,
`
`3 Abhai dismisses this statement, but the cases it cites do not apply here. See Def.’s Br. at 22–23.
`While the prosecution history generally does not trump the claims and specification, here there is
`no conflict between them. See Maggio Decl. ¶¶ 28–34; Maggio Rebuttal ¶¶ 28–39. In addition,
`the cases concern a patentee’s effort to broaden claims; they do not involve a patentee’s
`statements to “define (lexicography), explain, or disavow claim scope during prosecution,”
`which the Federal Circuit allows. Teva Pharm. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1343
`(Fed. Cir. 2015).
`4 The Amerigen court declined to construe this portion of the disputed term; it did not adopt an
`explicit construction such that AUC is calculated from time 0 to infinity, as Abhai insinuates. See
`Def.’s Br. at 23.
`
`9
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 14 of 21
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`roughly ± 20%, for example as used by FDA in its determinations of bioequivalency.” (emphasis
`
`added), and the fact that the POSA would have been well aware of FDA bioequivalence
`
`standards. See Maggio Decl. ¶¶ 38–40, 43. Because the patentee explicitly defined “about” with
`
`respect to the AUC and Cmax pharmacokinetic elements of the claims, Amerigen’s musings about
`
`the meaning of “about” with respect to unrelated claim elements is of no moment.
`
`
`
`Abhai’s chief objection appears to be that the claimed AUC ranges would be too “broad”
`
`if the Court were to adopt Shire’s construction. Def.’s Br. at 24. But Abhai misses the point
`
`that—irrespective of its potential impact on Abhai’s non-infringement positions—Shire’s
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`construction is derived directly from FDA’s guidance on standards for bioequivalence, which
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`was referenced during prosecution. See Maggio Decl. ¶¶ 21–25; Pall Corp. v. Micron
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`Separations, Inc., 66 F.3d 1211, 1217 (Fed. Cir. 1995) (explaining that an “about” range “must
`
`be interpreted in its technologic and stylistic context”). The non-controlling cases Abhai cites do
`
`not address the context of this patent, and in each of the cases the court found no evidentiary
`
`basis to support the proponent’s asserted ranges. By contrast, the Impax court, after considering
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`the same substantial intrinsic and extrinsic evidence at issue here, adopted Shire’s proposed
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`construction of ±20%. Impax, 2005 WL 319983, at *2.
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`3.
`
`“said plasma concentration curve has a maximum concentration (Cmax) of
`about 22.5 to about 40 ng/ml” (’148 Patent, Claim 2)
`
`Shire’s Proposed Construction
`“the plasma concentration versus time curve
`(ng/ml versus hours) for d-amphetamine has a
`maximum concentration (Cmax) of 22.5 to 40
`ng/ml, ± 20%”
`
`
`
`Abhai’s Proposed Construction
`“the plasma concentration versus time curve
`(ng/ml versus hours) for amphetamine has a
`maximum concentration (Cmax) of about 22.5
`to about 40 ng/ml”
`
`This term in claim 2 recites “said plasma concentration curve” and refers to the plasma
`
`concentration versus time curve recited in claim 1 and discussed above. Shire therefore refers to
`
`its discussion in Section III.B.2 above.
`
`10
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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 15 of 21
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`4.
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`“peak plasma concentration” (’148 Patent, Claims 1 and 12)
`
`Shire’s Proposed Construction
`Requires no construction. Alternatively, the
`term means:
`
`“highest plasma concentration”
`
`Abhai’s Proposed Construction
`“the point where the plasma concentration
`reaches a high-point before declining”
`
`
`
`The term “peak plasma concentration” refers to the “highest” plasma concentration
`
`within a specific time interval; it imposes no requirements on the shape of the curve on either
`
`side of the highest concentration. Maggio Rebuttal ¶¶ 6–7, 14. Unlike Abhai’s proposal, Shire’s
`
`construction would properly identify as a “peak” the highest measurement over a given time
`
`period, even if that measurement occurs as the last observation of the time period. See id. ¶ 7
`
`(analogizing to a “peak temperature” which occurs on the last day of a recorded month). Abhai’s
`
`proposal is also flawed because the existence or nonexistence of “peaks” (as Abhai defines them)
`
`in a plasma concentration curve can be influenced by the frequency of measurements over time.
`
`See id. ¶ 8.
`
`Abhai does not dispute that its construction would exclude the embodiment illustrated in
`
`FIG. 7 of the specification, in which the plasma concentration unquestionably does not exhibit a
`
`peak that then declines. Def’s. Br. at 16. Rather, Abhai dismisses FIG. 7 because supposedly “the
`
`plasma concentrations limitations of claims 1 and 12 are averages or means derived from a
`
`human patient population,” and FIG. 7 is “derived from ‘subject 3’ – a single individual.” Id. But
`
`as explained in Shire’s Opening Brief, a person of ordinary skill having read the specification
`
`and the prosecution history would have understood that FIG. 7 reflects an embodiment covered
`
`by claim 1. Op. Br. at 20–21. And while Abhai wishes to couple its construction of “peak plasma
`
`concentration” to its constructions of “human individual” and “human patient”—arguing that if
`
`the latter terms are construed to refer to patient populations the only relevant peak plasma
`
`concentrations would be those of patient populations—Figure 7 is, at a minimum, illustrative of
`
`11
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 16 of 21
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`the claimed invention. There is no basis to simply ignore it and pretend that it is not part of the
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`patent, as Dr. Bergstrom does when he concludes that “Figure 7 is not illustrative of the plasma
`
`concentration curves of claims 1 and 12” (Bergstrom Decl. ¶ 41).5
`
`Abhai’s shape-centric construction is hinged on a single book excerpt cited by Dr.
`
`Bergstrom that does not even include the word “peak.” Maggio Rebuttal ¶ 10. Moreover,
`
`because the excerpt shows a drug plasma concentration curve for oral administration of a drug
`
`every 12 hours (see id. ¶ 11), it does not reflect the reality of the claimed invention, which
`
`involves relatively short-interval administration dictated by gastric emptying times, which are
`
`known to vary from subject to subject. Maggio Rebuttal ¶¶ 11–12.
`
`5.
`
`“a human individual” / “a human patient” (’148 Patent, Claim 1)
`
`Abhai’s Proposed Construction
`“human patient population”
`
`Shire’s Proposed Construction
`Requires no construction. Alternatively, “a
`human individual” means:
`
`“one or more humans”
`
`And “a human patient” means:
`
`“one or more patients”
`
`
`
`Primarily relying on Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349 (Fed. Cir.
`
`2014), which the Federal Circuit expressly warned was limited to its facts, Abhai seeks to rewrite
`
`“a human individual” and “a human patient” as if they were written in the plural. Additionally,
`
`Abhai—with no justification—construes both “a human individual” and “a human patient” as a
`
`
`5 Moreover, while Abhai contends that the claimed plasma concentration elements are “averages
`or means”—presumably as part of its effort to read Figure 7 out of the patent—that contention is
`unsupported by the intrinsic evidence. Even Figure 1 (to which Abhai points to support its
`definition of “peak”) does not indicate whether its profile derives from an individual or
`population data.
`
`12
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`

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`Case 1:15-cv-13909-WGY Document 73 Filed 07/21/16 Page 17 of 21
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`“human patient population”—even though only one of these terms involves a patient. The Court
`
`should adopt Shire’s proposed constructions, which are consistent with their plain meaning (and
`
`basic grammar), the specification, and prosecution history
`
`
`
`“a human individual”: The claim at issue in Braintree was directed to a “composition
`
`for inducing purgation of the colon of a patient, . . . wherein the composition does not produce
`
`any clinically significant electrolyte shifts.” Braintree, 749 F.3d at 1353. And while the court did
`
`co