`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`CFT PHARMACEUTICALS LLC,
`
`
`
`
`
`Defendant.
`
`
`
`PLAINTIFFS’ REPLY CLAIM CONSTRUCTION BRIEF
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintiffs
`
`
`
`OF COUNSEL:
`
`Thomas H.L. Selby
`David I. Berl
`Stanley E. Fisher
`Adam D. Harber
`Galina I. Fomenkova
`Martha C. Kidd
`Sara K. Creighton
`Barrett J. Anderson
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`
`July 15, 2015
`
`
`
`
`
`C.A. No. 14-781 (SLR)
`
`))))))))))))
`
`
`
`PFIZER INC., WYETH LLC, PFIZER
`PHARMACEUTICALS LLC, PF PRISM
`C.V. and PFIZER MANUFACTURING
`HOLDINGS LLC,
`
`
`
`
`
`
`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 2 of 21 PageID #: 860
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`
`
`TABLE OF CONTENTS
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`Page
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`TABLE OF AUTHORITIES ...................................................................................................... ii
`
`I.
`
`’828 Patent—“pH of the composition in a solution is” ..................................................... 1
`
`A.
`
`B.
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`C.
`
`D.
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`A Proper Phillips Analysis Supports Pfizer’s Construction ................................... 1
`
`CFT Cannot Support Inferring a Limitation .......................................................... 3
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`A POOS Would Understand the Claims Using Pfizer’s Construction ................... 8
`
`CFT’s Construction Imports a Process Limitation into a Composition
`Claim ................................................................................................................. 10
`
`’828 Patent—“pH . . . between about X and about Y” .................................................... 11
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`’995 Patent—“Form I tigecycline” ................................................................................. 12
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`’995 Patent—“A process for preparing Form I tigecycline” ........................................... 13
`
`
`
`II.
`
`III.
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`IV.
`
`
`
`i
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`
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 3 of 21 PageID #: 861
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`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Am. Med. Sys., Inc. v. Biolitec, Inc.,
`
`618 F.3d 1354 (Fed. Cir. 2010) ............................................................................................ 13
`
`Andersen Corp. v. Fiber Composites, LLC,
`
`474 F.3d 1361 (Fed. Cir. 2007) ............................................................................................ 10
`
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`
`289 F.3d 801 (Fed. Cir. 2002).................................................................................. 13, 14, 15
`
`GE Lighting Sols., LLC v. AgiLight, Inc.,
`
`750 F.3d 1304 (Fed. Cir. 2014) .......................................................................................... 2, 7
`
`In re Nuijten,
`
`500 F.3d 1346 (Fed. Cir. 2007) ............................................................................................ 10
`
`Intervet Inc. v. Merial Ltd.,
`
`617 F.3d 1282 (Fed. Cir. 2010) .............................................................................................. 8
`
`Marine Polymer Techs., Inc. v. HemCon, Inc.,
`
`672 F.3d 1350 (Fed. Cir. 2012) (en banc) ............................................................................ 15
`
`Medicines Co. v. Teva Parenteral Medicines, Inc.,
` No. 09-750-RGA, 2013 WL 3658020 (D. Del. July 11, 2013) ............................................. 11
`
`Merck & Co. v. Teva Pharm. USA, Inc.,
`
`395 F.3d 1364 (Fed. Cir. 2005) ............................................................................................ 12
`
`Nazomi Commc’ns, Inc. v. ARM Holdings, PLC,
`
`403 F.3d 1364 (Fed. Cir. 2005) .............................................................................................. 7
`
`Phillips v. AWH Corp.,
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`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ..................................................................... passim
`
`Playtex Prods., Inc. v. Procter & Gamble Co.,
`
`400 F.3d 901 (Fed. Cir. 2005).............................................................................................. 11
`
`Roche Diagnostics Operations, Inc. v. Abbott Diabetes Care,
`
`667 F. Supp. 2d 429 (D. Del. 2009) ..................................................................................... 12
`
`Schoenhaus v. Genesco, Inc.,
`
`440 F.3d 1354 (Fed. Cir. 2006) ............................................................................................ 14
`
`
`
`
`ii
`
`
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 4 of 21 PageID #: 862
`
`
`
`SourceOne Glob. Partners, LLC v. KGK Synergize, Inc.,
` No. 08 C 7403, 2010 WL 2232944 (N.D. Ill. June 3, 2010) ........................................... 14, 15
`
`Symantec Corp. v. Comput. Assocs. Int’l, Inc.,
`
`522 F.3d 1279 (Fed. Cir. 2008) ............................................................................................ 15
`
`UCB, Inc. v. KV Pharm. Co.,
` No. 08-223-JJF, 2009 WL 2524519 (D. Del. Aug. 18, 2009) ............................................... 12
`
`
`
`
`iii
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`
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 5 of 21 PageID #: 863
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`
`
`ARGUMENT
`
`I. ’828 Patent—“pH of the composition in a solution is”
`CFT’s extraordinary attempt to redefine the plain term “in a solution” in the claims to mean
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`“in the bulk solution and before lyophilization” is contrary to the admitted plain language of the
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`claims and specification. Neither the intrinsic record nor the credible extrinsic testimony permits
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`CFT’s incorrect construction.
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`A. A Proper Phillips Analysis Supports Pfizer’s Construction
`Although CFT seeks to limit the plain language of the claims to require that the bulk solution
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`meet the claimed pH limitation, it fails to identify any specific point in the claims, specification,
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`or file history where this restriction is recited. Such an approach is wholly unmoored from the
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`analysis required under Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), and
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`should be rejected at the threshold.
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`It is undisputed that nothing in the claim language itself limits the term “in a solution” to the
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`bulk solution; it applies equally to all three solutions in the ’828 patent: bulk, reconstituted, and
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`admixed. CFT concedes that the claim language on its own “appears to refer simply to any
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`solution.” Df.’s Br. at 15. CFT’s expert, Dr. Lee Kirsch, agreed that a person of ordinary skill in
`
`the art (“POOS”) would understand that the claim “language standing on its own implicates any
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`solution whatsoever,” D.I. 53, Kirsch Decl. ¶ 24, and “nothing in the claims limits the term
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`‘solution’ to a particular solution,” Ex. 1, Kirsch Dep. 44:20–45:18. Pfizer and its expert agree.
`
`Majumdar Decl. ¶¶ 26–29; Pls.’ Br. at 10. This alone is devastating to CFT’s attempts to unduly
`
`narrow the patent. Phillips, 415 F.3d at 1312 (finding claim language is “of primary importance,
`
`in the effort to ascertain precisely what it is that is patented” (internal quotation marks omitted)).
`
`CFT also cannot point to where in the specification the definition of “in a solution” that CFT
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`now urges is set forth, because such a definition does not exist. CFT’s own expert admits that
`
`1
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 6 of 21 PageID #: 864
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`
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`the specification does not define the term “a solution” to mean “the bulk solution,” and does not
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`exclude the other solutions of the invention. Ex. 1, Kirsch Dep. 46:2–20. Nor does the
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`specification express anywhere that the invention does not include reconstituted solutions made
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`from bulk solutions outside the claimed pH ranges. Id. 58:1–5; Majumdar ¶¶ 31–35. Rather, the
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`specification explains that “compositions of the invention” include all three solutions. JA-1465
`
`at col. 5:27–29, 41–47; Pls.’ Br. at 10–11. Absent an express act of lexicography or surrender of
`
`claim scope, this Court should decline to import such a limitation. Phillips, 415 F.3d at 1323–
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`24; GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1309 (Fed. Cir. 2014).
`
`Nor can CFT find support for its imported limitation in the prosecution history. CFT
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`concedes that Pfizer provided data to the Examiner reporting the pH levels of solutions after
`
`reconstitution. Df.’s Br. at 13 n.5; see also JA-2962 (pH Data). The presentation of this data is
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`directly contrary to CFT’s position that the pH after reconstitution is irrelevant, or worse,
`
`immeasurable. Not only was it measured, it was used to show stable pH at the reconstitution
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`stage, once again highlighting the importance of the role of pH at the reconstitution and
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`admixture stages. Majumdar Decl. ¶¶ 48–49. CFT concedes as much, retreating to the statement
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`that “[r]epresentations during prosecution cannot enlarge the content of the specification,” Df.’s
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`Br. at 13 n.5 (internal quotation marks omitted). But this is inapposite here, because (as
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`discussed above) CFT agrees that the claims implicate all of the solutions. Df.’s Br. at 15. The
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`prosecution history, consistent with the claims and specification, rejects CFT’s construction.
`
` Given the clear intrinsic record, there is no basis to diverge from the plain meaning of the
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`term “pH of the composition in a solution” under Phillips, and the analysis should end there.
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`Phillips, 415 F.3d at 1318 (“[A] court should discount any expert testimony that is clearly at
`
`odds with the claim construction mandated by the claims themselves, the written description, and
`
`
`
`2
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 7 of 21 PageID #: 865
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`
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`the prosecution history, in other words, with the written record of the patent.” (internal quotation
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`marks omitted)). CFT’s attempt to cloud the issue with irrelevant digressions into whether the
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`invention requires certain pH ranges in order to function more effectively has nothing to do with
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`the scope of the claims and is merely an attempt to create out of whole cloth a limitation on the
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`pH of the bulk solution. This Court should reject CFT’s improper approach and adopt Pfizer’s,
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`which is consistent with the intrinsic record. Majumdar Decl. ¶ 25; Pls.’ Br. at 10–12.
`
`B. CFT Cannot Support Inferring a Limitation
`Lacking support in the express language of the patent, CFT offers a mishmash of arguments
`
`seeking to infer that such a limitation should be imported into the claims. This is not only
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`contrary to Phillips, it is unsupported in the patent itself.
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`1. Although CFT admits the plain claim language applies to all three solutions, it
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`nonetheless asserts that because the claims recite a “composition comprising tigecycline, lactose,
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`and an acid,” and allows the use of hydrochloric acid which disassociates in water, that must
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`limit the solutions of the invention to bulk solutions, where those ingredients are first combined.
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`Df’s. Br. at 13. This inference is entirely unsupported. Nothing in the claim language specifies
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`that it only applies immediately after mixing the ingredients, particularly in light of the fact that
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`the “compositions of the invention” defined in the specification include all three solutions (as
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`CFT’s own expert acknowledged). Ex. 1, Kirsch Dep. 51:19–52:3 (all three solutions), 52:14–23
`
`(reconstituted solutions), 54:2–6 (admixed solutions). A POOS would understand that a
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`“composition comprising tigecycline, lactose, and an acid” exists even after those ingredients are
`
`combined, be it in the bulk solution or the post-reconstitution solutions. JA-1469 at col. 14:36–
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`37; Majumdar Decl. ¶ 44. CFT’s interpretation would impose a temporal limitation on the pH
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`range (requiring that it exist at the bulk stage) by virtue of the fact that the claims list the
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`invention’s ingredients. Such an argument—if adopted—would turn any composition claim
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`3
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 8 of 21 PageID #: 866
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`
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`where one ingredient changes after combination into a process claim simply because it lists the
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`composition’s ingredients. Nothing in the claims supports such an interpretation, and CFT cites
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`no authority to support its novel “changed ingredient” approach to claim construction.
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`2. Notwithstanding the clear language in the specification that reconstituted and admixed
`
`solutions are “compositions of the invention,” JA-1465 at col. 5:41–47, CFT erroneously argues
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`that it requires that (i) any bulk solution must meet the claimed pH limitation and therefore (ii)
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`“in a solution” in the claims should read “in a the bulk solution, and before lyophilization.” Df.’s
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`Br. at 7–13. CFT cannot identify any express redefinition of the term “in a solution” in the
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`specification; rather, CFT urges the Court to find an implied definition, ignoring the plain
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`language of the specification, the admissions of CFT’s expert, or both. Majumdar Decl. ¶ 36.
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`a. CFT notes that the ’828 invention is directed to tigecycline formulations that are stable
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`“when dissolved, lyophilized, reconstituted, and/or diluted,” JA-1463 at col. 1:18–21, and argues
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`that the stability in the reconstituted and admixed states is dependent on the stability of the bulk
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`solution, Df.’s Br. at 7–9. CFT plainly ignores the “and/or” used by the inventors, which
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`expressly severs any supposed dependency. But more fundamentally, CFT has it backwards:
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`that the invention operates at the claimed pH range in the bulk solution does not suggest that the
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`pH range must apply to the bulk solution in all instances, nor is it inconsistent with the invention
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`also operating at the same pH range in the reconstituted and admixed solutions. Majumdar Decl.
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`¶¶ 37, 52. The purpose of the invention is a stable formulation at the time of administration, i.e.,
`
`after reconstitution. Id. ¶¶ 46–47; Ex. 1, Kirsch Dep. 33:14–17, 35:6–10. Having a stable
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`composition earlier in the process is desirable, and is one embodiment of the invention, but the
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`additional purposes of the invention are served only if it is stable against oxidation at
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`reconstitution and admixture. Id. 38:2–5. The prior tigecycline formulation oxidized rapidly
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`
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`4
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 9 of 21 PageID #: 867
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`
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`upon reconstitution at its natural pH, without adjustment. JA-1463 at col. 2:23–42. A POOS
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`would understand that dilution changes the pH, and that having a pH in the claimed range (about
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`3.0 to about 7.0) at dilution and admixture is part of the invention at these additional stages. Ex.
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`1, Kirsch Dep. 22:4–19, 23:21–24:5; Majumdar Decl. ¶¶ 20, 46–47. A POOS would understand
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`that the solutions are all compositions of the invention. Id. ¶¶ 25, 30.
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`There is no statement in the patent that the pH must meet the proposed limitations at the bulk
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`solution phase, and it is repeatedly disclosed in the patent, and was known at the time, that acidic
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`pHs will reduce oxidation. JA-1463 at col. 2:44–48; JA-1464 at cols. 3:28–30, 4:51–57; JA-
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`1465 at col. 6:10–11, 16–18. The term “acidic” does not, of course, limit the pH to the claimed
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`range of about 3.0 to about 7.0, as pH values below 3.0 are also “acidic.” Majumdar Decl. ¶ 19.
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`Thus, CFT proves nothing by pointing to references that the bulk solution be “acidic,” without
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`any reference to specific pH ranges. Id. ¶ 38. Because the bulk solution could be more acidic
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`(having a pH lower than the claimed ranges) and still satisfy the specification’s description,
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`CFT’s argument that a reconstituted solution must have been a bulk solution at some prior point
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`is unavailing. Id. ¶ 52.
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`b. CFT misconstrues “compositions of the invention,” to argue that the term “in a
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`solution” means only the bulk solution before lyophilization. Df.’s Br. at 9 (citing JA-1465 at
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`col. 5:27–47). But the part of the patent cited by CFT expressly defines the reconstitution and
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`admixture solutions as “compositions of the invention.” JA-1465 at col. 5:41–47; Ex. 1, Kirsch
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`Dep. 52:14–23 (reconstituted solutions), 54:2–6 (admixed solutions). CFT claims that, because
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`the same passage points out that reconstitution solutions are made from lyophilized cake and
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`admixed solutions are made from reconstituted solutions, this means that all embodiments must
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`be made from a bulk solution with a specific pH. Df.’s Br. at 9. An explicit linkage ties to a
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`5
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 10 of 21 PageID #: 868
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`particular pH range like that argued by CFT does not appear in the specification and, as is taught
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`in the patent, a stable reconstitution and admixture solution can be made without the bulk
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`solution falling within the claimed range so long as the pH of the bulk solution is acidic. Ex. 1,
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`Kirsch Dep. 77:15–20, 78:9–14. Because the “compositions of the invention” include the
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`admixed and reconstitution solutions, and because the specification does not require a specific
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`pH range for the bulk solution, id. 54:12–23, a POOS would understand that they do not require
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`that the bulk solution fall within the claimed pH ranges, Majumdar Decl. ¶¶ 31–35, 40.1
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`c. CFT places great reliance on the fact that the specification describes a process to
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`prepare compounds of the invention, which CFT declares that “uniformly teach that the pH of
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`the bulk solution is adjusted prior to lyophilization.” Df.’s Br. at 9–10 (citing JA-1465 at col.
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`6:10–35). Completely absent from CFT’s brief is the line immediately preceding the disclosed
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`procedure, which states: “Compounds of the invention may be prepared via a number of
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`acceptable methods. The methods described below are exemplary and not meant to limit the
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`invention.” JA-1465 at col. 6:6–8 (emphasis added). A POOS would understand from this
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`language that the procedure is not a limitation. Majumdar Decl. ¶ 41. A POOS would further
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`understand that there would be more than one way to make the claimed invention. Id. For
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`example, the POOS could make a stable tigecycline formulation where the bulk solution did not
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`fall within the claimed pH range (by starting at a pH below about 3.0), but after adjustment by
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`the diluent the reconstitution and admixed solutions did fall within the claimed range. Id. ¶ 52.
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`The very purpose of the patent, after all, includes stable formulations that do not degrade after
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`1 CFT cites a passage stating that “[s]uch compositions are also expected to possess reconstitution
`and admixed stability times greater than that of existing compositions,” JA-1464 at col. 4:63–65, to
`refer to the lyophilized state mentioned in the prior sentence, Df.’s Br. at 8–9. But “[s]uch
`compositions” clearly refers back to “[c]ompositions of the invention,” which can include the
`reconstituted and admixed solutions. Majumdar Decl. ¶ 39. This interpretation is so obvious that
`CFT’s expert was quick to abandon CFT’s argument while being deposed, Ex. 1, Kirsch Dep. 80:6–
`14, and this Court should similarly decline to endorse it.
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`
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`6
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`
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 11 of 21 PageID #: 869
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`reconstitution and admixture. See supra; Pls.’ Br. at 12–13. This fact, added to the law that
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`disclosed embodiments do not limit the claimed invention, means that CFT’s argument fails.
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`Phillips, 415 F.3d at 1323 (“[P]ersons of ordinary skill in the art rarely would confine their
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`definitions of terms to the exact representations depicted in the embodiments.”); Nazomi
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`Commc’ns, Inc. v. ARM Holdings, PLC, 403 F.3d 1364, 1369 (Fed. Cir. 2005) (claims can cover
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`“different subject matter than is illustrated in the specific embodiments in the specification”).
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`d. CFT contends that Examples 1 and 3 contain “controls,” which “alone are dispositive
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`of the matter” because the controls did not have an adjusted pH and were also not referred to as
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`compositions of the invention. Df.’s Br. at 10–11. CFT’s argument fails for a simple reason, as
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`conceded by Dr. Kirsch: absent lactose and an acid, the controls were not compositions of the
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`invention whether they met the pH limitation or not. Ex. 1, Kirsch Dep. 92:2–7; Majumdar Decl.
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`¶ 43. The controls are not indicative of whether the pH limitation must be met at the bulk
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`solution stage or not. But even if the controls included the required ingredients, CFT’s argument
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`is unconvincing, because it requires a tenuous chain of inference: a POOS would need to
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`connect the unaltered pH levels in a control sample to the term “solution” in the claims. Id. Far
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`from being “dispositive of the matter,” CFT’s contention fails to even approach the “exacting”
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`standards for redefining a term in the specification as required by the Federal Circuit. GE
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`Lighting, 750 F.3d at 1309.
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`e. CFT argues that the six Examples in the specification mean the “pH limitation in the
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`claims . . . appl[ies] to the bulk solution.” Df.’s Br. at 11–13. But the specification states that
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`“[t]he following six examples illustrate various embodiments of the invention and are not
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`intended to limit the invention in any way.” JA-1465 at col. 6:63–65 (emphasis added). On this
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`basis, a POOS would understand that the Examples are not limitations. Majumdar Decl. ¶ 42.
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`
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`7
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 12 of 21 PageID #: 870
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`CFT’s use of the examples is also incompatible with the Federal Circuit’s admonition that it is
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`“important not to confuse exemplars or preferred embodiments in the specification that serve to
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`teach and enable the invention with limitations that define the outer boundaries of claim scope.”
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`Intervet Inc. v. Merial Ltd., 617 F.3d 1282, 1287 (Fed. Cir. 2010); see also Phillips, 415 F.3d at
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`1323. The Examples cannot support CFT’s construction.
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`3. CFT’s reach into the prosecution history of a related patent, U.S. Patent No. 8,975,242
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`(“the ’242 patent”), also misses the mark. Df.’s Br. at 14–15. CFT argues that during the
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`prosecution of the ’242 patent, the patentee cited as support for a claimed pH range a part of the
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`specification discussing the pH of the bulk solution. CFT elides the limiting language in the
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`Amendment, i.e., that the patentee cited the bulk solution pH level “inter alia,” clearly
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`suggesting that it was merely one basis for supporting the narrowing amendment. D.I. 52,
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`McFarland Decl., Ex. D, Amendment Remarks at 5. Further, CFT again ignores limiting
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`language in the cited specification, which notes that the pH range of “about 4.0 to about 5.0” is
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`in only “[i]n one embodiment” of the invention. Df.’s Br. at 15 n.7; D.I. 52, McFarland Decl.,
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`Ex. C, ’242 Patent at col. 4:58–60; JA-1465 at col. 5:10–12; Ex. 1, Kirsch Dep. 81:5–16. As
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`discussed above, citing one bulk solution’s pH to support a claimed pH range says nothing about
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`whether reconstituted and admixed solutions must always be derived from bulk solutions within
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`that range. Supra Section I.B. CFT’s argument is entirely unhelpful. Majumdar Decl. ¶ 45.
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`C. A POOS Would Understand the Claims Using Pfizer’s Construction
`In an effort to make its proposed construction seem palatable, CFT advances the theory that a
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`POOS would not be able to make sense of the claims if they apply to all of the solutions. Df.’s
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`Br. at 15–17. But neither CFT nor Dr. Kirsch has identified a single concept in the claims that a
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`POOS would actually have trouble comprehending if Pfizer’s construction were adopted. Ex. 1,
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`Kirsch Dep. 97:9–20, 100:8–101:11, 102:16–103:15; Majumdar Decl. ¶¶ 50–51. First, CFT
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`8
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 13 of 21 PageID #: 871
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`argues that a POOS would understand that the pH limits always apply to the bulk solution
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`because otherwise the tigecycline would be degraded before it was reconstituted. Df.’s Br. at 16.
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`But the ’828 patent directs only that the bulk solutions be acidic to avoid oxidation. JA-1464 at
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`col. 4:52–57; Ex. 1, Kirsch Dep. 31:8–12, 71:25–72:4, 73:4–8. A POOS would understand that
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`nothing in the patent excludes preparation of a bulk solution more acidic than the claimed pH
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`range and thus not subject to oxidation, but then within the claimed pH range upon reconstitution
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`with a diluent with a higher pH. Majumdar Decl. ¶¶ 38, 52–53; Ex. 1, Kirsch Dep. 78:9–14.
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`Second, CFT contends that the specification offers no guidance to a POOS on how to
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`reconstitute or admix the invention and, thus, the pH limitations must apply to the bulk solution.
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`Df.’s Br. at 16–17. But CFT does not dispute, nor could it, that a POOS in the relevant field
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`would know how to reconstitute and admix formulations or measure the pH levels of those
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`solutions; in fact, these tasks are so well known to a POOS that they are “routine.” Ex. 1, Kirsch
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`Dep. 25:11–26:20, 107:2–108:23; D.I. 53, Kirsch Decl. ¶ 11; Majumdar Decl. ¶ 54. CFT’s
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`reference to the difficulty of determining dilution volumes or measuring pH in the hospital
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`setting is a red herring: the patent is judged from the perspective of the POOS, not a bedside
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`hospital employee. Id. ¶ 55. And there is no need to measure in the hospital in any case, as the
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`dilution and admixture solutions and volumes will be determined in a laboratory setting. Id.
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`Third, relying on its specious argument that the specification needs to explain to a POOS
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`how to reconstitute and admix solutions, and how to measure a solution’s pH, CFT invents
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`indefiniteness, written description, and enablement arguments and urges the Court to avoid them
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`by adopting its proposed construction. Df.’s Br. at 17 & n.9. Because a POOS is already well-
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`equipped to handle those tasks, the problems to which CFT alludes are phantoms and this Court
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`should reject them out-of-hand. Majumdar Decl. ¶¶ 56–58.
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`9
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 14 of 21 PageID #: 872
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`D. CFT’s Construction Imports a Process Limitation into a Composition Claim
`CFT wrongly contends that it is not importing a process claim because its proposed
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`construction merely requires that a “property of the claimed composition . . . must be measured
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`in the bulk solution.” Df.’s Br. at 18. But that is exactly what a process claim is: a temporal
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`limitation requiring certain characteristics at a given point in the process. In re Nuijten, 500 F.3d
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`1346, 1355 (Fed. Cir. 2007) (“[A] process claim must cover an act or series of acts.”). CFT
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`argues that Pfizer “pursue[d] functional claiming” in the ’828 patent by “providing only one
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`appropriate time” to measure the pH of the solution. Df.’s Br. at 18. That is a creation of CFT’s
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`imagination: there is no direction that the pH must be measured only at the bulk stage; the
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`prosecution history shows otherwise; and the measurement of pH at the reconstitution or
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`admixture stage is routine for a POOS. Moreover, if a solution meets the pH limitation, it will
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`infringe whether it is measured or not; in other words, measurement is only an issue of proof, not
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`of claim scope. Because there is no instruction in the intrinsic evidence that the pH must be
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`measured at the bulk stage, CFT’s argument fails.
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`CFT asserts that its process limitation should be imported because “obtaining the proper pH
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`during the compounding stage is essential to the invention as a whole.” Id. at 18–19. As
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`discussed above, CFT has not met the “exacting” standard to import a limitation from the
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`specification. Even if it had, the cases cited by CFT do not support its argument. In Andersen
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`Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1366–67 (Fed. Cir. 2007), the court found the
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`patent-in-suit clearly explained that a particular step was necessary—the specification used the
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`word “require[d]”—to manufacture the invention “having the claimed physical properties,” and
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`that the specification “repeatedly states that the steps . . . are not merely embodiments, but are
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`essential features of the claimed composite composition.” In contrast, the ’828 patent expressly
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`identifies that the embodiments are not limitations, and contains none of the clear language like
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`10
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 15 of 21 PageID #: 873
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`that of the patent in Andersen. Likewise, in Medicines Co. v. Teva Parenteral Medicines, Inc.,
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`No. 09-750-RGA, 2013 WL 3658020, at *3 (D. Del. July 11, 2013), the court held that (1) the
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`term in question was “explicitly defined in the specification as resulting from the compounding
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`process,” (2) the claim “already has a process step,” and (3) the process limitation was critical to
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`distinguish the invention from prior art. None of these three vital factors is present here.
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`CFT wrongly suggests that Pfizer’s construction—by using the word “when”—also includes
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`a temporal limitation. Df.’s Br. at 19. But Pfizer’s interpretation merely acknowledges a
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`scientific fact: only solutions may have pH values and, to be measured, the pH must be in “a
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`solution.” Majumdar Decl. ¶ 19; D.I. 53, Kirsch Decl. ¶ 28. Unlike CFT’s, Pfizer’s construction
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`does not require that the pH be measured at any particular point to practice the invention or
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`prove infringement. CFT also contends that Claims 2 and 3—which recite lyophilized and solid
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`versions of the composition in Claim 1—suggest that Claim 1 may only apply to the bulk
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`solution and thus create an “inherent process step.” Df.’s Br. at 19. But those claims do not
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`limit Claim 1’s scope because it is undeniably broader than the dependent claims in that it
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`implicates all three solutions. Ex. 1, Kirsch Dep. 63:24–64:1; Majumdar Decl. ¶ 29.
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`Because CFT attempts to import a process limitation into the pure composition claims in the
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`’828 patent, this Court should reject its proposed construction and instead adopt Pfizer’s, which
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`is faithful to the intrinsic evidence. See Phillips, 415 F.3d at 1316 (“The construction that stays
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`true to the claim language and most naturally aligns with the patent’s description of the invention
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`will be, in the end, the correct construction.” (internal quotation marks omitted)).
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`II. ’828 Patent—“pH . . . between about X and about Y”
`CFT incorrectly argues that construing “about” as “approximately” is unhelpful and does not
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`resolve the dispute. Df.’s Br. at 20–21. But the Federal Circuit has long recognized that
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`inventors may use terms of approximation to avoid strict numerical boundaries, Playtex Prods.,
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`11
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`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 16 of 21 PageID #: 874
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`Inc. v. Procter & Gamble Co., 400 F.3d 901, 907 (Fed. Cir. 2005), and has had no difficulty
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`construing “about” to mean “approximately,” Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d
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`1364, 1372 (Fed. Cir. 2005); see also Roche Diagnostics Operations, Inc. v. Abbott Diabetes
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`Care, 667 F. Supp. 2d 429, 441 (D. Del. 2009); UCB, Inc. v. KV Pharm. Co., No. 08-223-JJF,
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`2009 WL 2524519, at *3–7 (D. Del. Aug. 18, 2009). CFT’s desire to have a strict numerical
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`boundary—no matter how “helpful” to CFT’s argument such a boundary might be—cannot
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`overcome the inventor’s explicit choice not to have one.
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`CFT cites Pfizer’s position in a related inter partes review proceeding to argue that “about”
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`in relation to pH units “had essentially the same meaning that CFT is now proposing.” Df.’s Br.
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`at 21–22. But CFT ignores that Pfizer never proposed a strict numerical boundary in that
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`proceeding; consequently, Pfizer’s position in the IPR cannot support CFT’s argument here.
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`CFT also argues that a POOS would understand that ±0.05 pH is the proper limit because it
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`fits with significant digits as reported in the patent, it correlates with common measurement
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`techniques, and claim differentiation suggests it. Df.’s Br. at 22–23. CFT’s arguments are
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`unavailing because they begin with the false premise that a POOS would need to find a strict
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`numerical boundary. But just as the ’828 inventors chose not to include a strict numerical
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`boundary, a POOS would also be able to comprehend the patent without one; instead, a POOS
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`would construe “about” as “approximately.” Majumdar Decl. ¶¶ 59–60; Pls.’ Br. at 14–17.
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`III. ’995 Patent—“Form I tigecycline”
`In a backdoo