throbber
Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 1 of 21 PageID #: 859
`
`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
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ...................................................................................................... ii 
`
`I. 
`
`’828 Patent—“pH of the composition in a solution is” ..................................................... 1 
`
`A. 
`
`B. 
`
`C. 
`
`D. 
`
`A Proper Phillips Analysis Supports Pfizer’s Construction ................................... 1 
`
`CFT Cannot Support Inferring a Limitation .......................................................... 3 
`
`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 
`
`’995 Patent—“Form I tigecycline” ................................................................................. 12 
`
`’995 Patent—“A process for preparing Form I tigecycline” ........................................... 13 
`
`
`
`II. 
`
`III. 
`
`IV. 
`
`
`
`i
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 3 of 21 PageID #: 861
`
`
`
`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.,
`
`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
`
`

`
`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
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 5 of 21 PageID #: 863
`
`
`
`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
`
`“in the bulk solution and before lyophilization” is contrary to the admitted plain language of the
`
`claims and specification. Neither the intrinsic record nor the credible extrinsic testimony permits
`
`CFT’s incorrect construction.
`
`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
`
`meet the claimed pH limitation, it fails to identify any specific point in the claims, specification,
`
`or file history where this restriction is recited. Such an approach is wholly unmoored from the
`
`analysis required under Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), and
`
`should be rejected at the threshold.
`
`It is undisputed that nothing in the claim language itself limits the term “in a solution” to the
`
`bulk solution; it applies equally to all three solutions in the ’828 patent: bulk, reconstituted, and
`
`admixed. CFT concedes that the claim language on its own “appears to refer simply to any
`
`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
`
`solution whatsoever,” D.I. 53, Kirsch Decl. ¶ 24, and “nothing in the claims limits the term
`
`‘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
`
`now urges is set forth, because such a definition does not exist. CFT’s own expert admits that
`
`1
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 6 of 21 PageID #: 864
`
`
`
`the specification does not define the term “a solution” to mean “the bulk solution,” and does not
`
`exclude the other solutions of the invention. Ex. 1, Kirsch Dep. 46:2–20. Nor does the
`
`specification express anywhere that the invention does not include reconstituted solutions made
`
`from bulk solutions outside the claimed pH ranges. Id. 58:1–5; Majumdar ¶¶ 31–35. Rather, the
`
`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–
`
`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
`
`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
`
`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
`
`stage, once again highlighting the importance of the role of pH at the reconstitution and
`
`admixture stages. Majumdar Decl. ¶¶ 48–49. CFT concedes as much, retreating to the statement
`
`that “[r]epresentations during prosecution cannot enlarge the content of the specification,” Df.’s
`
`Br. at 13 n.5 (internal quotation marks omitted). But this is inapposite here, because (as
`
`discussed above) CFT agrees that the claims implicate all of the solutions. Df.’s Br. at 15. The
`
`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
`
`term “pH of the composition in a solution” under Phillips, and the analysis should end there.
`
`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
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 7 of 21 PageID #: 865
`
`
`
`the prosecution history, in other words, with the written record of the patent.” (internal quotation
`
`marks omitted)). CFT’s attempt to cloud the issue with irrelevant digressions into whether the
`
`invention requires certain pH ranges in order to function more effectively has nothing to do with
`
`the scope of the claims and is merely an attempt to create out of whole cloth a limitation on the
`
`pH of the bulk solution. This Court should reject CFT’s improper approach and adopt Pfizer’s,
`
`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
`
`contrary to Phillips, it is unsupported in the patent itself.
`
`1. Although CFT admits the plain claim language applies to all three solutions, it
`
`nonetheless asserts that because the claims recite a “composition comprising tigecycline, lactose,
`
`and an acid,” and allows the use of hydrochloric acid which disassociates in water, that must
`
`limit the solutions of the invention to bulk solutions, where those ingredients are first combined.
`
`Df’s. Br. at 13. This inference is entirely unsupported. Nothing in the claim language specifies
`
`that it only applies immediately after mixing the ingredients, particularly in light of the fact that
`
`the “compositions of the invention” defined in the specification include all three solutions (as
`
`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
`
`“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–
`
`37; Majumdar Decl. ¶ 44. CFT’s interpretation would impose a temporal limitation on the pH
`
`range (requiring that it exist at the bulk stage) by virtue of the fact that the claims list the
`
`invention’s ingredients. Such an argument—if adopted—would turn any composition claim
`
`
`
`3
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 8 of 21 PageID #: 866
`
`
`
`where one ingredient changes after combination into a process claim simply because it lists the
`
`composition’s ingredients. Nothing in the claims supports such an interpretation, and CFT cites
`
`no authority to support its novel “changed ingredient” approach to claim construction.
`
`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
`
`that it requires that (i) any bulk solution must meet the claimed pH limitation and therefore (ii)
`
`“in a solution” in the claims should read “in a the bulk solution, and before lyophilization.” Df.’s
`
`Br. at 7–13. CFT cannot identify any express redefinition of the term “in a solution” in the
`
`specification; rather, CFT urges the Court to find an implied definition, ignoring the plain
`
`language of the specification, the admissions of CFT’s expert, or both. Majumdar Decl. ¶ 36.
`
`a. CFT notes that the ’828 invention is directed to tigecycline formulations that are stable
`
`“when dissolved, lyophilized, reconstituted, and/or diluted,” JA-1463 at col. 1:18–21, and argues
`
`that the stability in the reconstituted and admixed states is dependent on the stability of the bulk
`
`solution, Df.’s Br. at 7–9. CFT plainly ignores the “and/or” used by the inventors, which
`
`expressly severs any supposed dependency. But more fundamentally, CFT has it backwards:
`
`that the invention operates at the claimed pH range in the bulk solution does not suggest that the
`
`pH range must apply to the bulk solution in all instances, nor is it inconsistent with the invention
`
`also operating at the same pH range in the reconstituted and admixed solutions. Majumdar Decl.
`
`¶¶ 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
`
`composition earlier in the process is desirable, and is one embodiment of the invention, but the
`
`additional purposes of the invention are served only if it is stable against oxidation at
`
`reconstitution and admixture. Id. 38:2–5. The prior tigecycline formulation oxidized rapidly
`
`
`
`4
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 9 of 21 PageID #: 867
`
`
`
`upon reconstitution at its natural pH, without adjustment. JA-1463 at col. 2:23–42. A POOS
`
`would understand that dilution changes the pH, and that having a pH in the claimed range (about
`
`3.0 to about 7.0) at dilution and admixture is part of the invention at these additional stages. Ex.
`
`1, Kirsch Dep. 22:4–19, 23:21–24:5; Majumdar Decl. ¶¶ 20, 46–47. A POOS would understand
`
`that the solutions are all compositions of the invention. Id. ¶¶ 25, 30.
`
`There is no statement in the patent that the pH must meet the proposed limitations at the bulk
`
`solution phase, and it is repeatedly disclosed in the patent, and was known at the time, that acidic
`
`pHs will reduce oxidation. JA-1463 at col. 2:44–48; JA-1464 at cols. 3:28–30, 4:51–57; JA-
`
`1465 at col. 6:10–11, 16–18. The term “acidic” does not, of course, limit the pH to the claimed
`
`range of about 3.0 to about 7.0, as pH values below 3.0 are also “acidic.” Majumdar Decl. ¶ 19.
`
`Thus, CFT proves nothing by pointing to references that the bulk solution be “acidic,” without
`
`any reference to specific pH ranges. Id. ¶ 38. Because the bulk solution could be more acidic
`
`(having a pH lower than the claimed ranges) and still satisfy the specification’s description,
`
`CFT’s argument that a reconstituted solution must have been a bulk solution at some prior point
`
`is unavailing. Id. ¶ 52.
`
`b. CFT misconstrues “compositions of the invention,” to argue that the term “in a
`
`solution” means only the bulk solution before lyophilization. Df.’s Br. at 9 (citing JA-1465 at
`
`col. 5:27–47). But the part of the patent cited by CFT expressly defines the reconstitution and
`
`admixture solutions as “compositions of the invention.” JA-1465 at col. 5:41–47; Ex. 1, Kirsch
`
`Dep. 52:14–23 (reconstituted solutions), 54:2–6 (admixed solutions). CFT claims that, because
`
`the same passage points out that reconstitution solutions are made from lyophilized cake and
`
`admixed solutions are made from reconstituted solutions, this means that all embodiments must
`
`be made from a bulk solution with a specific pH. Df.’s Br. at 9. An explicit linkage ties to a
`
`
`
`5
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 10 of 21 PageID #: 868
`
`
`particular pH range like that argued by CFT does not appear in the specification and, as is taught
`
`in the patent, a stable reconstitution and admixture solution can be made without the bulk
`
`solution falling within the claimed range so long as the pH of the bulk solution is acidic. Ex. 1,
`
`Kirsch Dep. 77:15–20, 78:9–14. Because the “compositions of the invention” include the
`
`admixed and reconstitution solutions, and because the specification does not require a specific
`
`pH range for the bulk solution, id. 54:12–23, a POOS would understand that they do not require
`
`that the bulk solution fall within the claimed pH ranges, Majumdar Decl. ¶¶ 31–35, 40.1
`
`c. CFT places great reliance on the fact that the specification describes a process to
`
`prepare compounds of the invention, which CFT declares that “uniformly teach that the pH of
`
`the bulk solution is adjusted prior to lyophilization.” Df.’s Br. at 9–10 (citing JA-1465 at col.
`
`6:10–35). Completely absent from CFT’s brief is the line immediately preceding the disclosed
`
`procedure, which states: “Compounds of the invention may be prepared via a number of
`
`acceptable methods. The methods described below are exemplary and not meant to limit the
`
`invention.” JA-1465 at col. 6:6–8 (emphasis added). A POOS would understand from this
`
`language that the procedure is not a limitation. Majumdar Decl. ¶ 41. A POOS would further
`
`understand that there would be more than one way to make the claimed invention. Id. For
`
`example, the POOS could make a stable tigecycline formulation where the bulk solution did not
`
`fall within the claimed pH range (by starting at a pH below about 3.0), but after adjustment by
`
`the diluent the reconstitution and admixed solutions did fall within the claimed range. Id. ¶ 52.
`
`The very purpose of the patent, after all, includes stable formulations that do not degrade after
`
`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.
`
`
`
`6
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 11 of 21 PageID #: 869
`
`
`reconstitution and admixture. See supra; Pls.’ Br. at 12–13. This fact, added to the law that
`
`disclosed embodiments do not limit the claimed invention, means that CFT’s argument fails.
`
`Phillips, 415 F.3d at 1323 (“[P]ersons of ordinary skill in the art rarely would confine their
`
`definitions of terms to the exact representations depicted in the embodiments.”); Nazomi
`
`Commc’ns, Inc. v. ARM Holdings, PLC, 403 F.3d 1364, 1369 (Fed. Cir. 2005) (claims can cover
`
`“different subject matter than is illustrated in the specific embodiments in the specification”).
`
`d. CFT contends that Examples 1 and 3 contain “controls,” which “alone are dispositive
`
`of the matter” because the controls did not have an adjusted pH and were also not referred to as
`
`compositions of the invention. Df.’s Br. at 10–11. CFT’s argument fails for a simple reason, as
`
`conceded by Dr. Kirsch: absent lactose and an acid, the controls were not compositions of the
`
`invention whether they met the pH limitation or not. Ex. 1, Kirsch Dep. 92:2–7; Majumdar Decl.
`
`¶ 43. The controls are not indicative of whether the pH limitation must be met at the bulk
`
`solution stage or not. But even if the controls included the required ingredients, CFT’s argument
`
`is unconvincing, because it requires a tenuous chain of inference: a POOS would need to
`
`connect the unaltered pH levels in a control sample to the term “solution” in the claims. Id. Far
`
`from being “dispositive of the matter,” CFT’s contention fails to even approach the “exacting”
`
`standards for redefining a term in the specification as required by the Federal Circuit. GE
`
`Lighting, 750 F.3d at 1309.
`
`e. CFT argues that the six Examples in the specification mean the “pH limitation in the
`
`claims . . . appl[ies] to the bulk solution.” Df.’s Br. at 11–13. But the specification states that
`
`“[t]he following six examples illustrate various embodiments of the invention and are not
`
`intended to limit the invention in any way.” JA-1465 at col. 6:63–65 (emphasis added). On this
`
`basis, a POOS would understand that the Examples are not limitations. Majumdar Decl. ¶ 42.
`
`
`
`7
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 12 of 21 PageID #: 870
`
`
`CFT’s use of the examples is also incompatible with the Federal Circuit’s admonition that it is
`
`“important not to confuse exemplars or preferred embodiments in the specification that serve to
`
`teach and enable the invention with limitations that define the outer boundaries of claim scope.”
`
`Intervet Inc. v. Merial Ltd., 617 F.3d 1282, 1287 (Fed. Cir. 2010); see also Phillips, 415 F.3d at
`
`1323. The Examples cannot support CFT’s construction.
`
`3. CFT’s reach into the prosecution history of a related patent, U.S. Patent No. 8,975,242
`
`(“the ’242 patent”), also misses the mark. Df.’s Br. at 14–15. CFT argues that during the
`
`prosecution of the ’242 patent, the patentee cited as support for a claimed pH range a part of the
`
`specification discussing the pH of the bulk solution. CFT elides the limiting language in the
`
`Amendment, i.e., that the patentee cited the bulk solution pH level “inter alia,” clearly
`
`suggesting that it was merely one basis for supporting the narrowing amendment. D.I. 52,
`
`McFarland Decl., Ex. D, Amendment Remarks at 5. Further, CFT again ignores limiting
`
`language in the cited specification, which notes that the pH range of “about 4.0 to about 5.0” is
`
`in only “[i]n one embodiment” of the invention. Df.’s Br. at 15 n.7; D.I. 52, McFarland Decl.,
`
`Ex. C, ’242 Patent at col. 4:58–60; JA-1465 at col. 5:10–12; Ex. 1, Kirsch Dep. 81:5–16. As
`
`discussed above, citing one bulk solution’s pH to support a claimed pH range says nothing about
`
`whether reconstituted and admixed solutions must always be derived from bulk solutions within
`
`that range. Supra Section I.B. CFT’s argument is entirely unhelpful. Majumdar Decl. ¶ 45.
`
`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
`
`POOS would not be able to make sense of the claims if they apply to all of the solutions. Df.’s
`
`Br. at 15–17. But neither CFT nor Dr. Kirsch has identified a single concept in the claims that a
`
`POOS would actually have trouble comprehending if Pfizer’s construction were adopted. Ex. 1,
`
`Kirsch Dep. 97:9–20, 100:8–101:11, 102:16–103:15; Majumdar Decl. ¶¶ 50–51. First, CFT
`
`
`
`8
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 13 of 21 PageID #: 871
`
`
`argues that a POOS would understand that the pH limits always apply to the bulk solution
`
`because otherwise the tigecycline would be degraded before it was reconstituted. Df.’s Br. at 16.
`
`But the ’828 patent directs only that the bulk solutions be acidic to avoid oxidation. JA-1464 at
`
`col. 4:52–57; Ex. 1, Kirsch Dep. 31:8–12, 71:25–72:4, 73:4–8. A POOS would understand that
`
`nothing in the patent excludes preparation of a bulk solution more acidic than the claimed pH
`
`range and thus not subject to oxidation, but then within the claimed pH range upon reconstitution
`
`with a diluent with a higher pH. Majumdar Decl. ¶¶ 38, 52–53; Ex. 1, Kirsch Dep. 78:9–14.
`
`Second, CFT contends that the specification offers no guidance to a POOS on how to
`
`reconstitute or admix the invention and, thus, the pH limitations must apply to the bulk solution.
`
`Df.’s Br. at 16–17. But CFT does not dispute, nor could it, that a POOS in the relevant field
`
`would know how to reconstitute and admix formulations or measure the pH levels of those
`
`solutions; in fact, these tasks are so well known to a POOS that they are “routine.” Ex. 1, Kirsch
`
`Dep. 25:11–26:20, 107:2–108:23; D.I. 53, Kirsch Decl. ¶ 11; Majumdar Decl. ¶ 54. CFT’s
`
`reference to the difficulty of determining dilution volumes or measuring pH in the hospital
`
`setting is a red herring: the patent is judged from the perspective of the POOS, not a bedside
`
`hospital employee. Id. ¶ 55. And there is no need to measure in the hospital in any case, as the
`
`dilution and admixture solutions and volumes will be determined in a laboratory setting. Id.
`
`Third, relying on its specious argument that the specification needs to explain to a POOS
`
`how to reconstitute and admix solutions, and how to measure a solution’s pH, CFT invents
`
`indefiniteness, written description, and enablement arguments and urges the Court to avoid them
`
`by adopting its proposed construction. Df.’s Br. at 17 & n.9. Because a POOS is already well-
`
`equipped to handle those tasks, the problems to which CFT alludes are phantoms and this Court
`
`should reject them out-of-hand. Majumdar Decl. ¶¶ 56–58.
`
`
`
`9
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 14 of 21 PageID #: 872
`
`
`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
`
`construction merely requires that a “property of the claimed composition . . . must be measured
`
`in the bulk solution.” Df.’s Br. at 18. But that is exactly what a process claim is: a temporal
`
`limitation requiring certain characteristics at a given point in the process. In re Nuijten, 500 F.3d
`
`1346, 1355 (Fed. Cir. 2007) (“[A] process claim must cover an act or series of acts.”). CFT
`
`argues that Pfizer “pursue[d] functional claiming” in the ’828 patent by “providing only one
`
`appropriate time” to measure the pH of the solution. Df.’s Br. at 18. That is a creation of CFT’s
`
`imagination: there is no direction that the pH must be measured only at the bulk stage; the
`
`prosecution history shows otherwise; and the measurement of pH at the reconstitution or
`
`admixture stage is routine for a POOS. Moreover, if a solution meets the pH limitation, it will
`
`infringe whether it is measured or not; in other words, measurement is only an issue of proof, not
`
`of claim scope. Because there is no instruction in the intrinsic evidence that the pH must be
`
`measured at the bulk stage, CFT’s argument fails.
`
`CFT asserts that its process limitation should be imported because “obtaining the proper pH
`
`during the compounding stage is essential to the invention as a whole.” Id. at 18–19. As
`
`discussed above, CFT has not met the “exacting” standard to import a limitation from the
`
`specification. Even if it had, the cases cited by CFT do not support its argument. In Andersen
`
`Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1366–67 (Fed. Cir. 2007), the court found the
`
`patent-in-suit clearly explained that a particular step was necessary—the specification used the
`
`word “require[d]”—to manufacture the invention “having the claimed physical properties,” and
`
`that the specification “repeatedly states that the steps . . . are not merely embodiments, but are
`
`essential features of the claimed composite composition.” In contrast, the ’828 patent expressly
`
`identifies that the embodiments are not limitations, and contains none of the clear language like
`
`
`
`10
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 15 of 21 PageID #: 873
`
`
`that of the patent in Andersen. Likewise, in Medicines Co. v. Teva Parenteral Medicines, Inc.,
`
`No. 09-750-RGA, 2013 WL 3658020, at *3 (D. Del. July 11, 2013), the court held that (1) the
`
`term in question was “explicitly defined in the specification as resulting from the compounding
`
`process,” (2) the claim “already has a process step,” and (3) the process limitation was critical to
`
`distinguish the invention from prior art. None of these three vital factors is present here.
`
`CFT wrongly suggests that Pfizer’s construction—by using the word “when”—also includes
`
`a temporal limitation. Df.’s Br. at 19. But Pfizer’s interpretation merely acknowledges a
`
`scientific fact: only solutions may have pH values and, to be measured, the pH must be in “a
`
`solution.” Majumdar Decl. ¶ 19; D.I. 53, Kirsch Decl. ¶ 28. Unlike CFT’s, Pfizer’s construction
`
`does not require that the pH be measured at any particular point to practice the invention or
`
`prove infringement. CFT also contends that Claims 2 and 3—which recite lyophilized and solid
`
`versions of the composition in Claim 1—suggest that Claim 1 may only apply to the bulk
`
`solution and thus create an “inherent process step.” Df.’s Br. at 19. But those claims do not
`
`limit Claim 1’s scope because it is undeniably broader than the dependent claims in that it
`
`implicates all three solutions. Ex. 1, Kirsch Dep. 63:24–64:1; Majumdar Decl. ¶ 29.
`
`Because CFT attempts to import a process limitation into the pure composition claims in the
`
`’828 patent, this Court should reject its proposed construction and instead adopt Pfizer’s, which
`
`is faithful to the intrinsic evidence. See Phillips, 415 F.3d at 1316 (“The construction that stays
`
`true to the claim language and most naturally aligns with the patent’s description of the invention
`
`will be, in the end, the correct construction.” (internal quotation marks omitted)).
`
`II. ’828 Patent—“pH . . . between about X and about Y”
`CFT incorrectly argues that construing “about” as “approximately” is unhelpful and does not
`
`resolve the dispute. Df.’s Br. at 20–21. But the Federal Circuit has long recognized that
`
`inventors may use terms of approximation to avoid strict numerical boundaries, Playtex Prods.,
`
`
`
`11
`
`

`
`Case 1:14-cv-00781-SLR Document 60 Filed 07/15/15 Page 16 of 21 PageID #: 874
`
`
`Inc. v. Procter & Gamble Co., 400 F.3d 901, 907 (Fed. Cir. 2005), and has had no difficulty
`
`construing “about” to mean “approximately,” Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d
`
`1364, 1372 (Fed. Cir. 2005); see also Roche Diagnostics Operations, Inc. v. Abbott Diabetes
`
`Care, 667 F. Supp. 2d 429, 441 (D. Del. 2009); UCB, Inc. v. KV Pharm. Co., No. 08-223-JJF,
`
`2009 WL 2524519, at *3–7 (D. Del. Aug. 18, 2009). CFT’s desire to have a strict numerical
`
`boundary—no matter how “helpful” to CFT’s argument such a boundary might be—cannot
`
`overcome the inventor’s explicit choice not to have one.
`
`CFT cites Pfizer’s position in a related inter partes review proceeding to argue that “about”
`
`in relation to pH units “had essentially the same meaning that CFT is now proposing.” Df.’s Br.
`
`at 21–22. But CFT ignores that Pfizer never proposed a strict numerical boundary in that
`
`proceeding; consequently, Pfizer’s position in the IPR cannot support CFT’s argument here.
`
`CFT also argues that a POOS would understand that ±0.05 pH is the proper limit because it
`
`fits with significant digits as reported in the patent, it correlates with common measurement
`
`techniques, and claim differentiation suggests it. Df.’s Br. at 22–23. CFT’s arguments are
`
`unavailing because they begin with the false premise that a POOS would need to find a strict
`
`numerical boundary. But just as the ’828 inventors chose not to include a strict numerical
`
`boundary, a POOS would also be able to comprehend the patent without one; instead, a POOS
`
`would construe “about” as “approximately.” Majumdar Decl. ¶¶ 59–60; Pls.’ Br. at 14–17.
`
`III. ’995 Patent—“Form I tigecycline”
`In a backdoo

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket