Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 1 of 20 PageID #: 1648
`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 1 of 20 PageID #: 1648
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`
`
`HOSPIRA, INC,
`
`Plaintiff,
`
`v.
`
`Civil Action No. 15—697—RGA
`
`
`
`AMNEAL PHARMACEUTICALS LLC,
`
`Defendant.
`
`AMNEAL’S REPLY POST-TRIAL BRIEF ON INVALIDITY
`
`Frederick L. Cottrell, III (#2555)
`Kelly E. Farnan (#4395)
`Christine D. Haynes (#4697)
`Richards, Layton & Finger, PA.
`920 North King Street
`Wilmington, DE 19801
`(302) 651—7700
`cottrell@rlf.corn
`farnan@rlf.corn
`haynes@rlf.corn
`
`Aflomoyyfor Do/éodcml—CMiriam/arm P/az'olgfl
`AMflé’d/ P/oarmczoom‘z'm/J LLC
`
`OfCootmo/r
`
`Steven A. Maddox (pro [mo moo)
`Jeremy]. Edwards (pro [mo moo)
`Matthew C. Ruedy (pro bozo woo)
`Kaveh V. Saba (pro bozo woo)
`Maddox Edwards PLLC
`1900 K Street N.W., Suite 725
`Washington, DC. 20006
`(202) 830—0707
`smaddox@meiplaw.corn
`jedwards@meiplaw.com
`rnruedy@rneiplaw.corn
`ksaba@n1eiplaw.con1
`
`Dated: October 23, 2017
`
`RLF] 18317534V.l
`
`

`

`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 2 of 20 PageID #: 1649
`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 2 of 20 PageID #: 1649
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES ......................................................................................................................... ii
`
`I.
`
`The Asserted Claims Are Invalid as Obvious. ................................................................................. 1
`
`A.
`
`Hospira Cannot Avoid Inherency of the Claimed 2% Limitation by Rewriting
`the Law and Trial Record. ..................................................................................................... 1
`
`1.
`
`2.
`
`Hospira Misstates the Law of Inherency Applicable to the
`Unrebutted Experimental Evidence....................................................................... 2
`
`Hospira Misrepresents the Record in Asserting That There Was No
`Supporting Expert Testimony or That There Were Contrary
`Examples. ................................................................................................................... 3
`
`3.
`
`Hospira Cannot Avoid Its Interrogatory Admission of Inherency. .................. 5
`
`B.
`
`The Claimed 4 ug/mL Dex and Normal Saline in a Sealed Glass Container
`Was Obvious. .......................................................................................................................... 7
`
`1.
`
`2.
`
`3.
`
`The Sealed Glass Container Was Obvious, Regardless of What the
`Examiner Found. ...................................................................................................... 7
`
`Hospira Urges the Court to Blindly Accept the Inventor’s Self—
`Serving Testimony Over the Expert Evidence ..................................................... 9
`
`The Trial Record Contradicts Hospira’s “Hindsight” Argument. ................... 10
`
`C.
`
`Hospira Has No Response to the Lack of Probative Commercial Success ................. 12
`
`II.
`
`The 2% Limitation of the ’106 Patent Is Indefinite. ..................................................................... 12
`
`III.
`
`Conclusion ........................................................................................................................................... 15
`
`RLF] 18317534V.l
`
`i
`
`

`

`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 3 of 20 PageID #: 1650
`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 3 of 20 PageID #: 1650
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`AK 5166/ C04). 7). Sol/cw Q9“ ng'm',
`344 F.3d 1234 (Fed. Cir. 2003) .................................................................................................................. 14
`
`Alva” Reyeom‘b, Lid. 0. Apolex Im,
`687 F.3d 1362 (Fed. Cir. 2012) ............................................................................................................... 1, 7
`
`I‘ll/egg”, Im‘. 0. Tem P/mmz. USA, Im‘. et a/.,
`No. 15—CV—1455, slip op. (E.D. Tex. Oct. 16, 2017) ............................................................................... 12
`
`Haim/ex, 1m: 0. EXXO” C0771,
`434 F. Supp. 136 (D Del. 1977) ................................................................................................................. 6
`
`I” re Cmvferom Sprout 11723.,
`301 F.3d 1343 (Fed. Cir. 2002) .................................................................................................................... 3
`
`In 7'6 K610,
`
`639 F.3d 1057 (Fed. Cir. 2011) ............................................................................................................... 1, 7
`
`I” re Kuhn,
`
`561 F.3d 1351 (Fed. Cir. 2009) ............................................................................................................... 1, 7
`
`King P/aam., Im‘. 7/. Ban Law, 11%;,
`616 F.3d 1267 (Fed. Cir. 2010) .............................................................................................................. 1, 7
`
`Knaszm/cztz'ofl, 1m. 7). Roy/éwool Im’ZA/S,
`680 F. App’x 956 (Fed. Cir. 2017) .............................................................................................................. 5
`
`K5R [”17 C0. 0. Te/ef/ex, 11%;,
`550 US. 398 (2007) ....................................................................................................................................... 8
`
`Lzfl’ Tam/95., 1m. 0. Comet/9 Lam, 1715.,
`224 F.3d 1320 (Fed. Cir. 2000) ............................................................................................................. 9, 10
`
`Medicimy C0. 7/. My/om, 11%;,
`853 F.3d 1296 (Fed. Cir. 2017) ........................................................................................................... 14, 15
`
`Merv/é Q9“ C219 0. Warm” Lam, Ma,
`
`822 F.3d 1347 (Fed. Cir. 2016) .................................................................................................................. 11
`
`Mil/emz'um Pharm, 1m: 0. Sandoz 11%;,
`862 F.3d 1356 (Fed. Cir. 2017) .................................................................................................................... 3
`
`RLFl 18317534V.1
`
`

`

`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 4 of 20 PageID #: 1651
`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 4 of 20 PageID #: 1651
`
`N000 Nordz'xlé A/f e. Cameo P/mrm. Lam, Ltd,
`
`719 F.3d 1346 (Fed. Cir. 2013) .................................................................................................................... 8
`
`Omepmzole Paz‘em‘ Utzg,
`583 F.3d 1364 (Fed. Cir. 2007) .................................................................................................................... 7
`
`I). My/em Law,
`On‘bo-MeNez'l P/mmz., Me.
`520 F.3d 1358 (Fed. Cir. 2008) .................................................................................................................. 11
`
`One/kg P/aamezeezziz’ea/ Co., Ltd. a. Safldez, Im,
`678 F.3d 1280 (Fed. Cir. 2012) ............................................................................................................. 2, 11
`
`Pm" P/mmz., Im‘. e. mi P/mmz., Inez,
`
`120 F. Supp. 3d 468 (D Md. 2015) ............................................................................................... 1, 2, 4, 5
`
`Par Plume. 7/. TM Flamm, Men,
`
`773 F.3d 1186 (Fed. Cir. 2014) ............................................................................................................. 1, 10
`
`Ree/€277 Bem‘xéz'ser P/aemm. [mu 0. Watson Lam, Inez,
`
`Nos. 13—1674—RGA, 14—4222—RGA, 2016 WL 3186659 (D. Del. June 3, 2016) (Andrews,]). ....... 10
`
`Safe/e Pbemem Im‘. 7/. Lflpm Lid,
`684 F.3d 1253 (Fed. Cir. 2012) .................................................................................................................... 8
`
`Tom Co. v. Deere Q?“ Ca,
`
`355 F.3d 1313 (Fed. Cir. 2004) .................................................................................................................... 3
`
`Federal Rules
`
`Fed. R. Civ. P. 33 ............................................................................................................................................... 6
`
`RLF1 18317534V.1
`
`

`

`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 5 of 20 PageID #: 1652
`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 5 of 20 PageID #: 1652
`
`I.
`
`The Asserted Claims Are Invalid as Obvious.
`
`Hospira’s brief leads with the usual declamations against hindsight and for deference to the
`
`examiner.
`
`(See D.l. 106 at 1—11.) Amneal addresses these below, 279%; at 7—1 1. But first, Amneal
`
`addresses the specific obviousness issue on which the Court asked the parties to focus—that is, the
`
`inherency of the ’106 patent’s “no more than about 2% decrease” in the concentration of
`
`dexmedetomidine (“dex”) at five months.
`
`(Tr. 1178:6—11.)
`
`A.
`
`Hospira Cannot Avoid Inherency of the Claimed 2% Limitation by Rewriting
`the Law and Trial Record.
`
`Amneal showed that the trial record clearly and convincingly proves the factual issue of
`
`inherency, beginning with Hospira’s own admission, and Dr. Yaman’s testimony on the unrebutted
`
`and undisputed experimental evidence all showing less than about 2% decrease after at least five
`
`months.
`
`(D.l. 100 at 9—19.)
`
`Unable to refute any of this dispositive evidence under existing law, Hospira tries to create
`
`new law. Hospira generally asserts that the experimental evidence and interrogatory response should
`
`be dismissed because they come from the inventors and the patent themselves.
`
`(D.l. 106 at 14—22.)
`
`Hospira’s assertion contradicts the numerous Federal Circuit decisions cited by Amneal. These
`
`decisions confirm that evidence from the inventors’ work reflected in the patents is not only
`
`relevant, but often dszoafiz‘w proof of inherency.
`
`(D.I. 100 at 10—14 (citing I” re Kat/2m, 561 F.3d
`
`1351, 1357 (Fed. Cir. 2009); In re K420, 639 F.3d 1057, 1070 (Fed. Cir. 2011);A/L‘0fl Reyedrv/a, Ltd. 7).
`
`Apolex 17%;, 687 F.3d 1362, 1369 (Fed. Cir. 2012); Kiflg P5617772, Im‘. 0. E0” Lcl/flJ‘, 17%;, 616 F.3d 1267,
`
`1275 (Fed. Cir. 2010)).) Moreover, the few legal authorities on inherency that Hospira does
`
`acknowledge—including the Par 7). TM decisions—unmistakably counter Hospira’s argument about
`
`the relevance of the patentee’s work here.
`
`(See D.I. 106 at 16 (citing Par P/mm. p. Tle' Magma, 11%;,
`
`773 F.3d 1186, 1194—96 (Fed. Cir. 2014) and Par P/mmz., [mu a. TM P/mmz., 1m, 120 F. Supp. 3d 468,
`
`475 (D. Md. 2015), afi’d, 624 F. App’x 756 (Fed. Cir. 2015»)
`
`RLF] 18317534V.l
`
`

`

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`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 6 of 20 PageID #: 1653
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`As explained further below, Hospira’s novel legal proposition on inherency, as well as its
`
`secondary arguments about the expert testimony and purported contrary examples, are incorrect.
`
`1.
`
`Hospira Misstates the Law of Inherency Applicable to the Unrebutted
`Experimental Evidence.
`
`Hospira does not dispute that all the data presented by Amneal showed that 4 ug/mL dex in
`
`normal saline exhibited less than about 2% concentration decrease after five months, when disposed
`
`in a sealed glass container.
`
`(D1. 106 at 15—20.) Instead, Hospira first erroneously argues that the
`
`evidence came from Hospira and therefore cannot support inherency.
`
`(Id. at 15—16.)
`
`Hospira boldly asserts that “[t] he Federal Circuit has held that the inventors’ work is not
`
`available to prove inherency,” but has no basis for this proposition.
`
`(D1. 106 at 15.) Hospira’s
`
`proposed rule is at best a misunderstanding and at worst a misrepresentation of the law. Hospira
`
`seems to base this blanket legal standard on 0mm Pbdmavem‘lml Ca, Ltd. a. Samloz, 11%;, 678 F.3d
`
`1280 (Fed. Cir. 2012).
`
`(D1. 106 at 19.) But Orig/ea had ”of/9mg cll all to do wit/9 z'fl/aermgl Rather, that
`
`was a chemical compound obviousness case focused on the selection and modification of a lead
`
`compound. Orig/ea, 678 F .3d at 1295—96. Nor does the quote on which Hospira relies relate to
`
`inherency.
`
`(D1. 106 at 19.) It merely recites the general principle that primafim’e obviousness turns
`
`on what a person of ordinary skill in the art (“POSA”) would have done, not simply retracing the
`
`path of the inventor. Olly/ea, 678 F.3d at 1296.
`
`What is more, Hospira’s unsupported legal standard is flatly contradicted by the inherency
`
`determination on remand in Par Magma, 1m: 72. 71W Magma, 11%;, 120 F. Supp. 3d 468 (D. Md. 2015),
`
`which was affirmed without opinion by the Federal Circuit, 624 F. App’x 756 (Fed. Cir. 2015).
`
`There the district court considered, under the proper legal standard on remand, the inherency of a
`
`claimed food effect reduction in the context of obviousness. Pm" Pharm, 120 F. Supp. 3d at 474.
`
`The court found inherency based “[m]ost significantly” 011 cm example in flag patent, as well as on the
`
`patentee’s commercialized drug product (“Par’s Megace ES”).
`
`Id. It further relied on the accused
`
`RLF] 183 l7534v.l
`
`2
`
`

`

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`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 7 of 20 PageID #: 1654
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`infringer’s product and supporting expert testimony.
`
`Iel. This instructive case refutes Hospira’s
`
`position that the inventors’ work—as disclosed in the patent or as reflected by the patentee’s
`
`product—cannot be relied on to establish inherency.
`
`(See D.I. 106 at 19.)
`
`Indeed, the affirmed decision in Pun u. TWi is also in line with the Federal Circuit’s
`
`jurisprudence establishing that the factual question of inherency is not limited to evidence from a
`
`POSA, to the exclusion of the patentee’s work. See, e.g., Tom C0.
`
`72. Deere 2’?” Co., 355 F.3d 1313, 1321
`
`(Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior—art
`
`embodiment .
`
`.
`
`. is enough for [inherency], even if that fact was unknown at the time of the prior
`
`invention”); In re Crueuferouy Sprout Ling, 301 F.3d 1343, 1349 (Fed. Cir. 2002) (“lnherency is not
`
`necessarily coterminous with the knowledge of [POSAs],” who “may not recognize the inherent
`
`characteristics or functioning of the prior art.”). Hospira’s proposed departure from this and other
`
`Federal Circuit law is perplexing, especially in view of Hospira’s recent Federal Circuit petition
`
`arguing for a seemingly different, less stringent standard than what it offers here. fee Millennium
`
`Plaunm., Inc. 7/. Sundoz Ine. ei‘ ul, Federal Circuit Appeal No. 15—2066, Doc. 146, filed Sept. 15, 2017.1
`
`2.
`
`Hospira Misrepresents the Record in Asserting That There Was No
`Supporting Expert Testimony or That There Were Contrary Examples.
`
`Next, Hospira misrepresents the testimony of Dr. Yaman in claiming that he offered no
`
`scientific testimony supporting inherency of the 2% limitation.
`
`(D.l. 106 at 17.) Dr. Yaman
`
`explained that less than about 2% decrease at five months is expected under long—term conditions,
`
`especially for dex, because the prior art product showed that the drug is inherently stable in normal
`
`saline, without the need for any chemical stabilizers or additives.
`
`(Tr. 513:5—23, 542:20—543z11,
`
`(D1. 106 at 19 n.6 (citing Millennium
`1 Hospira buries Millennium in a footnote for good reason.
`Plenum, lne. n. Sundorz Inn, 862 F.3d 1356, 1367 (Fed. Cir. 2017).) Whereas in that case, “[n]o expert
`testified that they foresaw, or expected, or would have intended, the reaction [claimed],” here Dr.
`Yaman testified that no more than 2% decrease at five months was certainly expected, particularly
`given that the drug was known to be stable in normal saline in sealed glass. Millennium, 862 F .3d at
`1367.
`(Tr. 513:5—23, 542220—543z11, 543224—5449, 552:17—55323, 55528—18.)
`
`RLF] 183 17534v.1
`
`3
`
`

`

`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 8 of 20 PageID #: 1655
`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 8 of 20 PageID #: 1655
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`543224—5449, 552217—5536, 555:8—18.) Moreover, Dr. Yaman explained that the obvious Type 1
`
`glass was known to be chemically inert, further supporting the scientific fact of inherency of the 2%
`
`limitation.
`
`(Tr. 51529—15, 53228—20, 53826—19, 546217—549:12.) Thus, like in Par, and contrary to
`
`Hospira’s allegations, Amneal’s unrebutted experimental evidence of inherency was appropriately
`
`supported by Dr. Yaman’s scientific expert testimony. Par P/mrm, 120 F. Supp. 3d at 474.
`
`Hospira pretends that Dr. Yaman “conceded that there are combinations of glass and
`
`stopper that could lead to a loss of drug product,” but overlooks the fact that nothing in the record
`
`suggested greater than 2% loss from l/ae c‘em/arflalz'enproeed 1‘0 [wee been M037 o/m'om—a Type 1 glass vial
`
`with a coated stopper, like the prior art product.
`
`(D.I. 106 at 17.) What matters for inherency here
`
`is whether the elm'em product would exhibit the claimed stability, not whether some theoretical
`
`combination of glass and rubber may or may not do so.
`
`Even so, Hospira’s mischaracterizations of Dr. Yaman’s testimony here are inexcusable.
`
`From the very testimony Hospira cites, Dr. Yaman explained that oxidation would not have been a
`
`concern, but even if it were nitrogen blanking was a routine precaution; that glass treatments are
`
`readily used for even greater resistance to adsorption; and that an obvious coated stopper would
`
`prevent adsorption as well.
`
`(Tr. 529:11—530z8, 553:9—554zl3, 55525—556le, 69725—698le.) This
`
`testimony confirmed the inherent result of the Type 1 glass, coated stopper combination shown to
`
`be obvious, and Hospira’s argument about possible loss in “M sealed glass container” is a red
`
`herring.
`
`(D.I. 106 at 18.)
`
`Hospira now also Claims to have presented “contrary examples” to rebut inherency, but this
`
`too is illusory.
`
`(See D.I. 106 at 18—19.) Hospira did not offer a single sealed glass container example
`
`anywhere exhibiting greater than about 2% increase after five months. The testimony Hospira
`
`believes to be a “contrary example” is merely its inventor’s vague reference to container Closure
`
`failures.
`
`(Id. at 18 (citing Tr. 124217—1262, 1266—9).) This is not even relevant to inherency in a
`
`RLF] 18317534V.l
`
`

`

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`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 9 of 20 PageID #: 1656
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`sealed glass container, much less an actual instance of more than 2% loss. The same is true for the
`
`musings of Hospira’s Dr. Linhardt about what generally amt/d go wrong in in terms of added
`
`impurities, adsorption, absorption, or oxidation.
`
`(D1. 106 at 19.) There is no evidence in the record
`
`of any such issues for dex and normal saline stored in the obvious sealed glass container.
`
`Hospira’s proffered speculation is much like in Par, where the court found that “while [the
`
`patentee] implies that other counterexample formulations might exist, it does not actually come
`
`forward with any,” and therefore “has failed to rebut [the defendant’s] inherency case.” Pm" 13/947771,
`
`120 F. Supp. 3d at 475. It is also the type that the Federal Circuit has deemed insufficient to avoid
`
`inherency. Kflazyflmu/czz‘z'ofl, 1m. 7). Rockwoo/Iflt’lA/S, 680 F. App’x 956, 960—61 (Fed. Cir. 2017).
`
`In the end, Hospira simply asserts that Amneal’s non—infringement position negates
`
`inherency.
`
`(D1. 106 at 18.) This is incorrect. Amneal has consistently explained that the 2%
`
`limitation is inherent as a matter of scientific fact, under Hospira’s construction that only long—term
`
`stability testing applies.
`
`(D1. 105 at 1.) But if the Court does not adopt Amneal’s position on
`
`inherency, then a judgment of non—infringement is warranted for the ’106 patent because Dr.
`
`Linhardt’s statistically insignificant analysis of Amneal’s data failed to meet Hospira’s burden of
`
`proving infringement.
`
`(See D.I. 105.)
`
`3.
`
`Hospira Cannot Avoid Its Interrogatory Admission of Inherency.
`
`Recognizing the strength of inherency based on its own interrogatory response, Hospira
`
`buries this dispositive evidence at the very end of its obviousness discussion.
`
`(D1. 106 at 20—22.)
`
`Hospira argues that (1) its response was not an admission of inherency, (2) it is based on the patent
`
`and therefore not probative, and (3) Amneal is somehow trying to shift the burden of proof.
`
`([6].)
`
`These assertions fly in the face of the plain text of its response, and the controlling case law.
`
`Fz'm‘, Hospira states that the “interrogatory only asked for the identification of evidence
`
`known to Hospira” that the Claim limitation was not inherent.
`
`(D1. 106 at 20.) That, of course, is
`
`RLF] 18317534V.l
`
`

`

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`Case 1:15—cv-00697—RGA Document 108 Filed 10/23/17 Page 10 of 20 PageID #: 1657
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`precisely the point. If Hospira had evidence, or even contended without evidence, that the 2%
`
`limitation was ”02‘ inherent, it should have said so then. But Hospira did the opposite—it conceded
`
`the fact of inherency based on the patent itself. This is analogous to a patentee propounding an
`
`interrogatory about non—infringement, to which a defendant responds that its product would satisfy
`
`the claims. That hypothetical, as here, should properly dispose of the issue by a party’s interrogatory
`
`response, not by shifting the burden of proof as Hospira now alleges. Hana/ex, 1m: 7/. Exxon C0771,
`
`434 F. Supp. 136, 157 (D. Del. 1977) (“There is nothing impermissible in asking a party to state what
`
`he presently contends in an effort to ferret out or narrow the issues”) (Citation omitted).2
`
`Likewise, in trying to side—step the inherency implications of its interrogatory response,
`
`Hospira attempts to couch it as just “an example of what the inventors had learned.” (D1. 106 at
`
`20.) Hospira cannot rewrite the indisputable plain language of its response. Hospira’s response
`
`states clearly that “[t]he patents—in—suit explain that a solution of 4 ug/mL dexmedetomidine in 0.9%
`
`sodium chloride would, in the absence of degradative compounds, exhibit the claimed stability when
`
`stored in a sealed glass container.” (DTX—191 at 8.) It had no qualification that this would only
`
`occur only in certain glass containers, or with certain seals. Hospira never amended or
`
`supplemented that response during discovery, and should not be permitted to do so now.
`
`Swami, Hospira again asserts as a matter of law that its response “is not available as evidence
`
`of inherency” because it “referred back to the ’106 patent” and comes from the inventors’ work.
`
`(D1. 106 at 21. See also id. at 20 (arguing that the response reflects “what the inventors had learned
`
`2 Indeed, permitting Hospira to run from its interrogatory response on inherency would undermine
`the central purpose of interrogatories like this one. The Federal Rules have long encouraged parties
`to rely on such interrogatory responses to narrow the issues. Fed. R. Civ. P. 33, 1970 Advisory
`Committee Notes (“As to requests for opinions or contentions that call for the application of law to
`fact, they can be most useful in narrowing and sharpening the issues, which is a major purpose of
`discovery”) Allowing Hospira to give a different response now about the evidence of inherency
`would penalize Amneal after—the—fact for having appropriately relied on Hospira’s interrogatory
`response in accordance with the Federal Rules.
`
`RLF] 18317534V.l
`
`

`

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`about the stability of a 4 ug/mL solution of dexmedetomidine under certain test conditions and a;
`
`vim/wed in tbez'rpm‘mlf’) (emphasis added).) But as demonstrated above, the Federal Circuit has
`
`repeatedly determined a claim limitation to be an inherent characteristic based 50/66/ on the work of
`
`the inventors disclosed in the patent, whether for anticipation or obviousness.
`
`[Oz/72'”, 561 F.3d at
`
`1357; Kat), 639 F.3d at 1070;14/6071, 687 F.3d at 1369; King 13647777., 616 F.3d at 1275.
`
`Third, Hospira sets up and knocks down a strawman—offering a pointless explanation of the
`
`Omit/pmzo/e case cited by Amneal to disprove a burden—shifting argument that Amneal never made.
`
`(D1. 106 at 21 (citing Omc’pmzo/e Polz‘em‘ Lz'lzg., 583 F.3d 1364, 1372—73 (Fed. Cir. 2007).) The
`
`Omefvazole case merely reflects the logical notion that in view of Hospira’s interrogatory response, its
`
`lack of rebuttal evidence is telling of inherency.
`
`(See D.I. 100 at 13.) Indeed, even Hospira explains
`
`that in affirming inherency, “the Federal Circuit noted that if the patent owner had scientific
`
`evidence to disprove its earlier admission, then it would have been logical for the patent owner to
`
`present that evidence.” (D1. 106 at 21.) That is exactly the point here. Hospira made an assertion
`
`of inherency, never retracted it, and yet offered no evidence to refute it, like in Omc’pmzo/e.
`
`B.
`
`The Claimed 4 ug/mL Dex and Normal Saline in a Sealed Glass Container
`Was Obvious.
`
`Beyond inherency, Hospira offers generic patentee arguments based on (1) deference to the
`
`examiner in issuing the patents, (2) the inventor’s purported path to settling on a working glass vial
`
`and coated stopper, and (3) accusations of improper hindsight.
`
`(D1. 106 at 2—11.) None of these
`
`arguments is even relevant, much less sufficient to rebut obviousness.
`
`(566 DJ. 100 at 3—9.)
`
`1.
`
`The Sealed Glass Container Was Obvious, Regardless of What the
`Examiner Found.
`
`Hospira’s first argument—that the Court should defer to the examiner’s non—obviousness of
`
`the claimed sealed glass container from the prior art product labeling—should be rejected as a
`
`matter of law and fact.
`
`(See D.I. 106 at 2—4.)
`
`RLF] 18317534V.l
`
`

`

`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 12 of 20 PageID #: 1659
`Case 1:15—cv-00697-RGA Document 108 Filed 10/23/17 Page 12 of 20 PageID #: 1659
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`As a matter of law, the Federal Circuit has clearly instructed that “[t]he initial determinations
`
`by the PTO in determining to grant the application are entitled to no deference” here.
`
`JNTMJO NTordzbyé
`
`A/f v. Comm 13/947772. Lam, Ltd, 719 F.3d 1346, 1357 (Fed. Cir. 2013). Nor does the clear and
`
`convincing evidence standard heighten or lower depending on whether the examiner considered a
`
`reference during prosecution, as Hospira suggests in relying so heavily on the examiner over the trial
`
`record.
`
`(See D.I. 106 at 2—3.) Safe/e lemm 1m: 0. Lupin Ltd, 684 F.3d 1253, 1260 (Fed. Cir. 2012).
`
`Thus, the obviousness of the claimed sealed glass container here does not depend on what the
`
`examiner did or did not consider, including whether the examiner considered the undisputed prior
`
`product packaging itself as opposed to only the labeling (which is not clear).
`
`Accepting Hospira’s proposed deference to the prosecution history would also violate the
`
`basic tenets of obviousness. Hospira would have the Court defer to Hospira’s prosecution
`
`argument that because the prior art product labeling does not explicitly recite a container for the
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`diluted formulation, “no container of any type, either sealed or unsealed” was obvious other than
`
`perhaps an infusion bag.
`
`(D1. 106 at 3.) This defies common sense, and more importantly, the
`
`black—letter law that “[a] person of ordinary skill is also a person of ordinary creativity, not an
`
`automaton.” KSR Im‘7 C0. 7/. Te/g’flex, 11%;, 550 U.S. 398, 421 (2007).
`
`As a matter of fact, the trial record includes a wealth of pharmaceutical packaging literature
`
`”02‘ considered by the examiner, showing that using a Type I glass vial, coated stopper configuration
`
`like the prior product would have been obvious to a POSA, in developing a ready to use dex
`
`product.
`
`(fee, gag, Tr. 515:4—516z3, 533:13—534z18; DTX—202 at 147052.) Tellingly, Hospira’s
`
`examiner—based argument that “no container” other than an infusion bag would be used by a POSA
`
`flies in the face of the trial record—including the testimony of Hospira’s own Dr. Linhardt.
`
`(Tr.
`
`936211—938220.) The Court should decline Hospira’s invitation to reject all the evidence here and
`
`instead confine its decision to the examiner’s allowance during prosecution.
`
`RLF] 18317534V.l
`
`

`

`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 13 of 20 PageID #: 1660
`Case 1:15—cv-00697-RGA Document 108 Filed 10/23/17 Page 13 of 20 PageID #: 1660
`
`2.
`
`Hospira Urges the Court to Blindly Accept the Inventor’s Self-Serving
`Testimony Over the Expert Evidence.
`
`As with infringement, Hospira now tries to run from its expert Dr. Linhardt’s trial
`
`testimony. Instead, Hospira relies on its inventor to argue that there was no motivation or
`
`reasonable expectation of success.
`
`(D1. 106 at 4—10.)
`
`As an initial matter, Hospira’s reliance on its inventor’s testimony for non—obviousness
`
`violates the well—established rule—which Hospira should know well from its hindsight accusations
`
`against Amneal—that “the path that leads an inventor to the invention is expressly made irrelevant
`
`to patentability by statute.” sz‘é Tet/95., Im‘. a. Comer/9 Lam, Ma, 224 F.3d 1320, 1325 (Fed. Cir. 2000).
`
`Hospira apparently forgets that this rule applies to laof/a sides’ arguments and evidence.
`
`Hospira nevertheless relies on the inventor’s testimony to argue that “not every vial will
`
`work to store the solution,” and that it took a few months to settle on the particular glass vial and
`
`coated stopper combination used for Precedex premix.
`
`(D1. 106 at 7—10.) It simply does not
`
`matter how long it took the inventor to “re—discover” the prior art sealed glass container or to run
`
`routine tests to select among the commercially available glass vials and stoppers. And no witness in
`
`this case has ever contended that the specific glass vial and coated stopper of Precedex premix
`
`disclosed in the patents (but only generically claimed) was anything other than standard in the art.
`
`In fact, beyond the obviousness from the prior art product, the pharmaceutical literature and
`
`expert testimony showed that the coated stopper with glass vial configuration used by Hospira was
`
`one of the most common in the art.
`
`(Tr. 553:9—55524; DTX—219 at 147613—14.) The unrebutted
`
`expert testimony at trial established that two of the most common stoppers used by POSAs were
`
`the Flurotec and Omniflex.
`
`([6].) Hospira’s 50—mL and 100—mL products were ultimately packaged
`
`using the latter, immediately after assessing the former.
`
`(DTX—113 at 2790; PTX—40.1 1—13.) And
`
`Hospira overlooks that its 20—mL product used t/ae Jame Teflon—mated flapper as the prior art product.
`
`(DTX—1 13 at 2764; PIX—40.11.)
`
`RLF] 18317534V.l
`
`

`

`Case 1:15-cv-00697-RGA Document 108 Filed 10/23/17 Page 14 of 20 PageID #: 1661
`Case 1:15—cv-00697-RGA Document 108 Filed 10/23/17 Page 14 of 20 PageID #: 1661
`
`Hospira’s purported “failures” therefore actually refer to the successful implementation of
`
`the same coated stopper as the concentrate for the 20—mL product, and one of the other most
`
`common coated stoppers in the art for the 50—mL and 100—mL products.
`
`(See D.I. 106 at 9—10.)
`
`Just like the use of a Type 1 glass vial, the selection of an appropriate seal was plainly obvious.
`
`Hospira makes the same mistake as to motivation that it does on the reasonable expectation
`
`of success, in arguing that the “inventors were motivated to use a material other than glass.” (D1.
`
`106 at 8.) Again, this is legally irrelevant. sze Tev/ax, 224 F.3d at 1325. The prior art product
`
`packaging, and the known standard in the art, was a sealed glass container.
`
`(D.I. 100 at 5—7.) It was
`
`thus the most obvious choice, far exceeding the merely “suitable” option threshold for obviousness.
`
`Par Magma, 773 F.3d at 1197—98 (“Our precedent, however, does not require that the motivation be
`
`the barf option, only that it be a suitable option from which the prior art did not teach away”).
`
`Ultimately, despite Hospira’s attempts to muddy the waters, the obviousness of the same
`
`type of common glass packaging of the prior art product here is quite straight—forward. Indeed, it is
`
`even stronger than this Court’s obviousness finding based on the patentee’s prior art product
`
`(Suboxone®) in Rev/€211 Bem/éz'ter P/mmaveufz'm/J. [mu 0. Watson Laboratorz'ex, Ina, Nos. 13—1674—RGA,
`
`14—4222—RGA, 2016 WL 3186659 (D. Del. June 3, 2016) (Andrews, J”) M. at *10 (concluding “that
`
`a skilled artisan would have copied the Suboxone® tablet’s buffer and its pH in creating a film
`
`dosage form of buprenorphine and naloxone”).
`
`3.
`
`The Trial Record Contradicts Hospira’s “Hindsight” Argument.
`
`Finally, Hospira accuses Amneal of improper hindsight, even though the contemporaneous
`
`Hospira documents that Amneal presented at trial were offered merely as corroborating evidence,
`
`and not as any sort ofprz'flmfmz'e obviousness.
`
`(566 D1. 106 at 10—1