Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 1 of 16 PageID #:3436
`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 1 of 16 PageID #:3436
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`SECTION VI-A-1
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`SECTION VI—A-l
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 2 of 16 PageID #:3437
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF
`ILLINOIS EASTERN DIVISION
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`C.A. No. 1:16-cv-00651
`C.A. No. 1:17-cv-07903
`(Consolidated)
`
`Hon. Rebecca R. Pallmeyer
`
`CONTAINS CONFIDENTIAL
`INFORMATION
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`
`HOSPIRA, INC.
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`v.
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`FRESENIUS KABI USA, LLC,
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`Plaintiff,
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`Defendant.
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`FRESENIUS KABI’S MEMORANDUM IN SUPPORT OF ITS
`MOTIONS IN LIMINE
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 3 of 16 PageID #:3438
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`Fresenius Kabi USA, LLC moves in limine to exclude or limit the following expert
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`testimony and evidence by Hospira, Inc.:
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`(A) Hospira’s expert, law professor James White, who intends to provide his legal
`interpretation of contract provisions under the U.C.C.—a legal issue for the Court not
`suitable for witness testimony (page 3);
`
`(B) Hospira’s expert Dr. Stephan Ogenstad, a statistician, who is not a person of ordinary
`skill in the art that makes formulations, and instead relies on unreliable and unverified
`statistics (page 7);
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`(C)
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`(D)
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`evidence erroneously applying the higher threshold for FDA approval to show
`whether prior art was “on sale,” and applying a nonexistent experimental use
`exception to show whether prior art was “ready for patenting” (page 10); and
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`testimony regarding the secondary consideration of “long-felt need,” as the evidence
`proffered by Hospira contradicts this Court’s claim construction and was not provided
`in Hospira’s discovery responses (page 12).
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`These issues are inadmissible under Rules 402, 403, 702, and Daubert. Resolving these issues
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`will help to streamline the trial by removing irrelevant and time-wasting evidence and testimony.
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`I.
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`Background
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`This section lists background pertinent to the four issues raised in this motion.
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`One issue at trial will be whether the subject of the patents in this case was already part of
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`a prior commercial sale, which would invalidate the invention. Hospira’s patents-in-suit1
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`generally relate to putting the drug dexmedetomidine in glass. But while Hospira did not file for
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`its patents until 2012, others had already used the same drug and put it in the same container in
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`1989. Back then, Farmos Group Ltd. filed Investigational New Drug Application No. 32,934
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`(“the Dexmedetomidine IND”). (See Ex. A, HOSPIRA_00308480–00308778.) That
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`Dexmedetomidine IND was sold to Abbott Laboratories in 1994. (Ex. B, HOSPIRA_02501571–
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`1 U.S. Patent Nos. 8,648,106 (“the ’106 patent”); 8,455,527 (“the ’527 patent”); 9,320,712 (“the
`’712 patent”); and 9,616,049 (“the ’049 patent”) (collectively, “the Patents-in-Suit”).
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`
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`1
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`

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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 4 of 16 PageID #:3439
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`02501705.) Abbott sold that same IND in 2004 to Hospira. (Ex. C, HOSPIRA_02501093–
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`02501570.) As discussed further below, Hospira disputes whether these two transactions count
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`as “prior sales” and, as part of that challenge, offers the testimony of a law professor—James
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`White—to give his interpretation of the Uniform Commercial Code (“U.C.C.”). (See Ex. D,
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`White ¶¶ 13-15.)
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`Hospira also provides testimony from other experts, including Dr. Eric Sheinin, that an
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`invention is “ready for patenting” as part of the on-sale bar only when the FDA standard for
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`approval to commercialize a drug product is met. As discussed below, it is legally erroneous to
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`confuse FDA standards with prior art requirements.
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`For the ’106 patent, the claims require a certain stability result (“no more than about 2%
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`decrease” at five months). The evidence at trial will show that this result is an inherent property,
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`because all tests of dexmedetomidine in glass—the claimed invention—showed less than about
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`2% decrease at five months. This was shown by analyzing and graphing the raw data, and by
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`drawing a “regression” line or “best fit line” for the raw data points. Yet in response, Hospira’s
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`expert Dr. Stephan Ogenstad will apparently argue that he created “simulated” data and new
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`“confidence interval” analyses—not actual data—that he will use to say the 2% claim limitation
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`is not met. (See Ex. E, Ogenstad ¶¶ 39, 54-55, 58-59, 64, 73-75, 79-83.) Both sides’ experts
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`agree that no person of ordinary skill in the art would use these techniques, so the evidence
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`should be excluded. In any event, there is no precedent for the methodology, which uses a
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`random number generator, and it should not be allowed in this case.
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`In response to Fresenius Kabi’s evidence of obviousness, Hospira asserts that there was a
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`long-felt but unmet need in the industry for a product described by the Patents-in-Suit. Long-felt
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`need is a secondary consideration, but Hospira’s only purported evidence for it involves
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`2
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`pharmaceutical compounding facilities and how they could have made dexmedetomidine
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`formulations. This is an argument offered by Hospira’s economics expert, Mr. Andrew Carter,
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`and its medical expert, Dr. Michael Ramsay. But Hospira’s own technical experts concede that
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`compounding facilities could not make “ready-to-use” dexmedetomidine formulations as that
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`term has been construed by the Court. As a result, the compounding facility argument is
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`irrelevant. Moreover, Hospira failed to identify the compounding facility argument in response
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`to discovery requests, so should not be allowed to present it now at trial.
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`II.
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`Legal Standard
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`“Motions in limine are well-established devices that streamline trials and settle
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`evidentiary disputes in advance, so that trials are not interrupted mid-course for the consideration
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`of lengthy and complex evidentiary issues.” U.S. v. Tokash, 282 F.3d 962, 968 (7th Cir. 2002).
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`District court judges have “broad discretion” in ruling on motions in limine. Jenkins v. Chrysler
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`Motors Corp., 316 F.3d 663, 664 (7th Cir. 2002). Ruling on motions in limine to “ensure the
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`trial proceeds efficiently and economically without unnecessarily consuming judicial resources
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`or the resources of the parties” is a “proper use of a motion in limine even in a bench trial.”
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`Sellers Capital, LLC v. Wight, No. 15-C-7644, 2017 WL 3037802, *1 n.1 (N.D. Ill. July 18,
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`2017).
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`III. Argument
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`A.
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`The Court Should Exclude Professor White’s Testimony.
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`The Court should exclude Hospira’s law professor James White because he opines only
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`about purely legal issues (contract interpretation), and does so without any industry knowledge to
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`lend to his interpretation. That is irrelevant and unhelpful to the Court. Professor White teaches
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`contracts at the University of Michigan Law School, but he admitted that he does not have any
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`personal experience or expertise relating to the pharmaceutical industry or the types of
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`3
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 6 of 16 PageID #:3441
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`agreements at issue in this case. (Ex. D, White ¶¶ 21, 27-39; Ex. F, White Dep. Tr. at 30:16-
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`37:7, 38:8-40:2.)
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`“Argument about the meaning of…contracts…belongs in briefs, not in ‘experts’
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`reports.’” RLJCS Enters., Inc. v. Prof’l Benefit Tr. Multiple Emp’r Welfare Benefit Plan & Tr.,
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`487 F.3d 494, 498 (7th Cir. 2007). This is because “contract interpretation is a question of law,”
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`to be resolved by the Court. Hanover Inc. Co. v. N. Bldg. Co., 751 F.3d 788, 791 (7th Cir. 2014).
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`In addition, courts may properly exercise their “gatekeeping role” by excluding opinions
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`from an unqualified expert lacking expertise in the relevant field. See Daubert v. Merrell Dow
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`Pharms., Inc., 509 U.S. 579, 597 (1993). Under Rule 702 and the Daubert standard, an expert
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`“witness must be qualified as an expert by knowledge, skill, experience, training, or education[;]
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`the expert’s reasoning or methodology underlying the testimony must be scientifically reliable;
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`and the testimony must assist the trier of fact to understand the evidence or to determine a fact in
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`issue.” Ervin v. Johnson & Johnson, Inc., 492 F.3d 901, 904 (7th Cir. 2007) (citations omitted).
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`Courts in this Circuit routinely exclude opinions from experts unqualified in the
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`particular field relevant to the dispute. See, e.g., Wintz By and Through Wintz v. Northrop Corp.,
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`110 F.3d 508, 514 (7th Cir. 1997) (affirming exclusion of testimony from an expert toxicologist
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`because of his lack of experience in the specific effects of bromide exposure in pregnant
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`mothers); Padilla v. Hunter Douglas Window Coverings, Inc., 14 F. Supp. 3d 1127, 1131-33
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`(N.D. Ill. 2014) (disqualifying expert who was Commissioner of the United States Consumer
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`Product Safety Commission from testifying about window blind design and safety because he
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`lacked the relevant experience specifically in the field of window blind design despite his general
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`knowledge of consumer safety); Charter Nat’l Bank & Tr. v. Charter One Fin., Inc., No. 01-C-
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`0905, 2001 WL 1035721, *6 (N.D. Ill. Sept. 4, 2001) (excluding testimony of a University of
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`4
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 7 of 16 PageID #:3442
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`Chicago law professor with extensive experience in telecommunications law and patent law from
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`opining on a trademark issues, despite his having read a large number of trademark cases).
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`1.
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`Professor White’s testimony is nothing more than legal conclusions.
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`This Court does not need a party’s expert to explain the U.C.C. or its application to any
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`contract provision at issue in this case, and therefore Professor White’s testimony should be
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`excluded. RLJCS Enters., 487 F.3d at 498. In fact, Professor White’s testimony has previously
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`been excluded where he opined about the definition of a term in a bond, because it was the
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`court’s prerogative to interpret the term’s definition. Flagstar Bank, FSB v. Fed. Ins. Co., No.
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`05-70950, 2006 WL 2466250, *3-*4 (E.D. Mich. Aug. 24, 2006).
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`Judge Andrews of the District of Delaware recently excluded a law professor’s testimony
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`on contract interpretation with respect to the on-sale bar. In excluding the professor’s testimony,
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`Judge Andrews noted that “[t]he only specialized knowledge that Professor Lipson has is the
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`same thing – contract law – which in our system is [the court’s] responsibility.” BASF Corp. v.
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`Johnson Matthey Inc., No. 14-1204, 2018 WL 2729123, *1 (D. Del. June 6, 2018).
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`Likewise, here, Professor White will opine about his interpretation of the law from the
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`perspective of a contract law professor, and will reach his own conclusion about whether or not
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`there was a commercial sale—a legal issue. (See, e.g., Ex. D, White ¶¶ 68-72, 80, 97-100.)
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`Legal conclusions, of course, are for the Court. Mr. White’s testimony should be excluded as
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`irrelevant and unhelpful to the Court.
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`2.
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`Professor White is not qualified to opine on any non-U.C.C. topics present
`in his expert report.
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`Professor White’s testimony should also be excluded because he has never worked in or
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`opined on topics related to the pharmaceutical field and therefore is not qualified to provide an
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`opinion as to any custom or practice in the industry. He therefore has no basis to provide any
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`5
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 8 of 16 PageID #:3443
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`opinion except for his legal conclusion. Professor White admittedly has absolutely no
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`experience, let alone expertise, in the pharmaceutical field:
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`• “Q: Prior to this case, is it fair to say that you had-- A: Yes. Q: --no experience in
`the pharmaceutical industry? A: Yes.” (Ex. F, White Dep. Tr. at 33:11-16.)
`• “Q: Have you ever seen an IND before?...A: No.” (Id. at 36:23-37:1.)
`• “Q: And before this case, you had never heard of an IND before, correct?
`A: That’s correct.” (Id. at 72:12-14.)
`• “Q: Is it fair to say that you have no experience with the FDA?...
`A: Yes, I think so.” (Id. at 34:15-19.)
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`(See also id. at 30:16-37:7, 38:8-40:2, 40:20-41:7.)
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`Additionally, Professor White repeats technical conclusions provided by others about
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`whether the Dexmedetomidine IND represents a ready-to-use product (Ex. D, White ¶¶ 2, 12, 14,
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`20, 62, 74, 81-88), was ready for patenting (Id. at ¶¶ 62, 77-80), and was sold for experimental
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`purposes (Id. at ¶¶ 13, 15, 73, 99-100). But he has no basis or personal knowledge about these
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`issues, which he again readily admitted:
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`•
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` “Q: So you’re not giving an opinion as to whether the IND describes something
`that was ready for patenting, right? A: That’s right.” (Ex. F, White Dep. Tr. at
`71:6-9.)
`• Testifying he does not know when FDA approval would be required for certain
`steps throughout the drug development process (Id. at 75:9-18.)
`• Admitting that he has “never done work under” an IND and does not know the
`nature of any work to be performed (Id. at 138:2-139:10.)
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`Professor White has never been an employee of a pharmaceutical company, nor does he consider
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`himself to be a member of the pharmaceutical commercial community. (Id. at 33:11-16, 65:10-
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`12.) His opinions relating to the industry are either based solely on information given to him in
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`this case by others, or his personal assumptions about the industry. (Id. at 33:11-16, 75:9-76:14,
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`103:4-14, 114:3-6, 157:1-5, 166:20-24.) In fact, Professor White considers himself an expert on
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`6
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`

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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 9 of 16 PageID #:3444
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`the U.C.C., not on the pharmaceutical industry, INDs, the FDA regulatory framework, or even
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`patent law. (Id. at 40:3-5, 40:20-41:7.) See Charter National, 2001 WL 1035721 at *6; Dura
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`Auto. Sys. of Ind., Inc. v. CTS Corp., 285 F.3d 609, 614-15 (7th Cir. 2002) (affirming exclusion
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`of testimony of a hydrogeologist where his opinions relied on information gathered from
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`groundwater modelers, because groundwater modeling is itself a separate expertise).
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`Because Professor White has no experience regarding the pharmaceutical industry, INDs,
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`or the FDA, he is not an expert on these topics and his opinions are unreliable. 2
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`B.
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`The Court Should Exclude Dr. Ogenstad’s Testimony.
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`The Court should exclude testimony from Hospira’s biostatistics expert, Dr. Stephan
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`Ogenstad, whose opinions are irrelevant, scientifically unreliable, and not helpful to the Court.
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`“The proponent of the expert bears the burden of demonstrating that the expert’s testimony
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`would satisfy the Daubert standard.” Lewis v. CITGO Petroleum Corp., 561 F.3d 698, 705 (7th
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`Cir. 2009). Courts have broad discretion in determining the reliability of expert testimony, often
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`considering “(1) whether the proffered theory can be and has been tested; (2) whether the theory
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`has been subjected to peer review; (3) whether the theory has been evaluated in light of potential
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`rates of error; and (4) whether the theory has been accepted in the relevant scientific
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`community.” Baugh v. Cuprum S.A. de C.V., 845 F.3d 838, 844 (7th Cir. 2017).
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`1.
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`Dr. Ogenstad’s testimony does not opine on invalidity from the perspective
`of a POSA.
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`Dr. Ogenstad’s opinion fails to satisfy the Rule 702 and Daubert standards because his
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`2 Even Professor White’s opinion regarding one of the key agreements at issue is unreliable.
`Professor White testified that he had not even read the Separation and Distribution Agreement
`before opining on it. (Ex. F, White Dep. Tr. at 184:4-10 (“Q: Okay. Let’s turn -- is this the
`separation agreement that we’ve been discussing? A: I think -- I assume it is. I’ve never read
`it. Q: Okay. You never read the separation agreement? A: I don’t think so.”).) Any testimony
`on this agreement is therefore completely unreliable.
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`7
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 10 of 16 PageID #:3445
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`opinions regarding invalidity are not from the perspective of either party’s proposed person of
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`ordinary skill in the art (“POSA”). He admits he is not qualified in any pertinent technical
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`pharmaceutical field, and instead works in the field of statistics. (Ex. G, Ogenstad Rough Tr. at
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`6:13-7:22.) It would be an abuse of discretion under Rule 702 to admit testimony on patent
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`validity from an expert who is not a person of ordinary skill in the art. Sundance, Inc. v.
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`DeMonte Fabricating Ltd., 550 F.3d 1356, 1362-63 (Fed. Cir. 2008).
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`Moreover, both sides’ technical experts agreed that a POSA would never use the type of
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`statistical analyses that Dr. Ogenstad used. Hospira’s own technical expert, Dr. Robert Linhardt,
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`agreed that a “pharmaceutical scientist” POSA would use a “regression” line (also known as a
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`“best fit line”) to analyze raw data points. (Ex. H, Linhardt Dep. Tr. at 224:8-22.) In the same
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`response, Hospira’s expert contrasted the work a POSA would do from what Dr. Ogenstad did:
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`“He’s answering a different question about the statistics of a data set, and that’s beyond my—the
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`scope of my understanding of how he does the analysis.” (Id.) That is because rather than look
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`at the actual raw data, Dr. Ogenstad created “simulated” data and new “confidence interval”
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`analyses, to which Dr. Linhardt commented: “And so I’m an experimental scientist. I’m not a
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`modeler. And one day maybe simulations will be good enough to match experimental work; but
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`today is not that day, in my view.” (Id. at 211:16-212:12.) No person of ordinary skill in the art
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`would use these techniques—as both sides’ experts agree—so the evidence should be excluded.
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`2.
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`Dr. Ogenstad’s testimony is scientifically unreliable.
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`In addition, there is no precedent for Dr. Ogenstad’s methodology, which uses a random
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`number generator to “simulate” data, and it should not be allowed in this case. Dr. Ogenstad’s
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`approach was to do a “random number generation” and “found other numbers that could have
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`been measurements there in a predicted way.” (Ex. G, Ogenstad Rough Tr. at 41:23-42:3.)
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`There is no basis for this approach.
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`8
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 11 of 16 PageID #:3446
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`First, Hospira provided no precedent for Dr. Ogenstad’s “random number generation”
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`method to show it has been or can be reliably used. When asked to identify any publications that
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`supported his theory, Dr. Ogenstad instead testified that he would look to the test itself and that
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`“[o]ne can study that by simulation and get the correct answers.” (Id. at 40:2-8.) Courts in this
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`Circuit exclude testimony from an expert where the applied methodology had been tested on a
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`limited basis, or only by the expert himself. In re Emerald Casino, Inc., 530 B.R. 44, 217-218
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`(N.D. Ill. 2014), vacated in part on other grounds, 867 F.3d 743 (7th Cir. 2017). The testimony
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`in Emerald Casino was excluded even though it was only a variation on a well-accepted
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`methodology. Id.; see also Mejdrech v. Lockformer Co., No. 01-C-6107, 2003 WL 22078388,
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`*3 (N.D. Ill. Sept. 5, 2003) (excluding as unreliable an “unprecedented variation on peer-
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`reviewed procedure…[which] was not tested.”).
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`Second, while Dr. Ogenstad cited one article he co-authored, where he had previously
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`used biostatistics for predictions, he admitted that this article used a different software service
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`and that the published approach was for “clinical trial design and simulations.” (Ex. G, Ogenstad
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`Rough Tr. at 116:4-14.) It was not used to address stability data. And in any event, Dr.
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`Ogenstad admitted that even his published protocol was only adequate to “take the results from
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`simulations and then do a trial in the future,” and not to replace raw data. (Id. at 117:10-19.) As
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`far as any other examples where he had tried to interpret stability data, Dr. Ogenstad admitted
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`that he had only written a report distributed “internally” and “not published.” (Id. at 34:23-35:5.)
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`Dr. Ogenstad’s methodology has not been tested, peer-reviewed, nor generally accepted
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`in the field of biostatistics. For these reasons, it is unreliable and should be excluded under Rule
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`702 and Daubert.
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`9
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`C.
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`Hospira’s Experts Apply Legally Erroneous Standards To The On-Sale Bar.
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`Fresenius Kabi respectfully requests this Court exclude evidence from Hospira equating
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`the standard to trigger the on-sale bar of § 102 with the separate and distinct standard for FDA
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`regulatory approval of a New Drug Application. Fresenius Kabi also respectfully requests this
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`Court exclude evidence from Hospira which erroneously applies an experimental use exception
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`to the on-sale bar’s “ready for patenting” prong, an exception which does not exist.
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`“Evidence is relevant if it has any tendency to make a fact more or less probable than it
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`would be without the evidence, and the fact is of consequence in determining the action.”
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`Empire Bucket, Inc. v. Contractors Cargo Co., 739 F.3d 1068, 1071 (7th Cir. 2014) (citing Fed.
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`R. Evid. 401). A fact is of consequence when it relates to an element of the legal claim or
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`defense at issue. See Thompson v. City of Chicago, 472 F.3d 444, 454 (7th Cir. 2006).
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`Irrelevant and confusing evidence is not admissible under Rules 402 and 403.
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`The on-sale bar (35 U.S.C. § 102(a)) provides that a patent is invalid if its claimed
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`invention was (1) the subject of a commercial sale or offer for sale and (2) was ready for
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`patenting. Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67 (1998). An invention is “ready for
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`patenting” when it is either (a) reduced to practice or (b) sufficiently described to enable a person
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`of skill in the art to practice the invention. Id.
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`1.
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`The on-sale bar does not require FDA regulatory approval.
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`Hospira’s experts erroneously equate FDA approval with the standard for triggering the
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`on-sale bar under Pfaff. The Federal Circuit has been clear that FDA approval is not a
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`prerequisite for finding an invention invalid under the on-sale bar. For example, the court in
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`Helsinn stated that “the absence of FDA or other regulatory approval before the critical date does
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`not prevent a sale or offer for sale from triggering the on-sale bar.” Helsinn Healthcare S.A. v.
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`Teva Pharms. USA, Inc., 855 F.3d 1356, 1365 (Fed. Cir. 2017); see also Enzo Biochem, Inc. v.
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`10
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 13 of 16 PageID #:3448
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`Gen-Probe, Inc., 424 F.3d 1276, 1279, 1282 (Fed. Cir. 2005) (applying the on-sale bar to a
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`contract involving a product which was still subject to clinical testing); DSL Dynamic Scis. Ltd.
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`v. Union Switch & Signal, Inc., 928 F.2d 1122, 1126 (Fed. Cir. 1991) (“[T]here is certainly no
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`requirement that an invention, when tested, be in a commercially satisfactory stage of
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`development in order to reduce the invention to practice.”).
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`Despite these clear rules, several of Hospira’s experts intend to assert that the disclosures
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`in the Dexmedetomidine IND are insufficient to trigger the on-sale bar because they did not
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`already have FDA approval for commercial use. (E.g., Ex. D, White ¶¶ 77-78, 86, 100; Ex. I,
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`Ramsay Reb. ¶¶ 90-108; Ex. J, Seaton ¶ 73; Ex. K, Sheinin ¶¶ 22, 90, 98-106; Ex. L, Linhardt
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`Reb. ¶¶ 223-230). Because the case law is clear that FDA approval is not required to show an
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`invention was on sale or offered for sale for purposes of the on-sale bar, such testimony should
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`be excluded.
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`2.
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`There is no experimental use exception to the on-sale bar’s “ready for
`patenting” prong.
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`Hospira’s experts improperly apply an experimental use exception to the “ready for
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`patenting” prong of the on-sale bar when no such exception exists. The Federal Circuit has been
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`clear that with respect to “the second Pfaff prong, ready for patenting[,]…there can be no
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`experimental use exception.” Atlanta Attachment, 516 F.3d at 1368. Nonetheless, Hospira’s
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`experts intend to assert that the Dexmedetomidine IND was not “ready for patenting” because it
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`was submitted to the FDA for “experimental purposes.” (E.g., Ex. D, White ¶¶ 77-78, 86, 100;
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`Ex. I, Ramsay Reb. ¶¶ 90-108; Ex. J, Seaton ¶ 73; Ex. K, Sheinin ¶¶ 22, 90, 98-106; Ex. L,
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`Linhardt Reb. ¶¶ 223-230.) Hospira’s FDA expert Dr. Sheinin makes it the focus of his analysis
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`that “the documents and studies in IND 32,934 were for experimental purposes and did not
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`disclose a ready to use dexmedetomidine formulation that was ready for patenting.” (Ex. K,
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 14 of 16 PageID #:3449
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`Sheinin ¶ 90, emphasis added.) Because there is no experimental use exception to the ready for
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`patenting prong of the on-sale bar, such testimony should be excluded.
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`D.
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`Hospira’s Only Alleged Evidence Of Long-Felt Need Has No Nexus To The
`Claims And Was Not Disclosed During Discovery.
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`Fresenius Kabi respectfully requests this Court exclude Hospira from offering its
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`purported evidence of long-felt need because it is legally irrelevant. An obviousness analysis
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`allows examination of secondary considerations of non-obviousness, when such factors are
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`presented by the patentee. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). Hospira
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`confirms it intends to present evidence of commercial success and long-felt need as its two
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`secondary considerations. But evidence of long-felt need is only relevant where there is a nexus
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`between the evidence offered and the claimed features of the patent. See Ormco Corp. v. Align
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`Tech., Inc., 463 F.3d 1299, 1311-12 (Fed. Cir. 2006).
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`Here, there is no nexus because the evidence Hospira cites for “long-felt need” does not
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`meet the patent claims according to Hospira’s own experts. Hospira’s only support for an
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`alleged long-felt need is offered by its economics expert Mr. Anthony Carter, and its medical
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`expert Dr. Michael Ramsay, who say that compounding pharmacies could have diluted and sold
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`product. (Ex. M, Ramsay Opening ¶¶ 77-78; Ex. N, Carter at 46.) This compounding argument
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`was not present in Hospira’s Response to Fresenius Kabi’s discovery request about secondary
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`considerations, and was only raised for the first time in Hospira’s opening expert reports of Mr.
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`Carter and Dr. Ramsay. (Ex. O, Plaintiff’s Supplemental Responses To Defendant’s First Set Of
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`Interrogatories, Supplemental Response to Interrogatory No. 1.) But the Court already
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`determined that diluting Precedex® Concentrate—which is what Hospira’s experts say a
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`compounding pharmacy could do—is not “ready-to-use” as that term is used in the Patents-in-
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`Suit according to the Court’s construction. (1:16-cv-00651, D.I. 69 at 11 (“To the extent
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 15 of 16 PageID #:3450
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`Defendant suggests that the dexmedetomidine composition may be diluted by anyone else at
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`some point before administration, the court rejects that construction.”).) Hospira’s own experts
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`agree that a compounding facility diluting concentrated dexmedetomidine to a lower
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`concentration does not result in a “ready-to-use” formulation under this construction. (Ex. H,
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`Linhardt Dep. Tr. at 118:17-119:2; Ex. P, Ramsay Dep. Tr. at 266:13-267:3.) Therefore,
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`Hospira’s alleged evidence of long-felt need has no nexus to the claims of the Patents-in-Suit,
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`which all recite a “ready-to-use” limitation. Both because Hospira never disclosed this
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`compounding pharmacy argument during discovery, and because it bears no nexus to the claimed
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`invention anyway, it should be excluded.
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`IV. Conclusion
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`For the foregoing reasons, Fresenius Kabi respectfully requests that this Court grant
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`Fresenius Kabi’s motions in limine to:
`
`(A)
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`(B)
`
`(C)
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`exclude testimony from Hospira’s expert Professor James White;
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`exclude testimony from Hospira’s expert Dr. Stephan Ogenstad;
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`exclude evidence erroneously applying the FDA regulatory standard and
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`experimental use exception to the on-sale bar; and
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`(D)
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`exclude testimony from Hospira regarding long-felt need.
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`Case: 1:16-cv-00651 Document #: 114-10 Filed: 06/25/18 Page 16 of 16 PageID #:3451
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`Dated: June 18, 2018
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`
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`Respectfully submitted,
`
`/s/ Imron T. Aly
`
`Imron T. Aly (IL Bar No. 6369322)
`Kevin M. Nelson (IL Bar No. 6275586)
`Joel M. Wallace (IL Bar No. 6304223)
`Emily M. Peña (IL Bar No. 6321281)
`Tara L. Kurtis (IL Bar No. 6323880)
`233 South Wacker Drive, Suite 7100
`Chicago, Illinois 60606
`(312) 258-5500
`ialy@schiffhardin.com
`knelson@schiffhardin.com
`jwallace@schiffhardin.com
`epena@schiffhardin.com
`tkurtis@schiffhardin.com
`
`Ahmed M.T. Riaz (pro hac vice)
`666 Fifth Avenue, 17th Floor
`New York, NY 10103
`(212) 753-5000
`ariaz@schiffhardin.com
`
`Attorneys for Defendant Fresenius Kabi USA,
`LLC
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