Case: 1:16-cv-00651 Document #: 114-12 Filed: 06/25/18 Page 1 of 19 PageID #:3456
`Case: 1:16-cv-00651 Document #: 114-12 Filed: 06/25/18 Page 1 of 19 PageID #:3456
`
`SECTION VI-B-1
`
`SECTION VI—B-l
`
`

`

`Case: 1:16-cv-00651 Document #: 114-12 Filed: 06/25/18 Page 2 of 19 PageID #:3457
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`HOSPIRA, INC.,
`
`
`
`
`
`
`FRESENIUS KABI USA, LLC,
`
`
`
`
`v.
`
`
`
`
`
`
`
`
`
`Plaintiff,
`
`Defendant.
`
`
`
`
`
`
`
`Civil Action Nos. 1:16-cv-00651
` 1:17-cv-07903
`
`Hon. Judge Rebecca R. Pallmeyer
`
`
`
`
`
`
`HOSPIRA’S RESPONSE TO FRESENIUS KABI’S MOTIONS IN LIMINE
`
`
`
`
`
`

`

`Case: 1:16-cv-00651 Document #: 114-12 Filed: 06/25/18 Page 3 of 19 PageID #:3458
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`INTRODUCTION ...............................................................................................................1
`
`LEGAL STANDARD ..........................................................................................................2
`
`III.
`
`ARGUMENT .......................................................................................................................2
`
`A.
`
`B.
`
`The Court Should Not Exclude Professor White’s Testimony ................................2
`
`The Court Should Not Exclude Dr. Ogenstad’s Testimony ....................................7
`
`1.
`
`2.
`
`The perspective of a person of ordinary skill in the art is irrelevant
`to whether the data prove that no more than about 2%
`concentration reduction at five months is necessarily present in all
`dexmedetomidine formulation .....................................................................8
`
`Dr. Ogenstad’s sampling methodology is widely-accepted and
`reliable........................................................................................................10
`
`C.
`
`Hospira’s Evidence Regarding FDA Approval and Experimentation Is
`Relevant to Fresenius Kabi’s On-Sale Theories. ...................................................12
`
`1.
`
`The Absence of FDA Approval Is Relevant to the Alleged Offer
`for Sale .......................................................................................................12
`
`2.
`
`Experimentation Is Relevant to Both Pfaff Prongs ....................................13
`
`D.
`
`Long-Felt Need ......................................................................................................15
`
`CONCLUSION ..................................................................................................................15
`
`
`
`i
`
`IV.
`
`
`
`
`

`

`Case: 1:16-cv-00651 Document #: 114-12 Filed: 06/25/18 Page 4 of 19 PageID #:3459
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`
`
`I.
`
`INTRODUCTION
`
`The Court should deny Fresenius Kabi’s motions in limine for many reasons, not the least
`
`of which is that Fresenius Kabi fails to spell out the specific relief that it seeks as to any of the four
`
`categories of evidence that it challenges. Just as importantly, Fresenius Kabi is wrong about the
`
`import of the evidence that Hospira proposes to offer at trial and is equally mistaken about the
`
`proper legal standard against which Hospira’s evidence should be measured in this bench trial,
`
`where the Court is free to rely on expert testimony and other evidence as it chooses within the
`
`exercise of its sound discretion.
`
`In the following pages, Hospira shows:
`
` The proposed testimony of James White, an admitted expert on the Uniform
`Commercial Code, will not usurp the Court’s role in interpreting law, but rather
`constitutes appropriate (indeed routine) rebuttal of Fresenius Kabi’s own expert
`witness, Peter Lankau, who fails to account for the requirements of the UCC in his
`own opinion testimony. Moreover, Fresenius Kabi can show no prejudice that
`could result from Professor White’s testimony in this bench trial.
`
` The proposed testimony of Dr. Stephan Ogenstad, who Fresenius Kabi concedes is
`a qualified biostatistician, is directed to measuring the variability of stability data
`relied on by James Kipp, Fresenius Kabi’s expert, where it is also conceded that the
`data is variable and the issue is whether it is so variable that it cannot be relied upon
`to prove that the 2% stability limitation is inherent to dexmedetomidine
`formulations. Dr. Ogenstad’s testimony is highly probative on this disputed
`question, will result in no unfair prejudice to Fresenius Kabi, and should be received
`by the Court.
`
` The evidence relating to FDA approval is misconceived by Fresenius Kabi. It is
`germane to the question of whether the invention was on sale, a question that the
`Court will be called on to resolve as part of the trial. Relatedly, experimental use
`is a well-established exception to the on-sale bar and there is no basis in patent or
`trial law for excluding evidence relevant to that issue, particularly, where Fresenius
`Kabi again has not shown there will be prejudice in this bench trial.
`
` Finally, the question of “long felt need” is moot because Hospira has no plan to
`offer evidence of “long felt need” in its case-in-chief.
`
`
`
`
`
`
`
`
`
`
`
`1
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`

`

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`
`
`II.
`
`LEGAL STANDARD
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`“[W]here the factfinder and the gatekeeper are the same, the court does not err in admitting
`
`the evidence subject to the ability later to exclude it or disregard it if it turns out not to meet the
`
`standard of reliability established by Rule 702.” In re Salem, 465 F.3d 767, 777 (7th Cir. 2006).
`
`Exclusion is appropriate where the proffered evidence is “clearly inadmissible on all potential
`
`grounds.” Hawthorne Partners v. AT&T Techs., 831 F. Supp. 1398, 1400 (N.D. Ill. 1993). Expert
`
`testimony may be excluded if it is unreliable or will not assist the trier of fact. Se-Kure Controls,
`
`Inc. v. Vanguard Prods. Grp., 2008 WL 169054, at *3 (N.D. Ill. Jan. 17, 2008). When
`
`admissibility is unclear, evidentiary rulings should be “deferred until trial so questions of
`
`foundation, relevancy, and prejudice can be resolved in their proper context.” Marlow v. Winston
`
`& Strawn, No. 90 C 5715, 1994 WL 424124, at *3 (N.D. Ill. Aug. 11, 1994).
`
`III. ARGUMENT
`
`A.
`
`The Court Should Not Exclude Professor White’s Testimony
`
`Fresenius Kabi does not dispute that Professor James White is an expert in the Uniform
`
`Commercial Code (“UCC”). Yet Fresenius Kabi argues that Professor White’s testimony should
`
`be excluded, citing cases that merely state the general proposition that an expert must be qualified
`
`in the field in which he is providing expert opinions are sought. Unlike in those cases, Professor
`
`White will opine on subject matter squarely within his expertise: application of the UCC to
`
`Fresenius Kabi’s on-sale bar theories. 1
`
`
`1 There is no per se rule against allowing expert testimony on the law. Courts in this district
`regularly allow legal expert testimony. See e.g., The Medicines Co. v. Mylan Inc., No. 11-CV-
`1285, 2014 WL 1758135, at *3 (N.D. Ill. May 2, 2014) (“Dr. Linck is qualified by her
`experience and expertise to testify as a patent law expert regarding the application and issuance
`of the ′727 patent relating to Mylan's inequitable conduct claims”); Se-Kure Controls, Inc. v.
`Vanguard Prod. Grp., Inc., No. 02 C 3767, 2008 WL 169054, at *3 (N.D. Ill. Jan. 17, 2008)
`(“Mr. Gerstman is permitted to testify about general procedures involved in the patent
`application process and the operations and functions of the PTO. This type of testimony can be
`
`
`
`2
`
`

`

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`
`
`Case law from the Court of Appeals for the Federal Circuit makes clear that the UCC is an
`
`important consideration relevant to Fresenius Kabi’s on-sale bar theories. Simply put, not every
`
`transaction qualifies as a sale for purposes of the on-sale bar. Where it is disputed, the Federal
`
`Circuit has said, “since Pfaff, we have generally looked to the UCC for the definition of a ‘sale.’”
`
`Medicines Company v. Hospira, 827 F.3d 1363, 1375 (Fed. Cir. 2016) (en banc). Quoting from
`
`its own opinion earlier in Group One v. Hallmark Cards, 254 F.3d 1041, 1047-48 (Fed. Cir. 2001),
`
`the en banc court in Medicines Company elaborated:
`
`As a general proposition, we will look to the Uniform Commercial
`Code (‘‘UCC’’) to define whether, as in this case, a communication
`or series of communications rises to the level of a commercial offer
`for sale. As this court has previously pointed out, ‘‘[t]he UCC has
`been recognized as the general law governing the sale of goods and
`is another useful, though not authoritative, source in determining the
`ordinary commercial meaning of’’ terms used by the parties. 254
`F.3d at 1047-48 (quoting Enercon GmbH v. Int’l Trade Comm’n,
`151 F.3d 1376, 1382 (Fed. Cir. 1998)). We have since reaffirmed
`the usefulness of the UCC in analyzing the on-sale bar. See In re
`Kollar, 286 F.3d at 1332; Linear Tech. Corp. v. Micrel, Inc., 275
`F.3d 1040, 1048 (Fed. Cir. 2001) (stating that ‘‘Group One further
`instructs that the Uniform Commercial Code (‘UCC’) should inform
`the analysis of the contractual issues’’ in connection to the on-sale
`bar).
`
`Id. at 1375-76 (internal quotes omitted).
`
`Hospira offers Professor White, an expert on the UCC, as a rebuttal witness to Peter A.
`
`Lankau. Mr. Lankau plans to testify that each of three separate events involving dexmedetomidine
`
`qualify as a sale of the invention of the patents-in-suit and each activated the on-sale bar. Mr.
`
`Lankau, a consultant to pharmaceutical companies, is expected to opine that:
`
`
`helpful to the fact-finder.”); see also Pivot Point Int'l, Inc. v. Charlene Prod., Inc., No. 90 C
`6933, 1996 WL 284940, at *6 (N.D. Ill. May 23, 1996) (allowing expert testimony on the
`copyrightability of objects and the procedures for registering and obtaining a copyright).
`
`
`
`
`3
`
`

`

`Case: 1:16-cv-00651 Document #: 114-12 Filed: 06/25/18 Page 7 of 19 PageID #:3462
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`
`
`1.
`
`2.
`
`3.
`
`When Orion transferred something known as an Investigational New Drug
`(“IND”)2 Application to Abbott Laboratories in 1994, that transfer activated the on-
`sale bar;
`
`When Orion offered to supply dexmedetomidine to Abbott Laboratories in 1994,
`that offer activated the on-sale bar; and
`
`When Abbott Laboratories spun-off Hospira as a separate company in 2004, that
`corporate spin-off activated the on-sale bar.
`
`(Ex. A, White Tr. 79:5-21; 83:18-24.)
`
`Professor White disagrees with Mr. Lankau’s opinions. (Ex. A, White Tr. 84:1-11.) But he
`
`will not testify that the on-sale bar was not “activated” by these events. That is for the Court to
`
`decide. Rather, he will limit his testimony to his area of expertise and will demonstrate that none
`
`of these events, given their characteristics as embodied in the contract documents and described
`
`by other witnesses (which Professor White takes as true), meet the UCC definition of a sale. Id.
`
`Professor White understands that the UCC is not the only factor that controls when a transaction
`
`qualifies as a sale for purposes of the on-sale bar. But he understands that it is an important factor.
`
`(Ex. A, White Tr. 61:23-63:2.) His testimony is offered in that spirit.
`
`First, Professor White will testify that the transfer of the IND in 1994 was pursuant to a
`
`license, not a sale, and that the IND would revert back to Orion in the event the license was
`
`terminated. (Ex. A, Tr. 85:8-86:1; 97:17-98:12.) A license does not qualify as a sale within the
`
`meaning of the UCC. Further, and separately, the transfer of an IND is the transfer of a “general
`
`intangible” and does not fall within the purview of the UCC. (Ex. A, White Tr. 140:4-141:2.)
`
`Second, Professor White will explain that Orion’s offer in 1994 to supply Abbott
`
`Laboratories with dexmedetomidine is limited to, at most, supplying raw dexmedetomidine or
`
`
`2 An Investigational New Drug Application is a confidential submission to the Food & Drug
`Administration and permits the sponsor to conduct human clinical trials using an investigational
`new drug. (21 C.F.R. §§ 312.1, 312.130.)
`
`
`
`4
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`

`

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`
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`ampoules of dexmedetomidine formulated at a concentration of 200 micrograms per mL. (Ex. A,
`
`White Tr. 105:7-23; 170:3-175:7.) He understands that neither raw dexmedetomidine nor
`
`dexmedetomidine at a concentration of 200 micrograms/mL is considered a “ready to use”
`
`dexmedetomidine formulation as claimed in the patents-in-suit. (Ex. A, White Tr. 49:15-57:17;
`
`84:8-11.) He also will explain that, to the extent that the 1994 offer is argued by Fresenius to
`
`include any form of dexmedetomidine beyond the raw material or the 200 microgram/mL
`
`ampoules, it would not be an offer that could be accepted to create a binding contract because it
`
`would be incomplete as to critical terms, and, therefore, would be unenforceable. (Ex. A, White
`
`Tr. 165:12-167:10; 170:3-172:6.)
`
`Third, Professor White will testify that “the spin-off” of Hospira was a corporate re-
`
`organization, not a sale or a sale of goods, and does not qualify as a sale under the UCC. (Ex. A,
`
`White Tr. 177:14-178:13.) Even if the IND was transferred to Hospira in the spin-off, that was
`
`not a sale of the IND. First, Abbott Laboratories had only a license to the IND and, therefore,
`
`could not sell it. (Ex. A, White Tr. 181:6-182:24.) In any event, the separation of assets into two
`
`companies is not a sale under the UCC, or general contract principles, even if the IND wound up
`
`in Hospira’s control and not Abbott’s. 3 (Ex. A, White Tr. 177:14-178:13.)
`
`Defendant’s reliance on BASF Corp. v. Johnson Matthey, Inc., is misplaced. 2018 WL
`
`2729123, at *1 (D. Del. 2018). In BASF Corp., the court excluded a law professor’s testimony
`
`related to the on-sale bar in a jury trial and explained that there was no evidence that the professor
`
`
`3 Fresenius Kabi further asserts that Professor White’s opinions pertaining to the Hospira spin-
`off should be excluded because he did not read the Separation and Distribution Agreement in its
`entirety. (Br. at 7 n.2.) But Fresenius Kabi has not identified any term or provision in the
`Separation and Distribution Agreement that might have influenced Professor White’s opinion if
`he had read it.
`
`
`
`5
`
`

`

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`
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`of contract law brought any expertise to the matter. By contrast, Fresenius Kabi has not disputed
`
`that Professor White is an expert on the UCC in this bench trial.
`
`Fresenius Kabi further asserts that Professor White is not qualified to provide expert
`
`opinions because “he has never worked in or opined on topics related to the pharmaceutical
`
`industry.” (Br. at 4.) But courts have stated that “practical experience is not essential to expert
`
`testimony and sometimes gets in the way of scientific detachment.” DePaepe v. Gen. Motors
`
`Corp., 141 F.3d 715, 719 (7th Cir. 1998). Professor White’s expertise here is derived from his
`
`decades-long work related to the UCC. Professor White has taught classes on the UCC, published
`
`extensively on the UCC, is a member of the American Law Institute, a member of the National
`
`Conference of Commissioners and was a longstanding member on the committee to revise Article
`
`2 of the UCC. (FK Ex. D, CV; Ex. A, White Tr. 19:2-9; 28:7-10; 29:4-17.)
`
`Professor White’s anticipated testimony is appropriate rebuttal to Mr. Lankau, who simply
`
`fails to account for the requirements imposed by the UCC. Moreover, Professor White’s testimony
`
`will benefit the Court and enhance the record in the event of an appeal. Trial counsel for Hospira
`
`litigated the afore-mentioned Medicines Company case in the trial court and Court of Appeals.
`
`Hospira eventually prevailed and counsel can verify that the trial judge, the initial panel on appeal,
`
`the en banc Court and the panel on remand from the en banc court, all indicated a desire for a
`
`fuller record on the commercial terms relating to the one-sale bar as disputed in that case. Professor
`
`White’s narrow testimony will provide appropriate support for Hospira’s arguments and will not
`
`intrude on the province of the trial court to decide the ultimate questions relating to whether the
`
`on-sale bar was triggered and whether Fresenius Kabi has shown the asserted claims are invalid
`
`by clear and convincing evidence.
`
`
`
`6
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`

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`
`
`B.
`
`The Court Should Not Exclude Dr. Ogenstad’s Testimony
`
`Fresenius Kabi seeks an order excluding Dr. Stephan Ogenstad’s testimony. Dr. Ogenstad
`
`is a statistician who will testify about what can, or cannot, be concluded from certain test results
`
`relied upon by Fresenius Kabi to support its theory that the prior art inherently met the 2%
`
`limitation (discussed below).
`
`Specifically, Fresenius Kabi contends that any dexmedetomidine formulation in a sealed
`
`glass container inherently meets the requirement of the ‘106 patent that the concentration of
`
`dexmedetomidine decreases by no more than about 2% over at least five months of storage. Under
`
`the inherency doctrine of patent law, a prior art reference is held to “inherently disclose[] a
`
`particular claim element if, even though not expressly described, that element would necessarily
`
`be present in the prior art reference.” (Ex. B, Kipp Rep. ¶41.) See PAR Pharma. v. TWI Pharma.,
`
`773 F.3d 1186, 1195 (Fed.Cir. 2014).
`
`To show that dexmedetomidine formulations “necessarily” would meet the 2% limitation,
`
`Fresenius Kabi’s expert, Dr. Kipp, calculated predictions for five-month stability using statistical
`
`analyses of stability data for certain dexmedetomidine formulations. There is no dispute that the
`
`stability data Dr. Kipp used for his predictions is subject to measurement error and variability. As
`
`he explained:
`
`You’ve got data at different time points subject to both assay error
`and day-to-day variability, because you may have different analysts
`on different days, different bottles. Somebody may have gotten
`sick, and somebody may have replaced them as an analyst.
`Someone might not weigh out things as carefully. So you've got
`quite a bit of variability.
`
`(Ex. C, Kipp Tr. 157:4-12.) In fact, some data show an increase in the concentration over time,
`
`which is physically impossible. (Ex. B, Kipp Rep. ¶¶356, 370 and 372.)
`
`
`
`7
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`

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`
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`The undisputed existence of this variability begs the questions—what conclusions can be
`
`drawn from a particular stability study, as well as how much variability is there in the
`
`measurements of stability and is the variability so high that the data cannot establish by clear and
`
`convincing evidence that the concentration drop for dexmedetomidine in a sealed glass container
`
`inherently never exceeds 2% after five months? That statistical question is what Dr. Ogenstad
`
`addresses in his opinions.
`
`Dr. Ogenstad has more than 40 years’ experience performing statistical analyses of
`
`pharmaceutical and medical data. That is his profession. Before moving to the United States from
`
`Sweden, Dr. Ogenstad was the Chief Statistical Advisor and reviewer to the Nobel Prize
`
`Committee for Medicine and Physiology in Stockholm. After emigrating to the United States, he
`
`worked as an in-house statistician at pharmaceutical companies such as Vertex Pharmaceuticals,
`
`AstraZeneca and Amgen. He is also an Adjunct Faculty Member and Professor of Biostatistics at
`
`Georgia Southern University.
`
`Fresenius Kabi attacks Dr. Ogenstad’s analysis for two reasons, neither of which has any
`
`merit.
`
`1.
`
`The perspective of a person of ordinary skill in the art is irrelevant to
`whether the data prove that no more than about 2% concentration
`reduction at five months is necessarily present in all dexmedetomidine
`formulation
`
`First, Fresenius Kabi argues that Dr. Ogenstad’s testimony is unreliable because he is not
`
`testifying from the vantage point of a person of ordinary skill in the art to which the patent pertains.
`
`However, that is not necessary for the subject of Dr. Ogenstad’s opinion.
`
`Dr. Ogenstad’s opinion addresses whether the raw data on which Fresenius Kabi’s Dr.
`
`Kipp relies actually shows, as a scientific matter, that any sealed glass formulation of
`
`
`
`8
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`

`

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`
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`dexmedetomidine will necessarily meet the claim limitation requiring no more than 2% reduction
`
`in drug concentration at five months.
`
`There is no dispute that this data is variable and suffers from measurement error. Dr.
`
`Ogenstad quantifies the degree of that variability and determines, as a scientific matter, whether
`
`the degree of measurement error apparent from the data itself is too high to reliably conclude
`
`whether there is no more than 2% degradation at five months for any dexmedetomidine
`
`formulation in a sealed glass container. His analysis simply looks at the data and calculates what
`
`the data itself reveals about the variability that everyone agrees is present.
`
`Dr. Ogenstad does not address any issues requiring a determination from the vantage point
`
`of a person of ordinary skill in the art. Fresenius Kabi is taking on the burden of proving the
`
`inherent properties of dexmedetomidine formulations in glass containers. For inherency to be
`
`shown, it is insufficient to show that the 2% limitation may result for a particular dexmedetomidine
`
`formulation. Rather, Fresenius Kabi must prove, among other things, that the 2% limitation is
`
`“necessarily” a property of all dexmedetomidine formulations, and this property is “the natural
`
`result flowing from” formulating dexmedetomidine as claimed. PAR Pharma. v. TWI Pharma.,
`
`773 F.3d 1186, 1195 (Fed.Cir. 2014). Dr. Ogenstad’s analysis rebuts Fresenius Kabi’s allegation
`
`that the 2% limitation is necessarily a property of the dexmedetomidine formulations that Dr. Kipp
`
`discusses. As Hospira will show at trial, Dr. Ogenstad demonstrates that the available data fails to
`
`show with any degree of scientific certainty that all formulations were stable at the requisite degree
`
`(and further, that stability varies across different formulations of dexmedetomidine, which further
`
`shows that the property is not inherent).
`
`Furthermore, Dr. Ogenstad’s analysis is the kind of analysis a person of ordinary skill in
`
`the art would rely on in seeking to answer this question. Dr. Ogenstad has spent most of his forty-
`
`
`
`9
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`

`

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`
`
`four year career in statistics in the pharmaceutical area using statistics to analyze pharmaceutical
`
`data, including stability data, and in his in-house roles at Amgen and AstraZeneca he frequently
`
`worked with the FDA in connection with regulatory submissions. Indeed, Fresenius Kabi’s own
`
`experts routinely look to statistics to analyze data and Fresenius Kabi does not dispute that Dr.
`
`Ogenstad is an expert in statistics in the pharmaceutical field.
`
`2.
`
`Dr. Ogenstad’s sampling methodology is widely-accepted and reliable
`
`Fresenius Kabi also argues that Dr. Ogenstad’s use of data simulation with respect to
`
`stability data in the IND is unreliable because he used simulated data to evaluate the strength of
`
`Dr. Kipp’s statistical prediction of the stability of the dexmedetomidine formulations at five
`
`months. Fresenius Kabi argues that there is no basis for this approach and this “methodology has
`
`not been tested, peer-reviewed, nor generally accepted in the field of biostatistics.” (Br. at 9.)
`
`Fresenius Kabi is wrong.
`
`First, Dr. Ogenstad’s simulation analysis was only one part of his methodology. Primarily,
`
`he analyzed the data on stability from the IND formulations and applied statistical methods such
`
`as linear regression to calculate the degree of variability of the data. He used a host of other
`
`methods to analyze that data that do not depend on simulation and Fresenius Kabi does not object
`
`to any of these.
`
`Dr. Ogenstad further performed a simulation analysis because of the insufficiently limited
`
`amount of data available for the IND formulations. This is typical in the field of his expertise and
`
`he has used this method many times. It has been used routinely in biostatistics for more than 100
`
`years and is frequently used in peer-reviewed articles. For example, Dr. Ogenstad in the
`
`accompanying declaration cites a number of articles, all published in refereed journals, using this
`
`very technique.
`
`
`
`10
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`

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`
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`Fresenius Kabi makes a number of misleading citations to Dr. Ogenstad’s deposition
`
`transcript in an attempt to support its erroneous contention that simulation analysis is not widely
`
`accepted. First, Fresenius Kabi contends he was unable “to identify any publications that
`
`supported his theory [and] instead testified he would look to the test itself.” (Br. at 9.) However,
`
`the cited testimony actually relates to “prediction intervals,” a completely different analysis that
`
`has nothing to do with the simulation methodology that Fresenius Kabi is attacking. A prediction
`
`interval is calculated from the actual data and is independent of simulated data. (Ex. D, Ogenstad
`
`Dec. ¶ 10.)
`
`Second, Fresenius Kabi suggests Dr. Ogenstad wrote only one article using simulation data.
`
`While this may be the only article Fresenius Kabi asked about at his deposition, in fact he has
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`published quite frequently using simulation data in the pharmaceutical area. (Ex. D, Ogenstad
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`Dec. ¶ 11.)
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`Fresenius Kabi also argues that Dr. Ogenstad’s methodology should be rejected because
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`predicted data cannot replace raw data. However, it is Fresenius Kabi’s Dr. Kipp who is relying
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`on predicted calculations for five month stability data based on regression analysis.4 Dr. Ogenstad
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`rebuts Dr. Kipp’s opinion by showing, using standard techniques, the flaws in Dr. Kipp’s predicted
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`data. If use of data predictions is inadmissible, then Dr. Kipp’s opinion that the 2% limitation is
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`inherent should be excluded.
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`Finally, Fresenius Kabi argues that because Dr. Ogenstad has only conducted proprietary,
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`commercial analyses of stability data and never published them that somehow his entire analysis
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`4 Dr. Kipp also relies on predicted calculations regarding the stability of the dexmedetomidine
`molecule generally.
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`
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`11
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`Case: 1:16-cv-00651 Document #: 114-12 Filed: 06/25/18 Page 15 of 19 PageID #:3470
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`
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`is suspect. However, that does not mean the technique is not widely accepted in biostatistics. In
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`fact, it has been used in that context frequently. (Ex. D, Ogenstad Dec. ¶¶ 7-8.)
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`Consequently, Dr. Ogenstad’s testimony should be allowed.
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`C.
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`Hospira’s Evidence Regarding FDA Approval and Experimentation Is
`Relevant to Fresenius Kabi’s On-Sale Theories.
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`The on-sale bar doctrine has two requirements. More than one year before filing of a patent
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`application, the invention must have been (1) “the subject of a commercial offer for sale,” and (2)
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`“ready for patenting.” Pfaff v. Wells Elecs., 525 U.S. 55, 67 (1998). Hospira’s evidence regarding
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`FDA approval and experimentation establish that Fresenius Kabi cannot meet this two-prong Pfaff
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`test here. The evidence should not be excluded.
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`1.
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`The Absence of FDA Approval Is Relevant to the Alleged Offer for
`Sale
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`One of Fresenius Kabi’s on-sale theories asserts an alleged offer for sale based on a 1994
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`License and Supply Agreement between Orion and Abbott Laboratories. The theory centers on a
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`provision in the Agreement concerning Orion’s supply to Abbott of “Product Ampoules for sale
`
`in the United States.”
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`It is undisputed that, for a drug product to be permissible for sale in the United States, the
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`drug product must have FDA approval. The absence, then, of FDA approval of any Orion Product
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`Ampoules means that Orion Product Ampoules for sale in the United States did not exist, and so
`
`were not offered for sale and ‘ready for patenting’ under the Pfaff test. See, e.g., Sparton Corp. v.
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`United States, 399 F.3d 1321, 1324 (Fed. Cir. 2005) (“Under the Claims Court’s analysis, the
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`patented single part release plate was the subject of an offer for sale before it was even conceived.
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`12
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`Case: 1:16-cv-00651 Document #: 114-12 Filed: 06/25/18 Page 16 of 19 PageID #:3471
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`
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`Such a result is illogical.”). Contrary to Fresenius Kabi’s assertion that FDA approval has no
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`relevance, its absence here is actually dispositive.5
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`The cases cited by Fresenius Kabi are inapposite. (Br. at 10-11.) In Helsinn, for example,
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`the patentee offered to begin selling its later-patented drug formulation once the drug received
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`FDA approval. Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., 855 F.3d 1356, 1365-67 (Fed.
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`Cir. 2017). Unlike here, the offered product in Helsinn was fully developed, and the parties just
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`needed to wait for FDA approval for sales to commence. See id. at 1366 (“[T]he absence of FDA
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`approval may be a relevant consideration depending upon the other circumstances surrounding a
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`transaction relating to a pharmaceutical formulation . . . . This is not a case like Elan Corp., PLC
`
`v. Andrx Pharm., Inc., 366 F.3d 1336 (Fed. Cir. 2004), where the purported offer concerned a
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`product when and if it had been developed, and there was no price or quantity term.”). Similarly,
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`in Enzo, the claimed nucleic acid probes were developed and even delivered to the buyer prior to
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`the critical date. See, e.g., Enzo Biochem, Inc. v. Gen-Probe, Inc., 424 F.3d 1276, 1285 (Fed. Cir.
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`2005).
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`Because the lack of FDA approval of Orion Product Ampoules is relevant to whether Orion
`
`triggered the on-sale bar by purportedly offering to sell ‘Product Ampoules for sale in the United
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`States,’ evidence regarding FDA approval of the ampoules should not be excluded.
`
`2.
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`Experimentation Is Relevant to Both Pfaff Prongs
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`While Fresenius Kabi appears to agree that a showing of experimental, rather than
`
`commercial, use of an invention may negate the on-sale bar under the first prong of Pfaff, it
`
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`5 As Hospira will demonstrate at trial, there are other reasons not at issue in this motion as to
`why Fresenius Kabi’s on-sale theory regarding Product Ampoules fails.
`
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`13
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`Case: 1:16-cv-00651 Document #: 114-12 Filed: 06/25/18 Page 17 of 19 PageID #:3472
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`
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`incorrectly asserts that experimental use is not relevant to the second, ‘ready for patenting’ prong.
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`(Br. at 11-12.)
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`An invention is ‘ready for patenting’ if it is reduced to practice before the critical date, or
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`“the inventor prepared drawings or other descriptions of the invention that were sufficiently
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`specific to enable a person skilled in the art to practice the invention.” Pfaff, 525 U.S. at 67-68.
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`An invention has been reduced to practice if an inventor has both “constructed an embodiment or
`
`performed a process that met all the limitations” claimed and “determined that the invention would
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`work for its intended purpose.” In re Omeprazole Patent Litig., 536 F.3d 1361, 1373 (Fed. Cir.
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`2008).
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`Experimental use, on the other hand, concerns work designed to “(1) test claimed features
`
`of the invention or (2) determine whether an invention will work for its intended purpose—itself
`
`a requirement of patentability.” Energy Heating, LLC v. Heat On-The-Fly, LLC, 889 F.3d 1291,
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`1300 (Fed. Cir. 2018). Thus, experimental use is intertwined with the ‘ready for patenting’
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`analysis. The ‘ready for patenting’ prong assesses whether the invention was shown to work for
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`its intended purpose, and experimentation is the means through which an inventor determines
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`whether the invention will work for its intended purpose.
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`The sole support offered by Fresenius Kabi to support its claim that “there is no
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`experimental exception to the ready for patenting prong” is a truncated quote from Atlanta
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`Attachment Co. v. Leggett & Platt, Inc., 516 F.3d