Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 1 of 70 PageID #: 1180
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`Exhibit A
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`

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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 2 of 70 PageID #: 1181
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`BAYER HEALTHCARE LLC and BAYER
`HEALTHCARE PHARMACEUTICALS
`INC.
`
`
`
`
`
`APOTEX INC. and APOTEX CORP.,
`
`
`
`Plaintiffs,
`
`
`
`v.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`C.A. No. 16-1221-LPS
`(Consolidated)
`
`CONFIDENTIAL – FILED UNDER SEAL
`
`Defendants.
`
`
`EXHIBIT 12
`
`PLAINTIFFS’ MOTION IN LIMINE NO. 1
`TO PRECLUDE APOTEX’S UNTIMELY NON-ENABLEMENT THEORY
`
`
`
`
`
`
`
`
`

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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 3 of 70 PageID #: 1182
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`
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`Defendants Apotex Inc. and Apotex Corp. (collectively, “Apotex”) should be precluded
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`from arguing at trial that asserted claims 11, 14, and 20 of U.S. Patent No. 9,458,107 (the “’107
`
`Patent”) are invalid for lack of enablement based on the theory that the specification fails to enable
`
`the full scope of the claims— a theory first raised three days prior to the close of expert discovery.
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`I.
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`Apotex’s Effort to Raise a New Theory is Untimely
`
`On October 22, 2019—three days from the close of expert discovery, after Apotex and
`
`Bayer’s experts on the ’107 patent were deposed, and after Apotex had served its initial pretrial
`
`disclosures—Apotex notified Bayer of its intention “to assert that all of the asserted claims of the
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`’107 patent are invalid for lack of enablement because the specification fails to enable the full
`
`scope of the claims.” E-Mail from Haché (Oct. 22, 2019) (Ex. 12A). The asserted claims require
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`certain impurities be present “from 0.0001% to a maximum of 0.01%.” There is no dispute that
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`Apotex’s ANDA Product in fact contains levels below 0.01% and above 0.0001%, which is all
`
`that is required. The purported basis for Apotex’s new theory appears to be that the exemplary
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`methods disclosed in the ’107 patent do not enable making regorafenib having anilinic impurity
`
`levels at 0.0001% or 1 ppm, and that section 112 somehow requires that the ’107 patent expressly
`
`disclose a method to achieve all impurity levels between 0.0001% and 0.01%.
`
`To be clear, Apotex’s new non-enablement theory is completely different from any theory
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`advanced by Apotex’s experts during discovery or in Apotex’s previous pretrial disclosures.
`
`Apotex’s only expert on the ’107 patent, Dr. Marvin Hansen, opined that claims 11 and 14—but
`
`not claim 20—were invalid for lack of enablement because those claims express the amount of
`
`impurities in terms of percentage “by weight, based on the weight,” a phrase that does not literally
`
`appear in the specification. Dr. Hansen’s report discussed enablement only in passing, in a section
`
`spanning three paragraphs. Hansen Rep. ¶¶ 125-27 (Ex. 12B).
`
`At his deposition, Dr. Hansen reiterated that the “weight based on the weight of the
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`2
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`

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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 4 of 70 PageID #: 1183
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`compound” language was “the key point for enablement.” See Hansen Tr. at 234:13-15 (“So the
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`key point for the enablement is the lack of the weight, based on the weight language in the
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`specification.”), 235:12-15 (“So the key point for the enablement, as I said, is the weight, based
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`on the weight.”) (Ex. 12C). He has never offered the opinion that claim 20 is non-enabled for any
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`reason or that any claim is non-enabled based on the lower bound of the claimed range.
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`To justify its untimely theory, Apotex relies on Apotex’s examination of Bayer’s expert on
`
`the ’107 patent, Dr. Allan Myerson. Ex. 12A (“In light of Dr. Myerson’s testimony yesterday,
`
`Apotex is amending its contested facts . . . .”). While Dr. Myerson’s testimony does not actually
`
`support Apotex’s theory,1 that is beside the point. Apotex had every opportunity to explore the
`
`theory (which purports to rely on the adequacy of the ’107 patent’s examples) during fact discovery
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`and to disclose expert opinion regarding the issue. It chose not to do so. To allow Apotex to
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`change course now would deprive Bayer of the opportunity to meaningfully respond.
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`II.
`
`Preclusion is the Appropriate Remedy
`
`The appropriateness of preclusion turns on the factors recited in Meyers v. Pennypack
`
`Woods Home Ownership Ass’n, 559 F.2d 894, 904-05 (3d Cir. 1977). See ZF Meritor, LLC v.
`
`Eaton Corp., 696 F.3d 254, 298 (3d Cir. 2012). Those factors require preclusion here.
`
`A.
`
`Prejudice or Surprise to the Party Against Whom the Evidence Is Offered
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`Apotex’s attempt to pursue a new enablement theory would severely prejudice Bayer.
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`Bayer did not have the opportunity to take any fact or expert discovery on the new theory. Nor
`
`
`1 Apotex cobbles together its new non-enablement theory based on Dr. Myerson’s (1) opinion that
`the claims were non-obvious because the POSA, without the benefit of the patent’s disclosures,
`would not be able to make the claimed inventions without undue experimentation; and (2)
`purported acknowledgment that the specification does not expressly disclose how to make
`regorafenib with “1 ppm versus 100 ppm’s [sic]” of the recited impurities. Myerson Tr. at 85:7-
`18 (Ex. 12D). Because Apotex presents no evidence that the POSA, with the benefit of the patent,
`would be unable to make and use the claimed inventions without undue experimentation, its
`theory fails as a matter of law.
`
`3
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 5 of 70 PageID #: 1184
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`
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`did Bayer’s experts have the opportunity to rebut Apotex’s new theory during expert discovery.
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`B.
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`Ability to Cure and Extent of Trial Disruption
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`To the extent Bayer’s prejudice could be cured, Bayer would need to take additional fact
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`and expert discovery, including an opportunity to submit supplemental expert reports, and if
`
`necessary, perform testing regarding the exemplary methods. Such remedies are impossible
`
`without reopening both fact and expert discovery. See Intellectual Ventures I LLC v. AT&T
`
`Mobility LLC, C.A. No. 13-1668-LPS, 2017 WL 658469, at *3 (D. Del. Feb. 14, 2017) (granting
`
`motion to strike infringement contentions that failed to conform to claim construction, citing
`
`opposing party’s inability to receive notice).
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`C.
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`Bad Faith or Willfulness in Not Disclosing the Evidence
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`Even though Apotex disclosed its new non-enablement theory following the deposition of
`
`Dr. Myerson, three days from the close of expert discovery, Apotex’s theory appears to rest entirely
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`on the ’107 patent’s disclosures. Given that, Apotex cannot plausibly argue that it unexpectedly
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`discovered the theory at Dr. Myerson’s deposition. Indeed, Apotex’s questioning of Dr. Myerson
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`makes clear that Apotex entered his deposition with the theory in mind.
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`D.
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`Importance of the Excluded Evidence
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`Apotex has had more than three years to prepare its defense at trial. That Apotex has only
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`now somehow stumbled its way into a case-winning argument beggars belief. Indeed, Apotex has
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`represented that it “does not intend to submit any of its own expert evidence” on the issue.
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`Soderstrom E-mail (Oct. 25, 2019) (Ex. 12E). Were Apotex’s new non-enablement theory actually
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`important, it is unlikely that Apotex’s experts would have failed to address it (unlike Apotex’s
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`other obviousness, written description, non-enablement, and indefiniteness theories). Apotex
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`should be precluded from presenting at trial its new and untimely non-enablement theory.
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`4
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`

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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 6 of 70 PageID #: 1185
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`OF COUNSEL:
`
`Bruce R. Genderson
`Adam L. Perlman
`Dov P. Grossman
`Jessica B. Rydstrom
`Seth R. Bowers
`Ben Picozzi
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`(202) 434-5000
`
`November 20, 2019
`
`
`
`
`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Anthony D. Raucci
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Derek J. Fahnestock (#4705)
`Anthony D. Raucci (#5948)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`dfahnestock@mnat.com
`araucci@mnat.com
`
`Attorneys for Plaintiffs Bayer HealthCare
`LLC and Bayer HealthCare Pharmaceuticals
`Inc.
`
`5
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 7 of 70 PageID #: 1186
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`
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`CERTIFICATE OF SERVICE
`
`I hereby certify that on November 20, 2019, copies of the foregoing were caused to
`
`be served upon the following in the manner indicated:
`
`Kenneth L. Dorsney, Esquire
`MORRIS JAMES LLP
`500 Delaware Avenue, Suite 1500
`Wilmington, DE 19801-1494
`Attorneys for Defendants Apotex Inc.
`and Apotex Corp.
`
`Phillip Y. Kouyoumdjian, Esquire
`Ian Scott, Esquire
`TAFT STETTINIUS & HOLLISTER LLP
`111 East Wacker Drive, Suite 2800
`Chicago, IL 60601
`Attorneys for Defendants Apotex Inc.
`and Apotex Corp.
`
`Deepro R. Mukerjee
`Lance A. Soderstrom
`KATTEN MUCHIN ROSENMAN LLP
`575 Madison Avenue
`New York, NY 10022
`
`Jitendra (“Jitty”) Malik
`Joseph M. Janusz
`KATTEN MUCHIN ROSENMAN LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202
`
`Guylaine Haché
`KATTEN MUCHIN ROSENMAN LLP
`525 W. Monroe Street
`Chicago, IL 60661
`
`
`
`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
`
`
`
`
`
`
`
`VIA ELECTRONIC MAIL
`
`
`
`
`
`VIA ELECTRONIC MAIL
`
`
`
`
`
`VIA ELECTRONIC MAIL
`
`
`
`/s/ Seth Bowers
`_____________________________________
`Seth Bowers
`
`6
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`

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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 8 of 70 PageID #: 1187
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`Exhibit 12A
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`

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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 9 of 70 PageID #: 1188
`
`Subject:
`
`Bayer HealthCare LLC v. Apotex
`
`From: Hache, Guylaine [mailto:guylaine.hache@katten.com]  
`Sent: Tuesday, October 22, 2019 5:34 PM 
`To: Bowers, Seth <SBowers@wc.com>; Picozzi, Ben <BPicozzi@wc.com>; Genderson, Bruce <BGenderson@wc.com>; 
`Perlman, Adam <APerlman@wc.com>; Grossman, Dov <DGrossman@wc.com>; jblumenfeld@mnat.com; 
`dfahnestock@mnat.com; araucci@mnat.com 
`Cc: Kouyoumdjian, Philip Y. <pkouyoumdjian@taftlaw.com>; Skinner, Patricia <PSkinner@taftlaw.com>; Mukerjee, 
`Deepro R. <deepro.mukerjee@katten.com>; Soderstrom, Lance A. <lance.soderstrom@katten.com>; Malik, Jitty 
`<jitty.malik@katten.com>; Janusz, Joe <joe.janusz@katten.com>; Kenneth Dorsney <kdorsney@morrisjames.com>; 
`elarson@morrisjames.com 
`Subject: Bayer HealthCare LLC v. Apotex 
`
`Counsel –  
`
`In light of Dr. Myerson’s testimony yesterday, Apotex is amending its contested facts to assert that all of the asserted 
`claims of the ’107 patent are invalid for lack of enablement because the specification fails to enable the full scope of the 
`claims. A redline of Apotex’s amendments is attached.  
`
`Regards, 
`
`Guylaine Haché, Ph.D.
`Associate
`Katten
`Katten Muchin Rosenman LLP
`525 W. Monroe Street | Chicago, IL 60661-3693
`direct +1.312.902.5619 mobile +1.312.343.7138
`guylaine.hache@katten.com | katten.com
`
`===========================================================
`CONFIDENTIALITY NOTICE:
`This electronic mail message and any attached files contain information intended for the
`exclusive
`use of the individual or entity to whom it is addressed and may contain information that
`is
`proprietary, privileged, confidential and/or exempt from disclosure under applicable
`law. If you
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`disclosure or
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`the sender, by electronic mail or telephone, of any unintended recipients and delete the
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`message without making any copies.
`===========================================================
`NOTIFICATION: Katten Muchin Rosenman LLP is an Illinois limited liability partnership
`that has
`elected to be governed by the Illinois Uniform Partnership Act (1997).
`===========================================================
`
`1
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 10 of 70 PageID #: 1189
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`Exhibit 12B
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`

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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 11 of 70 PageID #: 1190
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 11 of 70 PageID #: 1190
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`BAYER HEALTHCARE LLC and t
`
`BAYER HEALTHCARE ,
`PHARMACEUTICALS INC. .
`
`Plaintiff,
`
`V.
`
`CA. No. 16-Cv-122l-LPS
`
`(CONSOLIDATED)
`
`APOTEX INC. and APOTEX CORR.
`
`Defendants.
`
`Centains Material Designated
`as HIGHLY CONFIDENTIAL
`
`Pursuant to Protective Order
`
`
`
`EXPERT REPORT OF MARVIN M. HANSEN, PH.D.
`
` Date: May 31, 2019
`May 31, 2019
`
`Marvin M. Hansen, Ph.D.
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 12 of 70 PageID #: 1191
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`Table of Contents
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`

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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 13 of 70 PageID #: 1192
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`
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`IX.IX.IX.IX.
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`
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`CLAIMS 1, 2, AND 9-14 OF THE ’107 PATENT ARE INVALID FOR LACK OF CLAIMS 1, 2, AND 9-14 OF THE ’107 PATENT ARE INVALID FOR LACK OF CLAIMS 1, 2, AND 9-14 OF THE ’107 PATENT ARE INVALID FOR LACK OF CLAIMS 1, 2, AND 9-14 OF THE ’107 PATENT ARE INVALID FOR LACK OF
`
`ENABLEMENT ENABLEMENT
`
`
`125. As discussed above, I have been informed by counsel that to meet the 125. As discussed above, I have been info125. As discussed above, I have been informed by counsel that to meet the
`
`
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`enablement requirement, a patent’s specification must set forth and describe the invention in terms enablement requirement, a patent’s specification must set forth and describe the invention in terms
`
`
`
`
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`such that a POSA would be able to carry out or practice the claimed invention without undue or such that a POSA would be able to carry out or practice the claimed isuch that a POSA would be able to carry out or nvention without undue or
`
`
`
`
`
`
`
`
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`unreasonable experimentation. However, detailed procedures for making and using the invention unreasonable experimentation. However, dunreasonable experimentation. However, detailed procedures for making and using the invention etailed procedures for making and using the invention
`
`
`
`may not be necessary if the description of the invention itself is sufficient to permit a POSA to may not be necessary if the description of the invention itself is sufficient to permit a POSA to
`
`
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`make and use the invention. In my opinion, this requirement has not been met. make and use the invention. In my opinion, this requirement has not been met.
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`
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`
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`126. As discussed above with regard to the written description requirement, there 126. As discussed above with regard to th126. As discussed above with regard to the written description requirement, there
`
`
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`is no description in the specification of the claimed language “weight based on the weight of the is no description in the specification of the claimed language “weight based on the weight of the
`
`
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`compound,” such that a POSA would be able to prepare regorafenib with the claimed impurity compound,” such that a POSA would be able to prepare regorafenib with the claimed impurity
`
`
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`profile without undue experimentation. profile without undue experimentation.
`
`
`
`
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`127. Accordingly, based on the understanding of the enablement requirement 127. Accordingly, based on the understandi127. Accordingly, based on the understanding of the enablement requirement
`
`
`
`provided to me by counsel, in my opinion, claims 1, 2, and 9-14 are invalid for lack of enablement. provided to me by counsel, in my opinion, claims 1, 2, and 9-14 are invalid for lack of enablement.
`
`X.
`
`ALL ASSERTED CLAIMS OF THE ’107 PATENT ARE INVALID AS
`INDEFINITE
`128. As discussed above, I have been informed by counsel that to meet the
`
`definiteness requirement, a claimed invention must inform the POSA about the scope of the
`
`invention with reasonable clarity.
`
`129. As previously discussed, the specification of the ’107 patent does not
`
`provide adequate written support or enablement for the claimed impurity profiles with respect to
`
`the claim term “weight based on weight.”
`
`24754280.1
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`48
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`

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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 14 of 70 PageID #: 1193
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`Exhibit 12C
`
`

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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 15 of 70 PageID #: 1194
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 15 of 70 PageID #: 1194
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`1
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`EALTHCARE LLC
`
`'
`
`ER HEALTHCAK
`
`
`
`
`—x
`
`:
`
`:
`
`C.A. No. 16—1221
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`(LPS)
`
`CONSOLIDATED
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`24
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`25
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`PHARMACfiUT CAts
`
`INC.,
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`Plaintiffs, v.
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`APOTEX INC. and
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`APOTEX
`
`CORP.,
`
`
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`i
`
`
`fendants.
`
`CONFIDENTIAL PURSUANT TO THE PROTECTIVE ORDER
`
`
`
`Deposition of
`
`MARVIN M. HANSEN, PH.D.
`
`New York, New York
`
`Thursday, October 3, 2019
`
`8:07 a.m.
`
`Job No.: 264818
`
`Pages:
`
`1 — 317
`
`Reported By:
`
`Nancy Mahoney, CCR/RPR
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 16 of 70 PageID #: 1195
`Case 1:16-cv-01221—LPS Document 154-1 Filed 06/16/20 Page 16 of 70 PageID #: 1195
`CONFIDENTIAL PURSUANT TO THE PROTECTIVE ORDER
`
`Transcript of Marvin M. Hansen, Ph.D.
`
`Conducted on October 3, 2019
`
`2
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`1
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`Deposition of MARVIN M. HANSEN, PH.D., held at
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`the offices of:
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`
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`KATTEN MUCHZN ROSENMAN LLP
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`575 Madison Avenue
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`New York, New York 10022—2585
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`212.940.8800
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`Pursuant to agreement, before Nancy Mahoney,
`
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`Notary Public in and for the state 0: New York.
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`PLANET DEPOS
`
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 17 of 70 PageID #: 1196
`Case 1:16-cv-01221—LPS Document 154-1 Filed 06/16/20 Page 17 of 70 PageID #: 1196
`CONFIDENTIAL PURSUANT TO THE PROTECTIVE ORDER
`
`Transcript of Marvin M. Hansen, Ph.D.
`
`Conducted on October 3, 2019
`
`3
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`1
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`A P P E A R A N c E s
`
`ON BEHALF OF PLAINTIFFS:
`
`DOV P. GROSSMAN, ESQUIRE
`
`dgrossman@wc.com
`
`
`
`
`SETH R. BOW*'.RS,
`
`
`
`sbowersGwc.com
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`WILLIAMS & CONNOLLY LLP
`
`725 Twelfth St. NW
`
`Washington, DC 20005
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`202.434.5000
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`EHALE OF DEFENDANT APOTH
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`25
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`IAN SCOTT, ESQUIRE
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`iscott@taft1aw.com
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`TAFT STETTINIUS & HOLLISTER LLP
`
`225 W. 34th Street
`
`New York, New York
`
`917.534.7181
`
`PLANET DEPOS
`
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 18 of 70 PageID #: 1197
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 18 of 70 PageID #: 1197
`CONFIDENTIAL PURSUANT TO THE PROTECTIVE ORDER
`
`Transcript of Marvin M. Hansen, Ph.D.
`
`Conducted on October 3, 2019
`
`4
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`1
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`A P P E A R A N C E S
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`C O N T I N U E D:
`
`ON BEHALF OF DEFENDANT APOTEX:
`
`
`
`
`GUYLAINE HACHE, P{.D., ESQUIRE
`
`guylaine.hache@ka:ten1aw.com
`
`KATTEN MUCHIN ROSENMAN LLP
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`525 W. Monroe Street
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`Chicago,
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`IL 60661-3693
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`312.902.5619
`
`ALSO PRESENT:
`
`David Schramm
`
`{ead of Patents & Licensing Radiology
`
`
`
`Bayer U.S.
`
`Shaye Lankford, Videographer
`
`PLANET DEPOS
`
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 19 of 70 PageID #: 1198
`Case 1:16-cv-01221—LPS Document 154-1 Filed 06/16/20 Page 19 of 70 PageID #: 1198
`CONFIDENTIAL PURSUANT TO THE PROTECTIVE ORDER
`
`Transcript of Marvin M. Hansen, Ph.D.
`
`Conducted on October 3, 2019
`
`5
`
`1
`
`C O N T E N T S
`
`EXAMINATION OF MARVIN M. HANSEN, PH.D.
`
`By Mr. Grossman
`
`By Mr. Scott
`
`E X H I B I T S
`
`(Attached to transcript)
`
`25
`
`MARVIN M. HANSEN, PH.D.
`
`Exhibit
`
`1 Article,
`
`
`"An impact analysis of
`
`
`
`the application of the threshold of
`
`toxicological concern concept to
`
`
`pharmaceuticals," by Edward J. Delaney,
`
`Bates stamp APO—REG—0013l808 through 825
`
`Exhibit 2 Article, "Control of Genotoxic
`
`Impurities in Active Pharmaceutical
`
`Ingredients:
`
`A Review and Perspective,
`
`by Derek I. Robinson, Bates stamp
`
`
`APO—REG—OOl3l998 through 2011
`
`
`Exhibit 3
`
`
`ICH S9 document, Bates stamp
`
`
`APO—REG—00132l54 through 166
`
`PLANET DEPOS
`
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`2
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`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 20 of 70 PageID #: 1199
`Case 1:16-cv—01221—LPS Document 154-1 Filed 06/16/20 Page 20 of 70 PageID #: 1199
`CONFlDENTIAL PURSUANT TO THE PROTECTIVE ORDER
`
`Transcript of Marvin M. Hansen, PhD.
`
`Conducted on October 3, 2019
`
`233
`
`Okay.
`
`Have you reviewed this report?
`
`Yes.
`
` If you look at Paragraphs 21 and 22,
`
`he talks about
`
`the definition of the POSA and
`
`compares it to your definition of a POSA.
`
`A.
`
`Q.
`
`Yes,
`
`I have.
`
`And would you regard your definition
`
`of the POSA and Dr. Myerson's definition of the POSA
`
`to.
`
`to be substantively similar?
`
`Yes.
`
` If you can —— what is ppm?
`
`Parts per million.
`
`How do you calculate ppm?
`
`It's a weight of an impurity divided
`
`by the weight of what you're measuring it relative
`
`10
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`
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`PLANET DEPOS
`
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 21 of 70 PageID #: 1200
`Case 1:16-cv-01221—LPS Document 154-1 Filed 06/16/20 Page 21 of 70 PageID #: 1200
`CONFIDENTIAL PURSUANT TO THE PROTECTIVE ORDER
`
`Transcript of Marvin M. Hansen, PhD.
`
`Conducted on October 3, 2019
`
`234
`
`:31:
`
`58
`
`:32
`
`:06
`
`
`
`Would you like a summary of the
`
`written description opinion as well?
`
`Q.
`
`determines as a mat
`
`If I understand —— so if the cour
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`-er 0.
`
`
`law that the specifica :ion
`
`
`
`:
`
`
`
`does provide suppor
`
`: for the claim language "weight,
`
`based on the weight of the compound," would you
`
`agree that the -- that Claims 11 and 14 are enabled?
`
`
`
`MR. SCOTT: Objection.
`
`A.
`
`I wouldn't want to give a legal
`
`opinion based on a court decision.
`
`PLANET DEPOS
`
`888.433.3767 | WWW.PLANETDEPOS.COM
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`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 22 of 70 PageID #: 1201
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 22 of 70 PageID #: 1201
`CONFIDENTIAL PURSUANT TO THE PROTECTIVE ORDER
`
`Transcript of Marvin M. Hansen, PhD.
`
`Conducted on October 3, 2019
`
`235
`
`I'm not asking for a legal opinion.
`
`
`
`written description opinion,
`
`would you agree that
`
`Claims 11 and 14 are enabled?
`
`MR. SCOTT:
`
`Same objection.
`
`PLANET DEPOS
`
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`Q.
`
`Well, you don't refer to
`
`indefiniteness in the discussion here,
`
`non—enablement;
`
`you as I
`
`think you identified
`
`re
`
` ferred to your written description.
`
` Do you see
`
`that?
`
`A.
`
`Q.
`
`Correct.
`
`And so if the court rejects your
`
`10
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`-:20
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`-:51
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`01
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`O6
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`O9
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`:35:"
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`20
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`26
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`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 23 of 70 PageID #: 1202
`
`Exhibit 12D
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 24 of 70 PageID #: 1203
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 24 of 70 PageID #: 1203
`
`Allan Myerson, Ph D. - October 21, 2019
`
`Page 1
`
`CONFIDENTIAL
`
`1
`
`UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`BAYER HEALTHCARE LLC and BAYER
`
`HEALTHCARE PHARMACEUTICALS,
`Plaintiff,
`
`INC.,
`
`v.
`
`INC.,
`TEVA PHARMACEUTICALS USA,
`APOTEX, CORP. AND APOTEX INC.,
`Defendants.
`
`Case No.
`
`16-1221(LPS) - USDC-DDE
`
`VVVVVVVVVVV
`
`2
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`3 4
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`5
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`19
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`2O
`
`21
`
`22
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`
`
`C O N F I D E N T I A L
`
`DEPOSITION OF ALLAN MYERSON, Ph.D.
`
`Washington, D.C.
`
`October 21, 2019
`
`REPORTED BY: Tina Alfaro, RPR, CRR, RMR
`
`GregoryEdwards, LLC I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 25 of 70 PageID #: 1204
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 25 of 70 PagelD #: 1204
`
`Allan Myerson, Ph D. - October 21, 2019
`
`Page 2
`
`CONFIDENTIAL
`
`Videotaped deposition of ALLAN MYERSON,
`
`Ph.D., held at the offices of:
`
`Williams & Connolly
`
`725 12th Street,
`
`NW
`
`Washington, D.C. 20005
`
`Taken pursuant to notice before Tina M.
`
`Alfaro, a Notary Public within and for the District
`
`of Columbia.
`
`2
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`3
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`
`GregoryEdwards, LLC I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 26 of 70 PageID #: 1205
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 26 of 70 PagelD #: 1205
`
`Allan Myerson, Ph D. - October 21, 2019
`
`Page 3
`
`CONFIDENTIAL
`
`1
`
`A P P E A R A N C E S
`
`ON BEHALF OF THE PLAINTIFFS:
`
`WILLIAMS & CONNOLLY, LLP
`
`BY: SETH BOWERS, ESQ.
`
`BRUCE GENDERSON, ESQ.
`
`725 12th Street,
`
`NW
`
`Washington, D.C. 20005
`
`(202) 434-5000
`
`ON BEHALF OF THE DEFENDANTS APOTEX CORP AND
`
`
`
`APOTEX,
`
`INC.:
`
`KATTEN MUCHIN ROSENMAN, LLP
`
`BY:
`
`JITENDRA MALIK, Ph.D., ESQ.
`
`GUYLAINE HACHE, ESQ.
`
`550 South Tryon Street, Suite 2900
`
`Charlotte, North Carolina 28202-4213
`
`(704) 444-2000
`
`ALSO PRESENT:
`
`Ian Scott
`
`(Taft Stettinius)
`
`David Schramm (Bayer)
`
`T.J. O'Toole (videographer)
`
`GregoryEdwards, LLC I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`2 3
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`4
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`5
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`6
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`7
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`8
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`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 27 of 70 PageID #: 1206
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 27 of 70 PageID #: 1206
`
`Allan Myerson, Ph D. - October 21, 2019
`
`Page 4
`
`CONFIDENTIAL
`
`1
`
`I N D E X
`
`EXAMINATION
`
`WITNESS
`
`ALLAN MYERSON, Ph.D.
`
`By Mr. Malik
`
`By Mr. Bowers
`
`By Mr. Malik
`
`PAGE
`
`7
`
`232
`
`247
`
`*******
`
`E X H I B I T S
`
`MYERSON EXHIBITS
`
`DESCRIPTION
`
`PAGE
`
`
`
`2
`
`3
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`4
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`5
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`6
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`7
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`3
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`14
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`16
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`Exhibit 1
`
`Expert report
`
`Exhibit 2
`
`Exhibit 3
`
`Exhibit 4
`Exhibit 5
`Exhibit 6
`Exhibit 7
`Exhibit 8
`
`107 Patent,
`BAYER-STIVARGA—63
`
`through 77
`
`Excerpt of file history,
`BAYER-355 through 364
`834 Patent
`Drawing
`Excerpt of file history
`Hansen expert report
`Orange Book listing for
`
`Stivarga
`
`Exhibit 9
`
`2006 EMA guidance
`
`Exhibit 10
`
`2008 FDA guidance
`
`7
`
`8
`
`47
`
`61
`66
`93
`97
`118
`
`129
`
`129
`
`GregoryEdwards, LLC I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 28 of 70 PageID #: 1207
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 28 of 70 PagelD #: 1207
`
`Allan Myerson, Ph D. - October 21, 2019
`
`Page 80
`
`CONFIDENTIAL
`
`11
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`:06:
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`28
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`11
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`57
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`00
`
`11
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`:09:
`
`03
`
`O‘U'l-bOON
`
`11
`
`12
`
`check. Yeah, mine is off.
`
`THE VIDEOGRAPHER:
`
`The time is 11:06:45.
`
`Off the record.
`
`(A short break was had.)
`
`THE VIDEOGRAPHER:
`
`0n the record.
`
`The
`
`time is 11:09:03.
`
`BY MR. MALIK:
`
`0.
`
`Let me restate the question so it's
`
`crystal clear because I
`
`think I made an error when
`
`it came to the decimal points.
`
`Claim 11 of the '107 Patent requires the
`
`impurity levels be between 0.0001 percent to a
`
`
`
`11
`
`:09:
`
`08
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`11
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`:09:
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`12
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`11
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`:09:
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`11
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`maximum of 0.1 percent by weight, correct?
`
`A. Correct.
`
`0.
`
`And the other claims -- asserted claims 14
`
`and --
`
`MR. BOWERS:
`
`I'm sorry to interrupt.
`
`Did
`
`you say 0.1 percent by weight or 0.01 percent by
`
`weight?
`
`MR. MALIK:
`
`I hope I said 0.01 percent.
`
`Let me start over.
`
`Third time lucky.
`
`BY MR. MALIK:
`
`
`
`GregoryEdwards, LLC I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 29 of 70 PageID #: 1208
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 29 of 70 PagelD #: 1208
`
`Allan Myerson, Ph D. - October 21, 2019
`
`Page 81
`
`CONFIDENTIAL
`
`O‘U'l-bOON
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`:09:
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`0.
`
`Claim 11,
`
`the recited amounts of the
`
`impurities are 0.0001 percent to a maximum of
`
`0.01 percent by weight, correct?
`
`A. Correct.
`
`0.
`
`And the same is true for the other
`
`asserted claims, correct?
`
`A. Correct.
`
`0.
`
`Does the '107 Patent exemplify a
`
`regorafenib composition having impurities in an
`
`amount of 0.0001 percent to a maximum of
`
`0.1 percent -- 0.01 percent?
`
`A.
`
`I'm sorry.
`
`I don't think I understand the
`
`
`
`
`
`GregoryEdwards, LLC I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
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`question.
`
`0.
`
`Sure.
`
`Is there any example in the
`
`'107 Patent that has the impurity levels within the
`
`recited limits?
`
`A.
`
`Ah, okay.
`
`I gotcha.
`
`They don't actually report the impurity
`
`limits in the example.
`
`30 if you did stage 4,
`
`practiced it and did the HPLC analysis,
`
`I would
`
`think you would get that
`
`level, both levels, but
`
`it's not -- it's not shown.
`
`I would agree with
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 30 of 70 PageID #: 1209
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 30 of 70 PagelD #: 1209
`
`Allan Myerson, Ph D. - October 21, 2019
`
`Page 82
`
`CONFIDENTIAL
`
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`that.
`
`0. Well,
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`let's just kind of break that up.
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`So there are four stages in the example, correct?
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`A. Correct.
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`0.
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`And looking at stage 3, which is on
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`column 14, what amount of impurities do you
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`achieve?
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`A.
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`It doesn't say.
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`0. Certainly doesn't tell you whether
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`0.0001 percent was ever achieved, correct?
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`A.
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`It doesn't say, but, of course, a POSA
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`could perform this example and do the analysis and
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`
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`
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`GregoryEdwards, LLC I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
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`they would know.
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`0.
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`Stage 4 also measures the amount of
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`impurities, correct?
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`A. Correct.
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`0.
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`And it does not tell you whether
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`0.0001 percent was ever achieved, correct?
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`A.
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`The data's not
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`in there,
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`that's correct.
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`The POSA would have to perform example 4 and
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`determine if it was achieved.
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`0.
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`To achieve 0.001 percent can you show me
`
`

`

`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 31 of 70 PageID #: 1210
`Case 1:16-cv-01221-LPS Document 154-1 Filed 06/16/20 Page 31 of 70 PagelD #: 1210
`
`Allan Myerson, Ph D. - October 21, 2019
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`Page 83
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`CONFIDENTIAL
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`1
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`O‘U'l-bOON
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`in the patent where it says what changes need to be
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`made to the basic synthetic pathway?
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`A.
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`I
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`think you mean 0.0001 percent.
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`You left
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`a zero out again.
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`0.
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`A.
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`Yes.
`
`Yeah.
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`If you want to make this simple for
`
`yourself, you could just say 1 PPM and a hundred
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`PPM if that's easier to do.
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`0. Let's do that.
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`1 PPM,
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`just so we're
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`clear,
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`is -- let's try this again --
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`0.0001 percent.
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`Fair enough?
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`
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`
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`GregoryEdwards, LLC I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
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`A.
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`I
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`think you left a zero out again.
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`THE REPORTER:
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`No, he didn't.
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`THE WITNESS:
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`He didn't that time? Good.
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`0kay.
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`BY MR. MALIK:
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`Q.
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`1 PPM,
`
`I actually do like that much