Case 1:16-cv-01221-LPS Document 161 Filed 07/06/20 Page 1 of 3 PageID #: 1349
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`M O R R I S , N I C H O L S , A R S H T & T U N N E L L L L P
`1201 NORTH MARKET STREET
`P.O. BOX 1347
`WILMINGTON, DELAWARE 19899-1347
`(302) 658-9200
`(302) 658-3989 FAX
`July 6, 2020
`
`ANTHONY RAUCCI
`(302) 351-9392
`(302) 498-6201 FAX
`araucci@mnat.com
`
`
`
`VIA ELECTRONIC FILING
`The Honorable Leonard P. Stark
`U.S. District Court for the District of Delaware
`844 North King Street
`Wilmington, DE 19801
`
`Bayer HealthCare LLC, et al. v. Apotex Inc. et al., C.A. No. 16-1221-LPS (Consolidated)
`Re:
`Dear Chief Judge Stark:
`Apotex admits that it cannot currently present any evidence on its new non-enablement
`theory in its case-in-chief—and, thus, could not survive a Rule 52(c) motion. Undeterred, Apotex
`appears to suggest—for the first time, thirteen months after it served expert reports and two months
`before trial during a global pandemic—that the solution to its failure of proof is to re-open discovery
`and allow its expert to address the issue, the burdens of which would fall disproportionally on Bayer.
` D.I. 159 at 3. Pennypack does not countenance such an approach. And Apotex’s regret that it
`focused on a now-discredited obviousness theory during discovery does not permit it to treat Dr.
`Myerson’s deposition as a pretext for raising a new defense. Bayer’s motion should be granted.
`Apotex makes no attempt to explain how its new theory could survive a Rule 52(c) motion
`without re-starting fact and expert discovery. Indeed, Apotex acknowledges that Pfizer and Kirk
`preclude its reliance on Dr. Myerson’s testimony in its case-in-chief. D.I. 159 at 2. Apotex’s
`solution to this conundrum—that it will establish the theory “through cross-examination,” id.—
`misses the crucial point that Dr. Myerson cannot testify in Apotex’s case-in-chief, entitling Bayer to
`judgment before he is cross-examined. See, e.g., Cosmo Techs. Ltd. v. Actavis Labs. FL, Inc., C.A.
`No. 15-164-LPS, 2017 WL 7185967 (D. Del. Oct. 27, 2017) (granting Rule 52(c) motion).1
`Clearly recognizing this fatal inability to carry its burden, Apotex reverses course: it no
`longer intends to abide by its promise not to “submit any of its own expert evidence,” D.I. 158-1 at
`4, but instead asserts that the short delay of trial somehow allows it to “cure any perceived prejudice
`by conducting limited fact and expert discovery.” D.I. 159 at 3. Any suggestion that Apotex now be
`permitted to submit additional expert evidence only further compounds the prejudice to Bayer.
`Apotex’s experts had over two years to develop their opinions, and its new theory relates to the
`patent’s disclosures, not some heretofore unknown fact. If Apotex wished to pursue the theory, the
`time to do so was long ago—not now, as the parties furiously prepare for a nearly unprecedented
`remote trial in the face of extremely challenging circumstances. Instead, Apotex effectively asks to
`serve a new expert report, following document and deposition fact discovery, requiring Bayer to
`depose Apotex’s expert and prepare a response on the eve of trial. Apotex is solely responsible for
`
`1
`In Pfizer, the court denied a motion in limine to preclude Pfizer from relying on Ranbaxy’s
`experts’ testimony. However, in contrast to this case, Pfizer had other evidence it could present to
`support its theory. Pfizer, Inc. v. Ranbaxy Labs., Ltd., 405 F. Supp. 2d 495, 510 (D. Del 2005).
`Pfizer also held that Kirk is not limited to prior litigations. 2005 WL 2296613, at *2.
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`July 6, 2020
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`disclosing its theory long after the deadline, but Bayer would bear the burdens. D.I. 158 at 3.2 That
`should not be permitted.
`To justify its approach, Apotex uses Dr. Myerson’s deposition as a pretext. Although Apotex
`professes innocence, its own arguments demonstrate its willfulness under Pennypack. Had Apotex
`intended to limit its examination of Dr. Myerson to its existing non-obviousness theory, it would
`have had no reason to question him about the lower limit of the claimed range because—as Apotex
`itself argues—its obviousness defense is based on the “upper limit.” D.I. 159 at 1 n.1. Instead—to
`inject a non-enablement theory it had not presented or preserved—Apotex questioned Dr. Myerson
`about the lower limit, intentionally trying to elicit testimony about the patent’s teachings that had
`nothing to do with obviousness (since, of course, the patent is not prior art). Id. at 3.
`In any event, Dr. Myerson’s testimony does not support non-enablement, and Apotex is left
`to mischaracterize it. Apotex confuses (a) whether the patent expressly states how to achieve 1 ppm
`versus 100 ppm, with (b) whether the POSA, based on the patent and the POSA’s own knowledge
`and skill, would be able to reasonably practice the full scope of the range without undue
`experimentation. D.I. 159 at 4. What Dr. Myerson actually testified—in response to questions
`framed in terms of whether there is “anything in the patent”—was that the disclosed method could
`be used to achieve values within the claimed range, but did not expressly state how to obtain one
`value versus another. Ex. A at 84:10-86:10. Recognizing this, Apotex points to Dr. Myerson’s
`testimony about non-obviousness, which explained that the POSA, without the patent’s teachings,
`could only achieve the claimed impurity levels, if at all, through “extensive experimentation.” Id.
`How this is an “extreme position” or inconsistent with the method in the patent enabling the full
`scope of the range, D.I. 159 at 1, 3, is baffling. While Apotex asserts that Dr. Myerson admitted that
`undue experimentation is required “even with the benefit of the patent’s disclosures,” id. at 4, 5 n.6,
`it provides no supportive citation. The reason is simple: Dr. Myerson said no such thing.
`None of the cases Apotex cites advances its position. In Alcon, the patentee conceded that
`the claims were not enabled for a significant portion of the range. Bayer, however, has not conceded
`non-enablement. Nor has Apotex—which has the burden—presented any evidence that the POSA,
`following the methods in the patent, would be unable to achieve the lower limit of the range (or any
`other value) without undue experimentation. Dr. Myerson’s testimony regarding what is “in the
`patent,” Ex. A at 84:10-86:10, comes nowhere close to admitting that the POSA would not achieve
`the lower limit without undue experimentation. Magsil and Fisher are even further afield, as they
`addressed claims without any limit on the range. Idenix and MorphoSys, which addressed vast
`chemical and biological genera, are also inapposite. In those cases, the POSA could not determine
`the scope of the claims without testing potentially billions of compounds. There is no such question
`about the scope of the claim here. Nor is there evidence that anywhere near that level of
`experimentation—if any at all—is required here. Moreover, Dr. Myerson explained that while the
`patent did not expressly state whether the lower limit was obtained, the POSA could find out simply
`by performing the method. Id. at 82:9-21. And of course, Dr. Myerson had no reason to analyze
`what exact purity the method achieves, because Apotex had not raised the issue.
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`2
`Apotex takes Bayer’s draft status report out of context. Unlike Apotex’s proposal, Bayer’s
`initial proposal sharply limited fact discovery and did not permit Apotex to submit new expert
`reports. D.I. 159-1 at 9-10. Instead, it simply permitted Dr. Myerson to respond to Apotex’s theory.
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`Case 1:16-cv-01221-LPS Document 161 Filed 07/06/20 Page 3 of 3 PageID #: 1351
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`July 6, 2020
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`Enclosure
`cc:
`All Counsel of Record (by e-mail)
`
`Respectfully,
`
`/s/ Anthony D. Raucci
`
`Anthony D. Raucci (#5948)
`
`
`
`