Case 1:16-cv-01221-LPS Document 159 Filed 07/02/20 Page 1 of 5 PageID #: 1289
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`July 2, 2020
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`Kenneth L. Dorsney
`302.888.6855
`kdorsney@morrisjames.com
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`VIA CM/ECF AND HAND DELIVERY
`The Honorable Leonard P. Stark
`United States District Court for the District of Delaware
`844 N. King Street
`Wilmington, DE 19801
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`Re: Bayer Healthcare LLC v. Apotex Inc., et al.,
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`C.A. No. 16-1221-LPS (Consolidated)
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`Dear Chief Judge Stark:
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`Plaintiffs’ Motion to Strike misses the mark. The predicate of their Motion is the misguided
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`allegation that Apotex is somehow trying to shoehorn a new defense to the patent-in-suit. Not so.
`Apotex’s primary invalidity argument is, and has been, that the asserted claims of the ’107 patent
`are obvious—a POSA would have lowered the identified impurities to the claimed ranges with a
`reasonable expectation of success. In attempting to rebut that position, however, Plaintiffs went
`too far. Plaintiffs’ expert, Dr. Myerson, testified at his deposition that it would require “extensive
`experimentation” to achieve the levels of impurities recited in the claims. In other words, the level
`of experimentation to practice the full scope of the claims would be undue.1 Not once did Dr.
`Myerson contradict his foregoing testimony. And, in taking such an extreme position, testified
`that the specification does not enable the asserted claims. Apotex is not taking liberties in making
`this assertion. That was Dr. Myerson’s testimony. Thus, far from Plaintiffs’ allegation that Apotex
`is now springing a surprise, the truth is that the defense is borne solely from Plaintiffs’ own expert
`– during literally the last deposition of expert discovery. To preclude Apotex the ability to rely
`upon such glaring admissions would be manifest prejudice.
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`I.
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`Exclusion Is Not the Appropriate Remedy
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`The balance of the Pennypack factors weighs in favor of admissibility. As this Court has
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`noted, “[i]t bears emphasis that exclusion of ‘critical evidence,’ . . . is an ‘extreme sanction not
`normally to be imposed absent a showing of willful deception or flagrant disregard of a court order
`by the proponent of the evidence.’” E.g., B. Braun Melsungen AG v. Terumo Med. Corp., 749 F.
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`1 Plaintiffs may argue that a claim cannot be both obvious and non-enabled. That is incorrect.
`The asserted claims recite a composition with an impurity level of 0.01% to 0.0001%. For this
`claim to be obvious, the prior art need only teach the POSA how to reach the upper limit of the
`claimed range with a reasonable expectation of success. Apotex’s expert opines that it does. But
`to be enabled, the specification must teach the POSA how to practice the full scope of the claims,
`i.e., the entire range of 0.01% to 0.0001%, without undue experimentation. Plaintiffs’ expert,
`Dr. Myerson, opined that it does not.
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`Case 1:16-cv-01221-LPS Document 159 Filed 07/02/20 Page 2 of 5 PageID #: 1290
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`The Honorable Leonard P. Stark
`July 2, 2020
`Page 2
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`Supp. 2d 210, 221 (D. Del. 2010) (Stark, J.) Here, invalidity of the ’107 patent is clearly critical
`to Apotex’s defense as Apotex stipulated to infringement. Plaintiffs actually agree that this is a
`“factor that could in theory justify permitting Apotex to proceed with its non-enablement defense.”
`(Opening Letter Brief at 2). Nevertheless, Plaintiffs argue that “Apotex’s defense is doomed to
`failure” because “Apotex cannot rely on Dr. Myerson’s testimony in its case-in-chief, because it
`is inadmissible hearsay.” (Opening Letter Brief at 2 (citing Kirk v. Raymark Indus., Inc., 61 F.3d
`147 (3d Cir. 1995) and Pfizer, Inc. v. Ranbaxy Labs., Ltd., 2005 WL 2296613 (D. Del. Sept. 20,
`2005)). But Kirk and Pfizer are distinguishable.
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`For example, in Kirk, the testimony that the plaintiff sought to introduce at trial was from
`an expert that the defendant had used in a prior litigation and was not using in the current litigation.
`61 F.3d 147, 163 (3d Cir. 1995). In Pfizer, the plaintiff sought to supplement its deposition
`designations by adding testimony from the defendant’s experts for use in plaintiff’s case-in-chief
`to prove infringement under the doctrine of equivalents. 2005 WL 2296613, at *2. In precluding
`plaintiff from offering deposition testimony of defendant’s experts, the court found that plaintiff
`failed to make any showing that the defendant’s experts had the authority to speak on behalf of the
`defendant. Id.2 Here, in contrast, Apotex does not plan on calling Dr. Myerson to testify, or
`designating his testimony, in its case-in-chief at trial. And Plaintiffs have cited no legal precedent
`that would prohibit Apotex from establishing its defense through cross-examination of Dr.
`Myerson. That is not surprising, as Apotex is aware of none. More importantly though, there is
`now time for this issue to be adjudicated on the merits, alleviating any perceived prejudice to either
`party.
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`Plaintiffs claim they “would be prejudiced if Apotex can pursue its theory [because it]
`would require Bayer to conduct further fact discovery that it had no reason to pursue before Apotex
`belatedly raised its defense.” (Opening Letter Brief at 3). Again, this defense arose from
`Plaintiffs’ own expert’s testimony. But regardless, Plaintiffs have admitted that such prejudice
`could easily be cured. For example, in a draft Status Report sent to Apotex on June 5, 2020,
`Plaintiffs stated that that they would be in a position to “produce any additional documents that
`Bayer may rely upon at trial in response to Apotex’s new theory . . . by July 10, 2020.” (Ex. A, 6-
`5-2020 Draft Status Report at 1; see also D.I. 153 at 1 (“Bayer had proposed providing discovery
`now.”)) Plaintiffs also argue that it would be especially burdensome to make additional witnesses
`available for deposition because “Bayer’s potential fact witnesses reside in Germany and are not
`native English speakers . . . and may need to rely on interpreters to interview them and to facilitate
`their testimony.” Yet in the same draft Status Report, Plaintiffs stated that they would make “fact
`witnesses available . . . in July or August 2020 to provide deposition testimony.” (Ex. A, 6-5-
`2020 Draft Status Report at 2).
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`2 Additionally, in Pfizer, defendant filed a motion in limine to exclude plaintiff from raising the
`doctrine of equivalents at trial. In its Answer Brief, Pfizer stated that it will rely on the testimony
`of defendant’s experts to establish equivalence. The Court denied defendant’s motion. 2005 WL
`2296613, at *1.
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`Case 1:16-cv-01221-LPS Document 159 Filed 07/02/20 Page 3 of 5 PageID #: 1291
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`The Honorable Leonard P. Stark
`July 2, 2020
`Page 3
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`This is particularly important because of the posture of the case. When this issue first
`arose, the parties were three weeks away from trial in November of 2019. At that juncture, there
`simply was not time for discovery on this issue, which is why Apotex stated that it did “not intend
`to submit any of its own expert evidence” on the issue. (Ex. B to Opening Letter Brief). Bayer’s
`and Apotex’s experts simply would have addressed the non-enablement issues at trial. That trial
`date, of course, was pushed to June 2020. (D.I. 141). As Apotex previously noted, it was willing
`to proceed with trial in June 2020, but accommodated Plaintiffs’ request to move it further
`(eventually to the currently scheduled September date)3. In light of these changes to the schedule,
`the parties now have the ability to cure any perceived prejudice by conducting limited fact and
`expert discovery related solely to this issue. That includes a full and fair opportunity for both sides
`to address Dr. Myerson’s testimony. Plaintiffs’ tenuous arguments would effectively allow the
`last testifying expert in expert discovery free reign to take positions contrary to the party’s case,
`yet prevent reliance on those positions since they were not previously at issue. That cannot be.
`Had Apotex’s expert raised the issue without prior notice, a motion to strike would make sense.
`But that is not what happened here. Plaintiffs’ expert took an extreme position to try to make the
`patent less obvious. He went too far, and the parties should be permitted to address the issue on
`the merits.
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`As to the last Pennypack, Plaintiffs cannot possibly argue that Apotex had any bad faith or
`willfulness in not disclosing its defense until the day immediately after Dr. Myerson’s deposition.
`As noted above, Apotex’s theory stems directly from Dr. Myerson’s deposition testimony
`regarding non-obviousness. Nor can Plaintiffs demonstrate that Apotex acted in flagrant disregard
`of a Court order or with willful deception. Braun Melsungen, 749 F. Supp. 2d at 221.
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`II.
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`Dr. Myerson’s Testimony Forms the Basis of Apotex’s Non-Enablement Theory
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`Enablement requires that claim scope be no broader than the scope of a patent’s teaching.
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`Idenix Pharm. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1154 (Fed. Cir. 2019). Here, each asserted
`claim requires “from 0.0001% to a maximum of 0.01%” impurities. At his deposition, Dr.
`Myerson testified that the examples disclose only “typically” achieving “less than 0.01%.” (Ex.
`B, Myerson Rough Transcript4 240:2-242:13). Dr. Myerson conceded that the examples do not
`disclose levels as low as 0.0001%: “The data’s not in there . . . The POSA would have to perform
`example 4 and determine if it was achieved.” (Id. at 82:19-21; 82:11-13). But, directing one of
`skill in the art to simply “perform the example” and “do the analysis” is not an enabling disclosure.
`See, e.g., Idenix Pharm., 941 F.3d at 1159 (affirming JMOL (Stark, J.) that claims were not enabled
`because, inter alia, plaintiff’s witness testified “you don’t know whether or not a nucleoside will
`have activity against HCV until you make it and test it”); MorphoSys AG v. Janssen Biotech, Inc.,
`358 F. Supp. 3d 354, 372-74 (D. Del. 2019) (Stark, J.).
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`3 Covid-19 is of course a more than valid reason for rescheduling trial. But, it remains true that
`the June 2020 trial could have occurred entirely remotely, just as it will in September.
`4 For consistency with Plaintiffs’ Opening Letter Brief, Apotex cites to the rough transcript of
`Dr. Myerson. (Opening Letter Br. at 2).
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`Case 1:16-cv-01221-LPS Document 159 Filed 07/02/20 Page 4 of 5 PageID #: 1292
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`The Honorable Leonard P. Stark
`July 2, 2020
`Page 4
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`Further, according to Dr. Myerson, reducing impurity levels 10-fold, “from 1000 ppm to
`100 ppm (i.e., the highest level allowed in the asserted claims of the ’107 patent) . . . would be
`difficult to achieve even with extensive experimentation.” (Ex. C, Myerson Report ¶ 85).
`“Extensive experimentation,” according to Dr. Myerson, “would require optimization involving a
`wide variety of variables.” (Id. ¶ 87; Ex. B, Myerson Rough Transcript 77:10-17). This, of course,
`is Dr. Myerson’s attempt to rebut Apotex’s obviousness challenge. In so doing, Dr. Myerson
`walked Plaintiffs’ into an enablement problem. Plaintiffs cannot feign surprise that Apotex would
`hold Dr. Myerson to his opinions when they undermine Plaintiffs’ own position.
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`But there is more. When asked whether the ’107 patent taught the POSA what variables
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`needed to be optimized to reduce the impurity levels 100-fold, from 100 ppm (i.e., 0.01%, the
`upper limit in the claims) to 1 ppm (i.e., 0.0001%, the lower limit in the claims), Dr. Myerson
`testified: “No, it does not. . . . [I]t doesn’t tell you how to achieve one [ppm] versus 100 [ppm].”
`(Ex. B, Myerson Rough Transcript 85:7-18; 86:3-10 (same); 86:14–87:7 (100-fold reduction
`would be harder to achieve than 10-fold)). Thus, Dr. Myerson confirmed that the POSA would
`not have been able to practice the full scope of the claims, even with the benefit of the patent’s
`disclosures, without undue experimentation.
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`Contrary to Plaintiffs’ assertion, the basis for Apotex’s non-enablement theory is not
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`merely that “the ’107 patent fails to disclose expressly how to achieve impurity levels of 100 ppm
`versus 1 ppm.” (Opening Letter Brief at 2). Rather, Apotex argues the specification has not
`enabled the values in the claimed range (something that is required). Indeed, Federal Circuit case
`law strongly supports Apotex’s position that the ’107 patent’s specification must enable the entire
`claimed range. Two cases— MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377,
`1380–81 (Fed. Cir. 2012) and Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1364-65 (Fed.
`Cir. 2012)—are particularly instructive.
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`In MagSil, the plaintiff asserted infringement of claims to a semiconductor device that
`could change in resistance by “by at least 10% at room temperature.” 687 F.3d at 1379. The
`district court construed the asserted claims to cover “resistance changes beyond 120% and up to
`infinity.” Id. at 1381. Yet the asserted patent’s specification taught “that the inventors’ best efforts
`achieved a maximum change in resistance of only 11.8% at room temperature.” Id. The Federal
`Circuit found the claims not enabled, holding that the patent’s specification only enabled a “small
`subset of the claimed range.” Id. at 1384. It “only disclose[d] enough information to achieve an
`11.8% resistive change.” Id. at 1383. Moreover, it disclosed no “working examples” of “resistive
`changes of 20%, 120%, 604%, or 1000%.” Id. at 1382.
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`In Alcon Research, Ltd. v. Apotex Inc., the patentee asserted infringement of various claims
`that contained drug concentration ranges, including one as wide as from 0.0001% to 5%. 687 F.3d
`at 1364-65. In arguing the validity of this claim, the patentee conceded it had not enabled the
`portion of the claimed range below a 0.001% concentration, but argued that the claim should be
`construed so that only the enabled portions of the range were covered. Id. at 1367-68. The Federal
`Circuit rejected this argument, stating that “[t]his is not how patent law works.” Id. at 1368. A
`patentee claiming a concentration range could not “simply disavow the invalid portion and keep
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`Case 1:16-cv-01221-LPS Document 159 Filed 07/02/20 Page 5 of 5 PageID #: 1293
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`The Honorable Leonard P. Stark
`July 2, 2020
`Page 5
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`the valid portion of the claim.” Id. Rather, “[i]f everything up to 0.001% w/v is admittedly not
`enabled, then the entire claim is invalid.” Id.
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`Here, as in MagSil and Alcon v. Apotex, Plaintiffs have claimed a range, but the
`specification does not enable the entire range, at least according to Dr. Myerson: “[I]t doesn’t tell
`you how to achieve one [ppm] versus 100 [ppm].” (Ex. B, Myerson Rough Transcript 85:7-18;
`86:3-10 (same); 86:14–87:7 (100-fold reduction would be harder to achieve than 10-fold)); see
`Par Pharm., Inc. v. TWi Pharm., Inc., 120 F. Supp. 3d 468, 478 (D. Md.) (discussing MagSil and
`Alcon, and finding claimed range not enabled), aff’d, 624 F. App’x 756 (Fed. Cir. 2015).5
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`Plaintiffs created their own enablement problem. To divorce them from their own
`admissions would be unfair. “In cases involving unpredictable factors, such as most chemical
`reactions . . . the scope of enablement obviously varies inversely with the degree of unpredictability
`of the factors involved.” In re Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970). By relying on the
`purported unpredictability of the art to establish non-obviousness of the claimed range, Plaintiffs
`brought upon themselves “the peril of losing any claim that cannot be enabled across the full scope
`of its coverage.” MagSil, 687 F.3d at 1381.6 Plaintiffs are not prejudiced by this extreme position
`taken by their expert—Apotex is. That prejudice can be cured by allowing limited fact and expert
`discovery prior to trial.
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`For the foregoing reasons, Plaintiffs’ motion to strike should be denied.
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`Respectfully,
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`Kenneth L. Dorsney
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`Kenneth L. Dorsney (I.D. #3726)
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`cc:
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`All counsel of record (via e-filing and email)
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`5 Plaintiffs argue that “Apotex’s defense fails” because “Dr. Myerson had neither performed
`experiments, nor reviewed documents—such as materials from Bayer reflecting impurity levels
`achieved with the patent’s method—pertinent to the questions of whether and how much
`experimentation would be required to practice the claims using that method.” (Opening Letter
`Brief at 2). With trial now scheduled for September 2020 (as opposed to June 2020 under the
`earlier schedule), Dr. Myerson will have ample opportunity to perform experiments and review
`documents from Bayer. And as Plaintiffs stated in their draft Status Report, they are prepared to
`“produce any additional documents that Bayer may rely upon at trial in response to Apotex’s
`new theory . . . by July 10, 2020.”
`6 Plaintiffs imply that Apotex’s argument is merely that “if the asserted claims are non-obvious,
`they cannot possibly be enabled.” (Opening Letter Brief at 3 (quoting Allergan, Inc. v. Sandoz
`Inc., 796 F.3d 1293, 1310 (Fed. Cir. 2015)). Not so. As explained above, Dr. Myerson
`confirmed that the POSA would not have been able to practice the full scope of the claims, even
`with the benefit of the patent’s disclosures, without undue experimentation.
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