Case 1:16-cv-01221-LPS Document 127 Filed 05/02/19 Page 1 of 4 PageID #: 1039
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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
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`1201 N OR TH MA RK E T S TRE E T
`P.O . BO X 1347
`W I LM I NG T O N, DE LA WA RE 19899-1347
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`(302 ) 658-9 200
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`(302 ) 658-3 989 FAX
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`REDACTED -- PUBLIC VERSION
`Original Filing Date: April 23, 2019
`Redacted Filing Date: May 2, 2019
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`The Honorable Leonard P. Stark
`U.S. District Court for the District of Delaware
`844 North King Street
`Wilmington, DE 19801
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`VIA ELECTRONIC FILING
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`Re:
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`Bayer HealthCare LLC v. Teva Pharmaceuticals USA, Inc.,
`C.A. No. 16-1221-LPS (D. Del.) (Consolidated)
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`Dear Chief Judge Stark:
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`I write on behalf of Plaintiffs Bayer HealthCare LLC and Bayer HealthCare
`Pharmaceuticals Inc. (collectively, “Bayer”) regarding discovery relating to Defendants Apotex
`Inc. and Apotex Corp.’s (collectively, “Apotex”) infringement of U.S. Patent No. 8,957,232 (the
`“’232 patent”). Bayer respectfully requests that the Court order Apotex to produce unexpired
`samples of the ANDA Product at issue. Alternatively, Bayer requests that the Court sever C.A.
`No. 18-1465 (the “’232 Patent Case”) from C.A. No. 16-1221 (the “Main Case”) and stay the
`’232 Patent Case until Apotex manufactures and produces to Bayer additional samples of its
`ANDA Product.
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`I.
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`Bayer Agreed to Consolidation and an Expedited Schedule Based in Part on the
`Understanding that Apotex Would Produce Unexpired Samples of Its ANDA
`Product.
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`This is a consolidated Hatch-Waxman case relating to Bayer’s Stivarga® product. In
`December 2016 and March 2017, Bayer sued Apotex for infringement of two Orange Book
`patents listed in connection with Stivarga®. In December 2017, those cases were consolidated
`with the Main Case, which at the time involved Teva Pharmaceuticals USA, Inc (“Teva”). C.A.
`No. 16-1221, D.I. 26. Trial in the consolidated action was set for June 2019. Id., D.I. 20, at 13.
`Bayer and Teva have since settled their dispute. Bayer’s claims against Apotex remain at issue.
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`The ’232 patent issued in May 2018 and claims the monohydrate form of regorafenib, the
`active pharmaceutical ingredient in Stivarga®. After Bayer listed the ’232 patent in the Orange
`Book in connection with Stivarga®, Bayer received a Notice Letter from Apotex and filed suit
`on September 21, 2018. See C.A. No. 18-1465, D.I. 1. Apotex denies that it infringes the ’232
`patent, allegedly, because its ANDA Product does not contain the monohydrate form of
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`Case 1:16-cv-01221-LPS Document 127 Filed 05/02/19 Page 2 of 4 PageID #: 1040
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`The Honorable Leonard P. Stark
`April 23, 2019
`Page 2
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`regorafenib. In light of the existing action, the parties held discussions as to how the ’232 Patent
`Case should proceed. During those discussions, Bayer requested that Apotex produce unexpired
`samples of various substances—including Apotex’s ANDA Product and regorafenib active
`pharmaceutical ingredient (“API”)—to permit Bayer’s experts to test them to determine whether
`Apotex’s ANDA Product contained regorafenib monohydrate. See Ex. A, at 5–7; Ex. B, at 1.
`Based on conversations between counsel, as memorialized in a November 19, 2018 email, Bayer
`understood that Apotex had “represented that Apotex can produce the samples requested in [Dov
`Grossman’s] August 29, 2018 letter to Ian Scott, with the caveat that Apotex no longer has
`unexpired samples of the regorafenib API.” See Ex. A, at 2. That letter specifically requested
`samples of Apotex’s ANDA Product itself and specified that all references to samples “should be
`understood to refer to unexpired samples.” Ex. B, at 1. In responding, Apotex did not contradict
`Bayer’s understanding.1 Ex. A, at 5. Bayer ultimately agreed to consolidation and an expedited
`schedule in reliance on its expressly stated understanding that Apotex would produce unexpired
`samples of its ANDA Product in time to permit expert discovery. The parties then requested that
`the Court consolidate the actions and re-schedule the trial. C.A. 16-1221, D.I. 105. The Court
`did so in December 2018. Trial is now scheduled for November 2019. C.A. 16-1221, D.I. 106,
`at 11.
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`In March 2019, in the midst of fact discovery for the ’232 patent, Apotex revealed that it
`did not, in fact, possess the unexpired samples of its ANDA Product. Ex. A, at 5. Instead,
`Apotex stated that its samples of its ANDA Product had expired in March 2018, months before
`the parties began the discussions referenced above. Ex. A, at 1, 3. Bayer asked when Apotex
`intended to manufacture additional batches of its ANDA Product. Ex. A, at 1. Apotex did not
`provide a clear answer. Ex. A, at 1. Bayer inquired whether Apotex would make additional
`samples for production in the ’232 Patent Case. Ex. A, at 1. Apotex declined to do so. Ex. A, at
`1. Bayer asked whether Apotex would agree to treat expired samples of its ANDA Product as
`representative (even though that was an imperfect solution). Ex. A, at 1. Apotex again declined.
`Ex. A, at 1. Bayer now seeks relief from the Court.
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`II.
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`If Apotex Wishes to Contest Infringement, the Court Should Order It To Produce
`Samples of Its ANDA Product.
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`This is not a case in which a party is simply refusing to produce documents or materials
`that it does not have in its possession, custody, or control. Bayer agreed to consolidation and
`amendment of the case schedule, including an expedited trial date for the ’232 patent, based in
`part on its understanding that Apotex had agreed to and would produce unexpired samples of its
`ANDA Product. Apotex’s subsequent revelation that it does not actually possess those samples
`has unfairly prejudiced Bayer. Bayer understood that it would be able to assess infringement by
`analyzing Apotex’s ANDA Product itself. Having obtained Bayer’s agreement to consolidation
`and an expedited schedule for the ’232 patent based on the prospect of Bayer’s obtaining
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`1 During the meet-and-confer process regarding this dispute, Apotex asserted that it had never
`represented that it would produce unexpired samples of its ANDA Product. Although Bayer has
`a different recollection, the parties’ correspondence clearly demonstrates Bayer’s understanding
`that Apotex would produce unexpired samples of its ANDA Product.
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`Case 1:16-cv-01221-LPS Document 127 Filed 05/02/19 Page 3 of 4 PageID #: 1041
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`The Honorable Leonard P. Stark
`April 23, 2019
`Page 3
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`unexpired samples of its ANDA Product, Apotex should not now be permitted to deny
`infringement, but not provide the unexpired samples that to Bayer’s documented understanding
`Apotex had agreed to produce. Thus, unless Apotex agrees not to contest infringement, the
`Court should order Apotex to produce unexpired samples of its ANDA Product.
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`III. Alternatively, the Court Should Sever the ’232 Patent Case from the Main Case.
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`In the alternative, Bayer requests that the Court sever the ’232 Patent Case from the Main
`Case under Fed. R. Civ. P. 21 and stay the ’232 Patent Case until such time as Apotex
`manufactures new samples of its ANDA Product. The question for the ’232 Patent Case is
`whether Apotex’s ANDA Product—which is not commercially available—infringes. Under the
`circumstances, if the Court decides not to grant the relief requested above, an alternative
`approach is to wait until Apotex actually has unexpired samples of its ANDA Product so that
`infringement can be analyzed using the product that Apotex proposes to market. There is no
`thirty-month stay applicable to the ’232 patent, and in any event Apotex cannot enter the market
`until at least June 28, 2022, in light of another Orange Book patent (U.S. Patent No. 7,351,834)
`that Apotex has not challenged. Should Bayer prevail in the Main Case on the other two patents,
`Apotex will not be able to enter the market until even later than June 2022. There is no reason
`why Bayer’s claims regarding the ’232 patent must be tried in November 2019, and under the
`circumstances, there is good reason not to do so. Apotex will need to manufacture its ANDA
`Product before it can enter the market. When it does, Apotex should provide samples to Bayer
`so that they can be tested for infringement, as the Hatch-Waxman regime contemplates. The
`parties can then discuss how to proceed in light of the results of that analysis.
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`Case 1:16-cv-01221-LPS Document 127 Filed 05/02/19 Page 4 of 4 PageID #: 1042
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`The Honorable Leonard P. Stark
`April 23, 2019
`Page 4
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`Respectfully,
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`/s/ Anthony D. Raucci
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`Anthony D. Raucci (#5948)
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`Clerk of Court (Via Hand Delivery)
`All Counsel of Record (Via Electronic Mail)
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`Enclosure
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`cc:
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