Case 1:16-cv-01221-LPS Document 81 Filed 08/15/18 Page 1 of 4 PageID #: 698
`Nathan R. Hoeschen 
`I.M. Pei Building 
`1105 North Market Street, 12th Floor 
`Wilmington, DE 19801 
`(302) 298‐0700 
`(302) 298‐0709 ‐ Direct 
`nhoeschen@shawkeller.com 
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`August 15, 2018
`
`BY HAND DELIVERY
`The Honorable Leonard P. Stark
`United States District Court
`844 North King Street
`Wilmington, DE 19801
`
`Bayer Healthcare LLC, et al. v. Teva Pharmaceuticals USA, Inc.,
`Re:
`
`
`C.A. No. 16-1221-LPS
`
`Dear Chief Judge Stark:
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`We represent Teva Pharmaceuticals USA, Inc. (“Teva”) in the above-referenced matter.
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`We write on behalf of Apotex Inc., Apotex Corp. (collectively, “Apotex”), and Teva
`(collectively, “Defendants”) to request that the Court compel Bayer HealthCare LLC and Bayer
`HealthCare Pharmaceuticals Inc. (collectively, “Bayer”) to produce documents concerning (1)
`the research and development of the alleged invention after certain cutoff dates and (2)
`documents from previous litigations involving one of the patents asserted in this case and/or the
`development of the invention claimed therein. This information is material to the depositions of
`the inventors of the patent-in-suit. Despite numerous meet and confers spanning months, Bayer
`has maintained its refusal to produce this relevant information.
`
`I.
`Brief Factual Background
`
`
`This is a patent infringement case in which Bayer alleges that Teva’s ANDA product
`infringes U.S. Patent Nos. 7,351,834 (“the ʼ834 patent”), 8,637,553 (“the ’553 patent”),
`8,680,124 (“the ’124 patent”), and 9,458,107 (“the ’107 patent”). Bayer alleges that Apotex
`infringes the ’553 and ’107 patents. The ’834 and ’553 patents are directed to compounds used
`to treat cancer, including the molecule at issue, regorafenib. The ’124 patent is directed to a
`method of treating certain cancers using regorafenib, and the ’107 patent is directed to
`regorafenib compositions containing certain levels of impurities.
`
`Defendants contend, inter alia, that each asserted claim of the ’834, ʼ553, ’124, and ’107
`patents is invalid for anticipation and/or obviousness, and, for certain claims, failure to satisfy
`the written description and enablement requirements under 35 U.S.C. § 112. In response to
`Defendants’ obviousness defenses, Bayer asserts secondary indicia of nonobviousness, including
`unexpected properties, commercial success, long-felt need, failure of others, regulatory approval,
`industry recognition/acceptance, skepticism, copying, and praise.
`
`II.
`Bayer Has a Duty to Produce Research and Development Documents
`
`Defendants served document requests seeking information concerning the research and
`development (“R&D”) of the alleged inventions. Bayer refuses to produce custodial R&D
`documents created after different cutoff dates for each of the asserted patents unless Defendants
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`

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`Case 1:16-cv-01221-LPS Document 81 Filed 08/15/18 Page 2 of 4 PageID #: 699
`SHAW KELLER LLP 
`The Honorable Leonard P. Stark
`Page 2
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`reimburse Bayer’s costs associated with review and production.1 Specifically, Bayer has
`unilaterally cut off its custodial document collection from the named inventors as follows: ’553
`patent – filing date of provisional application; ’124 patent – filing date of PCT application; ’107
`patent – filing date of foreign application to which priority is claimed. The cutoff date for the
`’107 patent precedes the U.S. filing date by four years.2
`
`During the meet-and-confer process, Defendants significantly narrowed their requests to
`an extension of searches of custodial emails for PowerPoint presentations, meeting minutes,
`memoranda, and reports relating to R&D of regorafenib to one year after the U.S. filing dates for
`the patent(s) on which the custodian is a named inventor to accommodate Bayer’s unsupported
`protestations of undue burden. Bayer still refused to produce these documents.
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`The routine R&D discovery that Defendants seek is relevant to, inter alia, Defendants’
`written description and enablement defenses. For example, Defendants allege that the patent
`applications lack sufficient information to show that the inventors were in possession of the
`alleged invention when they filed their application and that persons of skill would have had to
`engage in undue experimentation to determine whether the invention actually worked as
`described. The type and extent of tests Bayer performed after the filing date directly informs
`this inquiry. E.g., Amgen Inc. v. Sanofi, 872 F.3d 1367, 1375 (Fed. Cir. 2017) (holding that
`exclusion of post-patent-filing evidence was error and remanding for new trial on written
`description and enablement); Plant Genetic Sys. v. DeKalb Genetics Corp., 315 F.3d 1335, 1343-
`44 (Fed. Cir. 2003) (finding that district court properly considered post-filing-date research
`efforts in its non-enablement determination).
`
`Bayer has argued that the production of the requested documents would be unduly
`burdensome. But, despite Defendants’ repeated requests, Bayer has failed to demonstrate that
`this burden is undue or that this burden is not proportional to the importance and relevance of the
`requested documents. Costs associated with Bayer’s production of narrow categories of highly
`relevant, routine R&D documents should not be shifted to Defendants. See, e.g., Juster
`Acquisition Co., LLC v. N. Hudson Sewerage Auth., 12-3427 (JLL), 2013 U.S. Dist. LEXIS
`18372, at *8-12 (D.N.J. Feb. 11, 2013) (citing Zubulake v. UBS Warburg LLC, 216 F.R.D. 280,
`283-84, 287 (S.D.N.Y. 2003) and Zubulake v. UBS Warburg LLC, 217 F.R.D. 309, 318-321
`(S.D.N.Y. 2003)).
`                                                                 
`1 Bayer has agreed to produce only regulatory filings and “Pharma Reports” after these cutoff
`dates. Unlike the requested custodial documents (i.e., emails and attachments), these regulatory
`documents and Pharma Reports are vague narratives that fail to provide key information,
`including when various activities were performed, why Bayer chose to perform them, how they
`fit into Bayer’s R&D efforts, how long they took to perform, and who was involved in
`performing them.
`2 Bayer previously produced documents concerning the research and development of the ’834
`patent in another matter in this district and did not adopt a unilateral cutoff date. As a result, this
`dispute only pertains to the ’553, ’124, and ’107 patents. Bayer’s new approach in this case
`stands in stark contrast to its past practices (and defense counsels’ experience with ANDA
`litigation in this district).
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`

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`Case 1:16-cv-01221-LPS Document 81 Filed 08/15/18 Page 3 of 4 PageID #: 700
`SHAW KELLER LLP 
`The Honorable Leonard P. Stark
`Page 3
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`Bayer should be required to provide Defendants discovery relating to its R&D efforts
`during the critical, narrowly limited, post-filing timeframe. Indeed, Bayer’s invention story at
`trial will not stop with the filing of its provisional applications, and Defendants are entitled to the
`discovery necessary to test such testimony. For the foregoing reasons, Defendants respectfully
`submit that the Court should order Bayer to produce the custodial emails and attachments
`relating to research and development of regorafenib through the period ending one year after the
`U.S. filing dates for the patent(s) on which the custodian is a named inventor.
`
`III. Defendants Are Entitled to Certain Documents from Previous Litigations
`
`Bayer also refuses to produce certain documents from a previous litigation involving a
`dispute related to development of the claimed invention. In that litigation Bayer was sued by
`Onyx, a company with whom Bayer partnered to develop a drug known as sorafenib. Sorafenib,
`like the regorafenib compound at issue in this case, is covered by the asserted ’834 patent. The
`sorafenib and regorafenib compounds are nearly identical, and so Onyx sued Bayer for breach of
`their joint development agreement, arguing that regorafenib was a collaboration compound under
`the agreement entitling Onyx to share in the profits. While the Onyx litigation was a breach of
`contract action, the disputed issues centered on the development of sorafenib and regorafenib.
`Notably, sorafenib is not only an embodiment of the ’834 patent, it is also the closest prior art to
`the asserted claims of the ’553 patent, making it relevant to the issues of unexpected results and
`commercial success.3 In fact, there appears to be evidence that regorafenib may have been
`conceived during the development of sorafenib. As such, sorafenib is a focus of Defendants’
`obviousness and anticipation defenses to the ’553 patent.
`
`Naturally, Defendants requested production of documents from the Onyx litigation
`concerning the R&D of sorafenib, comparisons of regorafenib and sorafenib, and the marketing
`and sales of sorafenib. Bayer has withheld transcripts and corresponding exhibits from certain,
`unidentified, Onyx fact witness addressing these topics on the basis that they are not relevant and
`likely contain Onyx confidential information.4 While Bayer has confirmed that Onyx objected to
`the production of other materials (see n.4), Bayer has not indicated that Onyx objects to the
`production of these materials. Ex. A. Defendants request the Court to order Bayer to either
`produce the documents or proffer a written objection from Onyx to the production of these
`materials and the reasons therefore, taking into consideration Defendants’ willingness to
`maintain them on an outside-counsel-only basis.
`                                                                 
`3 Commercial success does not rebut obviousness if that success is attributable to features of the
`invention that are found in the prior art. E.g., Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299,
`1312 (Fed. Cir. 2006).
`4 Earlier today Bayer informed Defendants that Amgen, which has acquired Onyx, has objected
`to the production of confidential Onyx exhibits addressed by experts and fact witnesses, as well
`as the testimony of the damages experts in that matter. Defendants have followed up with
`Amgen to determine whether it will agree to production of these materials on an outside-counsel-
`only basis, and are hopeful that Amgen will consent to production under these terms since it
`would afford even greater protection of those documents than they presumably received in the
`Bayer/Onyx litigation.
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`Case 1:16-cv-01221-LPS Document 81 Filed 08/15/18 Page 4 of 4 PageID #: 701
`SHAW KELLER LLP 
`The Honorable Leonard P. Stark
`Page 4
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`Respectfully submitted,
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`/s/ Nathan R. Hoeschen
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`Nathan R. Hoeschen (No. 6232)
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`Clerk of Court (via hand delivery)
`Counsel of Record (via electronic mail)
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`cc:
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