Case 1:16-cv-01221-LPS Document 82 Filed 08/17/18 Page 1 of 4 PageID #: 708
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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
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`(302) 658-9200
`(302) 658-3989 FAX
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`
`
`Re:
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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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`August 17, 2018
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`VIA ELECTRONIC FILING
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`Bayer HealthCare LLC v. Teva Pharmaceuticals USA, Inc.,
`Civ. A. No. 1:16-01221-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. (“Bayer”) in response to Defendants’ August 15, 2018 letter. Bayer has
`more than satisfied its discovery obligations in this case, producing approximately 100,000
`documents constituting 8 million pages, the overwhelming majority of which are research and
`development documents. Defendants’ requests for additional discovery should be denied.
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`I.
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`Date Limitation for Inventor Emails
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`Although Defendants downplay the significance of their request, Defendants’ proposal to
`extend email searches for the named inventors on three patents would derail the Court’s schedule
`for this litigation and be highly prejudicial to Bayer. In essence, Defendants would have Bayer
`undertake a new, burdensome search and review process of email from multiple custodians, just
`weeks before the close of fact discovery and months after the deadline for substantial completion
`of document production. That extreme request is unjustified. Bayer informed Defendants of the
`date limitations it would use for inventor collections in January—seven months ago—when it
`served Responses to Defendants’ Requests for Production. Ex. A, at 13. Bayer then proceeded,
`at great burden and expense, to search for, review, and produce its documents, and the parties
`have already begun taking depositions. Yet now, at this last stage of fact discovery, Defendants
`for the first time raise this issue with the Court. It is far too late in the day to be debating this
`question, and Defendants, having sat on this issue, have no one to blame but themselves for
`failing to press it sooner. To be clear, what Defendants are asking for is a major project. Bayer
`would need to first conduct searches for documents in question, and then re-start its document
`review process before any productions could begin. That would take a significant amount of
`time. In the meantime, the Court’s schedule will require a substantial modification, imperiling
`not only the close of fact discovery, but later dates as well. Defendants could have raised this
`issue long ago. The prejudice caused by Defendants’ delay alone warrants denying their request.
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`

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`Case 1:16-cv-01221-LPS Document 82 Filed 08/17/18 Page 2 of 4 PageID #: 709
`The Honorable Leonard P. Stark
`August 17, 2018
`Page 2
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`Moreover, Defendants’ request is not the narrow compromise that they suggest. For two
`of the asserted patents that derive from U.S. priority documents (the ’553 and ’124 patents),
`Bayer applied date limitations based on the filing date of the U.S. or U.S.-PCT application1; for a
`third (the ’107 patent), Bayer applied a date limitation for the foreign priority document. For the
`’834 patent, Bayer reproduced the documents from a prior patent case before this Court
`involving Bayer’s Nexavar® product. As Defendants acknowledge, Bayer did not apply a date
`limitation in that litigation. However, it is precisely because of Bayer’s experience in that case—
`which resulted in Bayer’s production of substantial quantities of unused and irrelevant
`documents—that Bayer chose to impose reasonable date limitations here. Defendants are asking
`for one to four more years of inventor emails depending upon the patent at issue—all of which,
`by definition, post-date the conception of the invention and the filing of the relevant application.2
`And it is not as if the categories of documents Defendants request are already neatly organized
`somewhere, waiting to be picked up. Bayer would need to review the custodial emails to
`identify the particular categories of documents that Defendants have requested (many of which
`will be in German) and then produce them. That is no small task, and highlights the
`unreasonableness of Defendants’ request at this late stage in fact discovery.
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`Nor are Defendants able to articulate the relevance of these documents beyond a blind
`search for materials that they hope may be helpful to their written description and enablement
`defenses. Defendants have not presented any plausible argument that would justify additional
`custodial email productions, and certainly have not linked their request to any particular written
`description or enablement issue that they have raised in this case. Indeed, Defendants’ only
`explanation is a boiler-plate recitation of the applicable standards for written description and
`enablement. See D.I. 81, at 2. That is no explanation at all. Moreover, Defendants’ letter
`ignores the information that is actually in the patent applications that were used for the date
`limitations. For example, for the ’553 patent, Defendants’ enablement/written description
`allegations are limited to two claims directed to metabolites of regorafenib; but metabolites of
`regorafenib are described in the U.S. application. Similarly, Defendants’ enablement/written
`description arguments for the ’107 patent focus on methods of detecting certain impurities in
`regorafenib, but the priority application for the ’107 patent provides such methods of detection.
`What issue Defendants may be thinking of is anyone’s guess; it certainly is not in their letter.
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`Furthermore, Bayer has already produced numerous categories of research and
`development documents that are not subject to any date limitation, undermining Defendants’
`suggestion that Bayer’s production is somehow inadequate. Those documents include (1) files
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`1 Defendants incorrectly suggest that Bayer used the date of the first U.S. provisional application
`for the ’553 patent as a cut-off. See D.I. 81, at 2. Rather, Bayer applied the date of the non-
`provisional U.S. application, which was filed one year later.
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`2 The reason the application that led to the ’107 patent was filed four years after the relevant
`priority document (as opposed to one year) is that the ’107 patent issued from a continuation of
`an earlier application. Defendants’ suggestion that this additional period of time is somehow
`relevant to any issue in this case is without basis, and certainly is not justified by their letter.
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`

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`Case 1:16-cv-01221-LPS Document 82 Filed 08/17/18 Page 3 of 4 PageID #: 710
`The Honorable Leonard P. Stark
`August 17, 2018
`Page 3
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`from Bayer’s central archive of research and development reports (the “Pharma Reports”);
`(2) files from Bayer’s former West Haven facility, where regorafenib was first synthesized;
`(3) documents from Bayer’s archive of FDA regulatory materials; and (4) batch records of large-
`scale syntheses of regorafenib. Contrary to Defendants’ assertion, the Pharma Reports and
`regulatory documents are not “vague narratives that fail to provide key information.” D.I. 81, at
`2 n.1. They are files that Bayer relies upon outside of litigation to document its research and
`development efforts. Collectively, the documents that Bayer has produced constitute more than
`reasonable discovery. Defendants articulate no basis for their assertion that they are missing
`anything that is relevant to any issue actually in this case; and in any event, they could have
`raised this issue months ago. Put simply, there is no reason to blow up the schedule merely
`because Defendants want to go fishing for additional documents.
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`II.
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`Documents from the Onyx Litigation
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`Defendants’ request for certain transcripts from a prior litigation between Bayer and
`Onyx (which has since been acquired by Amgen) is also unjustified. The Onyx litigation was
`not a patent case and is not relevant to this action. It involved Onyx’s allegations of breach of
`contract and fiduciary duty over the terms of the parties’ collaboration, and centered on internal
`research at Bayer that was not public and was known only to Onyx on confidential terms.
`Nevertheless, despite this irrelevance,3 Defendants omit from their letter that Bayer has already
`agreed to produce the vast majority of materials that Defendants have requested from the Onyx
`case, specifically: (1) deposition transcripts and exhibits for all Bayer fact witnesses; (2) all
`expert reports and any exhibits to those reports; (3) expert deposition transcripts and exhibits;
`and (4) all pleadings, so long as those materials do not contain Onyx’s confidential information.
`Documents, pleadings, and testimony in the Onyx case, like this one, are covered by a protective
`order prohibiting their disclosure. Bayer requested permission from Amgen to produce Onyx’s
`confidential information. With certain very narrow exceptions, that permission was denied.
`Indeed, Bayer has expended substantial time, effort, and money to attempt to comply with
`Defendants’ requests, in particular to determine whether the materials can be properly disclosed.
`Following this review, Bayer is withholding only a narrow set of documents from the categories
`identified above on confidentiality grounds, as Bayer does not have permission to produce them.
`
`Despite the documents that Bayer has agreed to produce, Defendants still insist on
`obtaining deposition transcripts and exhibits for Onyx fact witnesses. However, Defendants
`have failed to articulate why the prior testimony of a third-party’s employees in an unrelated
`litigation regarding confidential contractual matters are relevant to any issue in this case.
`Moreover, at least some of these materials will contain Onyx’s confidential information, which
`Bayer could not produce, even if somehow relevant.
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`In short, there is no basis for Defendants’ position that they have not received enough
`materials or that the process has been somehow insufficient. The request should be denied.
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`3 Bayer disagrees with various statements that Defendants make about sorafenib and regorafenib,
`but will not provide a detailed response in the limited space available for this discovery dispute.
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`Case 1:16-cv-01221-LPS Document 82 Filed 08/17/18 Page 4 of 4 PageID #: 711
`The Honorable Leonard P. Stark
`August 17, 2018
`Page 4
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`Respectfully,
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`/s/ Derek J. Fahnestock
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`Derek J. Fahnestock (#4705)
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`DJF/bac
`Enclosure
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`cc:
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`Clerk of Court (via hand delivery; w/enclosure)
`All Counsel of Record (via electronic mail/ w/enclosure)
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