Case 1:18-cv-00924-CFC-SRF Document 29 Filed 09/04/18 Page 1 of 20 PageID #:
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC. and CITY OF HOPE,
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`Plaintiffs,
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`v.
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`AMGEN, INC.,
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`Defendant.
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` ) C.A. No. 18-924-GMS
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`JOINT STATUS REPORT
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`Pursuant to Fed. R. Civ. P. 16, D. Del. L.R. 16.2, and the Court’s August 3, 2018 Order
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`Re: Case Management in Civil Cases (D.I. 21), the parties, by and through their undersigned
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`counsel, jointly submit this Joint Status Report.
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`Counsel for the parties participated in telephone conferences pursuant to the Court’s
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`August 3, 2018 Order Re: Case Management in Civil Cases and as required by Fed. R. Civ. P.
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`26(f). Specifically, on July 31, 2018, Daniel M. Silver of McCarter & English, LLP and Andrew
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`J. Danford, Nora Q.E. Passamaneck and Stephanie Lin of Wilmer Cutler Pickering Hale and
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`Dorr LLP participated in a telephone conference on behalf of Genentech, Inc. and City of Hope
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`(“Plaintiffs” or “Genentech”), and Eve H. Ormerod of Smith Katzenstein & Jenkins LLP and
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`Michelle S. Rhyu and Susan M. Krumplitsch of Cooley LLP participated on behalf of Amgen,
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`Inc. (“Defendant” or “Amgen”). In addition, on August 23, 2018, Daniel M. Silver of McCarter
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`& English, LLP and Andrew J. Danford, Nora Q.E. Passamaneck, and Stephanie Neely of
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`Wilmer Cutler Pickering Hale and Dorr LLP participated in a further telephone conference on
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`behalf of Genentech and Eve H. Ormerod of Smith Katzenstein & Jenkins LLP and Michelle S.
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`Rhyu, Susan M. Krumplitsch, and Daniel J. Knauss of Cooley LLP participated on behalf of
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`Amgen.
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`1.
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`Jurisdiction and Service: Does the court have subject matter
`jurisdiction? Are all parties subject to the court's jurisdiction? Do any
`remain to be served?
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`The parties agree that this Court has subject matter jurisdiction pursuant to 28 U.S.C. §§
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`1331 and 1338. No party contests personal jurisdiction for the purposes of this action, and
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`Defendant has been served with the Summons and Complaint.
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`2.
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`Substance of the Action: What are the factual and legal bases for
`plaintiffs’ claims and defendant’s defenses?
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`This action concerns Amgen’s efforts to make and market a biosimilar version of
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`Genentech’s cancer drug, Herceptin® (trastuzumab). As set forth more fully in the Amended
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`Complaint, Genentech alleges that Amgen’s filing with the FDA of a Biologics License
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`Application seeking approval to market its biosimilar version of Herceptin® (“Amgen’s
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`Product”) has infringed claims of eighteen U.S. Patents (“Asserted Patents”). Plaintiffs also
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`allege that any future manufacture, importation, offer for sale, sale, or use within the United
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`States of Amgen’s Product would infringe those patents.
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`Amgen denies infringement of all claims of the Asserted Patents, and maintains that such
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`claims are invalid and/or unenforceable. Amgen also asserts that Plaintiffs are not otherwise
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`entitled to the relief they seek.
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`The Asserted Patents are identified in the following table by their numbers, expiry dates,
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`and first named inventors.
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`Patent Number
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`6,121,428
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`6,331,415
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`Expiry
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`6/12/2018
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`12/18/2018
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`2
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`First Named Inventor
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`Blank
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`Cabilly
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`Patent Number
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`6,407,213
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`6,417,335
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`6,620,918
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`6,627,196
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`7,371,379
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`7,846,441
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`7,892,549
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`7,923,221
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`7,993,834
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`8,076,066
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`8,425,908
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`8,440,402
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`8,512,983
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`8,574,869
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`9,249,218
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`9,714,293
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`Expiry
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`6/18/2019
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`5/03/2019
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`5/26/2019
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`8/25/2020
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`2/16/2022
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`5/06/2021
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`5/06/2021
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`12/18/2018
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`2/18/2022
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`5/18/2021
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`12/10/2018
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`5/18/2021
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`1/04/2031
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`7/08/2028
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`5/03/2019
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`8/06/2030
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`First Named Inventor
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`Carter
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`Basey
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`Ansaldi
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`Baughman
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`Baughman
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`Hellmann
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`Paton
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`Cabilly
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`Mass
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`Mass
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`Hellmann
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`Mass
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`Gawlitzek
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`Kao
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`Basey
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`Gawlitzek
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`3.
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`Identification of Issues: What factual and legal issues are genuinely in
`dispute?
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`These are the principal factual and legal issues in dispute:
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`Plaintiffs’ Issues:
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`
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`the scope and construction of the claims of the Asserted Patents.
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`Amgen’s Issues:
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`
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`if necessary, the scope and construction of the claims of the Asserted Patents;
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` whether Genentech has engaged in inequitable conduct that would preclude
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`enforcement of any valid claims; and
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` whether Genentech is entitled to the relief it has requested, as a result of its
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`unclean hands or otherwise.
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`Joint Issues:
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` whether Amgen has infringed and/or is infringing, directly or indirectly, any
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`claim of the Asserted Patents, and if so, whether such infringement is willful;
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` whether the claims of the Asserted Patents are invalid;
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` whether Plaintiffs are entitled to equitable relief, including an injunction against
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`Amgen’s infringement of the Asserted Patents; and
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` whether this case is “exceptional” under 35 U.S.C. § 285, and whether either side
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`should be awarded its reasonable attorney fees, costs, and disbursements.
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`4.
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`Narrowing of Issues: Can the issues in litigation be narrowed by
`agreement or by motions? Are there dispositive or partially dispositive
`issues appropriate for decision on motion?
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`a.
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`Coordination with Other Herceptin® Biosimilar Cases
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`Plaintiffs’ Position:
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`This case is one of several patent infringement actions before the Court relating to
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`proposed biosimilar versions of Genentech’s Herceptin® drug. All the Herceptin® biosimilar
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`cases are at an early stage, and the Plaintiffs believe that it would be most efficient to place those
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`cases on a coordinated schedule, which would allow common issues across those cases—
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`including claim construction, inventor depositions, document discovery, discovery disputes, and
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`expert discovery—to be addressed together.
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`There are currently three other patent infringement actions before the Court relating to
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`proposed biosimilar versions of Genentech’s Herceptin® drug developed by Pfizer (C.A. No. 17-
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`1672-GMS), Celltrion (C.A. No. 18-95-GMS), and Samsung Bioepis (filed September 4, 2018).
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`All cases are at an early stage. In the Pfizer case, Pfizer has answered the complaint, and the
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`most recent amended answer was filed on April 24, 2018. The parties in the Pfizer case have
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`served initial discovery requests and are beginning document discovery. In the Celltrion case,
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`the most recent amended answer was filed on July 3, 2018, and the parties served a first set of
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`discovery requests on August 21, 2018. The complaint in the Samsung Bioepis case was filed on
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`September 4, 2018. Plaintiffs do not anticipate that there will be litigation involving any other
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`proposed trastuzumab biosimilar products in the near term.
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`Because each of these cases involves proposed biosimilar versions of Genentech’s
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`Herceptin® drug, the issues across these cases overlap significantly. For example, the Pfizer case
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`involves 13 of the 18 Asserted Patents in this case, the Celltrion case involves 16 of the 18
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`Asserted Patents in this case, and the Samsung Bioepis case involves 13 of the 18 Asserted
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`Patents in this case. There are thus significant efficiency benefits in placing each of these cases
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`on a coordinated schedule that will permit the common issues across these cases to be addressed
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`together.
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`No schedule has yet been entered in the Pfizer, Celltrion or Samsung Bioepis cases. The
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`Court has set a hearing for September 6, 2018 and ordered the parties in the Pfizer, Celltrion, and
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`Amgen Herceptin® biosimilar cases to attend. Given the status of each of these cases, Plaintiffs
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`have proposed a schedule outlined below that would provide for a coordinated schedule that
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`would allow for a bench trial in each of the Herceptin® biosimilar cases in April 2020. Plaintiffs
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`believe that April 2020 is the earliest trial date that could be reasonably achieved while
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`efficiently coordinating the overlapping issues across these multiple cases involving proposed
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`Herceptin® biosimilar products.
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`Amgen contends that a coordinated schedule with the other cases is not appropriate
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`because (1) Plaintiffs’ theories of infringement on Plaintiffs’ manufacturing patents may differ as
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`to each defendant, (2) defendants may have distinct theories of invalidity, and (3) there is not
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`complete overlap of patents in each case. Contrary to Amgen’s arguments, the benefits of
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`efficiency provided through coordination far outweigh Amgen’s concerns in view of the
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`substantial overlap of patents among the four cases. Indeed, many of the patents asserted in all
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`of the actions are based on the Herceptin molecule or indications in the Herceptin label, which
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`would apply to all Herceptin biosimilar products and the issues with respect to those patents.
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`Further, to the extent that there may be unique infringement issues for certain defendants with
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`respect to particular patents, discovery and claim construction on those patents should remain the
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`same. Setting separate schedules for four complex BPCIA actions would waste both party and
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`judicial resources.
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`Defendant’s Position:
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`Amgen respectfully believes that, with notable exceptions, a coordinated schedule with
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`other cases involving proposed Herceptin® biosimilar products is not appropriate at this time.
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`Pfizer, Celltrion, Amgen, and Samsung will each face unique substantive issues in defending
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`against infringement claims brought by Genentech. Unlike generic drug products in Hatch-
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`Waxman cases, each proposed Herceptin® biosimilar is distinct and each defendant uses
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`different manufacturing processes. Specifically, the Hatch-Waxman Act provides that, the
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`proposed generic product must have the same active ingredient as the reference product. See 21
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`U.S.C. 355(j) (requiring, inter alia, “information to show that the active ingredients of the new
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`drug are the same as those of the listed drug”). Conversely, the Biologics Price Competition and
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`Innovation Act (“BPCIA”) merely requires a showing that the proposed biosimilar product is
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`“highly similar” to the reference product. See 42 U.S.C. §§ 262(i)(2)(A). Consequently, each
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`defendant likely has a unique manufacturing process resulting in differences in each product.
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`Each defendant’s non-infringement arguments will therefore be guided by the particulars
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`of its biosimilar product and manufacturing process. Indeed, 9 of the 18 patents presently
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`asserted against Amgen are related to manufacturing processes; Amgen will therefore likely have
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`unique positions with respect to at least half of the Asserted Patents. Genentech will likely have
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`distinct grounds for alleged infringement. Depending on the extent to which the defendants seek
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`to carve out indications in their respective proposed labels, arguments related to the 8 patents that
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`claim methods of treatment may also be different. The defendants may also have distinct
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`theories of invalidity. Additionally, the extent of overlap among the patents asserted against
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`Pfizer, Celltrion, and Amgen is far from complete. Genentech currently asserts four patents
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`against Amgen but not Pfizer,1 six patents against Pfizer but not Amgen,2 and 22 patent against
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`Celltrion but not Amgen.3 At the very least, coordination is premature because it is unclear
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`which Asserted Patents will remain in suit against Amgen following patent narrowing.
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`Despite the foregoing, Amgen is amenable to coordination with respect to a Markman
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`hearing as it provides a unique opportunity for efficiency. Amgen proposes that claim
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`construction exchanges begin November 7, 2018 and the hearing be scheduled for February
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`1 These four patents are U.S. Patent Nos. 6,417,335; 6,620,918; 8,512,983; 9,714,293.
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` 2
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` These six patents are U.S. Patent Nos. 6,242,177; 6,339,142; 6,610,516; 7,485,704; 7,807,799;
`8,314,225.
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` 3
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` Amgen notes that Plaintiffs have represented that they will soon dismiss 18 of those 22 patents
`from the Celltrion case. Plaintiffs further anticipate dismissing U.S. Patent Nos. 8,512,983 and
`9,714,293 (which are asserted in this case) from the Celltrion case.
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`2019. Pfizer and Celltrion have proposed a claim construction hearing in December 2018, with
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`the initial exchange of lists of terms to be construed on September 12, 2018. See C.A. No. 17-
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`1672-GMS, D.I. 34, Feb. 12, 2018 Joint Status Report at 13-14; C.A. No. 18-095-GMS, D.I. 46,
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`Aug. 6, 2018 Joint Status Report at 23. Amgen believes that its proposed timeline is more
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`reasonable in view of the current posture of the cases and the threshold need for Plaintiffs to
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`narrow the number of asserted patents and claims prior to claim construction (see infra p. 11). In
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`any event, Amgen supports one common claim construction hearing schedule among the three
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`pending cases.
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`Amgen proposes a trial date of February 2020. Plaintiffs have had access to Defendants’
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`BLA FDA submission and confidential manufacturing information for over ten months, since
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`October 13, 2017, and the parties have already exchanged initial infringement and invalidity
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`contentions on each of the asserted patents as part of the BPCIA information exchange.4 Thus
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`this case is already far ahead of where an ordinary pharmaceutical case would be at the close of
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`pleadings. Indeed, as set forth infra, the parties agree to forgo initial discovery under the
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`Delaware Default Discovery Standard in this case in light of previously exchanged contentions.
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`The parties should not have any issue completing the remainder of pretrial activities within 15
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`months. The February 2020 trial date serves the purposes of efficiency and expediency.
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`b.
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`Amgen’s Product Launch
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`Plaintiffs’ Position
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`Subject to the Court’s approval, Plaintiffs have proposed a schedule with a trial date of
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`April 2020. Plaintiffs believe that this trial date is only feasible if Amgen does not launch its
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`biosimilar product until after the entry of judgment following trial, which would simplify the
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`4 42 U.S.C. § 262(l)(3)(B), (C).
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`Case 1:18-cv-00924-CFC-SRF Document 29 Filed 09/04/18 Page 9 of 20 PageID #:
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`issues in this case in several respects—for example, by avoiding separate proceedings regarding
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`a preliminary injunction and eliminating the issue of damages for past infringement. In addition,
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`because damages would not be at issue, this case could proceed with a bench trial and avoid the
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`burden of pretrial summary judgment. If Amgen launches its biosimilar product, the case
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`schedule will need to be adjusted to allow for damages discovery and possible preliminary
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`injunction proceedings.
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`Defendant’s Position
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`Amgen respectfully urges that the case schedule and trial date should not be dependent on
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`whether or not Amgen launches its product. Amgen’s biosimilar product has not yet been
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`approved by the FDA, and thus it is premature to consider a potential product launch in planning
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`for trial. Amgen further disagrees with Plaintiffs’ position that a trial date of April 2020 is
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`feasible only if Amgen decides to launch its product after the entry of judgment following trial.
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`Plaintiffs are improperly advocating for a de facto injunction through their scheduling proposal.
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`If Plaintiffs want the Court to enter judgment prohibiting Amgen from commercial marketing of
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`ABP980 before April 2020, Plaintiffs should use the procedure contemplated by the BPCIA—a
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`motion for preliminary injunction based on alleged patent infringement. Furthermore, Amgen
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`believes that its proposed trial date of February 2020 is appropriate to resolve all of the legal
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`disputes concerning the Asserted Patents, particularly considering that the parties are working to
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`narrow the number of patents and claims.
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`c.
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`Summary Judgment
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`Plaintiffs’ Position
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`If Amgen does not launch its product prior to trial, Plaintiffs believe that including
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`summary judgment in the schedule is not necessary, consistent with the Court’s practice in bench
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`trials and in an effort to reduce the burden on the Court and the parties.
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`Defendant’s Position
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`Amgen respectfully requests that the Court include deadlines for Summary Judgment in
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`the schedule because Amgen believes there are numerous patents and claims among the 18
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`Asserted Patents that Genentech has no reasonable basis to assert under the circumstances. In
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`the event that the Parties determine that the case requires a jury trial, summary judgment will be
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`appropriate. Amgen has provided deadlines for Summary Judgment to account for that
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`possibility.
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`d.
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`Default Standard for Discovery
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`The parties believe that it is appropriate in this case to forgo the initial discovery in patent
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`litigation provided under Paragraph 4 of the Delaware Default Discovery Standard. The parties
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`propose that any final supplementation of contentions occur by the close of fact discovery.
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`Additionally, the parties expect to file a joint Document Production Protocol to replace the
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`Delaware Default Discovery Standard in its entirety.
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`e.
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`Narrowing the Number of Asserted Patents and Claims
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`Plaintiffs’ Position:
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`Plaintiffs have already significantly narrowed the number of asserted patents through the
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`parties’ exchanges under the BPCIA and believe that no further case narrowing is warranted at
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`this time. Plaintiffs initially filed this litigation with 37 patents-in-suit, but then were able to
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`reduce the number of asserted patents to 18 based upon the information exchanges under the
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`BPCIA. And there are commonalities among the asserted patents that Plaintiffs believe make
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`this case manageable without further case narrowing. For example, several of the asserted
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`patents are related patents that share a common specification (e.g., U.S. Patent Nos. 7,993,834,
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`8,076,066, and 8,440,4020). Moreover, several of the asserted patents will expire over the next
`10
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`several months and may drop out of the case (e.g., U.S. Patent Nos. 6,121,428, 8,425,908,
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`6,331,415, and 7,923,221) provided that Amgen does not engage in any activity in the United
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`States that would give rise to a claim of past damages prior to their expiration.
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`Plaintiffs disagree with Amgen’s position that Plaintiffs should narrow the case to eight
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`patents and 20 claims by October 29, 2018. In citing the BPCIA’s information exchange
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`procedures as reason for Plaintiffs to further narrow the number of patents in this case, Amgen
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`ignores that it was through the BPCIA information exchange that Plaintiffs were able to narrow
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`the number of patents at issue from 37 to 18 in this case. Further, Amgen’s biosimilar is still
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`subject to change. On June 5, 2018, Amgen announced that it had received a complete response
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`letter from the FDA, which has delayed the approval timeline for Amgen’s Herceptin biosimilar
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`product and which has also raised the possibility that Amgen may be required to change its
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`product or the label therefore in order to obtain FDA approval. Any resubmission by Amgen in
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`response to the complete response letter will inform Plaintiffs’ infringement allegations in this
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`case, and may affect the number of patents and claims at issue in this case. Further, Amgen’s
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`proposed deadline of October 29, 2018 to narrow the number of patents and claims is not
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`feasible since discovery, which has not yet begun, will be needed to assess the foregoing issues.
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`Also contrary to Amgen’s assertions, Amgen’s proposal is not consistent with this
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`Court’s recent order in Plaintiffs’ case against Amgen’s proposed biosimilar bevacizumab
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`product. Rather, in the Amgen bevacizumab cases, such order was entered only after the parties
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`had engaged in several months of discovery. See Genentech, Inc. et al. v. Amgen Inc., C.A. No.
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`17-1407-GMS (D. Del.) (D.I. 66 (discovery requests served February 1, 2018), D.I. 70
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`(discovery requests served February 8, 2018), D.I. 106 (scheduling order entered May 18,
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`2018).) Amgen’s proposal that Plaintiffs narrow the number of patents and claims in this case by
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`October 29, 2018, less than 60 days from now, is untenable where the parties first served written
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`discovery requests earlier this week, and where Amgen will not agree to wait to launch its
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`proposed biosimilar product until after trial.
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`Finally, dismissing patents from a BPCIA litigation potentially has significant
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`consequences for the remedies that Plaintiffs may seek. Plaintiffs believe that an order requiring
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`Plaintiffs to unilaterally abandon their infringement claims for certain patents—without any
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`commitment by Amgen not to launch their product prior to the expiration of those patents, and
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`without significant discovery—would be an unconstitutional taking of Plaintiffs’ property rights
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`and would violate principles of due process. See In re Katz Interactive Call Processing Pat.
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`Litig., 639 F. 3d 1303, 1311-1313 (Fed. Cir. 2011).
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`Defendant’s Position:
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`The BPCIA’s information exchange procedures include mechanisms designed to narrow
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`the scope of the parties’ patent disputes prior to the commencement of any litigation. Sandoz,
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`Inc. v. Amgen Inc., 137 S. Ct. 1664, 1670-72; Amgen Inc. v. Sandoz, Inc., 794 F.2d 1357, 1352
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`(Fed. Cir. 2015) (“The BPCIA also established a unique and elaborate process for information
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`exchange between the biosimilar applicant and the RPS to resolve patent disputes.”). Pursuant to
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`the BPCIA, on October 13, 2017, Amgen produced hundreds of thousands of pages of highly
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`detailed information about its product and manufacturing processes. On February 13, 2018,
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`Amgen served over 1,400 pages of detailed non-infringement, invalidity, and/or unenforceability
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`contentions for 745 claims.
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`In response, Plaintiffs served infringement contentions for 297 claims pursuant to 42
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`U.S.C. § 262(l)(3)(C). During the August 23, 2018 telephone conference, Plaintiffs stated that
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`they does not intend to assert any claims for which it did not provide contentions. However,
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`Case 1:18-cv-00924-CFC-SRF Document 29 Filed 09/04/18 Page 13 of 20 PageID #:
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`Plaintiffs’ First Amended Complaint puts at issue 459 claims across the 18 Asserted Patents
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`(including 162 claims for which infringement contentions were not provided in Plaintiffs’ (3)(C)
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`disclosure). The scope of litigation that Plaintiffs seek is too unwieldy for pre-trial and trial
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`purposes. Plaintiffs therefore should identify a narrower set of claims it seeks to assert.
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`To this end, Amgen proposes to further narrow and focus the case by requiring Plaintiffs
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`to identify no more than eight (8) Asserted Patents and twenty (20) Asserted Claims by October
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`29, 2018. This proposed deadline would provide the parties with certainty regarding the scope of the
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`case prior to claim construction briefing and the exchange of expert reports. Plaintiffs’ selection of
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`claims may be informed by a number of sources: (1) Amgen’s prior extensive production of
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`information relating to Herceptin® made during the BPCIA’s information exchange under 42
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`U.S.C. § 262(l)(2)(A) (hundreds of thousands of pages); (2) Amgen’s February 13, 2018, non-
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`infringement, invalidity, and unenforceability contentions under 42 U.S.C. § 262(l)(3)(B); and
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`(3) additional fact discovery. Amgen’s proposal for narrowing is consistent with this Court’s recent
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`order in Plaintiffs’ case against Amgen’s proposed biosimilar bevacizumab product. In that case, this
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`Court ordered Plaintiffs to narrow the number of asserted patents from 26 to no more than 8, and to
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`narrow the number of asserted claims to no more than 20. See Genentech, Inc. et al. v. Amgen Inc.,
`
`C.A. No. 17-1407-GMS (D. Del.) (D.I. 106); Genentech, Inc. et al. v. Amgen Inc., C.A. No. 17-1471-
`
`GMS (D. Del.) (D.I. 104). Amgen believes that a similar schedule for narrowing the Asserted
`
`Patents and Asserted Claims is appropriate here, given the significant number of patents and claims
`
`that will remain even after the 162 concededly non-infringed claims are dismissed.
`
`5.
`
`Relief: What specific relief does plaintiff seek? What is the amount of
`damages sought and generally how is it computed?
`
`Plaintiffs seek a judgment of infringement and willfulness; equitable relief, including a
`
`permanent injunction prohibiting Amgen and anyone acting in concert with Amgen from
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`ME1 28033285v.1
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`Case 1:18-cv-00924-CFC-SRF Document 29 Filed 09/04/18 Page 14 of 20 PageID #:
`3350
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`infringing the Asserted Patents; a determination that this is an exceptional case and an award of
`
`Plaintiffs’ reasonable attorney fees, costs, and expenses; and such other relief as the Court may
`
`deem just and proper.
`
`Amgen seeks a judgment that all claims asserted by Plaintiffs are invalid, unenforceable,
`
`and not infringed; judgments that this is an exceptional case and an award of Amgen’s
`
`reasonable attorney fees, costs, and expenses; and such other relief as the Court may deem just
`
`and proper.
`
`6.
`
`Amendments of Pleadings
`
`Plaintiffs’ Position
`
`As discussed above, Plaintiffs have previously amended the Complaint to remove certain
`
`patents from the litigation. The parties have proposed a deadline in the case schedule for
`
`amended pleadings.
`
`Defendant’s Position
`
`As set forth above, dismissal of the 162 claims for which Plaintiffs have identified no
`
`basis for infringement is a necessary first step to narrowing this case. Amgen respectfully
`
`submits that Plaintiffs should also amend their Complaint to further narrow the number of
`
`Asserted Patents to no more than 8 patents and 20 Asserted Claims. Amgen concurs in the
`
`proposed deadline for amended pleadings.
`
`7.
`
`Joinder of Parties
`
`At this time, the parties do not intend to move to join any additional parties. However, as
`
`set forth in the parties’ proposed case schedule, the parties have proposed that a deadline be set
`
`for joinder of parties.
`
`8.
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`ME1 28033285v.1
`
`Discovery: Discovery contemplated by each party and the amount of
`time it may take to complete discovery? Can discovery be limited? Are
`less costly and time consuming methods available to obtain necessary
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`Case 1:18-cv-00924-CFC-SRF Document 29 Filed 09/04/18 Page 15 of 20 PageID #:
`3351
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`information?
`
`Plaintiffs’ Position:
`
`Plaintiffs reiterate their position that coordination with other cases involving proposed
`
`Herceptin® biosimilar products will allow common issues in these cases to be addressed
`
`consistently, fairly, and efficiently.
`
`Defendant’s Position:
`
`
`
`Amgen reiterates its position that coordination with other cases involving proposed
`
`Herceptin® biosimilar products (with the exception of claim construction) is not appropriate at
`
`this time, in view of anticipated differences in asserted patents, accused processes and products,
`
`claims, and arguments.
`
`Amgen is open to having a trial after the Pfizer and Celltrion cases, as long as (1) Amgen
`
`is not prejudiced by any estoppel or issue preclusion based on the determinations in the other
`
`cases and (2) if this becomes a jury case, the judgments in any prior case are excluded from
`
`evidence – the jury is shielded from any verdicts or rulings from the Pfizer and Celltrion cases.
`
`The Parties’ Position:
`
`The parties currently contemplate taking fact and expert discovery regarding the issues
`
`identified in Paragraph 3. The parties agree to negotiate in good faith to propose appropriate
`
`limits on discovery. To the extent that discovery in this case is coordinated with the other cases
`
`involving proposed Herceptin biosimilar products, the parties will propose appropriate limits on
`
`discovery after conferring with all parties to these cases.
`
`The parties’ proposed case schedules are set forth below:
`
`
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`ME1 28033285v.1
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`Case 1:18-cv-00924-CFC-SRF Document 29 Filed 09/04/18 Page 16 of 20 PageID #:
`3352
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`Event
`
`Genentech Proposed
`Deadline
`
`Amgen Proposed
`Deadline
`
`Exchange Rule 26(a) Initial Disclosures
`
`Friday, August 31,
`2018
`
`Friday, August 31,
`2018
`
`Parties File Joint Proposed Protective
`Order
`
`Friday, September 14,
`2018
`
`Friday, September 14,
`2018
`
`Disclosure of Reliance on Advice of
`Counsel and, If Defendant Intends to
`Rely on Advice of Counsel, Production
`of Advice of Counsel Documents
`Complete
`
`Monday, November
`19, 2018
`
`Friday, March 1, 2019
`
`Joinder of Other Parties or Amendment
`of Pleadings
`
`Friday, January 4,
`2019
`
`January 4, 2019
`
`Plaintiffs Identify No More Than Eight
`(8) Asserted Patents and Twenty (20)
`Claims
`
`Exchange List of Terms to be Construed
`
`N/A
`
`Monday, October 29,
`2019
`
`Friday, February 8,
`2019
`
`Wednesday,
`November 7, 2018
`
`Exchange List of Proposed Constructions
`
`Friday, February 15,
`2019
`
`Wednesday,
`November 14, 2018
`
`Meet and Confer to Narrow Claim
`Construction Disputes
`
`Friday, February 22,
`2019
`
`Wednesday,
`November 28, 2018
`
`File Final Joint Claim Construction Chart
`
`Friday, March 1, 2019
`
`Wednesday,
`December 5, 2018
`
`Substantial Completion of Document
`Production
`
`Friday, March 15,
`2019
`
`Friday, December 14,
`2018
`
`Simultaneous Opening Claim
`Construction Briefs
`
`Friday, March 22,
`2019
`
`Wednesday, January
`16, 2019
`
`Simultaneous Answering Claim
`Construction Briefs
`
`Friday, April 19, 2019 Wednesday, January
`30, 2019
`
`Claim Construction Hearing
`
`May __, 2019
`
`February __, 2019
`
`Final Contentions
`
`ME1 28033285v.1
`
`Friday, August 16,
`2019
`
`Friday, April 12, 2019
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`Case 1:18-cv-00924-CFC-SRF Document 29 Filed 09/04/18 Page 17 of 20 PageID #:
`3353
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`Event
`
`Close of Fact Discovery
`
`Genentech Proposed
`Deadline
`
`Amgen Proposed
`Deadline
`
`Friday, August 16,
`2019
`
`Friday, April 12, 2019
`
`Opening Expert Reports on Issues on
`Which a Party Bears the Burden of Proof
`
`Friday, September 20,
`2019
`
`Friday, May 31, 2019
`
`Rebuttal Expert Reports
`
`Friday, November 22,
`2019
`
`Friday, July 19, 2019
`
`Reply Expert Reports
`
`N/A
`
`Friday, August 9, 2019
`
`Close of Expert Discovery
`
`Friday, January 17,
`2020
`
`Friday, September 6,
`2019
`
`Last Day to Notify Other Party of Intent
`to File Dispositive Motions
`
`N/A
`
`Friday, September 20,
`2019
`
`Plaintiffs Draft Pretrial Order
`
`Friday, February 7,
`2020
`
`SIMULTANEOUS
`EXCHANGE
`
`Friday, October 11,
`2019
`
`Joint Proposed Pretrial Order
`
`Friday, February 28,
`2020
`
`Friday, November 1,
`2019
`
`Pretrial Conference
`
`March __, 2020
`
`November __, 2019
`
`Trial (Bench or Jury)
`
`April __, 2020
`
`February __, 2020
`
`
`
`
`
`9.
`
`Protective Order:
`
`In light of the expected production of confidential technical information in this case, the
`
`parties agree that a Protective Order needed. Amgen has provided Plaintiffs with a draft of the
`
`Protective Order, and is awaiting any revisions from Plaintiffs. The parties will identify any
`
`areas of disagreement to the Court and intend to file a Joint Proposed Protective Order by
`
`September 14, 2018.
`
`Until such time as a protective order is entered by the Court, the Court’s default
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`ME1 28033285v.1
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`17
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`

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`Case 1:18-cv-00924-CFC-SRF Document 29 Filed 09/04/18 Page 18 of 20 PageID #:
`3354
`
`confidentiality provision under Local Rule 26.2 shall control.
`