Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 1 of 41 PageID #: 945
`
`
`v.
`
`C.A. No. 17-1672-CFC
`
`PFIZER INC.,
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE, )
`)
`Plaintiffs and Counterclaim Defendants, )
`)
`)
`)
`)
`)
`)
`)
`
`Defendant and Counterclaim Plaintiff.
`
`
`
`C.A. No. 18-95-CFC
`
`C.A. No. 18-924-CFC
`
`
`GENENTECH, INC., CITY OF HOPE, and )
`HOFFMANN LA ROCHE INC.,
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`Defendants and Counterclaim Plaintiffs. )
`)
`
`Plaintiffs and Counter Defendants,
`
`v.
`
`CELLTRION, INC., CELLTRION,
`HEALTHCARE CO., LTD., TEVA
`PHARMACEUTICALS USA, INC., and
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH,
`
`
`
`
`GENENTECH, INC. and CITY OF HOPE, )
`)
`Plaintiffs and Counterclaim Defendants, )
`)
`)
`)
`)
`)
`)
`)
`
`v.
`
`
`AMGEN, INC.,
`
`Defendant and Counterclaim Plaintiff.
`
`
`
`1
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`

`

`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 2 of 41 PageID #: 946
`
`
`GENENTECH, INC., CITY OF HOPE, and )
`HOFFMANN LA ROCHE INC.,
`)
`)
`Plaintiffs and Counterclaim Defendants, )
`)
`)
`)
`)
`)
`)
`)
`)
`)
`Defendants and Counterclaim Plaintiffs. )
`)
`
`v.
`
`CELLTRION, INC., CELLTRION,
`HEALTHCARE CO., LTD., TEVA
`PHARMACEUTICALS USA, INC., and
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH,
`
`
`
`Plaintiffs,
`
`v.
`
`SAMSUNG BIOEPIS CO., LTD,
`
`C.A. No. 18-1025-CFC
`
`C.A. No. 18-1363-CFC
`
`
`GENENTECH, INC. and CITY OF HOPE, )
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Defendant.
`
`
`
`JOINT STATUS REPORT
`
`Pursuant to the Court’s September 28, 2018 order, the parties in the above-
`
`
`
`
`
`captioned cases submit the following joint status report.
`
`I.
`
`Case Schedule
`
`On September 17, 2018, the Court entered a coordinated schedule for claim
`
`construction and fact discovery in the above-captioned cases. The parties have
`
`2
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`

`

`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 3 of 41 PageID #: 947
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`subsequently discussed a proposed case schedule through trial, and their respective
`
`positions are set forth below.
`
`Plaintiffs’ and Defendants’ respective proposed case schedules are set forth
`
`in the table below. Dates shown in bold have been ordered pursuant to the Court’s
`
`September 17, 2018 Scheduling Order.
`
`3
`
`

`

`
`
`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 4 of 41 PageID #: 948
`
`Event
`
`Plaintiffs to identify
`no more than 8
`asserted patents and 20
`asserted claims for
`claim construction in
`each case
`Parties to exchange
`list of terms to be
`construed in each
`case
`Exchange List of
`Proposed
`Constructions
`Meet and Confer to
`Narrow Claim
`Construction
`Disputes
`File Final Joint
`Claim Construction
`Chart
`
`Plaintiffs’
`Proposed
`Deadline
`
`Pfizer and
`Celltrion/Teva’s
`Proposed Deadline
`
`Amgen’s
`Proposed
`Deadline
`
`Samsung’s
`Proposed
`Deadline
`
`
`
`Friday, October 26, 2018
`
`Wednesday, November 7, 2018
`
`Wednesday, November 14, 2018
`
`Wednesday, November 28, 2018
`
`Wednesday, December 5, 2018
`
`4
`
`

`

`
`
`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 5 of 41 PageID #: 949
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`Event
`
`Joinder of Other
`Parties or Amendment
`of Pleadings
`Simultaneous
`Opening Claim
`Construction Briefs
`Substantial
`Completion of
`Document
`Production
`Simultaneous
`Answering Claim
`Construction Briefs
`Submission of Joint
`Appendix of Intrinsic
`Evidence
`
`Plaintiffs’
`Proposed
`Deadline
`Friday, January 4,
`2019
`
`Amgen’s
`Pfizer and
`Proposed
`Celltrion/Teva’s
`Deadline
`Proposed Deadline
`Thursday, November 15, 2018
`
`Samsung’s
`Proposed
`Deadline
`
`Monday, January 11, 2019
`
`Monday, January 14, 2019
`
`Friday, February 8, 2019
`
`Friday, February 15, 2019
`
`5
`
`

`

`
`
`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 6 of 41 PageID #: 950
`
`Event
`
`Disclosure of Reliance
`on Advice of Counsel
`and, If Defendant
`Intends to Rely on
`Advice of Counsel,
`Production of Advice
`of Counsel Documents
`Complete
`Claim Construction
`Hearing
`Final Contentions
`
`Close of Fact
`Discovery
`Opening Expert
`Reports on Issues on
`Which a Party Bears
`the Burden of Proof
`
`Plaintiffs’
`Proposed
`Deadline
`
`Pfizer and
`Celltrion/Teva’s
`Proposed Deadline
`
`Amgen’s
`Proposed
`Deadline
`
`Samsung’s
`Proposed
`Deadline
`
`Friday, March 1, 2019
`
`
`March 12, 2019
`
`Monday, May 13, 2019
`
`Monday, May 13, 2019
`
`Friday, July 19,
`2019
`
`Thursday, June 13, 2019
`
`Rebuttal Expert
`Reports
`
`Friday, September
`20, 2019
`
`Friday, July 19, 2019
`
`6
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`

`

`
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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 7 of 41 PageID #: 951
`
`Event
`
`Reply Expert Reports
`
`Plaintiffs’
`Proposed
`Deadline
`
`
`Pfizer and
`Celltrion/Teva’s
`Proposed Deadline
`
`
`Amgen’s
`Proposed
`Deadline
`Friday, August 9,
`2019
`
`Samsung’s
`Proposed
`Deadline
`
`
`Close of Expert
`Discovery
`
`Friday, November
`29, 2019
`
`Friday, August 30, 2019
`
`Last Day to Notify
`Other Party of Intent
`to File Dispositive
`Motions
`
`Plaintiffs’ Draft
`Pretrial Order
`
`
`
`
`
`
`N/A1
`
`Friday,
`September 6,
`2019
`
`Friday, January
`10, 2020
`
`Friday, September
`13, 2019
`
`Friday, October 18, 2019
`
`
`Joint Proposed Pretrial
`Order
`
`Friday, February
`7, 2020
`
`Friday, October 4,
`2019, 2019
`
`Pretrial Conference
`
`February __, 2020
`
`October __, 2019
`
`Friday, November 15, 2019
`
`
`November ___, 2019
`
`
`
`1 Amgen reserves the right to seek leave to file a dispositive motion.
`
`7
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`

`

`
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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 8 of 41 PageID #: 952
`
`Event
`
`Trial2
`
`Plaintiffs’
`Proposed
`Deadline
`March __, 2020
`
`Pfizer and
`Celltrion/Teva’s
`Proposed Deadline
`October 28, 2019
`
`Amgen’s
`Proposed
`Deadline
`December 2,
`2019
`
`Samsung’s
`Proposed
`Deadline
`December __,
`2019
`
`
`
`2 Amgen expects a bench or jury trial.
`
`8
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`

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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 9 of 41 PageID #: 953
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`Plaintiffs’ Position
`
`
`
`These cases are actions for patent infringement against four defendant
`
`groups: (1) Pfizer; (2) Celltrion and Teva; (3) Amgen; and (4) Samsung Bioepis.
`
`The Defendants in these cases are seeking FDA approval of a biosimilar version of
`
`Genentech’s anti-cancer drug Herceptin. Because these cases involve biosimilar
`
`versions of the same biologic drug, there is significant overlap in the patents
`
`currently asserted in each case. There are thirteen patents that are asserted against
`
`all Defendants, and all but two of the patents-in-suit are asserted against multiple
`
`Defendants.3
`
`Prior to these cases being transferred to Your Honor’s docket, Judge Sleet
`
`held a hearing on September 6, 2018 during which he placed these cases on a
`
`coordinated schedule for claim construction and fact discovery. Judge Sleet
`
`reserved addressing the remaining dates in the case schedule until the cases were
`
`reassigned to Your Honor.
`
`For efficiency and consistency, Plaintiffs believe that the Court should now
`
`enter a coordinated schedule across these cases for expert discovery and the
`
`remainder of the pretrial deadlines. For example, Plaintiffs expect that they will
`
`rely upon many of the same expert witnesses in each of these cases, and as a result,
`
`
`3
`The parties are negotiating a stipulation in the Celltrion matters (C.A. Nos.
`18-95-CFC, 18-1025-CFC) to dismiss 22 of the patents-in-suit.
`9
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`

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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 10 of 41 PageID #: 954
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`it would not be practical or efficient for these cases to proceed on separate
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`schedules. As Judge Sleet explained at the September 6, 2018 hearing, an overall
`
`coordinated pretrial schedule for these cases would promote judicial efficiency.
`
`See, e.g., Sept. 6, 2018 Hr’g Tr. 38:10-39:3; id. at 80:16-18 (“[I]f we’re going to
`
`coordinate, I would hope that there would be overall coordination, and that the
`
`dates would be the same [across all cases].”).
`
`Plaintiffs have proposed a coordinated pretrial schedule across these cases
`
`that would have them ready for a bench trial in March 2020. Plaintiffs believe that
`
`the structure of the trial (e.g., whether or not these cases are consolidated for trial
`
`in whole or in part) should be addressed at a later date when the issues for trial
`
`have crystallized.
`
`The FDA has not approved any of the Defendants’ proposed biosimilar
`
`products, and Defendants therefore are not yet able to bring their biosimilar
`
`products to market. Based on the current state of these cases, Plaintiffs are not
`
`asserting a claim of past damages, and these cases may therefore be decided by a
`
`bench trial without including pretrial summary judgment motions in the case
`
`schedule. Moreover, Plaintiffs believe that the proposed case schedules are
`
`feasible only if the Defendants do not launch their proposed biosimilar product
`
`prior to trial, which eliminates the need for damages discovery and preliminary
`
`injunction proceedings. If any of the Defendants launch their Herceptin biosimilar
`
`10
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`

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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 11 of 41 PageID #: 955
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`prior to trial, Plaintiffs believe that the case schedule would need to be adjusted to
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`account for the additional issues that a pretrial launch would raise so that all
`
`infringement, validity, and damages issues for that Defendant could be addressed
`
`together in a single jury trial.
`
`Although Defendants assert that a Court-ordered case schedule should not be
`
`conditioned on requiring Defendants to refrain from launching their products prior
`
`to trial, they cannot deny that a pre-trial launch by any Defendant will necessarily
`
`insert these additional issues into the case (e.g., preliminary injunction and
`
`summary judgment motions, as well as damages issues and whether the cases will
`
`be tried to a court or jury) that would delay a final adjudication. Defendants offer
`
`no provisions as to how these issues will be inserted into the case, and inserting
`
`them would be particularly unfeasible in context of the accelerated schedules
`
`proposed by Defendants. If Defendants truly wish to efficiently litigate the cases,
`
`then they too should consider how they can affirmatively narrow the issues.
`
`In comparison to Plaintiffs’ proposed pretrial schedule, Celltrion and Pfizer
`
`propose a schedule resulting in a trial on October 28, 2019, and Amgen and
`
`Samsung propose schedules with trials in December 2019. Plaintiffs note that
`
`Defendants’ proposals have accelerated the deadlines as previously proposed by
`
`Pfizer (Civ. No. 17-01672, Dkt. 34, proposing a bench trial by December 2019),
`
`and Amgen (Civ. No. 18-00924, Dkt. 29, proposing a bench trial by February
`
`11
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`

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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 12 of 41 PageID #: 956
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`2020), and even though the Court set a claim construction hearing for March 12,
`
`2019, which is after the dates for claim construction hearing previously proposed
`
`by Celltrion (Civ. No. 18-00095, Dkt. 46, proposing December 2018), Pfizer (Civ.
`
`No. 17-01672, Dkt. 34, proposing December 2018), and Amgen (Civ. No. 18-
`
`00924, Dkt. 29, proposing February 2019).
`
`Defendants’ Positions
`
`All Defendants submit that the Court-ordered case schedule should not be
`
`conditioned on requiring Defendants to refrain from launching their products prior
`
`to trial. All Defendants further submit that Plaintiffs should be required to narrow
`
`the respective cases to assert no more than 8 patents and 20 asserted claims against
`
`each Defendant Group by no later than October 26, 2018. All Defendants have
`
`agreed on proposed dates for opening and rebuttal expert reports and for the close
`
`of expert discovery.
`
`Amgen’s Position
`
`Amgen agrees with the overall objective to create efficiencies across the four
`
`separate lawsuits that Genentech has filed. Nonetheless it is important to
`
`appreciate that these cases brought under the Biologics Price Competition and
`
`Innovation Act (“BPCIA”), relating to biosimilar products, are fundamentally
`
`different from generics ANDA litigation brought under the Hatch-Waxman Act.
`
`Unlike generic drug products, which are identical to their reference product, each
`
`12
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`

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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 13 of 41 PageID #: 957
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`proposed Herceptin biosimilar is distinct, and each defendant uses different
`
`manufacturing processes. Non-infringement positions will thus involve distinct,
`
`defendant-specific confidential information. These distinctions will likely be
`
`relevant for at least nine of the eighteen patents asserted against Amgen, which
`
`relate to manufacturing processes. In addition, depending on the extent to which
`
`the defendants seek to “carve out” indications in their respective proposed labels,
`
`arguments related to the 8 patents that claim methods of treatment may also be
`
`different. Moreover, Genentech currently asserts four patents against Amgen but
`
`not Pfizer, six patents against Pfizer but not Amgen, and 22 patents against
`
`Celltrion but not Amgen.4 Accordingly, it is inappropriate to presume that
`
`coordination will lead to efficiency or conservation of resources. Amgen urges
`
`restraint in trying to fit this BPCIA case into any mold of consolidated Hatch-
`
`Waxman/ANDA cases.
`
`Amgen submits that case coordination is further complicated by the inter
`
`partes reviews (“IPRs”) pursued by the other defendants related to patents in these
`
`proceedings. Because, following a final written decision, the instituted IPRs could
`
`estop the other defendants from pursuing prior art invalidity defenses that they
`
`reasonably could have brought in their IPR petitions, the defendants’ invalidity
`
`
`4 Although Genentech has claimed that it intends to dismiss some patents against
`Celltrion, that has not yet come to pass.
`
`13
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`

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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 14 of 41 PageID #: 958
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`defenses are also likely to vary substantially. Amgen has not filed any IPR
`
`challenges to the patents asserted against it and is not subject to any possible IPR
`
`estoppel. On the other hand, the other defendants may be estopped as to six of the
`
`eighteen patents asserted against Amgen, as summarized in the chart below:
`
`ASSERTED PATENT
`
`USPN 6,407,213
`
`USPN 7,371,379
`
`USPN 6,627,196
`
`USPN 7,846,441
`
`USPN 7,892,549
`
`USPN 9,249,218
`
`IPR PROCEEDINGS INITIATED BY ONE OR MORE
`DEFENDANTS
`IPR2017-2139 (Samsung); IPR2017-2140
`(Samsung); IPR2017-1488 (Pfizer); IPR2017-1489
`(Pfizer); IPR2017-1374 (Celltrion); IPR2017-1373
`(Celltrion)
`
`IPR2017-1959 (Samsung); IPR2017-1140
`(Celltrion); IPR2017-805 (Pfizer/Hospira)
`IPR2017-1958 (Samsung); IPR2017-1139
`(Celltrion); IPR2017-804 (Pfizer/Hospira)
`IPR2017-2063 (Pfizer); IPR2017-1121 (Celltrion);
`IPR2017-731 (Pfizer/Hospira)
`
`IPR2017-1960 (Samsung); IPR2017-1122
`(Celltrion); IPR2017-737 (Pfizer/Hospira)
`IPR2017-2020 (Pfizer)
`
`For the foregoing reasons, “coordination” may lead to greater inefficiencies
`
`for defendants while diminishing the presumptive rights provided by the Federal
`
`Rules of Civil Procedure, for example: (1) significant portions of deposition
`
`testimony may be relevant to only one party but other parties may be obligated to
`
`participate; (2) defendants may be prejudiced by being forced to share deposition
`
`time with competitors who have very different issues to pursue during the
`
`deposition because of differences between manufacturing processes, marketing
`
`14
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`

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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 15 of 41 PageID #: 959
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`plans, launch plans, and regulatory issues; (3) coordination for briefing,
`
`depositions, and hearings may create additional risk that defendants’ highly
`
`confidential information will be disclosed to competitors; (4) defendants may
`
`waste time and resources coordinating on filings, briefing, hearings, and
`
`depositions that are not relevant to a particular defendant; (5) in view of possible
`
`IPR estoppel, defenses maybe different and the court may be required to treat the
`
`defendants differently with respect to the estoppel, while avoiding unfair prejudice
`
`to non-estopped defendants.
`
`Amgen further respectfully urges that the case schedule and trial date should
`
`not be dependent on whether or not Amgen launches its product. Amgen’s
`
`biosimilar product has not yet been approved by the FDA, and thus it is premature
`
`to consider a potential product launch in planning for trial. Amgen disagrees with
`
`Plaintiffs’ position that its proposed trial date of March 2020 is feasible only if
`
`Amgen decides to launch its product after the entry of judgment following trial.
`
`Plaintiffs are improperly advocating for a de facto injunction through their
`
`scheduling proposal. If Plaintiffs want the Court to enter judgment prohibiting
`
`Amgen from commercial marketing of ABP 980 before March 2020, Plaintiffs
`
`should use the procedure contemplated by the BPCIA—a motion for preliminary
`
`injunction based on alleged patent infringement.
`
`15
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`

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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 16 of 41 PageID #: 960
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`With these considerations in mind, Amgen agrees to a pre-trial schedule
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`consistent with that of the other defendants, with the exception that Amgen seeks a
`
`deadline for Reply Expert Reports in accordance with the Court’s standing case
`
`management schedule. Amgen further seeks a separate trial from the other
`
`defendants beginning on or about December 2, 2019. At this time, based on the 18
`
`asserted patents, Amgen anticipates that the trial would require 3 weeks. If
`
`Genentech narrows the case to 8 patents, Amgen anticipates the trial would require
`
`2 weeks.
`
`Celltrion/Teva and Pfizer’s Position
`
`Celltrion/Teva and Pfizer submit that the cases against all defendants can be
`
`trial ready within one year, and therefore respectfully request a trial date in late
`
`October 2019. Plaintiffs have had access to the parties’ aBLA submissions since
`
`prior to filing of the complaints, and the parties have already exchanged extensive
`
`infringement and invalidity contentions on each of the asserted patents as part of
`
`the pre-suit BPCIA exchanges. The BPCIA framework includes a set of pre-suit
`
`information disclosures. Those disclosures begin when the biosimilar applicant
`
`provides “a copy of the application submitted to the Secretary under subsection (k),
`
`and such other information that describes the process or processes used to
`
`manufacture the biological product that is the subject of such application.” See 42
`
`U.S.C. § 262(l)(2). The BPCIA then states that the reference product sponsor (in
`
`16
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`

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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 17 of 41 PageID #: 961
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`the above-captioned cases, Genentech, Inc.) shall provide a list of all the patents it
`
`believes “could reasonably be asserted” against the proposed biosimilar (the “3(A)
`
`List”). 42 U.S.C. § 262(l)(3)(A). In response, the biosimilar applicant must
`
`provide “a detailed statement that describes, on a claim by claim basis, the factual
`
`and legal basis of the opinion” that each patent “is invalid, unenforceable, or will
`
`not be infringed” by the commercial marketing of the biosimilar product (the “3(B)
`
`Statement”). 42 U.S.C. § 262(l)(3)(A). The reference product sponsor in turn
`
`must respond with a reciprocal “detailed statement that describes,” for each patent
`
`substantively addressed in the 3(B) Statement, “the factual and legal basis of the
`
`opinion” that each patent will be infringed, as well as a “response to the statement
`
`concerning validity and enforceability” (the “3(C) Statement”). 42 U.S.C.
`
`§ 262(l)(3)(C). Teva/Celltrion, Pfizer, and Plaintiffs have collectively exchanged
`
`thousands of pages of information and argument in their respective 3(B) and 3(C)
`
`Statements.
`
`Thus, these cases are already far ahead of where a generic “small molecule”
`
`patent case would be at the close of pleadings. Indeed, Plaintiffs and the
`
`Celltrion/Teva and Pfizer Defendants are in agreement to forego initial contentions
`
`under Paragraph 4 of the Delaware Default Standard for Discovery in this case in
`
`light of the exchange of pre-suit contentions.
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`17
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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 18 of 41 PageID #: 962
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`The parties should not have any issue completing the remainder of pretrial
`
`activities within one year. The critical date for determining a patent trial schedule
`
`is customarily the close of fact discovery, which has already been ordered by the
`
`Court to be May 13, 2019. In a typical case, the parties provide approximately 30
`
`days after the close of fact discovery for opening expert reports.5 Here, Plaintiffs
`
`seek double that amount of time for opening reports, and then seek the same
`
`unusually long span of two months between opening and opposition reports.
`
`Provided that Plaintiffs promptly and reasonably narrow the case in order to avoid
`
`wasting the parties’ and court’s resources on patents and claims that will not be in
`
`issue at trial, the lengthy delays between deadlines in Plaintiffs’ proposal are
`
`unnecessary.
`
`Moreover, while Plaintiffs are right that Celltrion’s aBLA has not yet been
`
`approved by the FDA, approval could come as early as December 2018. Pursuant
`
`to the Prescription Drug User Fee Act (PDUFA), the FDA sets target timelines for
`
`action on pending biosimilar applications. See Biosimilar Biological Product
`
`
`5 Indeed, it is not unheard of for the parties to agree upon an even shorter amount
`of time between the close of fact discovery and opening expert reports. In the
`cases Plaintiffs have asserted against Amgen involving the biologic drug
`bevacizumab (AVASTIN®), the parties proposed that opening expert reports be
`due only two weeks after the close of fact discovery. See Proposed Scheduling
`Order at 7-8, Genentech, Inc. v. Amgen Inc., C.A. Nos. 17-1407-CFC & 17-1471-
`CFC (D. Del. May 18, 2018) (close of fact discovery on July 25, 2019 and opening
`expert reports on August 8, 2019).
`
`18
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`

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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 19 of 41 PageID #: 963
`
`
`Reauthorization Performance Goals and Procedures Fiscal Years 2018 through
`
`2022, United States Food and Drug Administration available at
`
`https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsU
`
`FA/UCM521121.pdf. The FDA’s target date as applied to Celltrion and Teva
`
`means that FDA could grant approval as early as two months from now. If, as
`
`Plaintiffs propose, trial were scheduled for March 2020 rather than October 2019,
`
`the later trial date could significantly delay cancer patients’ access to
`
`Celltrion/Teva’s and Pfizer’s much needed, lower cost alternatives to
`
`HERCEPTIN®.
`
`Plaintiffs’ discussion of adjusting the case schedule before it is even set is
`
`premature. Celltrion/Teva and Pfizer submit that the case schedule should not
`
`depend on whether or not they launch their proposed trastuzumab product at some
`
`point prior to trial. Even if any of the Defendants were to ultimately launch prior
`
`to trial, trial on liability could proceed as scheduled. Depending upon the outcome
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`of the trial on the merits, damages could then be addressed in a subsequent,
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`bifurcated trial if needed. Moreover, there is no basis to condition the trial date on
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`refraining from launching their trastuzumab product.
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`Celltrion/Teva and Pfizer are agreeable to Plaintiffs’ suggestion that, at this
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`juncture, the case schedule does not need to include a date for pretrial summary
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`judgment motions. Similarly, although Celltrion/Teva and Pfizer believe that it
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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 20 of 41 PageID #: 964
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`makes sense to set a trial date now, they agree with Plaintiffs that the exact
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`structure of the trial (e.g., whether or not these cases are consolidated for trial in
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`whole or in part) can be revisited later in the case, once Plaintiffs narrow the
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`number of asserted patents and claims and the degree of overlap of asserted patents
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`between defendant groups can be ascertained.
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`Samsung Bioepis’s Position
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`
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`Plaintiffs recently filed their complaint against Samsung Bioepis
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`(“Bioepis”) on September 4, 2018, asserting 21 patents. Bioepis’s Answer is due
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`on November 19, 2018, pursuant to the parties’ stipulation regarding service (D.I.
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`13). Bioepis believes that the parties can complete claim construction and
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`discovery within one year, assuming Plaintiffs promptly agree to narrow the
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`number of asserted patents and claims in this case (discussed below in Section IV).
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`Accordingly, Bioepis has proposed trial beginning in December 2019.
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`Bioepis agrees with Plaintiffs that the structure of the trial should be
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`addressed at a later date, depending on the number of patents ultimately asserted in
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`each case and the degree of overlap of asserted patents. Bioepis does not agree
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`that Plaintiffs’ proposed trial date is feasible only if Defendants do not launch until
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`after the trial has concluded. Bioepis believes that the proposed pretrial schedule
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`and trial date is appropriate to resolve all legal disputes in this case, particularly if
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`Plaintiffs narrow the number of asserted patents and claims without further delay.
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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 21 of 41 PageID #: 965
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`II.
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`Pre-Launch Notice
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`Plaintiffs’ Position
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`As discussed above, none of the Defendants’ proposed biosimilar versions of
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`Herceptin have been approved by the FDA, and the parties’ proposed case
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`schedules have not built in time to address the additional issues that would be
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`presented in the event that a Defendant chooses to launch prior to trial (e.g.,
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`damages discovery and preliminary injunction proceedings).
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`At the September 6, 2018 hearing before Judge Sleet, Plaintiffs raised the
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`concern that, unless the Defendants are willing to represent that they will not
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`launch their biosimilar products prior to trial, that the Defendants should be
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`required to provide Plaintiffs with meaningful notice of their intention to launch
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`their product so that there can be an orderly process for seeking a preliminary
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`injunction against that launch. Judge Sleet recognized the importance of having
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`the Defendants provide meaningful pre-launch notice, but declined to set a specific
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`pre-launch notice requirement at the September 6, 2018 hearing. See Sept. 6, 2018
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`Hr’g Tr. 34:24-35:9 (“I should think that should be pretty easy for the parties to
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`agree upon. I know there is a difference of view on this, but certainly an
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`appropriate notice period I would think in the interest of decision making, forget
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`your commercial interests, you need a decision, okay, and if you don't give the
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`decision maker an opportunity to engage in rationale and reasonable decision
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`making, you hurt yourselves ultimately and you hurt the process if you don't keep
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`that in mind. So we don’t have to visit that at the moment. I would rather deal
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`with some discrete sets of issues.”).
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`Unless the Defendants are willing to agree not to launch their biosimilar
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`product prior to trial, Plaintiffs respectfully request that the Court order that the
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`Defendants provide four months’ notice prior to any commercial launch of their
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`biosimilar product in the United States to ensure that the parties and the Court have
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`adequate time to present a motion for a preliminary injunction prior to any
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`commercial launch.
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`Defendants’ Positions
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`All Defendants disagree with Plaintiffs’ proposal regarding pre-launch
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`notice. All Defendants submit that the Court-ordered case schedule should not be
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`conditioned on requiring Defendants to refrain from launching their products prior
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`to trial.
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`Celltrion/Teva and Amgen’s Positions
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`Courts presiding over pharmaceutical patent cases routinely hold that
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`defendants’ launch decisions are highly confidential business information and that
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`there is no legal obligation to provide advance notification before launch. See,
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`e.g., Allergan, Inc. v. Teva Pharm. USA, Inc., No. 2:15-CV-1455-WCB, 2017 WL
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`3676745, at *2 (E.D. Tex. Aug. 25, 2017) (“While recognizing that the Court’s
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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 23 of 41 PageID #: 967
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`jurisdiction may extend to . . . orders for advance notice of launch plans, the Court
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`is cognizant of the prudential limitations on the exercise of that jurisdiction.
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`Launch dates are highly confidential and important commercial information. The
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`Court should not lightly order parties to disclose such information to their
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`competitors.”); Otsuka Pharm. Co. v. Torrent Pharm. Ltd., Inc., 99 F. Supp. 3d
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`461, 471–72 (D.N.J. 2015) (describing considerations for preliminary injunction
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`scheduling and noting that the “Court . . . recognized the confidential and sensitive
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`nature of these defendants’ launch intentions” and “observed the principle that the
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`generic defendants would not be required to provide notice of intent to launch at
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`risk”); Teva Pharms. USA, Inc. v. Sandoz, Inc., C.A. No. 0807611, 2010 WL
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`8760315, at *1 (S.D.N.Y. Oct. 12, 2010) (“Defendants are under no legal
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`obligation to provide Plaintiffs with notice of [] intent and ability to launch.
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`Plaintiff’s request amounts, in essence, for the Court to order Defendants to
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`provide Plaintiffs with confidential business information . . . .”).6
`
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`6 See also Novartis Corp. v. Teva Pharm. USA, Inc., C.A. No. 04-4473-HAA-ES,
`2007 WL 1695689, at *30 (D.N.J. June 11, 2007) (“Teva launched its products
`without first notifying the Court, or providing Novartis sufficient notice to obtain a
`TRO prior to the launch. Indeed, Teva was under no obligation to provide such
`notice.”); Hoffmann-La Roche, Inc. v. Teva Pharm. USA, et. al., Civ. A. No. 11-
`3635 (ES), ECF No. 124, (D.N.J. Feb. 5, 2013) (citing cases and finding that
`defendant “has no obligation to provide notice of its intent to launch,” as this “is
`indisputably confidential, sensitive business information”); AstraZeneca LP v.
`Breath, Ltd., Civ. A. No. 08-1512, ECF No. 86, at 3 (D.N.J. Sept. 8, 2009)
`(denying request to require defendant “to provide advance notice of any launch
`concerning its proposed budesonide inhalation suspension products”).
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`In addition to requiring Defendants to provide highly confidential business
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`information to Plaintiffs, an order directing advance notice of launch plans would
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`also inevitably inform the market of an impending launch. It would be readily
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`apparent to the public that Defendants had provided notice of intent to launch when
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`preliminary injunction proceedings appear on the docket. The Defendants in this
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`case are competitors, all seeking FDA approval to market biosimilar trastuzumab
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`products, thus public disclosure of launch timing is all the more sensitive in this
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`case. Celltrion/Teva and Amgen respectfully request that the Court reject
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`Plaintiffs’ request to require advance notice prior to launch.
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`Bioepis’s Position
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`Bioepis does not agree that it must give Plaintiffs four months’ notice prior
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`to any commercial launch of its biosimilar product. The parties have already
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`exchanged detailed infringement and invalidity contentions regarding each of the
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`asserted patents pursuant to 42 U.S.C. § 262(l)(2) and (3). As a result, Plaintiffs
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`should be able to promptly file a preliminary injunction motion based on
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`information received during the parties’ pre-suit exchanges, should they conclude
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`that such a motion is warranted in this case.
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`Pfizer’s Position
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`Given the position of the other parties, Pfizer should not be required to
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`provide advance notice prior to launch.
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`Case 1:18-cv-01363-CFC Document 22 Filed 10/09/18 Page 25 of 41 PageID #: 969
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`III.
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`Case Narrowing
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`Plaintiffs’ Position
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`Plaintiffs disagree with Defendants’ proposal that Plaintiffs should narrow
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`the case to eight patents and 20 asserted claims by Oc