Case: 22-1595 Document: 6 Page: 1 Filed: 04/08/2022
`
`No. 2022-1595
`
`
`United States Court of Appeals
`for the Federal Circuit
`
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`GENENTECH, INC., INTERMUNE, INC.,
`Plaintiffs-Appellants
`v.
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`
`
`SANDOZ INC., LEK PHARMACEUTICALS, D.D.,
`Defendants-Appellees
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`
`
`
`
`
`Appeal from the United States District Court for the District of Delaware in
`C.A. No. 1:19-cv-00078-RGA, Judge Richard G. Andrews
`
`MOTION TO EXPEDITE
`
`Kira A. Davis
`DURIE TANGRI LLP
`953 East 3rd Street
`Los Angeles, CA 90013
`Telephone: 213-992-4499
`Facsimile: 415-236-6300
`
`April 8, 2022
`
`
`
`
`
`
`Daralyn J. Durie
`Vera Ranieri
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`Telephone: 415-362-6666
`Facsimile: 415-236-6300
`
`Counsel for Plaintiffs-Appellants
`Genentech, Inc. and InterMune, Inc.
`
`
`
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`
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`
`
`No. 2022-1595
`
`
`United States Court of Appeals
`for the Federal Circuit
`
`
`GENENTECH, INC., INTERMUNE, INC.,
`Plaintiffs-Appellants
`v.
`
`
`
`SANDOZ INC., LEK PHARMACEUTICALS, D.D.,
`Defendants-Appellees
`
`
`
`
`
`
`Appeal from the United States District Court for the District of Delaware in
`C.A. No. 1:19-cv-00078-RGA, Judge Richard G. Andrews
`
`MOTION TO EXPEDITE
`
`Kira A. Davis
`DURIE TANGRI LLP
`953 East 3rd Street
`Los Angeles, CA 90013
`Telephone: 213-992-4499
`Facsimile: 415-236-6300
`
`April 8, 2022
`
`
`
`
`
`
`Daralyn J. Durie
`Vera Ranieri
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`Telephone: 415-362-6666
`Facsimile: 415-236-6300
`
`Counsel for Plaintiffs-Appellants
`Genentech, Inc. and InterMune, Inc.
`
`
`
`
`
`
`
`
`
`
`
`
`Case: 22-1595 Document: 6 Page: 2 Filed: 04/08/2022
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`FORM 9. Certificate of Interest
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`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`CERTIFICATE OF INTEREST
`
`
`Form 9 (p. 1)
`July 2020
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`Case Number
`Short Case Caption
`Filing Party/Entity
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`Instructions: Complete each section of the form. In answering items 2 and 3, be
`specific as to which represented entities the answers apply; lack of specificity may
`result in non-compliance. Please enter only one item per box; attach
`additional pages as needed and check the relevant box. Counsel must
`immediately file an amended Certificate of Interest if information changes. Fed.
`Cir. R. 47.4(b).
`
`
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`I certify the following information and any attached sheets are accurate and
`complete to the best of my knowledge.
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`
`Date: _________________
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`Signature:
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`Name:
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`2022-1595
`
`Genentech, Inc. v. Sandoz Inc.
`
`Appellants Genentech, Inc. and InterMune, Inc.
`
`Kira A. Davis
`
`/s/ Kira A. Davis
`
`04/08/2022
`
`
`
`Case: 22-1595 Document: 6 Page: 3 Filed: 04/08/2022
`
`FORM 9. Certificate of Interest
`
`1. Represented
`Entities.
`Fed. Cir. R. 47.4(a)(1).
`Provide the full names of
`all entities represented
`by undersigned counsel in
`this case.
`
`Form 9 (p. 2)
`July 2020
`
`2. Real Party in
`Interest.
`Fed. Cir. R. 47.4(a)(2).
`Provide the full names of
`all real parties in interest
`for the entities. Do not
`list the real parties if
`they are the same as the
`entities.
`
`3. Parent Corporations
`and Stockholders.
`Fed. Cir. R. 47.4(a)(3).
`Provide the full names of
`all parent corporations
`for the entities and all
`publicly held companies
`that own 10% or more
`stock in the entities.
`
`☐ None/Not Applicable ☐ None/Not Applicable
`
`Additional pages attached
`
`4
`
`Genentech, Inc.
`
`Roche Holdings Inc.
`
`Genentech, Inc.
`
`Roche Holdings Ltd.
`
`InterMune, Inc.
`
`Genentech, Inc.
`
`InterMune, Inc.
`
`Roche Holdings Inc.
`
`InterMune, Inc.
`
`Roche Holdings Ltd.
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`Case: 22-1595 Document: 6 Page: 4 Filed: 04/08/2022
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`FORM 9. Certificate of Interest
`
`Form 9 (p. 3)
`July 2020
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`4. Legal Representatives. List all law firms, partners, and associates that (a)
`appeared for the entities in the originating court or agency or (b) are expected to
`appear in this court for the entities. Do not include those who have already
`entered an appearance in this court. Fed. Cir. R. 47.4(a)(4).
`None/Not Applicable
`Additional pages attached
`
`5. Related Cases. Provide the case titles and numbers of any case known to be
`pending in this court or any other court or agency that will directly affect or be
`directly affected by this court’s decision in the pending appeal. Do not include the
`originating case number(s) for this case. Fed. Cir. R. 47.4(a)(5). See also Fed. Cir.
`R. 47.5(b).
`None/Not Applicable
`
`Additional pages attached
`
`6. Organizational Victims and Bankruptcy Cases. Provide any information
`required under Fed. R. App. P. 26.1(b) (organizational victims in criminal cases)
`and 26.1(c) (bankruptcy case debtors and trustees). Fed. Cir. R. 47.4(a)(6).
`None/Not Applicable
`Additional pages attached
`
`Jack B. Blumenfeld, Karen Jacobs, Cameron P. Clark
`Morris Nichols Arsht & Tunnell LLP
`
`Stephen J. Kraftschik
`Formerly with Morris Nichols Arsht & Tunnell LLP
`
`Mark E. Waddell, Warren K. MacRae,
`LOEB & LOEB LLP
`
`Ryan Haggland, Kathleen Gersh
`LOEB & LOEB LLP
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`
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`Alexandra Cavazos, Dan Liu
`LOEB & LOEB LLP
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`4
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`4
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`Case: 22-1595 Document: 6 Page: 5 Filed: 04/08/2022
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION ..................................................................................................... 1
`FACTUAL AND PROCEDURAL BACKGROUND .............................................. 3
`ARGUMENT ............................................................................................................. 4
`CONCLUSION .......................................................................................................... 6
`
`
`i
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`Case: 22-1595 Document: 6 Page: 6 Filed: 04/08/2022
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`TABLE OF AUTHORITIES
`
` Page(s)
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`Cases
`Abbott Labs. v. Sandoz, Inc.,
`544 F.3d 1341 (Fed. Cir. 2008) ............................................................................ 5
`Duramed Pharm., Inc. v. Watson Labs., Inc.,
`No. 2011-1438, 2011 WL 3156286 (Fed. Cir. July 27, 2011)
`(unpublished) ........................................................................................................ 6
`Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd.,
`601 F.3d 1359 (Fed. Cir. 2010), rev’d on other grounds, 132 S. Ct.
`1670 (2012) ........................................................................................................... 6
`Sanofi-Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006) ............................................................................ 5
`Other Authorities
`Fed. Cir. R. 27 ........................................................................................................ 1, 5
`Fed. R. App. P. 2 .................................................................................................... 1, 4
`Fed. R. App. P. 27 ...................................................................................................... 1
`
`
`
`ii
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`
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`Case: 22-1595 Document: 6 Page: 7 Filed: 04/08/2022
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`
`
`INTRODUCTION
`Pursuant to Federal Rule of Appellate Procedure 2, Federal Rule of
`
`Appellate Procedure 27, and Federal Circuit Rule 27, Plaintiffs Genentech, Inc.
`
`(“Genentech”) and InterMune, Inc. (collectively, “Plaintiffs”) respectfully request
`
`this Court order the unopposed expedited briefing schedule set forth below and
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`schedule oral argument at the earliest possible session:
`
`• Plaintiffs file opening brief no later than thirty-five (35) days after
`
`docketing, i.e., by May 10, 2022;
`
`• Defendants Sandoz Inc. and Lek Pharmaceuticals, d.d. (collectively,
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`“Sandoz”) file response brief (or, if there’s a cross-appeal,
`
`principal/response brief) no later than thirty-five (35) days from
`
`service of opening brief;
`
`• Plaintiffs file reply brief (or, if there’s a cross-appeal, response/reply
`
`brief) no later than twenty-one (21) days from service of Sandoz’s
`
`response (or principal/response) brief;
`
`• Sandoz files reply brief on cross-appeal, if any, no later than fourteen
`
`(14) days from service of Plaintiffs’ reply (or reply/response) brief;
`
`and
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`• Joint Appendix due no later than seven (7) days from service of the
`
`last brief;
`
`1
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`Case: 22-1595 Document: 6 Page: 8 Filed: 04/08/2022
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`
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`Counsel for Plaintiffs advised Counsel for Sandoz that Plaintiffs would
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`request expedited proceedings, and requested that Sandoz agree to the expedited
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`schedules outlined above. Sandoz agreed to the schedule above, and confirmed
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`that it does not intend to file a written response to this motion, and therefore, an
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`expedited briefing schedule for this motion will not be necessary.
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`There is good cause to expedite proceedings in the manner set forth above.
`
`This is a Hatch-Waxman case. Appellant Genentech sells Esbriet® (pirfenidone),
`
`which is approved to treat idiopathic pulmonary fibrosis (“IPF”). At least as of
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`today, Esbriet is the only pirfenidone product currently marketed in the U.S.
`
`Sandoz filed multiple Abbreviated New Drug Application (“ANDAs”) for FDA
`
`approval of generic pirfenidone products. In the opinion below, the district court
`
`concluded that the manufacture, use, sale, offer for sale, and/or importation of
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`Sandoz’s ANDA products will not infringe the patent claims asserted at trial, and
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`that the asserted claims of four of the six asserted patents were invalid as obvious.
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`As a result of the district court’s judgment, Sandoz may imminently begin selling
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`its generic pirfenidone, and it has said that it will not voluntarily agree to refrain
`
`from launching its products during the pendency of this appeal.
`
`Plaintiffs contend that launch will cause irreparable harm to Genentech as
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`outlined below. Thus, Plaintiffs have sought from the district court a temporary
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`restraining order and injunction pending appeal preventing Sandoz from launching
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`2
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`Case: 22-1595 Document: 6 Page: 9 Filed: 04/08/2022
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`
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`their generic pirfenidone. Plaintiffs also filed their Notice of Appeal on the same
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`day that the Final Judgment was entered. If Plaintiffs are not able to obtain
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`injunctive relief from the district court or from this Court (if it is necessary to seek
`
`such relief), then an expedited appeal will limit the period of time during which
`
`Genentech is irreparably harmed by Sandoz’s sale of generic pirfenidone.
`
`FACTUAL AND PROCEDURAL BACKGROUND
`Genentech’s Esbriet® (pirfenidone) is indicated for the treatment of
`
`idiopathic pulmonary fibrosis, or “IPF,” a chronic, irreversible, and devastating
`
`disease. Multiple distinct generic manufactures have filed ANDAs seeking to
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`market generic versions of Esbriet. Plaintiffs brought patent infringement cases
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`against each, and all but Sandoz settled. Plaintiffs asserted that Sandoz infringed
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`claims from six patents related to Esbriet: four patents collectively referred to as
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`the “liver enzyme” patents (U.S. Patent No. 7,566,729, U.S. Patent No. 7,635,707,
`
`U.S. Patent No. 8,592,462, and U.S. Patent No. 8,609,701), and two patents
`
`collectively referred to as the “fluvoxamine” patents (U.S. Patent No. 7,816,383
`
`and U.S Patent No. 8,013,002) (collectively the “Asserted Patents”).
`
`From November 8, 2021 to November 12, 2021 the district court held a
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`bench trial to determine whether Sandoz infringed the Asserted Patents and
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`3
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`
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`Case: 22-1595 Document: 6 Page: 10 Filed: 04/08/2022
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`
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`whether the Asserted Patents were invalid. See ECF Docket1, Minute Entries dated
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`Nov. 8, 2021 through Nov. 12, 2021. On March 22, 2022, the district court issued
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`its opinion as to these issues, finding that all Asserted Patents were not infringed,
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`and in addition that the liver enzyme patents are invalid. ECF No. 386.
`
`On April 1, 2022, judgment was entered. ECF No. 396. Also that same day,
`
`Plaintiffs filed their Notice of Appeal, ECF No, 397, and its appeal was docketed
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`four days later, on April 5, 2022. ECF No. 1-1, Fed. Cir. Case No. 2022-1595.
`
`This motion follows.
`
`In addition, on March 31, 2022, Plaintiffs moved in the district court for a
`
`temporary restraining order and injunction pending appeal. ECF No. 389; see also
`
`ECF Nos. 390-394 (declarations filed in support of motion for injunction setting
`
`forth irreparable harms). Under the parties’ agreed-upon schedule for that motion,
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`since ordered by the district court, the motion will be fully briefed on April 12,
`
`2022.
`
`ARGUMENT
`A circuit court may “expedite the determination of cases of pressing concern
`
`to the public or to the litigants by prescribing a time schedule other than that
`
`provided by the rules.” Fed. R. App. P. 2, advisory committee’s note to 1967
`
`
`1 Unless otherwise noted, all citations to ECF are to the docket at the district court,
`Case No. 1:19-cv-00078-RGA.
`
`4
`
`
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`Case: 22-1595 Document: 6 Page: 11 Filed: 04/08/2022
`
`
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`adoption. This case satisfies that standard. In particular, a motion for expedited
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`proceedings is appropriate in “appeals involving . . . injunctions,” practice notes to
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`Fed. Cir. R. 27, which is the relief Plaintiffs seek in their lawsuit and which the
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`district court denied.
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`Plaintiffs contend that resolving this appeal according to the default schedule
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`set by the rules will cause irreparable harm to Genentech if they are not successful
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`in enjoining Sandoz’s launch. This Court has repeatedly recognized the irreparable
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`harm to innovator pharmaceutical companies caused by generic launches. See,
`
`e.g., Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1361-62 (Fed. Cir. 2008) (pre-
`
`trial preliminary injunction); Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368,
`
`1381-82 (Fed. Cir. 2006) (pre-trial preliminary injunction).
`
`This will be a case in which Plaintiffs contend there is such irreparable
`
`harm. Had the district court not committed error in making its non-infringement
`
`and invalidity determinations, as Plaintiffs intend on showing this Court, Sandoz
`
`would not now be about to launch. Because of those errors, Sandoz will be able to
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`launch if not enjoined, and that launch will cause Esbriet to rapidly lose market
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`share to generic pirfenidone. That harm will be difficult to calculate and
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`impossible to reverse, including because Plaintiffs expect that some patients who
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`are currently taking Esbriet will not continue taking generic pirfenidone, resulting
`
`in damage to the market itself. Expedited resolution of this appeal will lessen these
`
`5
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`
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`Case: 22-1595 Document: 6 Page: 12 Filed: 04/08/2022
`
`
`
`and other harms.
`
`This Court has authorized expedited briefing in similar circumstances
`
`relating to generic entry into a market. See, e.g., Novo Nordisk A/S v. Caraco
`
`Pharm. Labs., Ltd., 601 F.3d 1359, 1364 (Fed. Cir. 2010), rev’d on other grounds,
`
`132 S. Ct. 1670, 1688 (2012); Duramed Pharm., Inc. v. Watson Labs., Inc., No.
`
`2011-1438, 2011 WL 3156286, at *1 (Fed. Cir. July 27, 2011) (unpublished).
`
`Sandoz has agreed to the schedule requested by this motion, thus no party
`
`will be prejudiced by the entry of the proposed schedule.
`
`CONCLUSION
`For these reasons, Plaintiffs request that the Court expedite this appeal, and
`
`enter the following schedule for briefing this appeal, and schedule oral argument
`
`the earliest possible session after service of the Joint Appendix:
`
`• Plaintiffs file opening brief no later than thirty-five (35) days after
`
`docketing, i.e., by May 10, 2022;
`
`• Sandoz files response brief (or, if there’s a cross-appeal,
`
`principal/response brief) no later than thirty-five (35) days from
`
`service of opening brief;
`
`• Plaintiffs file reply brief (or, if there’s a cross-appeal, response/reply
`
`brief) no later than twenty-one (21) days from service of Sandoz’s
`
`response (or principal/response) brief;
`
`6
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`
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`Case: 22-1595 Document: 6 Page: 13 Filed: 04/08/2022
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`
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`• Sandoz files reply brief on cross-appeal, if any, no later than fourteen
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`(14) days from service of Plaintiffs’ reply (or reply/response) brief;
`
`and
`
`• Joint Appendix due no later than seven (7) days from service of the
`
`last brief.
`
`Plaintiffs further request this Court grant this motion as soon as practicable, given
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`Sandoz’s confirmation they will not be filing a response to this motion.
`
`
`
`
`
`Dated: April 8, 2022
`
`
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`
`
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`
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`Respectfully submitted,
`
`
`
`By: /s/ Kira A. Davis
`Kira A. Davis
`DURIE TANGRI LLP
`953 East 3rd Street
`Los Angeles, CA 90013
`Telephone: 213-992-4499
`Facsimile: 415-236-6300
`
`7
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`
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`Case: 22-1595 Document: 6 Page: 14 Filed: 04/08/2022
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`FORM 30. Certificate of Service
`
`Form 30
`July 2020
`
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`CERTIFICATE OF SERVICE
`
`Case Number
`Short Case Caption
`
`NOTE: Proof of service is only required when the rules specify that service must
`be accomplished outside the court’s electronic filing system. See Fed. R. App. P.
`25(d); Fed. Cir. R. 25(e). Attach additional pages as needed.
`
`I certify that I served a copy of the foregoing filing on
`by
`
`U.S. Mail
`
`Hand Delivery
`Other:
`
`
`Facsimile
`
`on the below individuals at the following locations.
`Person Served
`Service Location (Address, Facsimile, Email)
`
`Additional pages attached.
`Date: _________________
`
`Signature:
`
`Name:
`
`2022-1595
`
`Genentech, Inc. v. Sandoz Inc.
`
`04/08/2022
`
`4
`
`Stephen B. Brauerman
`
`sbrauerman@bayardlaw.com
`
`Sarah T. Andrade
`
`sandrade@bayardlaw.com
`
`Ronald P. Golden II
`
`rgolden@bayardlaw.com
`
`Emily L. Rapalino
`
`erapalino@goodwinlaw.com
`
`Kathleen McGuinness
`
`kmcguinness@goodwinlaw.com
`
`4
`
`04/08/2022
`
`/s/ Kira A. Davis
`
`Kira A. Davis
`
`
`
`Case: 22-1595 Document: 6 Page: 15 Filed: 04/08/2022
`
`Genentech, Inc. v. Sandoz Inc.
`2022-1595
`
`CERTIFICATE OF SERVICE (Cont’d)
`
`Person Served
`Tara R. Melillo
`
`Service Location (Address, Facsimile,
`Email)
`tmelillo@goodwinlaw.com
`
`Beth Ashbridge
`
`bashbridge@goodwinlaw.com
`
`Srikanth K. Reddy
`
`sreddy@goodwinlaw.com
`
`Tiffany Mahmood
`
`tmahmood@goodwinlaw.com
`
`Natasha E. Daughtrey
`
`ndaughtrey@goodwinlaw.com
`
`Daryl L. Wiesen
`
`dwiesen@goodwinlaw.com
`
`Elaine H. Blais
`
`eblais@goodwinlaw.com
`
`Kevin J. DeJong
`
`kdejong@goodwinlaw.com
`
`William M. Jay
`
`wjay@goodwinlaw.com
`
`
`
`
`
`
`
`
`
`
`Case: 22-1595 Document: 6 Page: 16 Filed: 04/08/2022
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`
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`CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME
`LIMITATION, TYPEFACE REQUIREMENTS, AND TYPE STYLE
`REQUIREMENTS
`This motion complies with the type-volume limitation of Federal Rule
`
`1.
`
`of Appellate Procedure 27(d)(2)(A). This motion contains 1,315 words, excluding
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`the parts of the motion exempted by Federal Rule of Appellate Procedure 32(f) and
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`Federal Circuit Rule 32(b)(2).
`
`2.
`
`This motion complies with the typeface requirements of Federal Rule
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`of Appellate Procedure 32(a)(5) and the type style requirements of Federal Rule of
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`Appellate Procedure 32(a)(6). This motion has been prepared in a proportionally
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`spaced typeface using Microsoft Word in Times New Roman, 14-point font.
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`
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`Dated: April 8, 2022
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`
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`DURIE TANGRI LLP
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`
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`By: /s/ Kira A. Davis
`
`Kira A. Davis
`Attorney for Appellants
`
`10
`
`
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