Court Opinion

ID: 4520332
Source: CourtListenerOpinion
Date Created: 2020-03-27 19:00:41.352284+00
Date Added: 2024-06-11T09:24:56.609931
License: Public Domain

Case: 19-1263       Document: 61           Page: 1       Filed: 03/26/2020

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                     ______________________

                      GENENTECH, INC.,
                          Appellant

                                    v.

     ANDREI IANCU, UNDER SECRETARY OF
   COMMERCE FOR INTELLECTUAL PROPERTY
    AND DIRECTOR OF THE UNITED STATES
      PATENT AND TRADEMARK OFFICE,
                   Intervenor
             ______________________

                      2019-1263, 2019-1267
                     ______________________

    Appeals from the United States Patent and Trade-
 mark Office, Patent Trial and Appeal Board in Nos.
 IPR2017-00731, IPR2017-01121, IPR2017-02063.
                --------------------------------------------------
                      GENENTECH, INC.,
                          Appellant

                                    v.

     ANDREI IANCU, UNDER SECRETARY OF
   COMMERCE FOR INTELLECTUAL PROPERTY
    AND DIRECTOR OF THE UNITED STATES
      PATENT AND TRADEMARK OFFICE,
                  Intervenor
Case: 19-1263     Document: 61    Page: 2    Filed: 03/26/2020

 2                                  GENENTECH, INC.   v. IANCU

                  ______________________

                   2019-1265, 2019-1270
                  ______________________

     Appeals from the United States Patent and Trademark
 Office, Patent Trial and Appeal Board in Nos. IPR2017-
 00737, IPR2017-01122, IPR2017-01960.
                  ______________________

                  Decided: March 26, 2020
                  ______________________

     ROBERT J. GUNTHER, JR., Wilmer Cutler Pickering Hale
 and Dorr LLP, New York, NY, for appellant. Also repre-
 sented by ANDREW J. DANFORD, Boston, MA; THOMAS
 GREGORY SPRANKLING, Palo Alto, CA; THOMAS SAUNDERS,
 Washington, DC; NORA Q.E. PASSAMANECK, Denver, CO;
 ADAM R. BRAUSA, DARALYN JEANNINE DURIE, Durie Tangri
 LLP, San Francisco, CA.

     SARAH E. CRAVEN, Office of the Solicitor, United States
 Patent and Trademark Office, Alexandria, VA, for interve-
 nor. Also represented by THOMAS W. KRAUSE, FARHEENA
 YASMEEN RASHEED, MAUREEN DONOVAN QUELER.
                 ______________________

     Before LOURIE, MOORE, and WALLACH, Circuit Judges.
 MOORE, Circuit Judge.
     Genentech, Inc. appeals from the final written deci-
 sions of the Patent Trial and Appeal Board collectively
 holding unpatentable claims 1–14 of U.S. Patent No.
 7,846,441 and claims 1–17 of U.S. Patent No. 7,892,549. 1

      1  Hospira, Inc., Samsung Bioepis Co., Ltd., Celltrion,
 Inc., and Pfizer, Inc. collectively made up the named
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 GENENTECH, INC.   v. IANCU                                  3

 In the final written decisions, the Board construed the
 claim terms “an amount effective to extend the time to dis-
 ease progression in the human patient” and “an effective
 amount” to be in comparison to no treatment. Genentech
 appeals, arguing that the Board’s claim constructions were
 erroneous and that under its proposed claim construction
 the claims would not have been obvious. Genentech also
 appeals the Board’s denial of its motion to amend in
 IPR2017-00731. We have jurisdiction under 28 U.S.C
 § 1295(a)(4)(A).
     For the reasons discussed below, we affirm the Board’s
 decisions. The Board correctly construed the terms “an
 amount effective to extend the time to disease progression
 in the human patient” and “an effective amount.” Genen-
 tech does not challenge the Board’s obviousness conclusion
 under the Board’s constructions. We also hold that the
 Board did not abuse its discretion in entering partial ad-
 verse judgment on Ground 1 in IPR2017-00731 or in deny-
 ing Genentech’s motion to amend.
                I. The ’441 and ’549 Patents
     The ’441 and ’549 patents share a specification and are
 directed to treatment of disorders characterized by overex-
 pression of the erbB2 gene, which encodes the ErbB2 pro-
 tein. There is a correlation between individuals who
 overexpress the erbB2 gene (also known as her2) and
 breast cancer. ’441 patent at 1:10–27. The ’441 patent’s
 claims recite methods of treating cancer patients who over-
 express erbB2 by administering a combination of an anti-
 ErbB2 antibody and a taxoid, in the absence of an an-
 thracycline derivative. Relevant to these appeals, each in-
 dependent claim of the ’441 patent contains the limitation

 petitioners in the inter partes reviews. Following the
 Board’s final written decisions, those parties dropped out
 and the Director intervened.
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 4                                  GENENTECH, INC.   v. IANCU

 that the combination treatment be “in an amount effective
 to extend the time to disease progression in said human
 patient, without increase in overall severe adverse events.”
 Claim 1 is representative:
     1. A method for the treatment of a human patient
     with a malignant progressing tumor or cancer
     characterized by overexpression of ErbB2 receptor,
     comprising administering a combination of an in-
     tact antibody which binds to epitope 4D5 within
     the ErbB2 extracellular domain sequence and a
     taxoid, in the absence of an anthracycline deriva-
     tive, to the human patient in an amount effective to
     extend the time to disease progression in said hu-
     man patient, without increase in overall severe ad-
     verse events.
 ’441 patent at 33:46–54 (emphasis added).
     The ’549 patent’s claims recite methods of treating
 breast cancer by administering a combination of an anti-
 ErbB2 antibody, a taxoid, and either a “further growth in-
 hibitory agent” or a “further therapeutic agent.” Independ-
 ent claims 1 and 16 each contain the limitation that the
 combination be “in an amount effective to extend the time
 to disease progression in the human patient.” Independent
 claim 5 differs from claims 1 and 16 by simply reciting “ad-
 ministering an effective amount of [the] combination.” The
 parties treat the “amount effective” in claims 1 and 16 the
 same as “an effective amount” in claim 5. Independent
 claims 1 and 5 of the ’549 patent recite:
     1. A method for the treatment of a human patient
     with breast cancer that overexpresses ErbB2 re-
     ceptor, comprising administering a combination of
     an antibody that binds ErbB2, a taxoid, and a fur-
     ther growth inhibitory agent to the human patient
     in an amount effective to extend the time to disease
     progression in the human patient, wherein the
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 GENENTECH, INC.   v. IANCU                                   5

     antibody binds to epitope 4D5 within the ErbB2 ex-
     tracellular domain sequence.
     5. A method for the treatment of a human patient
     with breast cancer characterized by overexpression
     of ErbB2 receptor, comprising administering an ef-
     fective amount of a combination of an anti-ErbB2
     antibody which binds epitope 4D5 within the
     ErbB2 extracellular domain sequence, a taxoid,
     and a further therapeutic agent, to the human pa-
     tient.
 ’549 patent at 33:38–45 and 54–59 (emphases added).
     Petitioners filed six petitions collectively requesting in-
 ter partes review of all of the claims of the ’441 and ’549
 patents. The Board instituted all of the inter partes re-
 views and construed the terms “an amount effective to ex-
 tend the time to disease progression in [the/said] human
 patient” and “an effective amount” to mean in comparison
 to a patient who received no treatment. See, e.g., No. 19-
 1263, J.A. 12383. The Board maintained those construc-
 tions in its final written decisions and ultimately held the
 claims of the ’441 and ’549 patents would have been obvi-
 ous. See, e.g., id. at J.A. 47, 86. Genentech challenges the
 Board’s constructions on appeal.
                    II. Claim Construction
     When based solely on intrinsic evidence, as here, we
 review the Board’s claim construction de novo. Teva
 Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841
 (2015). The prosecution history “is often of critical signifi-
 cance in determining the meaning of the claims” because it
 “contains the complete record of all the proceedings before
 the Patent and Trademark Office, including any express
 representations made by the applicant regarding the scope
 of the claims.” Vitronics Corp. v. Conceptronic, Inc., 90
 F.3d 1576, 1582 (Fed. Cir. 1996). During prosecution,
 “[a]pplicants can define (lexicography), explain, or disavow
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 6                                   GENENTECH, INC.   v. IANCU

 claim scope.” Teva Pharm. USA, Inc. v. Sandoz, Inc., 789
 F.3d 1335, 1343 (Fed. Cir. 2015). “A statement made dur-
 ing prosecution of related patents may be properly consid-
 ered in construing a term common to those patents.” Id.
 “The public notice function of a patent and its prosecution
 history requires that a patentee be held to what he declares
 during the prosecution of his patent.” Springs Window
 Fashions LP v. Novo Indus., L.P., 323 F.3d 989, 995 (Fed.
 Cir. 2003).
     The claims and specifications of the ’441 and ’549 pa-
 tents do not clearly define what comparison is required by
 the disputed claim terms. The examiner recognized as
 much during prosecution of the ’441 patent, rejecting as in-
 definite the claim term “extend the time to disease progres-
 sion.” The examiner found the term to be a relative term
 undefined by the claim, without “a standard for ascertain-
 ing the requisite degree,” and that “one of ordinary skill
 would not be reasonably apprised of the scope of the inven-
 tion.” No. 19-1263, J.A. 2050–51. The examiner inquired:
     Specifically, it is never set forth what the extension
     of time to disease progress is relative to, for exam-
     ple, is the extension of time to disease progress rel-
     ative to untreated patients? Patients who received
     antibody or taxoid alone? Patients who received
     antibody and an anthracycline?
 Id. at J.A. 2051. Genentech responded:
     [T]he expressions “extend the time to disease pro-
     gression” and “response rate” are clear from the
     specification (see, in particular, page 15, lines 15-
     17; and pages 42-43) and would be readily under-
     stood by a skilled oncologist. Clearly, the combina-
     tion of an anti-ErbB2 antibody and a taxoid is
     administered in an amount effective to extend the
     time to disease progression relative to an untreated
     patient.
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 GENENTECH, INC.     v. IANCU                                7

 Id. at J.A. 2082.
     The Board determined that Genentech’s response to
 the examiner was an express choice, which defined the
 claim term and led to the issuance of the ’441 patent. Id.
 at J.A. 46. Genentech argues that the Board erred in its
 reliance on this exchange by using it “to override the mean-
 ing evident from the specification.” The specification does
 not, however, expressly define the disputed terms. And
 Genentech did not view this choice as inconsistent with the
 specification during prosecution. Instead, Genentech in-
 terpreted its own claim language, based on its own specifi-
 cation’s disclosure, as referring to a comparison to
 untreated patients. The examiner even provided Genen-
 tech with the very alternative option (“taxoid alone”) for
 which Genentech now advocates. Genentech expressly re-
 jected this comparator during prosecution and instead
 clearly stated that it was effectiveness relative to an un-
 treated patient. Genentech provided an unequivocal, di-
 rect response to the examiner’s inquiry—that the term
 “extend the time to disease progression” was compared to
 an untreated patient. Genentech’s comparator choice dur-
 ing prosecution of the ’441 patent applies equally to the
 same claim term that appears in the ’549 patent, which
 shares a specification and is in the same patent family.
 Given this relationship between the patents, the Board
 construed the relevant terms consistently in all six inter
 partes reviews. We see no error in the Board’s construc-
 tions.
     The Board’s construction of the term “extend the time
 to disease progression” as requiring comparison to an un-
 treated patient is consistent with the claims, specifications,
 and prosecution histories of the ’441 and ’549 patents. The
 claims do not themselves provide an explicit comparator.
 And the specifications discuss several drugs and drug com-
 binations that may be viable comparators, including a tax-
 oid, anthracycline/cyclophosphamide treatment, and
 chemotherapy. The specifications do not select any one of
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 8                                  GENENTECH, INC.   v. IANCU

 these as the comparator, nor do they preclude comparison
 to an untreated patient. We do not agree with Genentech
 that the Board’s construction is inconsistent with the claim
 language prohibiting an “increase in overall severe adverse
 events.” As discussed, Genentech is bound by the compar-
 ator choice it made during prosecution. Moreover, Genen-
 tech amended the claims to add the “severe adverse events”
 limitation after its statement that effectiveness is deter-
 mined by comparison to untreated patients.
      In light of Genentech’s prosecution statements, we de-
 termine that the terms “in an amount effective to extend
 the time to disease progression in the human patient” and
 “an effective amount” are properly construed as measured
 relative to an untreated patient. Genentech does not chal-
 lenge the Board’s unpatentability determinations under
 these constructions. We therefore affirm the unpatentabil-
 ity of claims 1–14 of the ’441 patent and claims 1–17 of the
 ’549 patent.
             III. Genentech’s Motion to Amend
     In IPR2017-00731, the petitioner challenged all four-
 teen claims of the ’441 patent under two alternative
 grounds: Ground 1 as the claims would have been obvious
 over Baselga ’97 2 and Baselga ’94, 3 and Ground 2 as the
 claims would have been obvious over Baselga ’96 4 and

     2   Baselga et al., HER2 Overexpression and
 Paclitaxel Sensitivity in Breast Cancer: Therapeutic Impli-
 cations, 11(3) (Suppl. 2) ONCOLOGY 43–48 (1997).
     3   Baselga et al., Anti-HER2 Humanized Monoclonal
 Antibody (MAb) Alone and in Combination with Chemo-
 therapy Against Human Breast Carcinoma Xenografts, 13
 PROC. AM. SOC. CLIN. ONCOL. 63 (Abstract 53) (1994).
     4   Baselga et al., Phase II Study of Weekly Intrave-
 nous Recombinant Humanized Anti-p185HER2 Monoclo-
 nal Antibody in Patients with HER2/neu-Overexpressing
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 GENENTECH, INC.   v. IANCU                                9

 Baselga ’94. The Board originally denied institution on
 Ground 1 because Genentech antedated Baselga ’97, and it
 denied institution on Ground 2 based on its determination
 that petitioner had not shown a reasonable likelihood that
 it would prevail. Petitioner requested a rehearing on the
 Board’s institution decision after which the Board insti-
 tuted inter partes review on Ground 2. The Board contin-
 ued to decline institution on Ground 1. Genentech then
 filed its first contingent motion to amend its claims under
 35 U.S.C. § 316(d)(1).
     After the Supreme Court’s decision in SAS Inst., Inc. v.
 Iancu, 138 S. Ct. 1348 (2018), the Board modified its insti-
 tution decision to include institution on Ground 1. Genen-
 tech then sought to amend its claims again, arguing that it
 had a statutory right to do so under § 316(d)(1). Mean-
 while, petitioner sought an adverse judgment on Ground 1,
 which the Board granted. The Board rejected Genentech’s
 argument that it had a statutory right to amend and
 treated the motion as an additional motion to amend under
 § 316(d)(2). Pursuant to 37 C.F.R. § 42.121(c), the Board
 required Genentech to make a good cause showing before
 the Board considered the second motion to amend. No. 19-
 1263, J.A. 13211. Having found that Genentech failed to
 establish good cause, the Board denied the second motion
 to amend.
     The Board alternatively held that, even if good cause
 existed, Petitioner’s request for adverse judgment as to
 Ground 1 under 37 CFR § 42.73(b) mooted the issue. No.
 19-1263, J.A. 21-22. The Board determined that 37 C.F.R.
 § 42.73(a) and (b) permit partial adverse judgment as to a
 single ground—in this case Ground 1. The Board referred
 to the “Frequently Asked Questions about SAS Implica-
 tions” issued by the PTO, which states that, in order to

 Metastatic Breast Cancer, 14 J. CLIN. ONCOL. 737–44
 (1996).
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 10                                 GENENTECH, INC.   v. IANCU

 limit the scope of the proceeding in the event the parties
 cannot agree to waive additional claims, “[t]he Petitioner
 can request adverse judgment on claims and/or grounds at
 any time.” The Board went on to explain that, under 37
 CFR § 42.5(b), it was permitted to waive any requirement
 that adverse judgment under § 42.73(b) is available only
 for disposition of all issues—“The Board may waive or sus-
 pend a requirement of parts 1, 41, and 42 and may place
 conditions on the waiver or suspension.”
      Genentech argues that the Board erroneously granted
 Petitioner’s request for partial adverse judgment because
 37 CFR § 42.73(a) defines a judgment as “dispos[ing] of all
 issues that were, or by motion reasonably could have been,
 raised and decided.” We need not reach whether the Board
 may grant partial adverse judgment under 37 CFR
 § 42.73(a), however, because 37 CFR § 42.5(b) gives the
 Board discretion to “waive or suspend a requirement of
 part[] . . . 42.” The Board exercised that discretion here to
 waive any requirement of § 42.73(a) that could be read to
 preclude partial adverse judgment. The Supreme Court in
 SAS stated that “Congress chose to structure a process in
 which it’s the petitioner, not the Director, who gets to de-
 fine the contours of the proceeding.” 138 S. Ct. at 1355.
 Here, the petitioner sought to “simplify the issues to be ad-
 dressed in the final written decision” by requesting a par-
 tial adverse judgment with respect to Ground 1. No. 19-
 1263, J.A. 13406. Genentech has identified no prejudice
 from the partial adverse judgment aside from purportedly
 losing its chance at a second motion to amend. The Board
 did not abuse its discretion when it waived any potential
 requirements precluding partial adverse judgment and we
 see no error in the Board’s treatment thereof.
     The grant of partial adverse judgment on Ground 1 re-
 turned the petition to a single ground, Ground 2, for which
 Genentech had already filed one motion to amend. Thus,
 the Board properly treated Genentech’s second motion to
 amend as one which required a showing of good cause. See
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 GENENTECH, INC.   v. IANCU                                 11

 35 U.S.C. § 316(d)(2) and 37 C.F.R. § 42.121(c). We review
 the Board’s application of its own procedural rules, such as
 whether good cause exists for an additional motion to
 amend under 37 C.F.R. § 42.121(c), for abuse of discretion.
 See Ultratec, Inc. v. CaptionCall, LLC, 872 F.3d 1267, 1271
 (Fed. Cir. 2017). “The Board abuses its discretion if the
 decision: (1) is clearly unreasonable, arbitrary, or fanciful;
 (2) is based on an erroneous conclusion of law; (3) rests on
 clearly erroneous fact findings; or (4) involves a record that
 contains no evidence on which the Board could rationally
 base its decision.” Id. at 1272. Genentech’s second motion
 to amend was directed to Ground 1 concerns and Ground 1
 was no longer part of the inter partes review following the
 Board’s grant of partial adverse judgment. We see no
 abuse of discretion in the Board’s denial of Genentech’s sec-
 ond motion to amend for lack of good cause.
                         CONCLUSION
     We conclude that the Board did not abuse its discretion
 in entering partial adverse judgment on Ground 1 in
 IPR2017-00731 or in denying Genentech’s second motion to
 amend. We further conclude that the Board correctly con-
 strued the terms “in an amount effective to extend the time
 to disease progression in the human patient” and “an effec-
 tive amount” in the ’441 and ’549 patents to be in compari-
 son to an untreated patient. Genentech does not challenge
 the Board’s unpatentability determinations under these
 constructions. We therefore affirm the Board’s decisions.
                         AFFIRMED