Court Opinion

ID: 5141352
Source: CourtListenerOpinion
Date Created: 2021-12-29 17:01:13.653998+00
Date Added: 2024-06-11T08:24:28.772461
License: Public Domain

Case: 20-2066    Document: 85    Page: 1   Filed: 12/29/2021

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                  ______________________

     SANOFI-AVENTIS DEUTSCHLAND GMBH,
                  Appellant

                            v.

         MYLAN PHARMACEUTICALS INC.,
                   Appellee

   ANDREW HIRSHFELD, PERFORMING THE
    FUNCTIONS AND DUTIES OF THE UNDER
       SECRETARY OF COMMERCE FOR
 INTELLECTUAL PROPERTY AND DIRECTOR OF
 THE UNITED STATES PATENT AND TRADEMARK
                   OFFICE,
                   Intervenor
             ______________________

            2020-2066, 2020-2068, 2020-2069
                ______________________

     Appeals from the United States Patent and Trademark
 Office, Patent Trial and Appeal Board in Nos. IPR2018-
 01679, IPR2018-01680, IPR2018-01682.
                  ______________________

                Decided: December 29, 2021
                  ______________________

    ADAM BANKS, Weil, Gotshal & Manges LLP, New York,
 NY, argued for appellant. Also represented by ANISH R.
Case: 20-2066     Document: 85    Page: 2   Filed: 12/29/2021

 2                           SANOFI-AVENTIS DEUTSCHLAND v.
                               MYLAN PHARMACEUTICALS INC.

 DESAI, SARAH M. STERNLIEB, ELIZABETH WEISWASSER;
 WILLIAM SUTTON ANSLEY, Washington, DC; LAUREN ANN
 DEGNAN, Fish & Richardson P.C., Washington, DC; SCOTT
 MICHAEL FLANZ, JOHN STEPHEN GOETZ, New York, NY.

     DOUGLAS H. CARSTEN, McDermott Will & Emery, Ir-
 vine, CA, argued for appellee. Also represented by ADAM
 WILLIAM BURROWBRIDGE, Washington, DC; WESLEY
 EUGENE DERRYBERRY, STEFFEN NATHANAEL JOHNSON,
 TASHA THOMAS, RICHARD TORCZON, Wilson, Sonsini,
 Goodrich & Rosati, PC, Washington, DC; ELHAM FIROUZI
 STEINER, San Diego, CA.

     BRIAN RACILLA, Office of the Solicitor, United States
 Patent and Trademark Office, Alexandria, VA, for interve-
 nor. Also represented by KAKOLI CAPRIHAN, DANIEL
 KAZHDAN, THOMAS W. KRAUSE, FARHEENA YASMEEN
 RASHEED.
                 ______________________

     Before DYK, CLEVENGER, and TARANTO, Circuit Judges.
 PER CURIAM.
      Sanofi-Aventis Deutschland GmbH (“Sanofi”) owns
 U.S. Patent Nos. 8,992,486 (“the ’486 Patent”) and
 9,526,844 (“the ’844 Patent”). The patents, which relate to
 pen-type injectors for administering medicinal products
 from a multidose cartridge where the user may set the in-
 jection dose, share a common specification and claim prior-
 ity to GB Patent Application No. 0304822.0 (“GB
 Application”). ’844 Patent col. 1 ll. 6–21, 25–29. 1
     These consolidated appeals arise from three inter
 partes reviews (“IPRs”). On appeal, Sanofi challenges the

      1  Citations to the common specification are to the
 ’844 Patent.
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 SANOFI-AVENTIS DEUTSCHLAND     v.                            3
 MYLAN PHARMACEUTICALS INC.

 Board’s determinations that (1) substitute claims 58–64 of
 the ’486 Patent would have been obvious over Steenfeldt-
 Jensen 2 with Klitgaard, 3 Atterbury, 4 and/or Burroughs 5;
 (2) original claims 21–30 of the ’844 Patent would have
 been obvious over Steenfeldt-Jensen or Steenfeldt-Jensen
 with Klitgaard; and (3) because the GB Application does
 not provide written description support for an internally-
 threaded piston rod, original claims 21–30 of the ’844 Pa-
 tent are not entitled to claim priority to the GB Application
 and substitute claims 31–38 of the ’844 Patent are unsup-
 ported amendments. 6 We affirm.
                       THE ’486 PATENT
     In IPR2018-01679, Sanofi proposed substitute claims
 directed at three features. The first is an arc-shaped body
 (“ASB”) that tracks each set dose of medicament. See
 Mylan Pharm. Inc. v. Sanofi-Aventis Deutschland Gmbh,
 IPR2018-01679, at 54–55 (P.T.A.B. May 29, 2020) (“1679
 Final Written Decision”). The second and third are different
 versions of a clicker (“Clicker A” and “Clicker B”) that pro-
 duce audible clicks corresponding to a unit dose of medica-
 ment. Id. at 55–57. In Clicker A, one element of the clicker
 produces clicks only during dialing down of a dose and a
 separate element produces clicks when rotating and mov-
 ing in a specific manner. Id. at 55–56. In Clicker B, one
 element of the clicker produces clicks only during dialing

     2   U.S. Patent No. 6,235,004.
     3   U.S. Patent No. 6,582,404.
     4   W.O. Patent Publication No. 2002/092153.
     5   U.S. Patent No. 6,221,046.
     6   Under the governing statutory and regulatory re-
 quirements, a substitute claim must have support in the
 original disclosure, as well as in any earlier-filed disclosure
 to which there is a priority claim, and may not enlarge the
 scope of the claims or introduce new matter. 35 U.S.C.
 § 316(d); 37 C.F.R. § 42.121.
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 4                            SANOFI-AVENTIS DEUTSCHLAND v.
                                MYLAN PHARMACEUTICALS INC.

 up of a dose and a separate element provides clicks only
 during dialing down of a dose. Id. at 56–57. The Board con-
 cluded that the ASB claims would have been obvious over
 Steenfeldt-Jensen and Klitgaard, where Klitgaard’s nut
 member (modified into a half-nut) would serve as the ASB
 in Steenfeldt-Jensen’s device, id. at 61–75; the Clicker A
 claims would have been obvious over Steenfeldt-Jensen
 and Atterbury, where Atterbury’s clickers would be incor-
 porated into Steenfeldt-Jensen’s device, id. at 77–90; and
 the Clicker B claims would have been obvious over Steen-
 feldt-Jensen, Burroughs, and Atterbury, where Atterbury’s
 clickers and Burroughs’s cartridge would be combined with
 Steenfeldt-Jensen’s device, id. at 93–99.
     Sanofi presents numerous arguments on appeal, chief
 among these being that the Board inappropriately relied on
 common knowledge to supply limitations missing in the
 prior art and on its Clicker A analysis, which the Board
 also used for the Clicker B claims. Based on the record be-
 fore us, we find that substantial evidence supports the
 Board’s obviousness determination. For the ASB claims,
 the Board found, based on the arguments and evidence pre-
 sented, that partial nuts and half-nuts were known, the
 proposed modifications would have been within the skill of
 a person of ordinary skill in the art (“POSA”), and a POSA
 would have been motivated to make those modifications.
 See 1679 Final Written Decision at 64–73. The Board cred-
 ited the testimony of Mylan Pharmaceuticals Inc.’s
 (“Mylan”) expert, Mr. Karl Leinsing, on what was known
 in the art, a POSA’s motivations for modifying the prior art,
 and the operation of the modified device. See id. at 65–69,
 71, 73. Sanofi provides no basis for disturbing the Board’s
 credibility determinations. For the Clicker A claims, the
 Board noted that Sanofi did not dispute the alleged benefit
 of the modified device, nor that a POSA would have had a
 reasonable expectation of success in arriving at the first el-
 ement. Id. at 85–86, 89. Although Sanofi disputed that the
 modification for the second element could be readily
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 SANOFI-AVENTIS DEUTSCHLAND     v.                            5
 MYLAN PHARMACEUTICALS INC.

 accomplished, the Board found Mylan’s arguments and ev-
 idence to be “more persuasive” in light of evidence demon-
 strating a POSA’s knowledge. Id. at 88–90. The numerous
 exhibits on which the Board relied provide substantial evi-
 dence for its findings. For the Clicker B claims, the Board
 noted that Sanofi used the same arguments for both Click-
 ers A and B. Id. at 97. The Board therefore appropriately
 relied on its analysis for the Clicker A claims in its analysis
 for the Clicker B claims.
                       THE ’844 PATENT
     Independent claim 21 of the ’844 Patent discloses “[a]
 drug delivery device comprising” a number of components,
 including “a driving member comprising a third thread”
 and “a piston rod comprising either an internal or an exter-
 nal fourth thread that is engaged with the third thread.”
 ’844 Patent col. 8 ll. 16–49.
     In IPR2018-01680, Mylan’s grounds for unpatentabil-
 ity all included Giambattista, 7 which issued from a patent
 application filed one month after the GB Application.
 Mylan Pharm. Inc. v. Sanofi-Aventis Deutschland Gmbh,
 IPR2018-01680, at 13 (P.T.A.B. May 29, 2020) (“1680 Final
 Written Decision”). The Board held that claims 21–30 are
 not entitled to claim priority to the GB Application because
 the GB Application does not provide written description
 support for an internally-threaded piston rod. Id. at 29.
 The Board determined that (1) the GB Application as a
 whole disclosed only a piston rod with external threads, id.
 at 16–22, and (2) a POSA reading the GB Application
 would not understand the inventors to be in possession of
 an internally-threaded piston rod, id. at 22–29. After deter-
 mining that Giambattista constituted prior art, the Board
 found that claims 21–30 would have been unpatentable. Id.
 at 40–90, 128. In IPR2018-01682, the Board separately

     7   U.S. Patent No. 6,932,794.
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 6                           SANOFI-AVENTIS DEUTSCHLAND v.
                               MYLAN PHARMACEUTICALS INC.

 found that claims 21–29 would have been obvious over
 Steenfeldt-Jensen and claim 30 would have been obvious
 over Steenfeldt-Jensen and Klitgaard. Mylan Pharm. Inc.
 v. Sanofi-Aventis Deutschland Gmbh, IPR2018-01682, at
 132 (P.T.A.B. May 29, 2020) (“1682 Final Written Deci-
 sion”).
      In both IPR2018-01680 and IPR2018-01682, Sanofi
 filed a contingent motion to amend proposing substitute
 claims 31–38. Substitute claim 31 is identical to claim 21
 except for the removal of the phrase “either an internal or
 an external” such that claim 31 recites “a piston rod com-
 prising a fourth thread that is engaged with the third
 thread.” 1680 Final Written Decision at 93, 101–102; 1682
 Final Written Decision at 95–96, 105. The Board observed
 that Sanofi, in making this amendment, sought to main-
 tain the same claim scope while receiving the benefit of the
 GB Application priority date. 1680 Final Written Decision
 at 102–103; 1682 Final Written Decision at 106. As in its
 analysis of the original claims, the Board found that the
 GB Application did not provide written description support
 for an internally-threaded piston rod and denied Sanofi’s
 motion to amend. 1680 Final Written Decision at 103–115;
 1682 Final Written Decision at 107–19.
     Sanofi appeals the Board’s determination that claims
 21–30 are not entitled to the priority date of the GB Appli-
 cation; claims 21–30 separately would have been obvious
 over Steenfeldt-Jensen or Steenfeldt-Jensen with
 Klitgaard; and substitute claims 31–38 are unsupported
 amendments. Sanofi does not contest the Board’s ultimate
 determination in IPR2018-01680 that claims 21–30 would
 have been anticipated by Giambattista and/or obvious in
 view of Giambattista with Steenfeldt-Jensen or Klitgaard.
     On appeal, Sanofi repeats its argument from below
 that the GB Application provides sufficient written de-
 scription for an internally-threaded piston rod because (1)
 it broadly discloses a piston rod with “a first threaded
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 SANOFI-AVENTIS DEUTSCHLAND    v.                           7
 MYLAN PHARMACEUTICALS INC.

 portion at a first end and a second threaded portion at a
 second end” without specifying whether the threading is
 internal or external, J.A. 3935 (2:2–3), and (2) original
 claim 1 of the GB Application broadly claims “a piston rod”
 without reference to any threading, J.A. 3945 (12:3–4).
 Sanofi also repeats its argument that the GB Application’s
 disclosure of an externally-threaded piston rod is sufficient
 to describe the genus of threaded piston rods because a
 POSA would understand that externally-threaded and in-
 ternally-threaded piston rods are the only two species in
 that genus.
     The Board, in its final written decision, correctly re-
 sponded to these arguments in detail and its analysis
 shows it considered the GB Application in its entirety, as
 well as Sanofi’s additional references that allegedly dis-
 close internally-threaded piston rods and testimony from
 both parties’ experts on this issue. See 1680 Final Written
 Decision at 16–29, 101–15; 1682 Final Written Decision at
 105–19. Based on the record before us, substantial evi-
 dence supports the Board’s written description analysis for
 claims 21–30 and substitute claims 31–38. In particular,
 the Board cited the GB Application’s claimed limitations
 and the arrangement of the features in the disclosed injec-
 tor as evidence that the threading on the piston rod is lim-
 ited to external threading. See 1680 Final Written Decision
 at 16–29, 102–107, 109–12; 1682 Final Written Decision at
 105–10. The Board found Sanofi’s references to be uncon-
 vincing, crediting Mr. Leinsing’s testimony regarding what
 a POSA would understand from the GB Application and
 Sanofi’s references. See 1680 Final Written Decision at 20–
 22, 25–26, 107, 110–14; 1682 Final Written Decision at 111,
 113–14, 116–18. Finally, the Board rejected the testimony
 from Sanofi’s expert, Dr. Alexander Slocum, that a POSA
 would have known to implement an alternative mechanism
 with an internally-threaded piston rod in the disclosed in-
 jector, finding Dr. Slocum’s testimony to be not credible,
 conclusory, and inconsistent with the GB Application’s
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 8                           SANOFI-AVENTIS DEUTSCHLAND v.
                               MYLAN PHARMACEUTICALS INC.

 disclosures and crediting Mr. Leinsing’s testimony instead.
 See 1680 Final Written Decision at 17, 19–29, 106–14; 1682
 Final Written Decision at 110, 111–18. Sanofi provides no
 basis for overturning these findings.
     Because we affirm the Board’s determination in
 IPR2018-01680 that claims 21–30 would have been un-
 patentable as obvious and/or anticipated and the Board’s
 decision to deny Sanofi’s motion to amend with substitute
 claims 31–38, the appeal from the final written decision in
 IPR2018-01682 is moot and we accordingly dismiss as moot
 Appeal No. 2020-2069.
     AFFIRMED IN PART, DISMISSED IN PART

                           COSTS
 Costs to Appellee.