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`IPR2017-02032
`Patent Owner’s Preliminary Response
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`
`Adam R. Brausa (Reg. No.
`60,287)
`Daralyn J. Durie (Pro Hac Vice
`to be filed)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
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`
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`Filed on behalf of Patent Owner Genentech, Inc. by:
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`David L. Cavanaugh (Reg. No. 36,476)
`Rebecca A. Whitfield (Reg. No. 73,756)
`Robert J. Gunther, Jr. (Pro Hac Vice to be filed)
`Lisa J. Pirozzolo (Pro Hac Vice to be filed)
`Kevin S. Prussia (Pro Hac Vice to be filed)
`Andrew J. Danford (Pro Hac Vice to be filed)
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________________________________
`
`BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`
`Case IPR2017-02032
`Patent No. 6,407,213
`____________________________________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
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` IPR2017-02032
`Patent Owner’s Preliminary Response
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION ........................................................................................... 1
`BACKGROUND ............................................................................................. 3
`A.
`The Invention of the ’213 Patent ........................................................... 3
`B.
`Prosecution History ............................................................................... 4
`C.
`Other IPR Petitions Involving the ’213 Patent ...................................... 5
`D.
`The Redundant Boehringer Petitions .................................................... 9
` ARGUMENT ................................................................................................. 10
`A.
`The Board Should Deny Institution of Grounds 1- 5 Because
`the Board is Already Considering Those Same Grounds in the
`Ongoing Celltrion and Pfizer IPRs ..................................................... 12
`The Board Should Deny Institution of Ground 6 Because the
`PTO Already Determined that the ’101 Patent is Not Prior Art. ........ 15
`Inter Partes Review Proceedings Violate the Constitution. ................ 17
`C.
` CONCLUSION .............................................................................................. 18
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`B.
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`TABLE OF AUTHORITIES
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` Page(s)
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`Federal Cases
`Cultec, Inc. v. Stormtech LLC,
`IPR2017-00777, Paper 7 (Aug. 22, 2017) .......................................................... 10
`Dynamic Drinkware LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ...................................................................... 2, 16
`Google Inc. v. Personal Web Techs., LLC,
`IPR2014-00980, Paper 10 (Oct. 30, 2014) ......................................................... 14
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) .................................................................... 10, 16
`Hospira, Inc. v. Genentech, Inc.,
`IPR2017-00739, Paper 16 (July 27, 2017) ............................................. 11, 13, 17
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996) ............................................................................................ 17
`McCormick Harvesting Mach. Co. v. C. Aultman & Co.,
`169 U.S. 606 (1898) ............................................................................................ 17
`Neil Ziegmann, N.P.Z., Inc. v. Stephens,
`IPR2015-01860, Paper 12 (Feb. 24, 2016) ......................................................... 17
`Neil Ziegmann N.P.Z., Inc. v. Stephens,
`IPR2015-01860, Paper 13 (Sept. 6, 2017) .......................................................... 11
`R.J. Reynolds Vapor Co. v. Fontem Holdings 1 B.V.,
`IPR2017-01118 and IPR2017-01119, Paper 8 (Oct. 4, 2017) ............................ 13
`Unified Patents, Inc. v. Berman,
`IPR2016-01571, Paper 10 (Dec. 14, 2016)......................................................... 11
`Federal Statutes
`35 U.S.C. § 325(d) ............................................................................................passim
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`ii
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`Patent Owner’s Preliminary Response
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`Regulations
`37 C.F.R. § 42.24(d) ................................................................................................ 20
`37 C.F.R. § 42.122 ................................................................................................... 14
`Constitutional Provisions
`U.S. Const. Amendment VII .................................................................................... 17
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`iii
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` IPR2017-02032
`Patent Owner’s Preliminary Response
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`Genentech, Inc. (“Patent Owner” or “Genentech”) submits this Preliminary
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`Response to the Petition that Boehringer Ingelheim Pharmaceuticals, Inc.
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`(“Petitioner” or “Boehringer”) filed challenging certain claims of U.S. Patent No.
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`6,407,213 (“the ’213 patent”) (Paper 2).
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`
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`INTRODUCTION
`On December 1, 2017, the Board instituted four IPRs in which Celltrion,
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`Inc. (IPR2017-01373 and IPR2017-01374) and Pfizer, Inc. (IPR2017-01488 and
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`IPR2017-01489) have challenged numerous claims of the ’213 patent (based on a
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`total of 32 separate grounds). Patent Owner’s responses in those proceedings are
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`due on February 15, 2018.
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`More than three months after Celltrion and Pfizer filed their now-instituted
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`petitions, Boehringer filed the present Petition (and a second petition in IPR2017-
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`02031). The Board should deny institution of the Boehringer petitions for at least
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`two reasons.
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`First, Boehringer copied Grounds 1-5 of this Petition from IPR2017-01373
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`(Celltrion) and IPR2017-01489 (Pfizer), and copied Grounds 1-3 and 5 of
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`IPR2017-02031 from IPR2017-01374 (Celltrion) and IPR2017-01488 (Pfizer)—
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`without seeking joinder with those earlier-filed proceedings. Boehringer thus asks
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`the Board to institute its IPRs on the same grounds already instituted in the
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`Celltrion and Pfizer proceedings—but on a schedule trailing those proceedings by
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`1
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`several months. This redundancy would waste the Board’s and Patent Owner’s
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`resources, and also would unfairly allow Boehringer to preview the parties’
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`arguments before having to address them itself. Given this resulting waste and
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`prejudice, institution of Grounds 1-5 of this Petition (and Grounds 1-3 and 5 of
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`IPR2017-02031) should be denied.
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`Second, Boehringer’s remaining Ground 6 in this proceeding is based on
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`U.S. Patent No. 5,530,101 (the “’101 patent”) (Ex. 1136). But this ground is not
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`“new” at all. To the contrary, as Boehringer admits, during prosecution of the ’213
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`patent, the Patent and Trademark Office (“PTO”) raised the ’101 patent and in
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`response Patent Owner successfully antedated the ’101 patent. This Ground
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`therefore fails on two bases—Boehringer has failed to carry its burden that the
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`’101 patent is prior art as required by Dynamic Drinkware LLC v. Nat’l Graphics,
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`Inc., 800 F.3d 1375 (Fed. Cir. 2015), and the Board should exercise its discretion
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`pursuant to Section 325(d) to reject Boehringer’s invitation to second-guess the
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`PTO’s finding that the ’101 patent was antedated.
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`Patent Owner therefore requests that the Board deny institution on all
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`grounds.
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`2
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` BACKGROUND
`A. The Invention of the ’213 Patent
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`In the early 1990s, the field of therapeutic antibodies was still in its infancy.
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`Although scientists had known since the 1970s how to obtain antibodies from
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`animals (e.g., mice) that would bind to specific targets, those antibodies generally
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`could not be used in humans because, over time, the body’s own immune system
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`would attack and inactivate them (known as an “immunogenic” response). (Ex.
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`1001 at 1:52-58.)
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`Beginning in the late 1980s, a few scientists created “humanized” antibodies
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`that incorporated the binding site from a non-human antibody into a human
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`antibody framework—which they hoped might address the immunogenicity
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`problem by reducing the amount of non-human amino acid sequences in the
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`antibody. But those early humanized antibodies suffered from reduced binding
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`affinity and/or still produced an immunogenic response. (Id. at 2:21-35, 3:50-55.)
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`The ’213 inventors Drs. Paul Carter and Leonard Presta at Genentech
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`developed a new “consensus human sequence” approach to humanizing antibodies
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`that solved the prior art binding and immunogenicity problems of other humanized
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`antibodies. (Id. at 11:32-38.) That “consensus” approach involved a single human
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`amino acid sequence that could be used for any humanized antibody of a particular
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`immunoglobulin subclass or subunit structure (e.g., light chain κ1). (Id. at 16:20-
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`22 (“All of the humanized antibody models of this invention are based on a single
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`three-dimensional computer graphics structure hereafter referred to as the
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`consensus structure.”).) Drs. Carter and Presta also identified specific amino acids
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`important to maintaining binding affinity. (Id. at 20:32-35.)
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`The ’213 challenged claims are directed to humanized variable domains or
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`humanized antibodies containing certain specified amino acid substitutions
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`identified using the inventors’ novel consensus sequence approach.
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`B.
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`Prosecution History
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`The ’213 patent is a continuation-in-part of an application filed on June 14,
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`1991. (Ex. 1001, coversheet.) During prosecution, Patent Owner presented, and
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`the PTO considered, a number of references describing humanized antibodies,
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`including each of the references relied upon by Boehringer in its petitions.
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`For example, the ’213 specification discussed at length both Jones and
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`Riechmann (relied upon by Boehringer in IPR2017-02031), including by
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`explaining that the references describe “substitut[ing] rodent CDRs or CDR
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`sequences for the corresponding segments of a human antibody.” (Ex. 1001 at
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`2:20-28.) The specification further contrasts Jones’s approach of “substituting
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`CDRs from rodent antibodies for the human CDRs in human frameworks [which
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`was] sufficient to transfer high antigen binding affinity,” with Riechmann’s
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`disclosure that it was “necessary to additionally replace one . . . framework region
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`(FR) residue[].” (Id. at 2:53-61.)
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`Moreover, during prosecution, Patent Owner raised Jones in overcoming a
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`written description rejection (Ex. 1002 at 370), and overcame an obviousness
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`rejection based on Riechmann (id. at 253-54 (Examiner asserting that Riechmann
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`teaches “altering the sequence of the antibody to restore packing or to increase
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`binding affinity”); id. at 372-74 (Patent Owner addressing rejection based in part
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`on Riechmann); id. at 508-11 (Examiner no longer raising Riechmann rejection).)
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`The Examiner ultimately allowed the challenged claims to issue over Jones and
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`Reichmann.
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`During prosecution of the ’213 patent, the Examiner also raised the ’101
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`patent as a Section 102(e) reference and initially rejected several ’213 claims based
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`on it. (E.g., Ex. 1002 at 739-40.) In response, Patent Owner explained how the
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`Examiner had misconstrued the teachings of the ’101 patent and submitted a joint
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`affidavit from Drs. Carter and Presta to antedate the ’101 patent. (Id. at 793, 802-
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`07.) The Examiner allowed the claims to issue over the ’101 patent after accepting
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`that antedation evidence. (Id. at 813.)
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`C. Other IPR Petitions Involving the ’213 Patent
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`In August 2016, Mylan Pharmaceuticals, Inc. challenged the ’213 patent in
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`two separate IPRs (IPR2016-01693 and IPR2016-01694), which the Board
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`terminated after settlement in March 2017. (IPR2016-01693, Paper 24 (Mar. 3,
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`2017); IPR2016-01694, Paper 24 (PTAB Mar. 3, 2017).) In May 2017, Celltrion
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`and Pfizer each filed “copy-cat” petitions of the two original Mylan petitions.
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`(IPR2017-01373 (Celltrion); IPR2017-01374 (Celltrion); IPR2017-01488 (Pfizer);
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`IPR2017-01489 (Pfizer).)
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`As shown in the table below, the copy-cat Celltrion IPR2017-01373 and
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`Pfizer IPR2017-01489 proceedings assert identical grounds based on six
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`references, including a 1989 article (“Queen 1989”), a PCT application published
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`on July 26, 1990 (“Queen 1990”), the Protein Data Bank Database (“PDB
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`Database”), a 1990 article (“Tramontano”), a 1987 reference book (“Kabat 1987”),
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`and a March 1989 publication (“Hudziak”):
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`Ground
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`1
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`2
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`3
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`Claims and Basis
`IPR2017-01373 (Celltrion)
`IPR2017-01489 (Pfizer)
`Claims 1, 2, 12, 25, 29, 63, 64, 66,
`Claims 1, 2, 12, 25, 29, 63, 66,
`67, 71-81
`67, 69, 71-81
` Queen 1989
` Queen 1989
` PDB Database
` PDB Database
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`Claims 1, 2, 4, 12, 25, 29, 62-67,
`69, 71-81
` Queen 1990
` PDB Database
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`Claims 65, 75-77, 79
` Queen 1989
` PDB Database
` Tramontano
`
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`Claims 1, 2, 4, 12, 25, 29, 62-64, 66,
`67, 69, 71-81
` Queen 1990
` PDB Database
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`Claims 65, 75-77, 79
` Queen 1989
` PDB Database
` Tramontano
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`6
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`4
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`5
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`6
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`7
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`Claims 65, 75-77, 79
` Queen 1990
` PDB Database
` Tramontano
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`Claims 4, 62, 64, 69
` Queen 1989
` PDB Database
` Kabat 1987
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`Claims 30, 31, 42, 60
` Queen 1989
` PDB Database
` Hudziak
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`Claims 30, 31, 33, 42, 60
` Queen 1990
` PDB Database
` Hudziak
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`Claims 65, 75-77, 79
` Queen 1990
` PDB Database
` Tramontano
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`Claims 4, 62, 64, 69
` Queen 1989
` PDB Database
` Kabat 1987
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`Claims 30, 31, 42, 60
` Queen 1989
` PDB Database
` Hudziak
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`Claims 30, 31, 33, 42, 60
` Queen 1990
` PDB Database
` Hudziak
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`In the other two copy-cat proceedings, Celltrion IPR2017-01374 and Pfizer
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`IPR2017-01488 assert similar grounds based on seven references, including a
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`European patent application published on December 19, 1990 (“Kurrle”), Queen
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`1990, a 1983 publication (“Furey”), a 1987 publication (“Chothia & Lesk”), a 1985
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`publication (“Chothia 1985”), and Hudziak:
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`Ground
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`1
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`2
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`Claims and Basis
`IPR2017-01374 (Celltrion)
`IPR2017-01488 (Pfizer)
`Claims 1, 2, 25, 29, 63, 66, 71,
`Claims 1, 2, 25, 29, 63, 66, 67, 71,
`75, 76, 78, 80, 81
`72, 75, 76, 80, 81
` Kurrle
` Kurrle
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`Claims 1, 2, 4, 29, 62-64, 80, 81
` Queen 1990
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`Claims 1, 2, 4, 29, 62-64, 80, 81
` Queen 1990
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`7
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`3
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`4
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`5
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`6
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`7
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`8
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`9
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`10
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`N/A
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`8
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`Claims 1, 2, 4, 25, 29, 62-64, 66,
`67, 69, 71, 72, 75, 76, 78, 80, 81
` Queen 1990
` Kurrle
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`Claim 12
` Queen 1990
` Kurrle
` Furey
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`Claims 65, 73, 74, 77, 79
` Queen 1990
` Kurrle
` Chothia & Lesk
` Chothia 1985
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`Claims 30, 31, 33
` Queen 1990
` Hudziak
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`Claim 42
` Queen 1990
` Kurrle
` Hudziak
` Furey
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`Claim 60
` Queen 1990
` Hudziak
` Chothia & Lesk
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`N/A
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`Claims 1, 2, 4, 25, 29, 62-64, 66,
`67, 69, 71, 72, 75, 76, 78, 80, 81
` Queen 1990
` Kurrle
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`Claim 12
` Queen 1990
` Kurrle
` Furey
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`Claims 73, 77
` Queen 1990
` Kurrle
` Chothia & Lesk
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`Claim 74
` Queen 1990
` Kurrle
` Chothia 1985
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`Claims 65, 79
` Queen 1990
` Kurrle
` Chothia & Lesk
` Chothia 1985
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`Claims 30, 31, 33, 42
` Queen 1990
` Hudziak
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`Claim 42
` Queen 1990
` Hudziak
` Furey
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`Claim 60
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`Patent Owner’s Preliminary Response
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` Queen 1990
` Hudziak
` Chothia & Lesk
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`On December 1, 2017, the Board instituted IPRs on all grounds recited in the
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`four Celltrion and Pfizer petitions. (IPR2017-01373 (Paper 16); IPR2017-01374
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`(Paper 15); IPR2017-01488 (Paper 27); IPR2017-01489 (Paper 27).) Patent
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`Owner’s response in those proceedings is due on or before February 15, 2018.
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`In September 2017, Samsung Bioepis also filed copy-cat petitions of the
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`Mylan/Celltrion/Pfizer petitions (IPR2017-02139 and IPR2017-02140). Unlike
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`Boehringer, however, Samsung filed motions seeking to join its petitions with the
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`earlier-filed Pfizer proceedings. (IPR2017-02139, Paper 3; IPR2017-02140, Paper
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`3.) Samsung’s motions remain pending.
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`D. The Redundant Boehringer Petitions
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`Boehringer filed its two petitions on August 31, 2017—i.e., over seven
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`months after Genentech filed its December 2016 Patent Owner’s Preliminary
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`Response in the original Mylan proceedings, over three months after Celltrion and
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`Pfizer filed their petitions, and without any explanation as to why it could not have
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`filed its petitions earlier. As shown in the chart below, Boehringer asserts the
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`following grounds of unpatentability in this proceeding:
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`Ground
`1
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`Claims and Basis
`Claims 1, 2, 25, 29, 63, 66-67, 71-73,75-78, 80-81
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`9
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`2
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`3
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`4
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`5
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`6
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` Queen 1989
` PDB Database
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`Claims 1, 2, 4, 25, 29, 62-64, 66-67, 69, 71-73, 75-78, 80-81
` Queen 19990
` PDB Database
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`Claims 75, 76, 77
` Queen 1989
` PDB Database
` Tramontano
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`Claims 75, 76, 77
` Queen 1990
` PDB Database
` Tramontano
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`Claims 4, 62, 64, 69
` Queen 1989
` PDB Database
` Kabat 1987
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`Claims 1, 2, 4, 25, 29, 62-64, 66-67, 69, 71, 73, 75-78, 80-81
` ’101 patent
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`
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`(Paper 1 at 4.)
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` ARGUMENT
`Under 35 U.S.C. § 325(d), the Board may exercise its discretion to deny
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`institution where “the same or substantially the same prior art or arguments
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`previously were presented to the Office.” Id.; see Harmonic Inc. v. Avid Tech.,
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`Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never
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`compelled, to institute an IPR proceeding.”); Cultec, Inc. v. Stormtech LLC,
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`IPR2017-00777, Paper 7 (Aug. 22, 2017) (designated as informative) (exercising
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`discretion to deny institution where same prior art and arguments were presented to
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`the PTO).
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`Where a petitioner raises substantially the same prior art or arguments that
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`were previously raised to the examiner or the Board, the patent owner’s interests in
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`avoiding harassment and the Board’s interests in conserving resources often
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`outweigh the petitioner’s desire to be heard. See Hospira, Inc. v. Genentech, Inc.,
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`IPR2017-00739, Paper 16 at 16-18 (July 27, 2017) (designated as informative)
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`(explaining considerations under Section 325(d)); Unified Patents, Inc. v. Berman,
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`IPR2016-01571, Paper 10 (Dec. 14, 2016) (designated as informative) (same); Neil
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`Ziegmann N.P.Z., Inc. v. Stephens, IPR2015-01860, Paper 13 at 6-14 (Sept. 6,
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`2017) (expanded PTAB panel) (explaining the rationale and purpose of § 325(d)).
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`As detailed below, five of Boehringer’s six asserted grounds (1-5) duplicate
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`grounds that the Board has already instituted in the Celltrion and Pfizer
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`proceedings, and the remaining ground (6) asserts a reference that the PTO
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`determined was not prior art. Because the Board’s and Patent Owner’s interests in
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`avoiding duplicative challenges far outweigh any interest Boehringer has in
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`retreading these grounds, and because Patent Owner would be prejudiced if
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`Boehringer is permitted to proceed separately on the same grounds at issue in other
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`11
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`proceedings, institution of all grounds should be denied pursuant to Section
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`325(d).1
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`A. The Board Should Deny Institution of Grounds 1- 5 Because the
`Board is Already Considering Those Same Grounds in the
`Ongoing Celltrion and Pfizer IPRs
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`As shown in the chart below, five of Boehringer’s grounds (1-5) are
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`essentially identical to those already instituted in the Celltrion and Pfizer IPRs (the
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`few minor differences are underlined):
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`Ground
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`1
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`2
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`3
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`IPR2017-02032
`(Boehringer)
`Claims 1, 2, 25, 29,
`63, 66, 67, 71-73,75-
`78, 80-81
` Queen 1989
` PDB Database
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`Claims 1, 2, 4, 25,
`29, 62-64, 66, 67, 69,
`71-73, 75-78, 80-81
` Queen 19990
` PDB Database
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`Claims 75-77
` Queen 1989
` PDB Database
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`IPR2017-01373
`(Celltrion)
`Claims 1, 2, 12, 25, 29,
`63, 66, 67, 69, 71-73,
`74, 75-78, 79, 80-81
` Queen 1989
` PDB Database
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`Claims 1, 2, 4, 12, 25,
`29, 62-64, 65, 67, 69,
`71-73, 74, 75-78, 79,
`80-81
` Queen 1990
` PDB Database
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`Claims 65, 75-77, 79
` Queen 1989
` PDB Database
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`IPR2017-01489
`(Pfizer)
`Claims 1, 2, 12, 25, 29,
`63, 64, 66, 67, 71-73,
`74, 75-78, 79, 80-81
` Queen 1989
` PDB Database
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`Claims 1, 2, 4, 12, 25,
`29, 62-64, 66, 67, 69,
`71-73, 74, 75-78, 79,
`80-81
` Queen 1990
` PDB Database
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`Claims 65, 75-77, 79
` Queen 1989
` PDB Database
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`1
`For this preliminary response, Patent Owner has only presented argument
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`under Section 325(d). Should the Board institute any aspect of this Petition, Patent
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`Owner will present arguments on the merits at that time.
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`12
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`4
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`5
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` Tramontano
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`Claims 75-77
` Queen 1990
` PDB Database
` Tramontano
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`Claims 4, 62, 64, 69
` Queen 1989
` PDB Database
` Kabat 1987
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` Tramontano
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`Claims 65, 75-77, 79
` Queen 1990
` PDB Database
` Tramontano
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`Claims 4, 62, 64, 69
` Queen 1989
` PDB Database
` Kabat 1987
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` IPR2017-02032
`Patent Owner’s Preliminary Response
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` Tramontano
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`Claims 65, 75-77, 79
` Queen 1990
` PDB Database
` Tramontano
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`Claims 4, 62, 64, 69
` Queen 1989
` PDB Database
` Kabat 1987
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`Specifically, Boehringer’s Grounds 1-5 raise the same prior art (Queen 1989 (Ex.
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`1034), Queen 1990 (Ex. 1050), the PDB database (Ex. 1030), Tramontano (Ex.
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`1051), Kabat 1987 (Ex. 1052) and Chothia & Lesk (Ex. 1062)), and challenge the
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`same claims as Celltrion IPR2017-01373 and Pfizer IPR2017-01489 (claims 1, 2,
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`4, 25, 29, 62-64, 66, 67, 69, 71-73, 75-78, 80, 81). The only difference is that
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`Celltrion and Pfizer assert invalidity of additional claims in several grounds.
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`Thus, because Boehringer’s Grounds 1-5 are wholly redundant of the
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`already-instituted grounds in the Celltrion and Pfizer IPRs, instituting an IPR on
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`those same grounds in this proceeding would unnecessarily waste both the Board’s
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`and Patent Owner’s resources. See R.J. Reynolds Vapor Co. v. Fontem Holdings 1
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`B.V., IPR2017-01118 and IPR2017-01119, Paper 8 at 4 (Oct. 4, 2017) (denying
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`institution where “[t]he asserted art is identical to that presented in the earlier inter
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`partes reviews”); Hospira, IPR2017-00739, Paper 16 at 18 (recognizing interests
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`Patent Owner’s Preliminary Response
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`“in conserving the resources of the Office and granting patent owners repose on
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`issues and prior art that have been considered previously” (citation omitted)).
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`Denying institution also is necessary to protect Patent Owner from the
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`significant prejudice that would result if Boehringer’s later-filed petition is
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`instituted. Over the last eighteen months, Boehringer could have sought to join the
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`earlier-filed Mylan, Celltrion, and/or Pfizer petitions, including after the Board
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`instituted the Celltrion and Pfizer decisions on December 1, 2017. But Boehringer
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`declined to do so (offering no explanation for its delay), and the time for joinder
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`has now passed. See 37 C.F.R. § 42.122 (providing that “[a]ny request for joinder
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`must be filed . . . no later than one month after the institution date of any inter
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`partes review for which joinder is requested”); see also Google Inc. v. Personal
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`Web Techs., LLC, IPR2014-00980, Paper 10 at 4-5 (Oct. 30, 2014) (denying
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`untimely motion for joinder).
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`By failing to seek joinder, Boehringer essentially asks for an unfair tactical
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`advantage—one that would allow it to preview all of Patent Owner’s arguments
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`and evidence in the Celltrion and Pfizer IPRs (Patent Owner’s Responses are due
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`on February 15, 2018) well before they are presented in this proceeding. The
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`Board should not allow Boehringer to engage in that sort of gamesmanship,
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`particularly when coupled with the inherent inefficiency that would result by
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`proceeding on the same grounds already instituted in the Celltrion and Pfizer IPRs.
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`Patent Owner’s Preliminary Response
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`Patent Owner therefore requests that the Board deny institution of Grounds 1-5 for
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`these reasons as well.
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`B.
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`The Board Should Deny Institution of Ground 6 Because the PTO
`Already Determined that the ’101 Patent is Not Prior Art.
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`Boehringer bases Ground 6 on the ’101 patent, which Boehringer admits in
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`its Petition was not only specifically raised during prosecution, but antedated by
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`Patent Owner:
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`The examiner also raised [the ’101 patent] as [a] §
`102(e) reference[]. Among other things, the examiner
`pointed out that the ’101 patent disclosed antibody
`species with a number of claimed [amino acid]
`substitutions, including at recited position 73H. See, e.g.,
`Ex._1002 at 739-40. However, Genentech ultimately
`provided an affidavit signed by the inventors, swearing
`behind the September 1990 priority date of the [’101
`patent]. Id. at 793, 802-07. They provided pages from a
`laboratory notebook disclosing proposed sequences for a
`humanized 4D5 antibody, relying on consensus
`sequences and at least substitution at site 73H.[] Id.
`The claims were then allowed.
`
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`(Paper 1 at 13-14.) The PTO’s decision that the ’101 patent is not prior art is fatal
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`to Boehringer’s Ground 6 for two reasons.
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`15
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` IPR2017-02032
`Patent Owner’s Preliminary Response
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`First, Boehringer failed to meet its burden to establish that the ’101 patent is
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`
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`prior art. See Harmonic Inc., 815 F.3d at 1363 (explaining that in an IPR “the
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`petitioner has the burden from the onset to show with particularity why the patent
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`it challenges is unpatentable”). The inventors’ affidavit submitted during
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`prosecution of the ’213 patent is evidence that the ’213 invention was reduced to
`
`practice prior to the filing date of the ’101 patent. Accordingly, Boehringer had
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`the burden “to prove that either the invention was not actually reduced to practice
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`as argued, or that [the ’101 patent] was entitled to the benefit of a filing date prior
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`to the date of [the ’213 inventors’] reduction to practice.” Dynamic Drinkware,
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`800 F.3d at 1380. Boehringer made no such showing, instead simply asserting in a
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`footnote that it “does not concede that the [’213 inventors’] declaration is sufficient
`
`to swear behind the genus of species disclosed by the claims of the ’213 patent.”
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`(Paper 1 at 13 n.1.) Needless to say, a mere refusal to concede the point cannot
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`carry Boehringer’s affirmative burden to establish the existence of prior art that
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`renders the claims unpatentable. See Dynamic Drinkware, 800 F.3d at 1378-79;
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`Harmonic Inc., 815 F.3d at 1363.
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`Second, the Board should reject Boehringer’s Ground 6 pursuant to Section
`
`325(d). The PTO considered the validity of the ’213 patent claims in light of the
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`’101 patent, and expressly found that the ’213 patent claims were entitled to
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`priority over the ’101 patent. In Ground 6 of this Petition, Boehringer similarly
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` IPR2017-02032
`Patent Owner’s Preliminary Response
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`asserts that the ’213 patent claims are unpatentable under Section 102(e) over the
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`’101 patent, thus raising “the same or substantially the same prior art or arguments
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`previously [] presented to the Office” as contemplated under 35 U.S.C. § 325(d).
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`The Board should reject Boehringer’s request to “second-guess” the PTO. See Neil
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`Ziegmann, N.P.Z., Inc. v. Stephens, IPR2015-01860, Paper 12 at 13 (Feb. 24, 2016)
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`(refusing to institute IPR where petition was the equivalent of asking the Board “to
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`second-guess the Office’s previous decision on substantially the same issue”);
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`Hospira, IPR2017-00739, Paper 16 at 18 (denying institution where examiner
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`already determined that patent owner had antedated prior art).
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`C. Inter Partes Review Proceedings Violate the Constitution.
`The Board should terminate this proceeding because it violates Patent
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`Owner’s constitutional rights. Because patents are private property rights and
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`disputes concerning their validity were traditionally decided by courts, patent
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`validity must be litigated in an Article III court, not before an executive branch
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`agency. McCormick Harvesting Mach. Co. v. C. Aultman & Co., 169 U.S. 606,
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`609 (1898). Adversarial challenges to an issued patent—like inter partes
`
`reviews—are also “Suits at common law” for which the Seventh Amendment
`
`guarantees a jury trial. U.S. Const. amend. VII; Markman v. Westview
`
`Instruments, Inc., 517 U.S. 370, 377 (1996). Moreover, even if inter partes review
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`17
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` IPR2017-02032
`Patent Owner’s Preliminary Response
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`is constitutional in other circumstances, it is unconstitutional for patents—like the
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`’213 patent—that issued before passage of the America Invents Act.
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`The Supreme Court is currently considering the constitutionality of inter
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`partes reviews in Oil States Energy Services, LLC v. Greene’s Energy Group,
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`LLC, No. 16-712. Patent Owner presents this constitutional challenge now to
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`preserve the issue pending the Supreme Court’s decision.
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` CONCLUSION
`Boehringer’s Petition raises grounds that the Board is already addressing in
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`other proceedings, and that rest on a reference that the PTO already determined
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`was not prior art. Allowing Boehringer to raise those redundant arguments in a
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`new IPR proceeding would waste the Board’s and Patent Owner’s resources, and
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`present Boehringer with an unfair tactical advantage. Genentech therefore
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`respectfully requests that the Board exercise its discretion to deny institution of all
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`grounds pursuant to Section 325(d).
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`Date: January 5, 2018
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` IPR2017-02032
`Patent Owner’s Preliminary Response
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`Respectfully submitted,
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`
`
`/David L. Cavanaugh/
`David L. Cavanaugh
`Registration No. 36,476
`Counsel for Patent Owner
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`
`
`WILMER CUTLER PICKERING HALE AND DORR LLP
`1875 PENNSYLVANIA AVENUE NW
`WASHINGTON, DC 20006
`TEL: 202-663-6000
`FAX: 202-663-6363
`EMAIL: david.cavanaugh@wilmerhale.com
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`IPR2017-02032
`Patent Owner’s Preliminary Response
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`CERTIFICATE OF COMPLIANCE
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`I hereby certify that the foregoing Patent Owner’s Preliminary Response,
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`contains 3,567 words as measured by the word processing software used to prepare
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`the document, in compliance with 37 C.F.R. § 42.24(d).
`
`
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`Dated: January 5, 2018
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`Respectfully submitted,
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`/David L. Cavanaugh/
`David L. Cavanaugh
`Registration No. 36,476
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`IPR2017-02032
`Patent Owner’s Preliminary Response
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`CERTIFICATE OF SERVICE
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`I hereby certify that, on January 5, 2018, I caused a true and correct copy of
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`the following materials:
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` Patent Owner’s Preliminary Response
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` Certificate of Compliance
`
`to be served electronically via electronic mail, as previously agreed by the parties,
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`on the following attorneys of record:
`
`
`
`Ira J. Levy
`GOODWIN PROCTER LLP
`620 Eighth Avenue, New York, NY 10018
`ILevy@goodwinlaw.com
`
`Brian A. Fairchild
`GOODWIN PROCTER LLP
`100 Northern Avenue Boston, MA 02210
`bfairchild@goodwinlaw.com
`
`DG-BI213@goodwinlaw.com
`
`
`/Rebecca Whitfield/
`Rebecca A. Whitfield
`Reg. No. 73,756
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`
`
`21
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