Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
` Paper No. 17
`
` Entered: January 3, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MERCK SHARP & DOHME CORP.,
`Petitioner,
`
`v.
`
`GENENTECH, INC. and CITY OF HOPE,
`Patent Owner.
`____________
`
`Case IPR2016-01373
`Patent 6,331,415 B1
`____________
`
`
`
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
` Paper No. 17
`
` Entered: January 3, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MERCK SHARP & DOHME CORP.,
`Petitioner,
`
`v.
`
`GENENTECH, INC. and CITY OF HOPE,
`Patent Owner.
`____________
`
`Case IPR2016-01373
`Patent 6,331,415 B1
`____________
`
`
`
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`IPR2016-01373
`Patent 6,331,415 B1
`
`
`INTRODUCTION
`
`Merck Sharp & Dohme Corp. (“Petitioner”) filed a Petition requesting
`an inter partes review of claims 1–4, 11, 12, 14–20, and 33 of U.S. Patent
`No. 6,331,415 B1 (Ex. 1001, “the ’415 patent”). Paper 1 (“Pet.”).
`Genentech, Inc. and City of Hope (collectively, “Patent Owner”) filed a
`Preliminary Response. Paper 24.
`We have jurisdiction under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” Upon considering the Petition and the
`Preliminary Response, we exercise our discretion under 35 U.S.C. § 325(d)
`and decline to institute an inter partes review.
`Related Proceedings
`A.
`Petitioner identifies four petitions for inter partes review challenging
`the ’415 patent. Pet. 62. A trial in IPR2016-01624 was instituted on
`February 5, 2016, to which the trial in IPR2016-00460 was joined. That
`joined proceeding settled on September 2, 2016. The petition in IPR2016-
`00383 was denied institution on June 23, 2016. Pet. 63. Petitioner identifies
`also IPR2016-00710 (id.), which was instituted on September 8, 2016.
`In addition, Petitioner has filed a second Petition for inter partes
`review of some of the same claims of the ’415 patent, IPR2017-00047, in
`which Petitioner seeks joinder to IPR2016-00710. A trial in IPR2017-00047
`has been instituted and joined to IPR2016-00710 concurrently with the
`instant decision.
`Patent Owner identifies also several district court and PTO
`proceedings related to the ’415 patent. Papers 15, 25.
`
`2
`
`
`
`IPR2016-01373
`Patent 6,331,415 B1
`
`
`The ’415 Patent (Ex. 1001)
`B.
`The ’415 patent issued on December 18, 2001, and claims priority to
`an application filed on April 8, 1983, now U.S. Patent No. 4,816,567. See
`Ex. 1001, Title Page. Shmuel Cabilly, Herbert L. Heyneker, William E.
`Holmes, Arthur D. Riggs, and Ronald B. Wetzel are the listed co-inventors.
`Id.
`
`The ’415 patent relates generally to processes for producing
`immunoglobulin molecules in a host cell transformed with a first DNA
`sequence encoding the variable domain of the heavy chain and a second
`DNA sequence encoding the variable domain of the light chain, as well as
`vectors and transformed host cells used in such processes. Id., Abstract.
`More specifically, the first and second DNA sequences are present either in
`different vectors or in a single vector, and independently expressed so that
`the immunoglobulin heavy and light chains are produced as separate
`molecules in the transformed single host cell. See id., Claims 1, 15, 18, 21,
`and 33.
`According to the Specification of the ’415 patent, prior to the
`invention, there were two major sources of vertebrate antibodies—they
`could be generated in situ by the mammalian B lymphocytes or in cell
`culture by B-cell hybrids (hybridomas). Id. at 1:42–45. The Specification
`notes, however, that monoclonal antibodies produced by these two sources
`suffer from disadvantages, including contamination with other cellular
`materials, instability, production of an undesired glycosylated form, high
`cost, and an inability to manipulate the genome. Id. at 2:40–66. The
`Specification recognizes that “recombinant DNA technology can express
`entirely heterologous polypeptides—so-called direct expression—or
`
`3
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`IPR2016-01373
`Patent 6,331,415 B1
`
`alternatively may express a heterologous polypeptide fused to a portion of
`the amino acid sequence of a homologous polypeptide.” Id. at 4:33–37.
`The Specification states that “[t]he invention relates to antibodies and
`to non-specific immunoglobulins (NSIs) formed by recombinant techniques
`using suitable host cell cultures,” which can “be manipulated at the genomic
`level to produce chimeras of variants which draw their homology from
`species which differ from each other.” Id. at 4:53–59. The Specification
`further indicates that “[t]he ability of the method of the invention to produce
`heavy and light chains or portions thereof, in isolation from each other offers
`the opportunity to obtain unique and unprecedented assemblies of
`immunoglobulins, Fab regions, and univalent antibodies.” Id. at 12:52–62.
`Illustrative Claims
`C.
`Petitioner challenges claims 1–4, 11, 12, 14–20, and 33 of the ’415
`patent. Claims 1, 15, 18, and 33 are independent. Independent claim 1 is
`illustrative, and is reproduced below:
`
`1. A process for producing an immunoglobulin molecule or an
`immunologically functional immunoglobulin fragment comprising at
`least the variable domains of the immunoglobulin heavy and light
`chains, in a single host cell, comprising the steps of:
`
`(i) transforming said single host cell with a first DNA sequence
`encoding at least the variable domain of the immunoglobulin heavy
`chain and a second DNA sequence encoding at least the variable
`domain of the immunoglobulin light chain, and
`
`(ii) independently expressing said first DNA sequence and said second
`DNA sequence so that said immunoglobulin heavy and light chains are
`produced as separate molecules in said transformed single host cell.
`
`4
`
`
`
`IPR2016-01373
`Patent 6,331,415 B1
`
`
`Mulligan Papers, Axel, and
`the Nobel Article3
`Mulligan Papers, Axel, and
`Builder4
`Southern5 and Axel
`
`§ 103
`
`§ 103
`
`§ 103
`
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–4, 11, 12, 14–20,
`and 33 of the ’415 patent on the following grounds (Pet. 12‒13):
`References
`Basis
`Claims Challenged
`Mulligan Papers1 and Axel2
`§ 103
`1, 3, 4, 11, 12, 14‒17, 19,
`and 33
`1, 3, 4, 11, 12, 14‒17, 19,
`and 33
`1, 3, 4, 11, 12, 14‒17, 19,
`and 33
`1, 2, 11, 12, 14, 18‒20,
`and 33
`1, 2, 11, 12, 14, 18‒20,
`and 33
`
`Southern, Axel, and Builder
`
`§ 103
`
`
`
`Petitioner relies also on the Declarations of Roger D. Kornberg, Ph.D.
`(Ex. 1009) and Richard A. Lerner, Ph.D. (Ex. 1008). Pet. 13.
`
`
`1 R.C. Mulligan and P. Berg, Expression of a Bacterial Gene in Mammalian
`Cells, 209 SCIENCE 1422‒27 (1980) (Ex. 1002); R.C. Mulligan and P. Berg,
`Selection for Animal Cells that Express the Escherichia coli Gene Coding
`for Xanthine-Guanine Phosphoribosyltransferase, 78 PNAS 2072‒76 (1981)
`(Ex. 1003) (collectively, the “Mulligan Papers”),
`2 Axel et al., U.S. Patent No. 4,399,216, issued Aug. 16, 1983 (Ex. 1006)
`(“Axel”).
`3 Paul Berg, Dissections and Reconstructions of Genes and Chromosomes,
`213 SCIENCE 296–303 (1981) (Ex. 1004) (“the Nobel Article”).
`4 Builder et al., U.S. Patent No. 4,511,502, issued Apr. 16, 1985 (Ex. 1007)
`(“Builder”).
`5 P.J. Southern and P. Berg, Transformation of Mammalian Cells to
`Antibiotic Resistance with a Bacterial Gene Under Control of the SV40
`Early Region Promoter, 1 J. MOLECULAR AND APPLIED GENETICS327–341
`(1982) (Ex. 1005) (“Southern”).
`
`5
`
`
`
`IPR2016-01373
`Patent 6,331,415 B1
`
`
`ANALYSIS
`
`35 U.S.C. § 325(d)
`Patent Owner argues that the only reference relied upon by Petitioner
`
`that refers to antibodies is Axel. Prelim. Resp. 20. Patent Owner contends,
`however, that the United States Patent and Trademark Office (“Office”)
`considered Axel extensively during reexamination, and affirmed
`the Cabilly ’415 claims over that reference—finding “Axel et al
`did not teach a single host cell transformed with immunoglobulin
`heavy chain and immunoglobulin light chain independently” or
`“co-expression of two foreign DNA sequences.”
`Id. at 29‒30 (citing Ex. 2005, 4).
`
`Patent Owner asserts further that “the Board has already concluded
`that Axel is a weaker reference than Bujard,6 which is the subject of already-
`instituted IPR2016-00710 that Merck is seeking to join.” Id. at 30 (footnote
`added) (citing IPR2015-01624, Paper 15, 16 (“We find Bujard’s teachings to
`be more specific and robust than the Axel reference that was previously
`considered by the PTO.”)). Patent Owner argues that the Petition does not
`explain “how Axel discloses anything more or different than Bujard.” Id.
`We have discretion under 35 U.S.C. § 325(d) to reject a petition when
`the same or substantially the same prior art or arguments were presented
`previously in another proceeding before the Office. The relevant portion of
`that statute is reproduced below:
`In determining whether to institute or order a proceeding under
`this chapter, chapter 30, or chapter 31, the Director may take into
`account whether, and reject the petition or request because, the
`same or substantially the same prior art or arguments previously
`were presented to the Office.
`
`
`6 Bujard et al., U.S. Pat. No. 4,495,280, issued Jan. 22, 1985.
`
`6
`
`
`
`IPR2016-01373
`Patent 6,331,415 B1
`
`35 U.S.C. § 325(d).
`Although Petitioner may have sound reasons for raising art or
`arguments similar to those previously considered by the Office, the Board
`weighs petitioners’ desires to be heard against the interests of patent owners,
`who seek to avoid harassment. See H.R. Rep. No. 112-98, pt.1, at 48 (2011)
`(AIA proceedings “are not to be used as tools for harassment or a means to
`prevent market entry through repeated litigation and administrative attacks
`on the validity of a patent. Doing so would frustrate the purpose of the
`section as providing quick and cost effective alternatives to litigation.”).
`
`All of the challenged claims require an immunoglobulin molecule. As
`Patent Owner notes (Prelim. Resp. 20), Axel is the only asserted reference
`that discloses an immunoglobulin molecule, i.e., an antibody. Axel was
`explicitly considered by the Office during reexamination of the ’415 patent.
`During that reexamination, as to the Axel reference, the Examiner stated:
`Axel et al taught a process for inserting foreign DNA into
`eukaryotic cell by cotransformation with the disclosed foreign
`DNA I and DNA II that encodes a selectable marker. Axel et al
`did not teach a single host cell transformed with immunoglobulin
`heavy chain and immunoglobulin light chain independently.
`Axel et al did not teach co-expression of two foreign DNA
`sequences (see Harris declaration, McKnight declaration,
`Botchan declaration, Rice declaration, and Colman declaration).
`Ex. 2005, 4.
`
`In addition, as further noted by Patent Owner (Prelim. Resp. 30), in
`considering Bujard, the Board in IPR2015-01624 noted that Bujard’s
`teachings are “more specific and robust” than Axel. IPR2015-01624, Paper
`15, 16. We agree with Patent Owner (Prelim. Resp. 30) that Petitioner has
`not explained how the instant challenges overcome that deficiency of Axel
`
`7
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`
`
`IPR2016-01373
`Patent 6,331,415 B1
`
`as compared to Bujard such that we should institute trial on the instant
`challenges, all of which rely on Axel for its teaching of an immunoglobulin.
`
`We determine, therefore, that Axel, the only reference that Petitioner
`relies upon to disclose an immunoglobulin molecule, was previously
`presented to, and considered by, the Office in the same substantive manner
`as Petitioner now advocates.
`
`Moreover, as noted by Patent Owner, Petitioner in the instant
`proceeding filed a second Petition (IPR2017-00047) seeking joinder with
`IPR2016-00710, which was instituted on September 8, 2016. Prelim. Resp.
`28. We have instituted trial in IPR2017-00047, and joined it with IPR2016-
`00710, concurrently with the instant decision. As Petitioner has agreed to
`abide by the Scheduling Order in IPR2016-00710, a final written decision
`will be entered in that case well before a final written decision would be
`entered in the instant proceeding. See Prelim. Resp. 29. See 35 U.S.C.
`§ 325(e)(1) (prohibiting a petitioner, when a post-grant review results in a
`final written decision, from requesting or maintaining a proceeding with
`respect to a claim challenged on any ground that the petitioner raised or
`reasonably could have raised during the post-grant review).
`Thus, balancing the competing interests involved in the multiple
`Petitions challenging the ’415 patent, and taking full account of the facts and
`equities involved in this particular matter, we exercise our discretion, under
`35 U.S.C. § 325(d), to deny the Petition and decline to institute inter partes
`review.
`
`8
`
`
`
`IPR2016-01373
`Patent 6,331,415 B1
`
`
`II. ORDER
`In consideration of the foregoing, it is hereby ordered that the Petition
`is denied, and no trial is instituted.
`
`
`
`
`
`
`
`9
`
`
`
`IPR2016-01373
`Patent 6,331,415 B1
`
`PETITIONER:
`
`Raymond N. Nimrod
`Matthew A. Traupman
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`raynimrod@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`
`Katherine A. Helm
`SIMPSON THACHER & BARTLETT LLP
`khelm@stblaw.com
`
`PATENT OWNER:
`
`David L. Cavanaugh
`Heather M. Petruzzi
`Owen Allen
`WILMER CUTLER PICKERING HALE AND DORR LLP
`david.cavanaugh@wilmerhale.com
`heather.petruzzi@wilmerhale.com
`owen.allen@wilmerhale.com
`
`Adam R. Brausa
`DURIE TANGRI
`abrausa@durietangri.com
`
`
`
`10
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