throbber
IPR2017-01374
`Patent Owner’s Motion to Strike
`
`Adam R. Brausa (Reg No. 60,287)
`Daralyn J. Durie (Pro Hac Vice)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`
`
`Filed on behalf of Patent Owner Genentech, Inc. by:
`
`David L. Cavanaugh (Reg. No. 36,476)
`Lauren V. Blakely (Reg. No. 70,247)
`Robert J. Gunther, Jr. (Pro Hac Vice)
`Lisa J. Pirozzolo (Pro Hac Vice)
`
`Kevin S. Prussia (Pro Hac Vice)
`
`Andrew J. Danford (Pro Hac Vice)
`
`WILMER CUTLER PICKERING
`
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`Case IPR2017-01374
`U.S. Patent No. 6,407,213
`____________________________________________
`PATENT OWNER’S MOTION TO STRIKE
`PURSUANT TO PAPER NO. 57
`
`
`
`
`
`

`

`
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`TABLE OF CONTENTS
`
`Page
`INTRODUCTION ........................................................................................... 1
`I.
`PETITIONER’S EVOLVING INVALIDITY ARGUMENTS ...................... 2
`II.
`III. PETITIONER’S NEW ARGUMENTS ARE FORECLOSED BY
`FEDERAL CIRCUIT PRECEDENT, STATUTE, AND THE
`BOARD’S REGULATIONS ........................................................................... 3
`A. Applicable Law ..................................................................................... 3
`B.
`Petitioner’s Reliance on Foote 1989 is Improper .................................. 4
`1.
`Petitioner’s arguments and testimony regarding Foote 1989
`present a new theory of unpatentability ...................................... 4
`The prejudice to Patent Owner outweighs any marginal
`relevance of Foote 1989 to unexpected results ........................... 5
`Petitioner Should Have Been Aware of Foote 1989 at the Time
`the Petition Was Filed ................................................................. 7
`IV. CONCLUSION ................................................................................................ 9
`
`
`
`2.
`
`3.
`
`
`
`i
`
`

`

`
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Apple Inc. v. e-Watch Inc.,
`IPR2015-00412, Paper 50 (PTAB May 6, 2016) ............................................. 4, 9
`Cox Comms., Inc. v. AT&T Intellectual Prop. II, L.P,
`IPR2015-01187, Paper 59 (PTAB Nov. 15, 2016) ............................................... 5
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litigation,
`676 F.3d 1063 (Fed. Cir. 2012) ............................................................................ 7
`Dexcom, Inc. v. Waveform Techs, Inc.,
`IPR2016-01679, Paper 53 (PTAB Feb. 28, 2018) ................................................ 4
`Intelligent-BioSystems, Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ............................................................................ 4
`Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc.,
`853 F.3d 1272 (Fed. Cir. 2017) ........................................................................ 4, 7
`Federal Statutes
`35 U.S.C. § 312(a) ..................................................................................................... 4
`35 U.S.C. § 325(d) ..................................................................................................... 7
`Regulations
`37 C.F.R. § 42.23 (b) ............................................................................................. 3, 4
`Patent Trial Practice Guide, 77 Fed. Reg. 48,612, 48,620 (Aug. 14,
`2012) ..................................................................................................................... 3
`
`
`
`ii
`
`

`

`
`I.
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`INTRODUCTION
`Pursuant to Paper No. 57, Patent Owner files this motion to strike evidence
`
`and argument pertaining to Petitioner’s new obviousness theory that a new exhibit,
`
`Foote 1989 (Ex. 1193) discloses using a “consensus” sequence as described in
`
`claims of the ’213 patent. Specifically, Patent Owner seeks to strike Exhibit 1193
`
`and the arguments and testimony that rely on this exhibit, including the first full
`
`paragraph of page 18 of the Reply, Ex. 1143 ¶30, and Ex. 1138 at 176:25 to
`
`178:23.
`
`Petitioner chose to file a copycat petition based on the petition filed by
`
`Mylan Pharmaceuticals, Inc. in IPR2016-01693 (the “Mylan IPR”). (Compare
`
`Paper 2 with Mylan Pharms. Inc. v. Genentech, Inc., IPR2016-01693 (Paper 1).)
`
`In doing so, Petitioner’s experts submitted nearly word-for-word copies of the
`
`analysis for the proposed grounds in the declarations from the Mylan IPR. (See
`
`Ex. 2062 (redline comparing Dr. Riechmann’s declaration with Mylan’s expert’s
`
`declaration); Ex. 1004 at ¶4 (Dr. Leonard stating he repeated the statements of
`
`Mylan’s expert and “revised only as necessary.”).) Having made that strategic
`
`choice, Petitioner should not now be permitted to deviate from the arguments made
`
`in the Petition and shoehorn in a new reference to support its obviousness case and
`
`better suit its experts here.
`
`1
`
`

`

`Petitioner’s new evidence and argument principally relies on Exhibit 1193
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`
`
`(“Foote 1989”)—a publication titled “Humanized Antibodies” authored by
`
`Jefferson Foote, the petitioners’ expert in the companion cases brought by Pfizer.
`
`As set forth in more detail below, Foote 1989 was submitted by Petitioner in reply
`
`to backdoor in a new ground for unpatentability and fill in the gaps in its prima
`
`facie case. Petitioner has no excuse for failing to identify Foote 1989 in the
`
`Petition because its own expert, Dr. Riechmann, now claims that Foote 1989
`
`discloses a consensus sequence that Dr. Riechmann himself used in his own work.
`
`Patent Owner therefore respectfully requests that the Board grant its motion to
`
`strike.
`
`II.
`
`PETITIONER’S EVOLVING INVALIDITY ARGUMENTS.
`Claims 4, 33, 62, 64, and 69 require the use of a “consensus” sequence. The
`
`’213 patent provides a specific definition of the claimed human “consensus”
`
`sequence, “which comprises the most frequently occurring amino acid residues at
`
`each location in all human immunoglobulins of any particular subclass or subunit
`
`structure.” (Ex. 1001, 11:32-38; Paper 15 at 7-8.) The Petition argued that the
`
`“consensus” limitation was met by Queen 1990’s (Ex. 1050) disclosure of “us[ing]
`
`a consensus framework from many human antibodies.” (See, e.g., Paper 2 at 34-
`
`36, 42-45, 47, 58.) Although Dr. Riechmann’s declaration describes his work on
`
`humanizing an anti-body called CAMPATH-1, that discussion (i) is not mentioned
`
`2
`
`

`

`
`in the Petition; and (ii) does not mention a consensus sequence, Dr. Foote, or the
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`Foote 1989 reference. (See Ex. 1003 at ¶31, 94-98, 340.)
`
`Consistent with the arguments in the Petition, Patent Owner’s Response
`
`focused on showing that Queen 1990 does not teach the “consensus” sequence
`
`limitations of claims 4, 33, 62, 64, and 69. (See, e.g., Paper 38 at 46-48.) For the
`
`first time in their Reply, Petitioner pivots from relying solely on Queen 1990 with
`
`respect to the “consensus” sequence limitations, and now invites the Board to find
`
`those limitations in a new reference, Foote 1989.
`
`III. PETITIONER’S NEW ARGUMENTS ARE FORECLOSED BY
`FEDERAL CIRCUIT PRECEDENT, STATUTE, AND THE BOARD’S
`REGULATIONS.
`Applicable Law
`Evidence introduced in a reply “must be responsive and not merely new
`
`A.
`
`evidence that could have been presented earlier” to support the petition. Patent
`
`Trial Practice Guide, 77 Fed. Reg. 48,612, 48,620 (Aug. 14, 2012); see also 37
`
`C.F.R. § 42.23 (b) (“A reply may only respond to arguments raised in the … patent
`
`owner response.”). But “‘[r]espond,’ in the context of 37 C.F.R. § 42.23(b), does
`
`not mean embark in a new direction with a new approach as compared to the
`
`position originally taken in the Petition.” Apple Inc. v. e-Watch Inc., IPR2015-
`
`00412, Paper 50 at 44 (PTAB May 6, 2016).
`
`3
`
`

`

`When a reply strays from “explaining how [the] original petition was
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`
`
`correct” and begins arguing new theories of unpatentability or relying on
`
`references not disclosed in the petition, this amounts to a shifting of arguments that
`
`is “foreclosed by statute, our precedent, and Board Guidelines.” Wasica Fin.
`
`GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286–87 (Fed. Cir. 2017); see also
`
`Dexcom, Inc. v. Waveform Techs, Inc., IPR2016-01679, Paper 53 at 50 (PTAB
`
`Feb. 28, 2018) (evidence necessary to make out a prima facie case of
`
`unpatentability may not be introduced for the first time in the reply brief); 35
`
`U.S.C. § 312(a) (petition must identify “with particularity” the evidence supporting
`
`the grounds). Thus, “[i]t is of the utmost importance that petitioners in the IPR
`
`proceedings adhere to the requirement that the initial petition identify with
`
`particularity the evidence that supports the grounds for the challenge to each claim
`
`….” Intelligent-BioSystems, Inc. v. Illumina Cambridge, Ltd., 821 F.3d 1359,
`
`1369-70 (Fed. Cir. 2016); id. at 1370 (“[T]he expedited nature of IPRs bring with it
`
`an obligation for petitioners to make their case in their petition to institute.”).
`
`1.
`
`B.
`
`Petitioner’s Reliance on Foote 1989 is Improper.
`Petitioner’s arguments and testimony regarding Foote 1989
`present a new theory of unpatentability.
`Petitioner for the first time in its Reply identified the Foote 1989 reference
`
`and argued that it teaches the “consensus” sequence limitations of claims 4, 33, 62,
`
`4
`
`

`

`
`64, and 69. Indeed, although Petitioner denied during the June 18, 2018
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`teleconference with the Board that it was relying on Foote 1989 to support its
`
`prima facie case of obviousness, Petitioner’s Reply plainly seeks to use Foote 1989
`
`to buttress its argument that the prior art discloses the consensus sequence. (Reply
`
`at 18 (“Both Foote and Queen-1990 teach use of a consensus sequence in
`
`humanizing antibody.”); see also Ex. 1143 ¶30 (arguing, outside the context of
`
`secondary considerations, that CAMPATH-1 used a consensus sequence).)
`
`Petitioner’s reliance on an entirely new reference in its Reply to advance a new
`
`theory for why the claim limitations are supposedly found in the prior art is
`
`improper. See Cox Comms., Inc. v. AT&T Intellectual Prop. II, L.P, Case No.
`
`IPR2015-01187, Paper 59 at 16-17 (PTAB Nov. 15, 2016) (declining to consider
`
`obviousness combination where a “background reference” would be substituted for
`
`part of instituted reference, finding the assertion comprised a “new argument of
`
`unpatentability,” and “trial was not instituted on this ground”).
`
`2.
`
`The prejudice to Patent Owner outweighs any marginal
`relevance of Foote 1989 to unexpected results.
`Petitioner’s attempt to use Foote 1989 to rebut unexpected results does not
`
`remove the prejudice to Patent Owner caused by Petitioner’s shifting obviousness
`
`theory. Using Foote 1989 to rebut unexpected results makes little practical sense.
`
`If Petitioner is correct that Queen 1990 discloses using a consensus sequence (it
`
`5
`
`

`

`
`does not), then the addition of another reference showing that the prior art
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`disclosed the same thing adds nothing to Petitioner’s response to “unexpected
`
`results”; Petitioner could simply rely on Queen 1990. And, in any event, Petitioner
`
`raised unexpected results in the Petition, (see, e.g., Paper 2 at 61) and its expert
`
`argued in the context of unexpected results that the consensuses sequences of the
`
`’213 patent are similar to sequences found in prior art humanized antibodies—but
`
`he does not argue that those antibodies embody the consensus sequence limitation.
`
`(Ex. 1003, ¶340.)
`
`The substantial prejudice caused by Petitioner’s reliance on a new piece of
`
`evidence to teach missing claim elements—even if in the context of secondary
`
`considerations—greatly outweighs the relevance of Foote 1989 to the secondary
`
`considerations debate. The Federal Circuit has required that all evidence—
`
`including objective indicia of non-obviousness—must be considered together
`
`before finding a patent invalid as obviousness. In re Cyclobenzaprine
`
`Hydrochloride Extended-Release Capsule Patent Litigation, 676 F.3d 1063, 1079-
`
`80 (Fed. Cir. 2012). Here, it is clear that Petitioner is attempting to use Foote 1989
`
`to fill the gaps in Petitioner’s prima facie case.
`
`6
`
`

`

`
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`3.
`
`Petitioner Should Have Been Aware of Foote 1989 at the Time
`the Petition Was Filed.
`Petitioner should have been aware of the Foote 1989 reference before filing
`
`the Petition for at least two reasons. First, Foote 1989 is substantively discussed in
`
`the prosecution history. (See, e.g., Ex. 1002 at 340.) Importantly, whether Patent
`
`Owner was on notice of the existence of the Foote 1989 reference is a different
`
`question from whether Patent Owner was on notice of Petitioner’s reliance on
`
`Foote 1989 to teach the “consensus” sequence limitations of the ’213 patent. See,
`
`e.g., Wasica, 853 F.3d at 1286-87 (shifting substantive arguments in reply is
`
`foreclosed by 35 U.S.C. § 312(a)(3)’s requirement that petitioner identify “with
`
`particularity … the grounds on which the challenge to each claim is based.”).
`
`Further, had Foote 1989 been raised in the Petition, Patent Owner would have
`
`responded differently, including, for example, presenting argument that the
`
`proposed grounds should be barred by 35 U.S.C. § 325(d) because the challenged
`
`claims were allowed over Foote 1989. (See, e.g., Ex. 1002 at 340 (discussing
`
`Foote 1989); id. at 743-53 (Notice of Allowability); Ex. 1001 at 4 (listing Foote
`
`1989).)
`
`Second, the reply declaration of Dr. Riechmann confirms that Petitioner
`
`should have been aware of Foote 1989 well prior to the filing of the Petition.
`
`Dr. Riechmann explains that at the time he was purportedly developing a
`
`7
`
`

`

`
`humanized antibody called CAMPATH-1, Dr. Foote was a “colleague” who gave
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`him a “light chain” he claims was designed to match a consensus light chain. (Ex.
`
`1143 ¶30.) Dr. Riechmann claims he used this to build a humanized antibody,
`
`CAMPATH-1. (See id.) But in his initial declaration describing his work on
`
`CAMPATH-1—a description that spans 7 paragraphs (Ex. 1003 at ¶¶31, 94-98,
`
`340)—Dr. Riechmann fails to mention Dr. Foote, the Foote 1989 reference, or that
`
`a critical claim limitation was purportedly met by an amino acid sequence received
`
`from his colleague. Further, in his deposition, Dr. Riechmann stated that when he
`
`worked in Dr. Winter’s lab, he had “a lot of discussions” with Dr. Foote about
`
`humanizing an antibody, (Ex. 2039 at 76:18-77:2), and that he received a “light
`
`chain” from Dr. Foote for use in his work (Id. at 144:10-18). But again, Dr.
`
`Riechmann does not mention that he received a light chain purportedly embodying
`
`a critical element of the claims until after Patent Owner submitted its Response.
`
`As a colleague of Dr. Foote, and one with whom he had “a lot of
`
`discussions” regarding humanizing antibodies, Dr. Riechmann should have known
`
`about Dr. Foote’s work, including Ex. 1193, at the time he was drafting his original
`
`declaration and should have raised it to Petitioner then.
`
`*
`
`*
`
`*
`
`In sum, allowing Petitioner to pivot from its reliance on Queen 1990 to
`
`Foote 1989 would be “unjust to the Patent Owner,” Apple Inc., IPR2015-00412,
`
`8
`
`

`

`
`Paper 50 at 44. Exhibit 1193, the arguments and testimony relying on it, and the
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`testimony elicited from questioning pertaining to it should be stricken because it is
`
`a new exhibit not included in the instituted grounds used by Petitioner to argue that
`
`substantive elements of the ’213 claims were disclosed in the prior art.
`
`IV. CONCLUSION
`The Board should strike Exhibit 1193 and the argument and testimony that
`
`rely on this exhibit, including the first full paragraph of page 18 of the Reply brief,
`
`Ex. 1143 ¶30, and Ex. 1138 at 176:25 to 178:23.
`
`
`
`Date: June 22, 2018
`
`
`
`
`
`Respectfully submitted,
`
`/David L. Cavanaugh/
`By:
`David L. Cavanaugh
`Reg. No. 36,476
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Avenue NW
`Washington, DC 20006
`202-663-6025
`
`
`
`9
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that, on June 22, 2018, I caused a true and correct
`copy of the following materials:
`
` Patent Owner’s Motion to Strike
`
`to be served via electronic mail on the following attorneys of record:
`
`Cynthia Lambert Hardman
`GOODWIN PROCTER LLP
`chardman@goodwinlaw.com
`620 Eighth Avenue, New York, NY 10018
`
`Robert V. Cerwinski
`GOODWIN PROCTER LLP
`rcerwinski@goodwinlaw.com
`620 Eighth Avenue, New York, NY 10018
`
`Elizabeth Holland
`GOODWIN PROCTER LLP
`eholland@goodwinlaw.com
`620 Eighth Avenue, New York, NY 10018
`
`Linnea P. Cipriano
`GOODWIN PROCTER LLP
`lcipriano@goodwinlaw.com
`620 Eighth Avenue, New York, NY 10018
`
`Sarah J. Fischer
`GOODWIN PROCTER LLP
`sfischer@goodwinlaw.com
`100 Northern Avenue, Boston, MA 02110
`
`
`
`
`
`
`10
`
`

`

`
`
`
`
`IPR2017-01374
`Patent Owner’s Motion to Strike
`
`/Lauren V. Blakely/
`Lauren V. Blakely
`Reg. No. 70,247
`Wilmer Cutler Pickering Hale and Dorr LLP
`950 Page Mill Road
`Palo Alto, CA 94304
`(650) 600-5039
`
`
`
`
`
`11
`
`

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