Trials@uspto.gov
`571-272-7822
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` Paper 13
` Entered: July 09, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PFIZER, INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00330
`Patent 6,339,142 B1
`____________
`
`Before ERICA A. FRANKLIN, ZHENYU YANG, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review and
`Dismissing Motion for Joinder
`35 U.S.C. §§ 314 and 325(d), 37 C.F.R. § 42.122
`
`
`571-272-7822
`
`
`
`
`
`
` Paper 13
` Entered: July 09, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PFIZER, INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00330
`Patent 6,339,142 B1
`____________
`
`Before ERICA A. FRANKLIN, ZHENYU YANG, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review and
`Dismissing Motion for Joinder
`35 U.S.C. §§ 314 and 325(d), 37 C.F.R. § 42.122
`
`
`
`IPR2018-00330
`Patent 6,339,142 B1
`
`
` INTRODUCTION
`Pfizer, Inc. (“Petitioner”) filed a Petition requesting an inter partes
`review of claims 1–3 of U.S. Patent No. 6,339,142 B1 (Ex. 1001, “the ’142
`patent”). Paper 1 (“Pet.”). Petitioner also filed a Motion for Joinder to join
`this proceeding with Pfizer, Inc. v. Genentech, Inc., Case No. IPR2017-
`02019 (the “2019 IPR”) which was instituted on March 12, 2018. Paper 3
`(“Mot.”). Genentech, Inc. (“Patent Owner”) filed a Preliminary Response to
`the Petition. Paper 11 (“Prelim. Resp.”). Patent Owner also filed an
`Opposition to the Motion for Joinder. Paper 7 (“Mot. Opp.”). Petitioner
`filed a Reply to Patent Owner’s Opposition. Paper 9.
`We have authority under 35 U.S.C. § 314 to determine whether to
`institute an inter partes review. See also 37 C.F.R. § 42.4(a). Upon
`considering the circumstances involved in this case, we exercise our
`discretion under 35 U.S.C. §§ 314(a) and 325(d) to deny instituting an inter
`partes review of the challenged claims.
`A.
`Related Proceedings
`The parties provide notice that the ’142 patent is at issue in
`Genentech, Inc. et al. v. Pfizer, Inc. (D. Del) 1:17-cv-01672. Pet. 1; Paper 4,
`4. Petitioner notes that the complaint in that litigation was served on
`November 20, 2017. Pet. 1.
`On August 29, 2017, Petitioner filed a first petition for inter partes
`review of claims 1–3 of the ’142 patent. 2019 IPR, Paper 2. An inter partes
`review was instituted in that proceeding on March 12, 2018. Id. at Paper 16;
`see also Paper 25 (modifying institution to include all claims and all
`grounds). A Final Written Decision has not been entered in that proceeding.
`
`
`
`
`
`2
`
`
`
`IPR2018-00330
`Patent 6,339,142 B1
`
`
`The ’142 Patent
`B.
`The ’142 patent relates to “a method for purifying a polypeptide (e.g.
`an antibody) from a composition comprising the polypeptide and at least one
`contaminant using the method of ion exchange chromatography.” Ex. 1001,
`1:12–15. The contaminant is a material that is different from the desired
`polypeptide product, and may be a variant of the desired polypeptide. Id. at
`5:14–16. Further, the invention provides a composition comprising a
`mixture of anti-HER2 antibody and one or more acidic variants thereof,
`wherein the amount of the acidic variant(s) is less than about 25%. Id. at
`3:35–38. The Specification explains that an “acidic variant” is “a variant of
`a polypeptide of interest which is more acidic (e.g. as determined by cation
`exchange chromatography) than the polypeptide of interest.” Id. at 5:45–47.
`According to the Specification, an example of an acidic variant is a
`deamidated variant. The Specification states that “[i]t has been found, for
`example, that in preparations of anti-HER2 antibody obtained from
`recombinant expression, as much as about 25% of the anti-HER2 antibody is
`deamidated.” Id. at 6:1–4.
`The Specification explains that the term “humMAb4D5-8” refers to
`humanized anti-HER2 antibody comprising the light chain amino acid
`sequence of SEQ ID NO:1 and the heavy chain amino acid sequence of SEQ
`ID NO:2, or amino acid sequence variants thereof which retain the ability to
`bind HER2 and inhibit growth of tumor cells which overexpress HER2. Id.
`at 13:58–65. When referring to the rhuMAb HER2 antibody in an example,
`the Specification identifies parenthetically “humAb4D5-8.” Id. at 8:1–2;
`20:48–49 (Example 1). Compositions comprising anti-HER2 antibody may
`optionally include a pharmaceutically acceptable carrier. Id. at 3:40–41;
`
`
`
`
`3
`
`
`
`IPR2018-00330
`Patent 6,339,142 B1
`
`19:35–62. According to the Specification, “[t]he humMAb4D5-8 antibody
`of particular interest herein may be prepared as a lyophilized formulation,
`e.g. as described in [Andya]; expressly incorporated herein by reference. Id.
`at 19:62–65.
`
`Claims
`C.
`Claims 1–3 are reproduced below:
`1. A composition comprising a mixture of anti-HER2
`antibody and one or more acidic variants thereof, wherein the
`amount of the acidic variant(s) is less than about 25%.
`
`The composition of claim 1 further comprising a
`2.
`pharmaceutically acceptable carrier.
`
`The composition of claim 1 wherein the anti-HER2
`3.
`antibody is humMAb4D5-8.
`
`
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1–3 of the ’142 patent
`on the following grounds:
`
`Claim(s) Basis
`1–3
`§ 102(b), § 103(a)
`
`1
`
`1– 3
`
`§ 102(b)
`
`§ 103(a)
`
`References
`Andya1
`
`Waterside2
`
`Waterside
`
`
`
` 1
`
` International PCT Application No. WO 97/04801 published on Feb. 13,
`1997 (Ex. 1004).
`2 Harris, Chromatographic Techniques for the Characterization of Human
`MAbs (slides presented at the Waterside Monoclonal Conference held at the
`Omni Waterside Hotel in Harborside-Norfolk, Virginia on Apr. 22–25.
`1996)(Ex. 1005).
`
`
`
`4
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`IPR2018-00330
`Patent 6,339,142 B1
`
`
`Petitioner also relies upon the Declarations of Drew N. Kelner, Ph.D.
`(Ex. 1002), Richard Buick, Ph.D. (Ex. 1015), and Keith L. Carson (Ex.
`1020). Pet. 3.
`
` ANALYSIS
`A. Discretionary Denial under 35 U.S.C. § 314(a)
`Patent Owner requests that we deny institution of trial under 35
`U.S.C. § 314(a), pursuant to the doctrine of General Plastic Industries Co. v.
`Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017)
`(precedential), in view of the previously filed petition by the same petitioner,
`identified above in Section I.A. Prelim. Resp. 11.
`In General Plastic, the Board identified seven nonexclusive factors
`that bear on the issue of whether the Board should invoke its discretion to
`deny institution of an inter partes review, based on a follow-on petition on
`the same patent, under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(a):
`1. Whether the same petitioner previously filed a petition
`directed to the same claims of the same patent;
`2. Whether at the time of filing of the first petition the petitioner
`knew of the prior art asserted in the second petition or should
`have known of it;
`3. Whether at the time of filing of the second petition the
`petitioner already received the patent owner’s preliminary
`response to the first petition or received the Board’s decision on
`whether to institute review in the first petition;
`4. The length of time that elapsed between the time the petitioner
`learned of the prior art asserted in the second petition and the
`filing of the second petition;
`5. Whether the petitioner provides adequate explanation for the
`time elapsed between the filings of multiple petitions directed to
`the same claims of the same patent;
`6. The finite resources of the Board; and
`
`
`
`
`5
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`IPR2018-00330
`Patent 6,339,142 B1
`
`
`7. The requirement under 35 U.S.C. § 316(a)(11) to issue a final
`determination not later than 1 year after the date on which the
`Director notices institution of review.
`General Plastic, slip. op. at 15–16 (citing NVIDIA Corp. v. Samsung Elec.
`Co., IPR2016-00134, slip op. 6–7 (PTAB May 4, 2016) (Paper 9)). In
`applying these factors, we consider not only the congressional intent that
`inter partes review proceedings provide an effective and efficient alternative
`to district court litigation, but also the potential for abuse of the review
`process through repeated attacks by the same petitioner with respect to the
`same patent. See Gen. Plastic, slip. op. at 18 n.14 (citing H.R. Rep. No.
`112-98, pt. 1, at 48 (2011) (“Allowing similar, serial challenges to the same
`patent, by the same petitioner, risks harassment of patent owners and
`frustration of Congress’s intent in enacting the Leahy-Smith America
`Invents Act”).
` Patent Owner contends the General Plastic factors support denial of the
`Petition. Prelim. Resp. 11–28. Regarding factors 1 and 2, Patent Owner
`argues that the Petition challenges the same claims with the same prior art as
`presented in the 2019 IPR. Id. at 12–13. Further, regarding factor 2, Patent
`Owner asserts also that the Petition additionally relies upon a new
`declaration from Dr. Buick describing a second set of experiments
`attempting to “recreate the product of the prior art” by expressing
`humMAb4D5-8 in HEK cells, wherein those experiments “were completed
`before Pfizer’s first petition and thus could have been included in that
`petition as well.” Id. at 13 (citing Paper 1, Ex. 1015). Patent Owner asserts
`also that Petitioner does not allege that it was unaware of the additional
`
`
`
`
`
`
`6
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`IPR2018-00330
`Patent 6,339,142 B1
`
`“background” references relied upon in the Petition, comprising books and
`journal articles published between 1987 and 2009, when it filed the petition
`in the 2019 IPR. Id. at 15.
`Regarding factor 3, Patent Owner notes that Petitioner filed the
`Petition four days after Patent Owner filed its Preliminary Response in the
`2019 IPR. Id. at 16. According to Patent Owner, the Petitioner uses that
`filing as a roadmap by attempting in its Petition to “remedy specific
`deficiencies that Genentech identified in its [2019 IPR] preliminary
`response.” Id. at 16. Regarding factors 4 and 5, Patent Owner asserts that
`Petitioner has not provided any explanation for the time that elapsed
`between the filings of its petitions. Id. at 23. As for factor 6, Patent Owner
`asserts that the Board’s finite resources should not be spent deciding the
`Petition when Petitioner “could have included its evidence and argument in
`its first petition, yet chose to hold them back until after receiving
`Genentech’s [2019 IPR] preliminary response.” Id. at 26. Similarly,
`regarding factor 7, Patent Owner asserts that Petitioner has not provided any
`explanation for its follow-on petition and that such petition serves only to
`prolong its challenged to the same claims of the ’142 patent over the same
`prior art, by relying on additional arguments and evidence. Id. at 27.
`As Patent Owner correctly asserts, Petitioner does not address the
`General Plastic factors in the Petition. As such, we are left to wonder why
`Petitioner has filed a second petition challenging the same claims over the
`same grounds included in a first petition. Petitioner’s Motion for Joinder
`with the 2019 IPR does not provide insight. Rather, in that motion,
`Petitioner confirms that “not only is there substantial overlap in the cited
`
`
`
`
`7
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`IPR2018-00330
`Patent 6,339,142 B1
`
`prior art, both [p]etitions rely on similar disclosures from each of the prior
`art to make substantially the same arguments for both anticipation and
`obviousness.” Mot. 5.
`Having considered the Petition and the Preliminary Response, we
`determine that Patent Owner’s request for us to exercise our discretion to
`deny institution of an inter partes review in this proceeding under 35 U.S.C.
`§ 314(a), in view of General Plastic, is well-reasoned and persuasive. For
`the reasons discussed by Patent Owner, as set forth above, we find that each
`General Plastic factor weighs in favor of denying the Petition.
`Significantly, we have already instituted an inter partes review of claims 1–
`3 of the ’142 patent based upon a petition filed by Petitioner and including
`the same grounds set forth in the current Petition. Petitioner has not
`explained its reasons for filing the second petition or why the substance of
`the second petition was not, or could not have been, included in the first
`petition. Indeed, Petitioner does not assert that the petitions materially
`differ.
`Moreover, Petitioner has not explained, nor do we see, that other facts
`are at issue in this case such that the Petitioner should be permitted to
`challenge the same claims of the ’142 patent in a second petition, apart from
`our consideration of the General Plastic factors. See General Plastic, slip
`op. at 18 (explaining that, apart from consideration of the General Plastic
`factors, “there may be circumstances where multiple petitions by the same
`petitioner against the same claims of a patent should be permitted, and that
`such a determination is dependent on the facts at issue in the case”).
`Accordingly, in view of Section 314(a) and General Plastic, we exercise our
`discretion to deny the Petition.
`
`
`
`
`8
`
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`IPR2018-00330
`Patent 6,339,142 B1
`
`
`
`
`B. Discretionary Denial under 35 U.S.C. § 325(d)
`Patent Owner additionally asserts that we should exercise our
`discretion to deny the Petition under 35 U.S.C. § 325(d) because the asserted
`grounds rely upon the same prior art previously presented to the Office
`during the prosecution of the ’142 patent and in the 2019 IPR. Prelim. Resp.
`28.
`
`Regarding consideration of the prior art during prosecution, Patent
`Owner asserts that “Andya is described in the ’142 patent specification and
`is directly incorporated by reference (Paper 1, Ex. 1001, 19:62–65), and
`Waterside is listed on the face of the patent (id., cover).” Prelim. Resp. 28–
`29. Patent Owner does not provide further discussion or evidence from the
`prosecution history to substantiate its assertion. Thus, we decline to exercise
`our discretion under § 325(d) based upon that bare assertion as Patent Owner
`has not demonstrated adequately that the Examiner substantively considered
`Andya or Waterside in allowing the claims by merely directing us to
`portions of the issued patent.
`Regarding Patent Owner’s position that the asserted grounds rely
`upon the same prior art previously presented to the Office in the 2019 IPR,
`we agree. Indeed, as discussed above in Section II. A, Petitioner concedes
`that, “both [p]etitions rely on similar disclosures from each of the prior art to
`make substantially the same arguments for both anticipation and
`obviousness.” Mot. 5. Petitioner has not asserted, however, any reason for
`us to not to exercise our discretion to deny the Petition under § 325(d) when
`such similarities exist between the two petitions, nor do we find one.
`
`
`
`
`9
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`
`
`IPR2018-00330
`Patent 6,339,142 B1
`
`Accordingly, because we are already considering the same prior art and
`substantially the same arguments in the 2019 IPR, we decline to do so again.
`
`
` MOTION FOR JOINDER
`An inter partes review may be joined with another inter partes
`review, subject to the provisions 35 U.S.C. § 315(c), which governs joinder
`of inter partes review proceedings:
`(c) JOINDER. — If the Director institutes an inter partes
`review, the Director, in his or her discretion, may join as a party
`to that inter partes review any person who properly files a
`petition under section 311 that the Director, after receiving a
`preliminary response under section 313 or the expiration of the
`time for filing such a response, determines warrants the
`institution of an inter partes review under section 314.
`
`Petitioner timely filed its Motion for Joinder within one month of the
`institution of the 2019 IPR, as required by 37 C.F.R. § 42.122(b). Mot.
`Patent Owner opposes the motion. Mot. Opp. In view of our determination
`to deny the Petition, we dismiss the Motion for Joinder as moot.
`
`
` CONCLUSION
`For the foregoing reasons, we exercise our discretion under § 314(a)
`and § 325(d) to deny the Petition and dismiss the Motion for Joinder as
`moot.
`
`
`
`
`
`
`10
`
`
`
`IPR2018-00330
`Patent 6,339,142 B1
`
`
`ORDER
`
`Accordingly, it is hereby:
`ORDERED that Petitioner’s request for an inter partes review of
`claims 1–3 of the ’142 patent is denied; and
`ORDERED that Petitioner’s Motion for Joinder is dismissed as moot.
`
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`11
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`
`
`IPR2018-00330
`Patent 6,339,142 B1
`
`PETITIONER:
`
`Thomas J. Meloro
`Michael W. Johnson
`WILLKIE FARR & GALLAGHER LLP
`tmeloro@willkie.com
`mjohnson1@willkie.com
`
`
`
`PATENT OWNER:
`
`David Cavanaugh
`Lauren Blakely
`Adam Brausa
`Emily Whelan
`Mark McBriar
`WILMER CUTLER PICKERING HALE AND DORR LLP
`david.cavanaugh@wilmerhale.com
`lauren.blakely@wilmerhale.com
`abrausa@durietangri.com
`emily.whelan@wilmerhale.com
`mark.mcbriar@wilmerhale.com
`
`
`
`
`
`
`12
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`
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