Paper 9
`Trials@uspto.gov
`Tel: 571-272-7822
`
`Entered: September 22, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN LABORATORIES LIMITED,
`Petitioner,
`
`v.
`
`AVENTIS PHARMA S.A.,
`Patent Owner.
`_____________
`
`Case IPR2016-00712
`Patent 8,927,592 B2
`______________
`
`
`
`Before BRIAN P. MURPHY, TINA E. HULSE, and
`CHRISTOPHER M. KAISER, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`Trials@uspto.gov
`Tel: 571-272-7822
`
`Entered: September 22, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN LABORATORIES LIMITED,
`Petitioner,
`
`v.
`
`AVENTIS PHARMA S.A.,
`Patent Owner.
`_____________
`
`Case IPR2016-00712
`Patent 8,927,592 B2
`______________
`
`
`
`Before BRIAN P. MURPHY, TINA E. HULSE, and
`CHRISTOPHER M. KAISER, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
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`IPR2016-00712
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`INTRODUCTION
`I.
`Mylan Laboratories Limited (“Petitioner”) filed a Petition requesting
`an inter partes review of claims 1–5 and 7–30 of U.S. Patent No. 8,927,592
`(Ex. 1001, “the ’592 patent”). Paper 3 (“Pet.”). Aventis Pharma S.A.
`(“Patent Owner”) filed a Preliminary Response to the Petition. Paper 7
`(“Prelim. Resp.”). We have statutory authority under 35 U.S.C. § 314(a),
`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.”
`Petitioner challenges claims 1–5 and 7–30 of the ’592 patent as
`unpatentable under 35 U.S.C. § 103(a). Pet. 13–14. Based on the arguments
`and evidence presented in the Petition and Preliminary Response, we
`determine there is a reasonable likelihood Petitioner would prevail with
`respect to at least one of the claims challenged in the Petition. Therefore, we
`institute an inter partes review.
`A. Related Proceedings
`Petitioner and Patent Owner identify the following as related district
`court proceedings in the District of New Jersey regarding the ’592 patent:
`Sanofi-Aventis U.S. LLC v. Mylan Laboratories Limited, C. A. No. 15-
`03392; Sanofi-Aventis U.S. LLC v. Apotex Corp, C. A. No. 15-01835;
`Sanofi-Aventis U.S. LLC v. Breckenridge Pharmaceutical, Inc., C. A. No.
`15-01836; Sanofi-Aventis U.S. LLC v. Accord Healthcare, Inc., C. A. No.
`15-02520; Sanofi-Aventis U.S. LLC v. BPI Labs, LLC, C. A. No. 15-02521;
`Sanofi-Aventis U.S. LLC v. Dr. Reddy Laboratories, Inc., C. A. No. 15-
`02522; Sanofi-Aventis U.S. LLC v. Glenmark Generics Inc., C. A. No. 15-
`02523; Sanofi-Aventis U.S. LLC v. Fresenius Kabi USA, LLC, C. A. No. 15-
`2
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`02631; Sanofi-Aventis U.S. LLC v. Actavis LLC, C. A. No. 15-03107;
`Sanofi-Aventis U.S. LLC v. BPI Labs, LLC, C. A. No. 15-02521. Pet. 12;
`Paper 6, 2–3.
`Petitioner further identifies IPR2016-00627 directed to the compound
`cabazitaxel, U.S. Patent No. 5,847,170. Id. We note that we have denied
`institution in IPR2016-00627 (Paper 10).
`B. Proposed Grounds of Unpatentability
`Petitioner advances ten grounds of unpatentability under 35 U.S.C.
`§ 103(a) in relation to the challenged claims in the ’592 patent:
`
`Reference[s]
`
`Winquist (Ex. 1009)1 and TROPIC Listing
`(Ex. 1008)2
`
`Statutory
`Basis
`§ 103
`
`Challenged
`Claims
`1, 2, 5, 7–9, 12,
`13, 17–20, 22–
`25, 27–29
`3, 4
`
`§ 103
`
`Winquist, TROPIC Listing, and Didier (Ex.
`1011)3
`Winquist, TROPIC Listing, and Mita (Ex.
`1012)4
`
`1 Eric Winquist et al., Open clinical uro-oncology trials in Canada, The
`Canadian Journal of Urology, 15(1), 3942–49 (February 2008) (“Winquist”).
`Ex. 1009.
`2 Sanofi-Aventis, XRP6258 Plus Prednisone Compared to Mitoxantrone
`Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
`(TROPIC), ClinicalTrials.gov (October 23, 2008) (“TROPIC Listing”). Ex.
`1008.
`3 U.S. Patent No. 7,241,907 B2 issued July 10, 2007 to Didier et al.
`(“Didier”). Ex. 1011.
`4 Alain C. Mita et al., Phase I and Pharmacokinetic Study of XRP6258
`(RPR116258A), a Novel Taxane, Administered as a 1-Hour Infusion Every 3
`Weeks in Patients with Advanced Solid Tumors, Clin. Cancer Res.
`2009:15(2), 723–730 (January 15, 2009) (“Mita”). Ex. 1012.
`3
`
`§ 103
`
`7–9
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`Reference[s]
`
`Winquist, TROPIC Listing, and Tannock
`(Ex. 1013)5
`Winquist, TROPIC Listing, and Pivot (Ex.
`1010)6
`Winquist, TROPIC Listing, Pivot, and
`Tannock
`Winquist and Pivot
`
`Winquist, Pivot, and Didier
`
`Winquist, Pivot, and Mita
`
`Winquist, Pivot, and Tannock
`
`Statutory
`Basis
`§ 103
`
`Challenged
`Claims
`10, 11, 14, 16
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`21, 26, 30
`
`15
`
`1, 2, 5, 7–9, 12,
`13, 17–30
`3, 4
`
`7–9
`
`10, 11, 14–16
`
`Pet. 13–14. Petitioner supports its challenge with a Declaration by Dr.
`Rahul Seth (“Seth Declaration”). Ex. 1002.
`
`C. The ’592 Patent
`The ’592 patent, titled “Antitumoral Use of Cabazitaxel,” issued
`January 6, 2015, from an application filed April 26, 2012. Ex. 1001. The
`’592 patent claims priority through an international application to a series of
`provisional applications, the earliest of which is dated October 29, 2009.
`Ex. 1001, (60), (63). The ’592 patent is directed to the use of cabazitaxel in
`
`
`5 Ian F. Tannock et al., Docetaxel plus Prednisone or Mitoxantrone plus
`Prednisone for Advanced Prostate Cancer, N. Engl. J. Med., 351:15, 1502–
`1512 (October 7, 2004) (“Tannock”). Ex. 1013.
`6 X. Pivot et al., A multicenter phase II study of XRP6258 administered as a
`1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer
`patients, Annals of Oncology, 19, 1547–1552 (April 23, 2008) (“Pivot”).
`Ex. 1010.
`
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`4
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`the treatment of prostate cancer, particularly metastatic castration resistant
`prostate cancer (“mCRPC”). Id. at 1:19–26. Because cancer cells may
`develop resistance to docetaxel (Taxotere®”7), administering cabazitaxel is
`intended to treat prostate cancer in patients with advanced metastatic disease
`that has progressed despite previous treatment with a docetaxel-based
`regimen. Id. at 2:61–67. Cabazitaxel is preferably administered in
`combination with a corticoid, such as prednisone or prednisolone, at a daily
`dose of 10 mg orally. Id. at 3:2–5.
`The chemical name for cabazitaxel is 4α-acetoxy-2α-benzoyloxy-5β,
`20-epoxy-lβ-hydroxy-7β,10β-dimethoxy-9-oxo-ll-taxen-13α-yl(2R,3S)-3-
`tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate. Id. at 4:28–31.
`Cabazitaxel is a taxane compound, the chemical structure of which is shown
`below:
`
`
`Id. at 4:8–26. Example 1 of the ’592 patent describes a large-scale
`comparative clinical trial of mCRPC patients, whose disease had progressed
`during or after docetaxel treatment, being treated with either 25 mg/m2 of
`
`7 Taxotere® is the brand name for docetaxel. We also refer to “Taxotere” in
`this Decision.
`
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`cabazitaxel or 12 mg/m2 mitoxantrone, and 10 mg/day of prednisone. Id. at
`10:30–48. Patients receiving cabazitaxel and prednisone demonstrated a
`median overall survival that was 2.4 months longer than those receiving
`mitoxantrone and prednisone. Id. at 11:28–37, 11:45–54. The claimed
`method is directed to administering an effective amount of cabazitaxel and a
`corticoid to prostate cancer patients whose disease has progressed in spite of
`previous docetaxel treatment. Id. at 5:33–67, 18:54–58, 20:25–30.
`D. Challenged Claims
`Petitioner challenges claims 1–5 and 7–30 of the ’592 patent.
`Independent claims 1 and 27 are illustrative and are reproduced below:
`1. A method for treating a patient with prostate cancer that has
`progressed during or after treatment with docetaxel, comprising
`administering to said patient a dose of 20 to 25 mg/m2 of cabazitaxel,
`or a hydrate or solvate thereof, in combination with a corticoid.
`
`27. A method of increasing the survival of a patient with a castration
`resistant or hormone refractory, metastatic prostate cancer that has
`progressed during or after treatment with docetaxel, comprising
`administering a dose of 20 to 25 mg/m2 of cabazitaxel, or hydrate or
`solvate thereof, to the patient in combination with prednisone or
`prednisolone.
`
`
`II. ANALYSIS
`A. Claim Construction
`We determine that only the following claim terms require express
`construction for purposes of this Decision. See, e.g., Wellman, Inc. v.
`Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms
`need only be construed ‘to the extent necessary to resolve the
`controversy.’”) (citation omitted).
`
`
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`1. Claim 1: “A method for treating a patient”
`
`Petitioner argues that the preamble phrase in claim 1, “a method for
`treating,” is a non-limiting statement of the purpose of the claimed method,
`or, at most, should be construed as “a method intended to benefit a patient.”
`Pet. 17–19. Patent Owner opposes, arguing that the preamble is limiting and
`should be construed to mean “a method that produces a therapeutic effect in
`a patient.” Prelim. Resp. 15–18. We agree with Petitioner for the reasons
`expressed below.
`“Whether to treat a preamble term as a claim limitation is determined
`on the facts of each case in light of the claim as a whole and the invention
`described in the patent.” Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354,
`1358 (Fed. Cir. 2010) (internal quotation marks omitted). “Absent clear
`reliance on the preamble in the prosecution history, or in situations where it
`is necessary to provide antecedent basis for the body of the claim, the
`preamble generally is not limiting.” Symantic Corp. v. Computer Assoc.
`Int’l, Inc., 522 F.3d 1279, 1288 (Fed. Cir. 2008). However, “a preamble
`limits the invention if it recites essential structure or steps, or if it is
`necessary to give life, meaning, and vitality to the claim.” Catalina Mktg.
`Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)
`(internal quotation marks omitted). “Conversely, a preamble is not limiting
`where a patentee defines a structurally complete invention in the claim body
`and uses the preamble only to state a purpose or intended use for the
`invention.” Id. (internal quotation marks omitted).
`Petitioner correctly notes that the phrase “a method for treating” does
`not provide antecedent basis for a limitation recited in the body of the claim
`
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`7
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`and is not necessary to give meaning to the recited method steps. Only the
`portion of the preamble reciting “a patient with prostate cancer that has
`progressed during or after treatment with docetaxel” provides antecedent
`basis for the step of administering to “said patient” the recited dosage of
`cabazitaxel and a corticoid. See Tom Tom, Inc. v. Adolph, 790 F.3d 1315,
`1323–24 (Fed. Cir. 2015) (portion of preamble that “provides a necessary
`structure for claim 1 does not necessarily convert the entire preamble into a
`limitation, particularly one that only states the intended use of the
`invention.”). Although “a method of treating a patient” expresses the
`purpose of administering an effective amount of cabazitaxel (20 to 25
`mg/m2) and a corticoid to a patient (see Prelim. Resp. 16), the quoted
`language “does not result in a manipulative difference in the steps of the
`claim” and “does not change those amounts or otherwise limit the claim.”
`See Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d
`1368, 1375–76 (Fed. Cir. 2001).
`As Petitioner points out, not every patient necessarily demonstrates a
`therapeutic effect from the method of treatment. Pet. 19–20 (citing Ex.
`1001, Fig. 1 overall survival rate); Ex. 1001, 16:43–44 (“The primary reason
`for treatment discontinuation in both groups was disease progression (Table
`5.)”). Moreover, the recited method steps “are performed the same way
`regardless [of] whether or not the patient experiences a [therapeutic effect].”
`Bristol-Myers Squibb, 246 F.3d at 1375. Therefore, neither the claim
`language nor the description of the claimed invention in the ’592 patent
`supports construing the “method of treating a patient” portion of the
`preamble to require producing a therapeutic effect in a patient.
`
`
`
`8
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`Patent Owner cites to the prosecution history of the ’592 patent,
`particularly patent Applicants’ reliance on evidence of therapeutic efficacy
`to distinguish the claimed invention from the prior art of record, in support
`of its argument that the “method of treating a patient” portion of the
`preamble is limiting. Prelim. Resp. 17–18 (citing Ex. 1004, 21, 93, 169–
`175, 184–85, 286, 2014). Patent Applicants relied on evidence of
`therapeutic efficacy to argue that the claims were not obvious because i) a
`person of ordinary skill in the art (“POSA”)8 would not have had a
`reasonable expectation of successfully treating prostate cancer patients with
`cabazitaxel, and ii) the therapeutic efficacy of treating prostate cancer
`patients with cabazitaxel and prednisone was, in fact, unexpected. Ex. 1004,
`146–49, 168–179, 184–85, 285–286, 2013–14. Patent Applicants, however,
`did not cite to or rely on the preamble language of claim 1 to distinguish the
`claimed invention from the prior art. Id. And the Examiner clearly stated
`his Reasons for Allowance, which acknowledge patent applicants’
`arguments and evidence of non-obviousness, i.e., “surprising and
`unexpected” clinical results. Id. at 21, 93. The Examiner’s Reasons for
`Allowance do not reference or implicate the preamble language or
`necessitate construing the “method of treating a patient” portion of the
`preamble as a claim limitation.
`Therefore, based on the current record, we determine that the
`preamble phrase “a method for treating a patient” in claim 1 is a non-
`
`
`8 The parties’ are in general agreement on the level of skill in the art—an
`oncologist with experience treating metastatic prostate cancer and related
`medical training and experience. Pet. 9–10; Prelim. Resp. 11. Any
`differences are not material to our Decision.
`9
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`limiting statement of the purpose of the claimed method. At most, the
`phrase would be construed as “a method intended to benefit a patient.”
`2. Claim 27: “A method of increasing the survival of a
`patient”
`Petitioner argues that the preamble phrase in claim 27, “[a] method of
`increasing the survival of [a patient],” is a non-limiting statement of the
`purpose of the claimed method or, at most, should be construed as “a method
`intended to increase the survival of a patient.” Pet. 19–20. Patent Owner
`opposes, arguing that the preamble is limiting and should be construed to
`mean “a method that prolongs the life of a patient as compared to no
`treatment or palliative treatment, where that method has been demonstrated
`to provide a statistically significant increase in overall survival.” Prelim.
`Resp. 19. We agree with Petitioner for the same reasons expressed above
`regarding “a method for treating a patient” in claim 1.
`Therefore, based on the current record, we determine that the
`preamble phrase in claim 27, “a method of increasing the survival of a
`patient,” is a non-limiting statement of the purpose of the claimed method.
`At most, the phrase would be construed as “a method intended to increase
`the survival of a patient.”
`B. Ground 1: Asserted Obviousness of Claims 1, 2, 5, 7–9, 12, 13,
`17–20, 22–25, and 27–29 over Winquist and the TROPIC Listing
`
`
`Petitioner asserts that the subject matter of claims 1, 2, 5, 7–9, 12, 13,
`17–20, 22–25, and 27–29 of the ’592 patent would have been obvious to a
`POSA based on the combined teachings of Winquist and the TROPIC
`Listing in view of the knowledge of a POSA. Pet. 25–38. Patent Owner
`opposes. Prelim. Resp. 23–35. We address the parties’ arguments below.
`
`
`
`10
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`1. Winquist
`Winquist (Ex. 1009) is a February 2008 disclosure of open, uro-
`oncology clinical trials in Canada. Ex. 1009, 3942. The format of each
`entry is the same; a descriptive title of the clinical trial followed by an
`identification of the trial and the entity coordinating it, the trial design,
`patient population, sample size, and primary endpoint. Id. Winquist
`discloses a randomized Phase III clinical trial coordinated by Sanofi-Aventis
`involving treatment of mCRPC patients previously treated with docetaxel.
`Id. at 3948. Winquist describes the clinical trial as a “study of XRP-6258
`[cabazitaxel] at 25 mg/m2 in combination with prednisone every 3 weeks
`compared to mitoxantrone in combination with prednisone for the treatment
`of hormone-refractory metastatic prostate cancer previously treated with a
`Taxotere-containing regimen.” Id. The primary endpoint is overall
`survival. Id.
`With regard to independent claims 1 and 27 of the ’592 patent,
`Winquist does not disclose that the prostate cancer “has progressed during or
`after treatment with docetaxel.” Id.; Pet. 25–26.
`2. The TROPIC Listing
`The TROPIC Listing (Ex. 1008) was published in the
`ClinicalTrials.gov database of the National Library of Medicine, and it was
`archived by The Internet Archive on October 23, 2008. Ex. 1026, Exh. A.
`The TROPIC Listing discloses the same Phase III clinical trial as Winquist,
`a “randomized, open-label, multi-center study comparing the safety and
`efficacy of XRP6258 [cabazitaxel] plus prednisone to mitoxantrone plus
`prednisone in the treatment of hormone refractory metastatic prostate cancer
`previously treated with a Taxotere [docetaxel]-containing regimen.” Ex.
`11
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`1008, 1; Ex. 1002 ¶ 118. The TROPIC Listing discloses that cabazitaxel is
`to be administered every three weeks. Ex. 1008, 1. Patients must have a
`“[d]ocumented progression of disease (demonstrating at least one visceral or
`soft tissue metastatic lesion, including a new lesion) . . . [or] rising PSA
`levels or appearance of [a] new lesion.” Id. at 1–2. The primary objective
`of the TROPIC clinical trial is overall survival. Id. at 1. The TROPIC
`Listing notes the start date of the clinical trial was December 2006. Id. at 2.
`With regard to independent claims 1 and 27 in the ’592 patent, the
`TROPIC Listing does not expressly disclose an administration dose. Id.;
`Pet. 7.
`
`3. Independent Claims 1 and 27
`A claimed invention is unpatentable if the differences between the
`claimed subject matter and the prior art are such that the subject matter as a
`whole would have been obvious at the time the invention was made to a
`person having ordinary skill in the art to which the subject matter pertains.
`35 U.S.C. § 103(a). Obviousness under 35 U.S.C. § 103 requires an
`assessment of (1) the “‘level of ordinary skill in the pertinent art,’” (2) the
`“‘scope and content of the prior art,’” (3) the “‘differences between the prior
`art and the claims at issue,’” and (4) “‘secondary considerations’” of
`nonobviousness such as “‘commercial success, long-felt but unsolved needs,
`failure of others, etc.’” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007) (quoting Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966)). A
`party who petitions the Board for a determination of obviousness must show
`that “‘a skilled artisan would have been motivated to combine the teachings
`of the prior art references to achieve the claimed invention, and that the
`skilled artisan would have had a reasonable expectation of success in doing
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`so.’” Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 994
`(Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361
`(Fed. Cir. 2007)). We assess Petitioner’s evidence and argument according
`to this standard.
`Petitioner argues that the TROPIC Listing discloses the only
`limitation of claims 1 and 27 not expressly disclosed in Winquist, namely
`that the patient’s prostate cancer “has progressed during or after treatment
`with docetaxel.” Pet. 26–27 (citing Ex. 1002 ¶¶ 118–119). Patent Owner
`does not directly contest the assertion in its Preliminary Response, instead
`relying on its preamble-as-claim-limitation argument that neither Winquist
`nor the TROPIC Listing provides any data to show that cabazitaxel would
`have produced a therapeutic effect in patients. Prelim. Resp. 23–24. We
`have rejected Patent Owner’s proposed preamble claim construction in
`section II.A, above. Petitioner also provides sufficient evidence to support
`its assertion that a POSA would have had reason to combine the teachings of
`Winquist and the TROPIC Listing because the two references disclose the
`same treatment method being used in the same clinical trial. Pet. 26–27
`(citing Ex. 1002 ¶¶ 118–120).
`The parties present sharply divergent testimonial and documentary
`evidence of whether a POSA would have had a reasonable expectation of
`successfully treating prostate cancer patients (claim 1) and mCRPC patients
`(claim 27) by administering 25 mg/m2 cabazitaxel and a corticoid, the
`treatment protocol disclosed in Winquist and the TROPIC Listing. Pet. 27–
`29, 33–34, 52–55 (citing, inter alia, Ex. 1002 ¶¶ 66–72, 98, 120–22, 132,
`133, 169–170, 221–224; Ex. 1008; Ex. 1009; Ex. 1021; Ex. 1022;); Prelim.
`Resp. 24–44 (citing, inter alia, Ex. 1004, 167––182, 184–190; Ex. 2001
`13
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`¶¶ 31, 32, 37–40, 42–52, 102–107, 110–114, 116–119, 129–134). For
`example, Petitioner relies on the disclosure and teachings of Attard,9 a
`review article reporting on a Phase I dosing study for cabazitaxel, for the
`proposition that “it was known in the art that anticancer activity against
`docetaxel-resistant, castration-resistant prostate cancer was observed in
`patients treated with cabazitaxel.” Pet. 27 (citing Ex. 1002 ¶¶ 66–69; Ex.
`1021, 74–75). Petitioner further relies on the disclosure and teachings of
`Beardsley.10 Beardsley reports on a Phase II clinical trial of cabazitaxel
`administered to docetaxel-resistant metastatic breast cancer patients,
`originally reported in Pivot (Ex. 1010), for the proposition that the 14%
`objective response rate was “known to have motivated a Phase III clinical
`study of cabazitaxel among metastatic prostate cancer patients.” Id. at 28
`(citing Ex. 1002 ¶¶ 70–72; Ex. 1022, 163).
`Patent Owner contests Petitioner’s reasonable expectation of success
`arguments and evidence, particularly the teachings of Attard and Beardsley.
`Patent Owner supports its position with new testimonial evidence from Dr.
`Alton Oliver Sartor, M.D. See e.g. Prelim. Resp. 27–28 (citing Ex. 2001
`¶¶ 31, 32, 37–40, 81–83 regarding Attard), 37–38 (citing Ex. 2001 ¶¶ 108–
`09 regarding Beardsley).11 For example, Patent Owner relies on Dr. Sartor’s
`
`
`9 Gerhardt Attard et al., Update on tubulin-binding agents, Pathologie
`Biologie 54, 72–84 (Elsevier 2006) (“Attard”). Ex. 1021.
`10 Emma K. Beardsley and Kim N. Chi, Systemic therapy after first-line
`docetaxel in metastatic castration-resistant prostate cancer, Curr. Opin.
`Support Palliat. Care 2, 161–66 (Wolters Kluwer Health 2008)
`(“Beardsley”). Ex. 1022.
`11 Patent Owner argues that Petitioner has not persuasively addressed Dr.
`Sartor’s prosecution declaration under 37 C.F.R. § 1.132, in support of
`Patent Owner’s assertion that the Phase III clinical results in Example 1 of
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`
`Declaration testimony for the proposition that “a therapeutic benefit was
`unpredictable because of the heterogeneity of the disease and the complexity
`of resistance to both hormone therapy and docetaxel therapy.” Id. at 28
`(citing Ex. 1004, 180–81, 184–87; Ex. 2001 ¶¶ 31–32, 37–40). The parties’
`competing testimonial and documentary evidence also bears on the question
`of whether the TROPIC clinical trial results were “unexpected” and the
`weight to be given Patent Owner’s objective evidence of nonobviousness.
`At this stage of the proceeding, we find the parties have raised
`disputed issues of material fact regarding the obviousness inquiries of a
`reasonable expectation of success and unexpected results. Under such
`circumstances, “a genuine issue of material fact created by such testimonial
`evidence will be viewed in the light most favorable to the petitioner solely
`for purposes of deciding whether to institute an inter partes review.” 37
`C.F.R. § 42.108(c). Therefore, based on the present record, we determine
`that Petitioner’s arguments and evidence in support of Ground 1 are
`sufficient to institute an inter partes review with respect to claims 1 and 27.
`The parties will have the opportunity to cross-examine the respective
`declarants and submit additional evidence during the trial. 81 Fed. Reg.
`18,750, 18,755 (third column) (April 1, 2016).
`Patent Owner also argues that Petitioner has failed to comply with 37
`C.F.R. § 42.104(b)(2), which requires a petitioner to “specify . . . the patents
`or printed publications relied upon for each ground,” by relying on
`
`
`the ’592 patent were unpredictable. Prelim. Resp. 28–30. Petitioner,
`however, cites to Dr. Seth’s Declaration responding directly to Dr. Sartor’s
`statements regarding unexpected results. Pet. 57 (citing Ex. 1002 ¶¶ 213–
`15).
`
`
`
`15
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`
`background references outside Ground 1. Prelim. Resp. 26. Patent Owner
`argues that Petitioner improperly attempts to supply missing claim
`limitations from such background references. Id. Patent Owner suggests
`denial of the Petition for failure to comply with our rules. Id.
`Contrary to Patent Owner’s argument, Petitioner does not rely on
`references other than Winquist and the TROPIC Listing for disclosure of the
`method steps recited in claims 1 and 27. Pet. 35–36, 38 (claim charts for
`claims 1 and 27). Petitioner does, however, rely on the teachings of other
`references, particularly Attard and Beardsley, to support Petitioner’s
`obviousness assertion that a POSA would have had a reasonable expectation
`of successfully treating prostate cancer patients (claim 1) and mCRPC
`patients (claim 27) based on the method steps disclosed in Winquist and the
`TROPIC Listing. Pet. 27–29, 33–34, 52–55. Therefore, for clarity, we
`exercise our discretion to recast Petitioner’s Ground 1 as one of obviousness
`over Winquist and the TROPIC Listing in view of Attard and Beardsley. 35
`U.S.C. § 314(a); see SightSound Techs., LLC v. Apple Inc., 809 F.3d 1307,
`1312–13 (Fed. Cir. 2015) (noting that governing statutory provisions do not
`limit the Board’s authority to proceed with AIA trial proceedings only on the
`specific statutory grounds alleged in the petition); see also In re Cuozzo
`Speed Techs., LLC, 793 F.3d 1268, 1273 (Fed. Cir. 2015) (“Nor does the
`IPR statute expressly limit the Board's authority at the final decision stage to
`the grounds alleged in the IPR petition.”), aff’d, Cuozzo Speed Techs., LLC
`v. Lee, 136 S. Ct. 2131, 2139–2140 (2016) (“[O]ne important congressional
`objective . . . [is] giving the Patent Office significant power to revisit and
`revise earlier patent grants.”).
`
`
`
`
`16
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`IPR2016-00712
`Patent 8,927,592 B2
`
`
`4. Dependent Claims 7–9
`Claims 7–9 depend from claim 1 and recite pharmacokinetic (“PK”)
`parameters produced by administration of 20–25 mg/m2 of cabazitaxel.
`Claims 7–9 recite that cabazitaxel is “administered in an amount to provide”
`either “an AUC of about 991 ng·h/mL (CV 34%)” (claim 7), “an Cmax of
`about 226 ng·h/mL (CV 107%)” (claim 8), or “a plasma clearance of
`48.5L/h (CV 39%)” (claim 9). Ex. 1001, 19:3–11. Winquist and the
`TROPIC Listing do not disclose or reference any pharmacokinetic
`parameters resulting from the treatment protocol. Petitioner argues that the
`recited PK parameters “inherently follow as a direct result of administering
`cabazitaxel at 25 mg/m2” and, therefore, would have been obvious in view
`of Winquist’s disclosure of a 25mg/m2 dose of cabazitaxel. Pet. 30–31
`(citing Ex. 1002 ¶¶ 56, 124).
`We agree with Patent Owner that Petitioner’s inherency assertion is
`not sufficiently supported. Dr. Seth’s conclusions, drawn from a description
`of PK analysis in the ’592 patent, are not sufficiently explained to satisfy the
`high standard required for inherency in an obviousness context. The Federal
`Circuit has cautioned that inherency “must be carefully circumscribed in the
`context of obviousness,” because, inter alia, “[o]bviousness cannot be
`predicated on what is unknown.” Par Pharm., Inc. v. TWI Pharms., Inc.,
`773 F.3d 1186, 1195 (Fed. Cir. 2014) (citing In re Rijckaert, 9 F.3d 1531,
`1533–34 (Fed. Cir. 1993), and quoting In re Shetty, 566 F.2d 81, 86
`(C.C.P.A. 1977)). Patent Owner also shows that infusion time impacts Cmax
`and AUC, and differences in formulation also may impact the recited PK
`distribution ranges. Prelim. Resp. 44–45 (citing Ex. 2061, 188 (Col. 1 ¶ 2);
`Ex. 2094, 674 (Table IV); Ex. 2089, 347). Petitioner and Dr. Seth do not
`17
`
`
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`IPR2016-00712
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`
`
`address how infusion times or formulation may affect PK distribution
`profiles.
`For the reasons given above, we determine Petitioner has not shown a
`reasonable likelihood of prevailing with respect to the asserted obviousness
`of claims 7–9 of the ’592 patent in Ground 1.
`5. Dependent Claims 2, 5, 12, 13, 17–20, 22–25, 28, and 29
`Petitioner argues that the remaining dependent claims recite additional
`limitations that would have been obvious to a POSA based on Winquist and
`the TROPIC Listing. Pet. 29–32, 34–38. Petitioner supports its arguments
`with claim charts containing citations to Winquist, the TROPIC Listing, and
`Dr. Seth’s Declaration. Id. at 36–38. Patent Owner does not address the
`remaining dependent claims in dispute.
`Based on the present record, we determine Petitioner has provided
`sufficient argument and evidence in support of Ground 1 to institute an inter
`partes review with respect to dependent claims 2, 5, 12, 13, 17–20, 22–25,
`28, and 29 of the ’592 patent.
`6. Conclusion
`Based on the present record, we determine Petitioner has provided
`sufficient argument and evidence in support of Ground 1 to institute an inter
`partes review with respect to claims 1, 2, 5, 12, 13, 17–20, 22–25, and 27–
`29 of the ’592 patent.
`
`
`C. Ground 2: Asserted Obviousness of Claims 3 and 4 over Winquist,
`the TROPIC Listing, and Didier
`
`Claim 3 depends from independent claim 1. Claim 3 recites
`cabazitaxel “in the form of an acetone solvate.” Ex. 1001, 18:61–62. Claim
`
`
`
`18
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`
`4 depends from claim 3 and further recites “the acetone solvate contains
`between 5% and 8% by weight of acetone.” Id. at 18:63–64.
`Petitioner acknowledges that Winquist and the TROPIC Listing do
`not disclose an acetone solvate form of cabazitaxel. Pet. 38. Petitioner,
`however, relies on Didier’s teaching of the preparation of an acetone solvate
`of cabazitaxel, where the “mean value of the content of acetone is 7%.” Id.
`at 38–39 (citing Ex. 1011, 2:39–42). Didier also states that cabazitaxel
`“exhibits noteworthy anticancer and antileukemic properties.” Ex. 1011,
`1:22–23. Petitioner, relying on Dr. Seth’s testimony, argues that a POSA
`would have had strong reasons to prepare cabazitaxel in solvate form, to
`“enable the drug’s dissolution into an aqueous solution suitable for
`intravenous infusion into a patient.” Pet. 39 (citing Ex. 1002 ¶ 142). Dr.
`Seth references Liu,12 which teaches that highly lipophilic paclitaxel has to
`be in soluble form for intravenous (“i.v.”) administration, in support of his
`opinion. Ex. 1002 ¶¶ 79–80.
`Patent Owner challenges Petitioner’s evidence, particularly Liu, as
`failing to support a motivation to combine the references to select Didier’s
`acetone solvate form of cabazitaxel for use in the i.v. treatment method
`disclosed by the combination of Winquist and the TROPIC Listing. Prelim.
`Resp. 50–51. Patent Owner argues that Liu does not support Dr. Seth’s
`opinion because, when the lipophilicity of a drug such as cabazitaxel
`presents a formulation problem, Liu suggests the use of surfactants and
`liposomes rather than alteration of the solid state form of the drug compound
`
`
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