Paper No. ______
`
`Filed on behalf of Apotex Inc.
`By: Kenneth J. Burchfiel
`
`Grant S. Shackelford
`
`Sughrue Mion, PLLC
`
`2100 Pennsylvania Ave., NW
`
`Washington, DC 20037
`
`Telephone: 202-293-7060
`
`Facsimile: 202-293-7860
`
`email:
`kburchfiel@sughrue.com
`
`
`
`gshackelford@sughrue.com
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`APOTEX INC.
`Petitioner
`
`v.
`
`MERCK & CO., INC.
`Patent Owner
`__________________
`
`Case IPR2015-00419
`Patent No. 5,691,336
`__________________
`
`
`
`ATTN: CHIEF ADMINISTRATIVE PATENT JUDGE
`
`APOTEX PETITION UNDER 37 CFR § 41.3
`SUGGESTING RECONSIDERATION BY
`AN EXPANDED PANEL UNDER S.O.P. 1
`
`
`
`
`
`Filed on behalf of Apotex Inc.
`By: Kenneth J. Burchfiel
`
`Grant S. Shackelford
`
`Sughrue Mion, PLLC
`
`2100 Pennsylvania Ave., NW
`
`Washington, DC 20037
`
`Telephone: 202-293-7060
`
`Facsimile: 202-293-7860
`
`email:
`kburchfiel@sughrue.com
`
`
`
`gshackelford@sughrue.com
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`APOTEX INC.
`Petitioner
`
`v.
`
`MERCK & CO., INC.
`Patent Owner
`__________________
`
`Case IPR2015-00419
`Patent No. 5,691,336
`__________________
`
`
`
`ATTN: CHIEF ADMINISTRATIVE PATENT JUDGE
`
`APOTEX PETITION UNDER 37 CFR § 41.3
`SUGGESTING RECONSIDERATION BY
`AN EXPANDED PANEL UNDER S.O.P. 1
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ........................................................................................II
`
`I.
`
`INTRODUCTION .............................................................................................. 1
`
`II.
`
`PROCEDURAL BACKGROUND .................................................................... 1
`
`III. REASONS WHY THE REQUEST FOR RECONSIDERATION
`SHOULD BE HEARD BY AN EXPANDED PANEL .................................... 1
`
`A.
`
`B.
`
`The Decision Denying Institution ......................................................... 1
`
`The Merits Panel Decision Conflicts With Other Board
`Decisions Concerning the Legal Standard for
`Obviousness ........................................................................................... 2
`
`1.
`
`2.
`
`3.
`
`The merits Panel’s “lead compound” analysis is
`incorrect ...................................................................................... 2
`
`The merits Panel’s decision conflicts with Ex parte
`Dong ............................................................................................ 3
`
`The merits Panel’s decision conflicts with Ex parte
`Cao .............................................................................................. 5
`
`C.
`
`The Correct Legal Standard for Obviousness of Chemical
`Compounds Is An Issue of Exceptional Importance ............................. 5
`
`IV. PAYMENT OF FEE ........................................................................................... 6
`
`
`
`
`
`
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293 (Fed.
`Cir. 2007) ................................................................................................................ 5
`
`Daiichi Sankyo Co., Ltd. v. Matrix Labs., Ltd., 619 F.3d 1346 (Fed.
`Cir. 2010) ............................................................................................................3, 4
`
`Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353 (Fed. Cir.
`2008) ....................................................................................................................... 5
`
`Ex parte Cao, Appeal No. 2010-004081 (BPAI Sept. 19, 2011) .............................. 5
`
`Ex parte Dong, Appeal No. 2011-0100471 (PTAB Jan. 28, 2013) .......................3, 4
`
`In re Dillon, 919 F.2d 688 (Fed. Cir. 1990) (en banc) ..........................................2, 5
`
`Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir.
`2012) ....................................................................................................................... 4
`
`
`
`REGULATIONS
`
`37 C.F.R. § 42.71(c) ................................................................................................... 2
`
`37 CFR § 41.3 ............................................................................................................ 1
`
`37 CFR § 41.3(c) ........................................................................................................ 6
`
`37 CFR § 41.3(e) ........................................................................................................ 1
`
`37 CFR § 41.20 .......................................................................................................... 6
`
`
`
`
`
`
`ii
`
`
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 CFR § 41.3 and Standard Operating Procedure 1.III.C (Rev.
`
`14, “SOP 1”) Apotex Inc. (“Petitioner”) respectfully suggests that its Request for
`
`Reconsideration of the Decision Denying Institution of Inter Partes Review (Paper
`
`14) be heard by an expanded panel. Because the merits Panel used an obviousness
`
`standard that conflicts with earlier Board decisions and en banc Federal Circuit
`
`precedent, hearing by an expanded Panel is needed to eliminate uncertainty as to
`
`the proper legal standard for obviousness of chemical compounds in proceedings
`
`before the Board.
`
`II.
`
`PROCEDURAL BACKGROUND
`
`This Petition under 37 CFR § 41.3 Suggesting Reconsideration By An
`
`Expanded Panel Under S.O.P. 1 is filed concurrently with a Request for
`
`Reconsideration and therefore is timely under 37 CFR § 41.3(e).
`
`III. REASONS WHY THE REQUEST FOR RECONSIDERATION
`SHOULD BE HEARD BY AN EXPANDED PANEL
`
`A. The Decision Denying Institution
`
`In denying institution of inter partes review, the merits Panel used an
`
`obviousness test that is contrary to both PTAB and en banc Federal Circuit
`
`precedent to hold that Petitioner did not establish a reasonable likelihood that it
`
`would prevail in showing the unpatentability of at least one challenged claim. For
`
`the reasons stated in the concurrently-filed Petitioner Request for Reconsideration
`
`
`
`1
`
`
`
`
`
`Under 37 CFR § 42.71(c), this decision is based on legal error and thus constitutes
`
`an abuse of discretion warranting reconsideration.
`
`The merits Panel applied a rigid and unduly restrictive “lead compound”
`
`analysis that has been specifically rejected by earlier PTAB decisions as being
`
`inconsistent with the structural obviousness standard required by In re Dillon, 919
`
`F.2d 688 (Fed. Cir. 1990) (en banc).
`
`B.
`
`The Merits Panel Decision Conflicts With Other Board Decisions
`Concerning the Legal Standard for Obviousness
`
`The obviousness analysis applied by the merits Panel conflicts with earlier
`
`Board decisions, which have consistently stated that the “lead compound” analysis
`
`applied by the merits Panel has not superseded the “structural obviousness”
`
`standard for prima facie obviousness of chemical compounds required by In re
`
`Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990) (en banc). Consideration by an
`
`expanded Panel is thus “necessary to secure and maintain uniformity of the
`
`Board’s decisions.” SOP 1(III)(A)(2). Review by an expanded Panel is
`
`particularly important, because merits Panel decisions denying IPR are not subject
`
`to review in the Federal Circuit or by the Board.
`
`1. The merits Panel’s “lead compound” analysis is incorrect
`
`The merits Panel’s decision is based on three incorrect legal conclusions,
`
`which conflict with other Board decisions and Federal Circuit precedent:
`
`
`
`2
`
`
`
`
`
`1)
`
`The prior art compound (aprepitant) having the closest chemical
`
`structure to the claimed prodrug (fosaprepitant) is not a “lead compound” for an
`
`obviousness analysis. Dec., at 9, 12.
`
`2)
`
`Aprepitant is not a “lead compound” because the primary reference
`
`does not disclose “activity data” for aprepitant. Dec., at 9, ll. 7-8, 19-21.
`
`3)
`
`Because the primary reference discloses over 600 specific
`
`compounds, the closest structurally related compound cannot be a “lead
`
`compound” in the obviousness analysis. Dec., at 11.
`
`2.
`
`The merits Panel’s decision conflicts with Ex parte Dong
`
`Review by an expanded Panel is required to eliminate conflict with the “lead
`
`compound” analysis applied in Ex parte Dong, Appeal No. 2011-010047 (PTAB
`
`Jan. 28, 2013) (Ex. 1026), which is correct and should be followed by the PTAB.
`
`In Ex parte Dong, the Board found claims to a compound obvious based on a
`
`structurally similar analog found in Example 378 of the reference (out of 411 total
`
`Examples), where the reference disclosed no “activity data” for any of the
`
`exemplified compounds. Ex. 1026, at 6-7. In doing so, the Board explicitly
`
`rejected the analysis employed by the merits Panel in the present IPR.
`
`1)
`
`The Board in Dong specifically disagreed with the present Panel’s
`
`requirement for “biological data” and its characterization of Daiichi Sankyo Co.,
`
`Ltd. v. Matrix Labs., Ltd., 619 F.3d 1346 (Fed. Cir. 2010): “We are not persuaded,
`
`
`
`3
`
`
`
`
`
`however, that Daiichi Sankyo, Otsuka, or other lead compound cases mandate that
`
`the only compounds useful for evaluating obviousness are those for which the prior
`
`art has provided specific comparative data. In this case, for example, accepting
`
`such an interpretation would effectively render [the reference] unavailable as prior
`
`art for determining obviousness, simply because [the reference] did not provide
`
`data comparing the biological properties of its compounds.” Ex. 1026, at 7.
`
`2)
`
`The Board in Dong specifically disagreed with the present Panel’s
`
`assertion that the closest chemical structure in a reference can be disregarded as a
`
`lead compound because it was present in a list of numerous other compounds:
`
`“Thus, we are not persuaded that [the reference] failed to provide a reason to select
`
`any of its exemplified compounds, including Example 378 [out of 411], as a
`
`compound suitable for further improvement.” Id. at 5-6. The Board in Dong
`
`correctly considered that when there is no evidence to the contrary, all compounds
`
`in a reference are suitable for selection as lead compounds: “Appellant points to no
`
`evidence of record, however, suggesting that an ordinary artisan would have
`
`expected any of the exemplified compounds, including the compound of Example
`
`378, to lack the therapeutic properties described in [the reference].” Id. at 6. In the
`
`present case, the contrary standard applied by the merits Panel would eliminate a
`
`reference from consideration merely because it discloses additional compounds,
`
`
`
`4
`
`
`
`
`
`having the same, disclosed therapeutic activity as a claimed compound, which are
`
`not as closely related by structure to the claimed compound.
`
`3.
`
`The merits Panel’s decision conflicts with Ex parte Cao
`
`The merits Panel decision also conflicts with Ex parte Cao, Appeal No.
`
`2010-004081 (BPAI Sept. 19, 2011) (Ex. 1027) in which the Board rejected the
`
`applicant’s argument that the identification of a “lead compound” is an essential
`
`step in the obviousness analysis. Ex. 1027, at 7. Rejecting such a per se rule, the
`
`Board confirmed the “long standing principles” of structural obviousness under
`
`which, “it is sufficient to show that the claimed and prior art compounds possess a
`
`‘sufficiently close relationship ... to create an expectation,’ in light of the totality of
`
`the prior art, that the new compound will have ‘similar properties’ to the old.’” Id.
`
`at 6, 7-8 (quoting Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353, 1357
`
`(Fed. Cir. 2008), quoting Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499
`
`F.3d 1293, 1301 (Fed. Cir. 2007), quoting In re Dillon, 919 F.2d at 692).
`
`C. The Correct Legal Standard for Obviousness of Chemical
`Compounds Is An Issue of Exceptional Importance
`
`The merits Panel’s rigid “lead compound” analysis, which excludes a
`
`structural obviousness analysis, conflicts with previous Board decisions and en
`
`banc Federal Circuit precedent. This issue is appropriate for review by an
`
`expanded Panel because it raises an issue of exceptional importance – inconsistent
`
`
`
`5
`
`
`
`
`
`legal standards being used by the Board to determine the obviousness of chemical
`
`compounds. SOP 1(III)(A)(1).
`
`It is respectfully requested that an expanded panel hear Petitioner’s Request
`
`for Reconsideration and confirm that the standard for determining the obviousness
`
`of chemical compounds is based on the consideration of the closest structurally
`
`related prior art compound, and does not require “biological data” or depend on the
`
`number of compounds specifically disclosed in a reference.
`
`IV. PAYMENT OF FEE
`
`The present Petition is understood to be a petition “seeking supervisory
`
`review” and thus, pursuant to 37 CFR § 41.3(c), no fee is required. In the event
`
`that a fee is required under 37 CFR §§ 41.3(c) and 41.20, the Board is authorized
`
`to charge a petition fee of $400.00 and any other fees required to deposit account
`
`19-4880.
`
`
`
`
`
`Date: July 24, 2015
`
`SUGHRUE MION, PLLC
`2011 Pennsylvania Ave., N.W.
`Washington, DC 20037
`(202) 293-7060
`
`
`Respectfully submitted,
`
`/Kenneth Burchfiel/
`
`Kenneth J. Burchfiel
`Attorney for Petitioner Apotex Inc.
`Registration No. 31,333
`
`
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`(37 C.F.R. §§ 42.6(e) and 42.105(a))
`
`The undersigned hereby certifies that the above-captioned “APOTEX
`
`PETITION UNDER 37 CFR § 41.3 SUGGESTING RECONSIDERATION
`
`BY AN EXPANDED PANEL UNDER S.O.P. 1” was served on July 24, 2015 by
`
`filing these documents through the Patent Review Processing System as well as
`
`delivering copies via electronic mail upon the following attorneys of record for the
`
`Patent Owner:
`
`Bruce M. Wexler (brucewexler@paulhastings.com)
`
`Preston K. Ratliff, II (prestonratliff@paulhastings.com)
`
`Gregory A. Morris (gregorymorris@paulhastings.com)
`
`Naveen Modi (naveenmodi@paulhastings.com)
`
`Richard C. Billups (richard_billups@merck.com)
`
`Gerard M. Devlin, Jr. (gerard_devlin@merck.com)
`
`/Grant Shackelford/
`Grant S. Shackelford
`Reg. No. 70,504
`SUGHRUE MION, PLLC
`2100 Pennsylvania Ave, NW
`Washington, DC 20037
`Telephone: (202) 293-7060
`Facsimile: (202) 293-7860
`
`
`
`DATE: July 24, 2015
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