WAS:287684.1
`
`
`
`
`
`Patent No. RE38,551
`Issue Date: July 6, 2004
`Title: ANTICONVULSANT ENANTIOMERIC AMINO ACID DERIVATIVES
`_______________
`
`Inter Partes Review No. IPR2016-00204
`____________________________________________________________
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.
`Patent Owner
`
`PETITIONER’S MOTION TO CONSOLIDATE
`REEXAMINATION WITH INTER PARTES REVIEW
`
`37 C.F.R. § 42.122(a)
`
`
`
`
`
`
`
`
`Patent No. RE38,551
`Issue Date: July 6, 2004
`Title: ANTICONVULSANT ENANTIOMERIC AMINO ACID DERIVATIVES
`_______________
`
`Inter Partes Review No. IPR2016-00204
`____________________________________________________________
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.
`Patent Owner
`
`PETITIONER’S MOTION TO CONSOLIDATE
`REEXAMINATION WITH INTER PARTES REVIEW
`
`37 C.F.R. § 42.122(a)
`
`
`
`
`Patent No. RE38,551
`
`
`
`
`
`TABLE OF CONTENTS
`
`IPR2016-00204
`
`I.
`
`II.
`
`III.
`
`RELIEF REQUESTED ......................................................................... 1
`
`STATEMENT OF MATERIAL FACTS .............................................. 1
`
`ARGUMENT ........................................................................................ 3
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`The Board Has Authority to Consolidate the IPR and the
`Reexam under 35 U.S.C. § 315(d) ..................................................... 3
`
`The Board Should Delineate a Set of Factors Applicable for
`Consolidating IPR and Reexam Proceedings .................................. 4
`
`Consolidation Will Prevent Inconsistent Outcomes ............................. 5
`
`Consolidation Will Create an Overall Simplification of the Issues
`and Proceedings ..................................................................................... 7
`
`The Timing of the Proceedings Favors Consolidation .......................... 8
`
`Non-Consolidation Will Prejudice Petitioner and the Public,
`Whereas Consolidation Will Not Prejudice the Patent Owner ............. 9
`
`The Board’s Prior Decisions Regarding Consolidation Are
`Distinguishable .................................................................................... 10
`
`CONCLUSION ................................................................................... 10
`
`IV.
`
`
`
`
`
`WAS:287684.1
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`I.
`
`
`
`RELIEF REQUESTED
`
`Argentum Pharmaceuticals LLC (“Petitioner”) respectfully requests the
`
`PTAB to consolidate ex parte Reexamination No. 10/058,634 (“Reexam”) with the
`
`present inter partes review (“IPR”) of U.S. Patent No. RE38,551 (“’551 patent”),
`
`pursuant to 35 U.S.C. § 315(d) and 37 C.F.R. § 42.122(a).
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`
`
`
`1. On November 23, 2015, Petitioner filed its petition against all claims of the
`
`’551 patent on several grounds. Ground 3A asserted obviousness of claims 1-9
`
`over Kohn 19911 and Silverman,2 and Ground 3B asserted obviousness of
`
`dependent claims 10-13 over Kohn 1991, Silverman, and the ’729 patent.3 The
`
`petition cited additional background prior art in support of Grounds 3A-3B,
`
`including the ’301 patent4 and LeGall.5 See Pet. 46-47. Two expert declarations
`
`were filed with the petition. Ex. 1002 (Wang Decl.); Ex. 1003 (Heathcock Decl.).
`
`
`
`2. On March 25, 2016, Petitioner filed a reexamination request for claims 1-13
`
`
`
` 1
`
` Kohn et al., Preparation and Anticonvulsant Activity of a Series of Functionalized
`α-Heteroatom-Substituted Amino Acids, 34 J. Med. Chem. 2444 (1991).
`2 Silverman, R. B., The Organic Chemistry of Drug Design and Drug Action,
`Academic Press (1992).
`3 U.S. Patent No. 5,378,729.
`4 U.S. Patent No. 5,654,301.
`5 Philippe LeGall, 2-Substituted-2-acetamido-N-benzylacetamides. Synthesis,
`Spectroscopic and Anticonvulsant Properties (Dec. 1987).
`
`WAS:287684.1
`
`-1-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`of the ’551 patent. Ex. 1045. The request proposed two grounds of rejection:
`
`(1) obviousness-type double patenting (“ODP”) of claims 1-13 over the ’301 patent
`
`in view of the ’729 patent and Kohn 1991; and (2) ODP of claims 1-13 over the
`
`’301 patent in view of the ’729 patent and LeGall. Petitioner’s request included the
`
`same two expert declarations by Drs. Wang and Heathcock filed in the IPR.
`
`
`
`3. On May 9, 2016, the Central Reexamination Unit (“CRU”) conducted a
`
`telephonic interview with the Patent Owner’s counsel pursuant to the Pilot
`
`Program for Wavier of Patent Owner’s Statement. Ex. 1046 at 3. Patent Owner
`
`refused to waive its right to file claim amendments and a statement under 35
`
`U.S.C. § 304, thus preventing the simultaneous issuance of an Office action. Id.
`
`
`
`4. On May 23, 2016, the Board instituted the IPR against all claims on
`
`Grounds 3A and 3B. Patent Owner’s response and motion to amend are due
`
`August 15, 2016. Paper 20 at 7.
`
`
`
`5. On June 16, 2016, the CRU ordered the reexamination of claims 1-13,
`
`finding a substantial new question of patentability based on the ’301 patent, the
`
`’729 patent, Kohn 1991, and LeGall. Ex. 1047 at 8. Patent Owner’s § 304
`
`statement and amendments are due August 16, 2016, followed by a two-month
`
`period for Petitioner to file a reply to such statement. Id. at 10.
`
`
`
`WAS:287684.1
`
`-2-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`III. ARGUMENT
`
`A. The Board Has Authority to Consolidate the IPR and the
`Reexam under 35 U.S.C. § 315(d)
`
`
`Under 35 U.S.C. § 315(d), “[n]othwithstanding . . . chapter 30,” “if another
`
`proceeding or matter involving the patent is before the Office, the Director may
`
`determine the manner in which the inter partes review or other proceeding or
`
`matter may proceed, including providing for stay, transfer, consolidation, or
`
`termination of any such matter or proceeding.” See also 37 C.F.R § 42.122(a).
`
`The Board thus “has the discretion to consolidate a review proceeding with a
`
`pending . . . reexamination that involves the same patent.” 77 Fed. Reg., 48,680,
`
`48,697 (Aug. 14, 2012). A consolidated reexam/IPR will proceed as “a single inter
`
`partes review proceeding,” i.e., a “merged proceeding.” Id. at 48,697–48,698.
`
`Patent Owner may argue that the Board is powerless to consolidate in this case
`
`because ODP is not a ground initially petitionable in IPR. That is incorrect. Upon
`
`consolidation, the Board may address the ODP grounds in a final IPR written
`
`decision. Section 318(a) does not limit the “patentability” issues the Board may
`
`decide in a final decision. For this reason, the Board has properly held that
`
`proposed new claims are unpatentable under grounds other than §§ 102 and 103
`
`and prior art other than patents and printed publications. See, e.g., Smith &
`
`Nephew, Inc. v. ConvaTec Techs., IPR2013-00102, at 53-54 (PTAB May 29, 2014)
`
`(deciding § 112(a) written description issue); Ariosa Diagnostics v. Isis Innovation
`
`WAS:287684.1
`
`-3-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`Ltd., IPR2012-00022, at 50-53 (PTAB Sept. 2, 2014) (deciding § 101 issue). The
`
`same word “patentability” in § 318(a) modifies the entire phrase “any patent claim
`
`challenged by the petitioner and any new claim added under section 316(d).”
`
`Therefore, an original claim of a patent can be held unpatentable under ODP in
`
`a final IPR written decision, if such ground is introduced in an instituted IPR via
`
`consolidation with another proceeding. Other proceedings, such as PGRs, CBMs,
`
`reissues, and supplemental examination, involve the full gamut of patentability
`
`issues. If the Board were to limit consolidation of such proceedings to situations
`
`involving only grounds initially petitionable in an IPR, the Board would effectively
`
`turn § 315(d) consolidation into a “white elephant” and undermine one of the main
`
`justifications for employing BRI in IPR. See 77 Fed. Reg. at 48,697–48,698.
`
`B. The Board Should Delineate a Set of Factors Applicable for
`Consolidating IPR and Reexam Proceedings
`
`
`To date, the Board has not set factors for consolidating a reexam with an IPR.
`
`This case presents the right opportunity to do so. The Board should consider the
`
`following
`
`factors:
`
`(1) avoidance of
`
`inconsistent decisions;
`
`(2) potential
`
`simplification of the issues and proceedings; (3) the status and timing of the
`
`proceedings; and (4) any prejudice to the parties and the public. These factors
`
`align with those applied in the analogous context of joinder. See, e.g., Microsoft
`
`Corp. v. Proxyconn, Inc., IPR2013-00109, Paper 15 (PTAB Feb. 25, 2013).
`
`
`
`WAS:287684.1
`
`-4-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`C. Consolidation Will Prevent Inconsistent Outcomes
`
`
`Consolidation of the Reexam with the IPR will eliminate the possibility of
`
`inconsistent factual findings and legal conclusions. Given the overlap of legal
`
`issues and prior art, the Board should seek to avoid any contradictory decisions
`
`relating to the ’551 patent. The Reexam’s ODP grounds are based on the same
`
`references cited within the IPR’s Grounds 3A and 3B and rely on identical expert
`
`declarations. In the Reexam, the ’301 patent’s methoxymethyl is cited as the
`
`starting point in the ODP analysis; likewise, in the IPR the ’301 patent’s
`
`methoxymethyl is cited in support of the final product in the § 103 analysis. Thus,
`
`in addition to construing identical claim terms, the PTO will need to conduct
`
`highly interrelated factual and legal inquiries in both cases. See Otsuka Pharm.
`
`Co. v. Sandoz, Inc., 678 F.3d 1280, 1298 (Fed. Cir. 2012) (explaining that ODP is
`
`similar in many ways, but not identical, to a § 103 analysis).
`
`Patent Owner may argue that there is an “inherent tension” in consolidating an
`
`IPR and a reexam due to procedural differences between the two. See Ford Motor
`
`Co. v. Signal IP, Inc., IPR2015-00861, Paper 14, at 3 (PTAB Nov. 17, 2015). But
`
`Congress did not believe that such procedural differences should prevent
`
`consolidation. Congress expressly provided for consolidation when, in § 315(d), it
`
`used the phrase “[n]othwithstanding . . . chapter 30,” specifying the chapter
`
`defining
`
`the reexamination procedures.
`
` Moreover, any such
`
`tension
`
`is
`
`WAS:287684.1
`
`-5-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`overshadowed by the overriding objective of ensuring that PTO decisions
`
`concerning the same patent are consistent and non-contradictory. In fact, the more
`
`significant “inherent tension” is permitting contradictory findings on the same
`
`patent, same claims, and same evidence.
`
`The PTO’s general policy of consolidating co-pending reissue and reexams
`
`embodies the goal of avoiding inconsistent decisions. See MPEP § 2285 (noting
`
`“[t]he reason for this policy is to permit timely resolution of both proceedings to
`
`the extent possible and to prevent inconsistent, and possibly conflicting,
`
`amendments from being introduced into the two proceedings on behalf of the
`
`patent owner”). Consolidation serves the same goal here.
`
`Moreover, the Supreme Court and the Solicitor General have identified
`
`consolidation of an IPR and a reexam as an important justification for applying the
`
`same BRI standard uniformly across PTO proceedings. See Cuozzo Speed Techs.,
`
`LLC v. Lee, No. 15-446, 2016 WL 3369425, at *12 (U.S. 2016) (citing 77 Fed.
`
`Reg., 48,697–48,698); Brief of Respondent at 42, Cuozzo Speed Techs., LLC v.
`
`Lee, No. 15-446 (U.S. 2016) (“Congress expressly contemplated that the PTO
`
`could consolidate an ex parte reexamination . . . with an inter partes review, 35
`
`U.S.C. 315(d), and petitioner does not suggest that Congress expected the agency
`
`to use different claim-interpretation methodologies simultaneously in a ‘truly
`
`merged’ proceeding.”). The Court implicitly recognized that consolidation
`
`WAS:287684.1
`
`-6-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`achieves intra-Office uniformity.
`
`Here, the Reexam and the IPR involve the same claims of the ’551 patent, the
`
`same declarations, and the same references. The grounds in both proceedings cite
`
`Kohn 1991, the ’729 patent, the ’301 patent, and LeGall, as mentioned above.
`
`Also, both proceedings include identical expert declarations. It makes little sense
`
`to risk inconsistent decisions by having the Board and the CRU independently
`
`decide these highly overlapping issues.
`
`D. Consolidation Will Create an Overall Simplification of the Issues and
`Proceedings
`
`
`Consolidation of the two proceedings here will simplify the issues to be
`
`decided. As noted, the two proceedings involve overlapping legal and factual
`
`issues. Consolidation will permit the Board to avoid duplicative work by allowing
`
`the Board to decide both ODP and § 103 in a single proceeding. Settlement of the
`
`consolidated proceeding under § 317 would also resolve both issues.
`
`Importantly, if the IPR and Reexam are consolidated, § 315(e) estoppel will
`
`simplify future disputes because it will eliminate relitigation in both the PTO and
`
`the courts. If consolidated, any ODP ground decided in the Board’s final written
`
`IPR decision would be a ground “raised during the inter partes review.” Id.
`
`Petitioner’s recognition of estoppel weighs in favor of consolidation.
`
`Further, if deemed necessary for consolidation, Petitioner is amenable to
`
`withdrawing Reexam Ground 2 (’301 patent in view of the ’729 patent and
`
`WAS:287684.1
`
`-7-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`LeGall), as the Board did not institute IPR on Grounds 1A or 1B. This will further
`
`simplify the consolidated proceeding, with each patent claim facing only one ODP
`
`ground and one § 103 ground.
`
`E. The Timing of the Proceedings Favors Consolidation
`
`The early stage of both proceedings strongly favors consolidation. In the IPR,
`
`Patent Owner has not yet filed its response and motion to amend (due Aug. 15,
`
`2016). In the Reexam, Patent Owner has not yet filed is § 304 statement and
`
`amendment, due August 16, 2016. Patent Owner will be prepared to address both
`
`ODP and § 103 in mid-August. To the extent that timing issues are of concern,
`
`Petitioner is amendable to modifications of the current IPR schedule. For example,
`
`the Board could extend Patent Owner’s Due Date 1 in the consolidated IPR by 24
`
`days (the number of days between the IPR institution decision and the Reexam
`
`order) and extend Petitioner’s Due Date 2 by no more than 12 days.
`
`Patent Owner may argue it is “premature” to consolidate because no Office
`
`action has issued in the Reexam. But Patent Owner chose to delay the issuance of
`
`the Office action by refusing to participate in the CRU’s pilot waiver program. Ex.
`
`1046 at 3; see MPEP § 2249 (waiver permits the Examiner to “draft[] the order and
`
`the first Office action on the merits together”). The Board should not condone
`
`such dilatory tactics as a means to avoid consolidation. Moreover, the Office will
`
`lose the efficiency gains by waiting for the CRU to issue an Office action, rather
`
`WAS:287684.1
`
`-8-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`than promptly consolidating now before the CRU invests more resources in the
`
`Reexam.
`
`F. Non-Consolidation Will Prejudice Petitioner and the Public,
`Whereas Consolidation Will Not Prejudice the Patent Owner
`
`
`The high likelihood of prejudice to Petitioner and the public, versus the little-
`
`to-no likelihood of prejudice to Patent Owner, weighs in favor of consolidation.
`
`Denial of consolidation will likely delay the Reexam until the ’551 patent expires
`
`in 2022. Even in the unlikely event that Patent Owner does not slow-walk the
`
`Reexam, the average pendency of an ex parte reexam is approximately twice that
`
`of an IPR. Thus, Patent Owner will likely run out most, if not all, of the remaining
`
`term of the ’551 patent by petitioning and extending deadlines, as further
`
`evidenced by Patent Owner’s refusal to waive its § 304 statement and amendments.
`
`Ex. 1046 at 3. Consolidation would thus further the “special dispatch” goal of
`
`§ 305 by placing the Reexam on the one-year timeline of the IPR.
`
`Consolidation will not prejudice Patent Owner. As mentioned above, if
`
`consolidation is granted, Petitioner is amenable to the Board: (i) withdrawing one
`
`of the two ODP grounds if consolidation is granted; (ii) extending Due Date 1 by
`
`21 days or as deemed appropriate by the Board; and (iii) enlarging briefing as
`
`necessary to address the one ODP ground. Consolidation will also give Patent
`
`Owner the ability to settle, take depositions and discovery, and enjoy the
`
`protections of estoppel, all of which are unavailable in the Reexam. The ultimate
`
`WAS:287684.1
`
`-9-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`burden of proving unpatentability will be the same regardless of consolidation.
`
`G. The Board’s Prior Decisions Regarding Consolidation Are
`Distinguishable
`
`
`The Board has denied consolidation in prior cases but primarily due to
`
`reasoning not present in this case. See, e.g., Ford Motor Co. v. Signal IP, Inc.,
`
`IPR2015-00861, Paper 14, at 4-5 (PTAB Nov. 17, 2015) (existing claim
`
`amendments in reexam); GEA Process Eng’g, Inc. v. Steuben Foods, Inc.,
`
`IPR2014-00051, Paper 12, at 3 (PTAB Dec. 6, 2013) (motion to consolidate
`
`rendered moot “given that the reexamination procedure has terminated”); GEA
`
`Process Eng’g. v. Steuben Foods, Inc., IPR2014-00041, Paper 15, at 11 (PTAB
`
`March 10, 2014) (consolidation would require the Board to address the many
`
`newly added claims in the Reexam, thereby delaying the time to a final decision).
`
`None of the prior cases demonstrated the optimal overlap of issues and timing,
`
`as exists with the presented proceedings. The timing of both the IPR institution
`
`and the Reexam here make the present proceedings ideal for consolidation to
`
`further Congress’s goal of administrative efficiency.
`
`IV. CONCLUSION
`
`Accordingly, Petitioner asks the Board to consolidate the IPR and the Reexam.
`
`
`
`WAS:287684.1
`
`-10-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`Respectfully submitted,
`
`Dated: July 13, 2016
`
`By:
`
`/ Matthew J. Dowd/
`Matthew J. Dowd
`Reg. No. 47,534
`ANDREWS KURTH LLP
`1350 I Street, NW
`Suite 1100
`Washington, DC 20005
`Phone: (202) 662-2701
`Fax: (202) 974-9511
`MatthewDowd@andrewskurth.com
`
`
`
`WAS:287684.1
`
`-11-
`
`
`
`Patent No. RE38,551
`
`
`
`IPR2016-00204
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing motion together
`with all exhibits and other papers filed therewith will be served on July 13, 2016,
`by e-mail to the attorney(s) of record for the patent at the following addresses:
`
`areister@cov.com
`jrobbins@cov.com
`rlongton@cov.com
`
`Covington & Burling LLP
`One City Center, 850 Tenth Street, NW
`Washington, DC 20001
`
`
`
`
`/s/ Matthew J. Dowd/_____________
`Matthew J. Dowd
`Reg. No. 47,534
`ANDREWS KURTH LLP
`1350 I Street, NW, Suite 1100
`Washington, DC 20005
`Phone: (202) 662-2701
`Fax: (202) 974-9511
`MatthewDowd@andrewskurth.com
`
`By:
`
`
`
`
`
`WAS:287684.1
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
