Paper No. 15
`Date Filed: November 4, 2016
`
`Filed On Behalf Of:
`
`Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`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
`U.S. Patent No. 8,927,592
`________________
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION
`TO SUBMIT SUPPLEMENTAL INFORMATION
`
`
`Date Filed: November 4, 2016
`
`Filed On Behalf Of:
`
`Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`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
`U.S. Patent No. 8,927,592
`________________
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION
`TO SUBMIT SUPPLEMENTAL INFORMATION
`
`
`
`I.
`
`INTRODUCTION
`
`On October 28, 2016, Mylan Laboratories Limited (“Mylan”) filed a Motion
`
`to Submit Supplemental Information under 37 C.F.R. § 42.123(a) (Paper No. 14)
`
`(“Motion”). Mylan seeks to introduce (1) an office action from the prosecution of
`
`U.S. Patent Application No. 14/575,566 (“Final Office Action”) (Exhibit 1040),
`
`and (2) the October 7, 2016 claim construction opinion from the district court
`
`litigation Sanofi-Aventis v. Fresenius Kabi USA et al., Lead Coordinated Case No.
`
`14-7869 (D.N.J.) (“Claim Construction Order”) (Exhibit 1039). Patent Owner
`
`Aventis Pharma S.A. (“Aventis”) opposes Mylan’s motion.
`
`Mylan’s Motion should be denied because neither exhibit is relevant to a
`
`claim for which trial has been instituted. Mylan’s Motion should also be denied as
`
`an improper attempt to respond to the Patent Owner’s Preliminary Response
`
`(“POPR”) and to bolster the challenges originally presented in the Petition.
`
`II.
`
`LEGAL STANDARD
`
`37 C.F.R. § 42.123(a) concerns supplemental information and states:
`
`(a) Motion to submit supplemental information. Once a
`trial has been instituted, a party may file a motion to
`submit supplemental information in accordance with the
`following requirements:
`(1) A request for the authorization to file a motion
`to submit supplemental information is made within one
`month of the date the trial is instituted.
`(2) The supplemental information must be relevant
`to a claim for which the trial has been instituted.
`
`1
`
`
`
`Even if a party meets the above-listed requirements of 37 C.F.R.
`
`§ 42.123(a), the Board does not automatically grant the motion. Redline Detection,
`
`LLC v. Star Envirotech, Inc., 811 F.3d 435, 445 (Fed. Cir. 2015). Instead, the
`
`“guiding principle” for the Board is to “ensure efficient administration of the
`
`Office and the ability of the Office to complete IPR proceedings in a timely
`
`manner.” Id. Under this “guiding principle,” the Board has broad discretion in
`
`granting or denying motions to submit supplemental information. Id.
`
`Applying that discretion, the Board has denied supplementation if the
`
`information is proffered to change the evidence presented in the petition to support
`
`the grounds of unpatentability authorized in the proceeding. Mitsubishi Plastics,
`
`Inc. v. Celgard, LLC, IPR2014-00524, Paper 30 at 5-6 (PTAB Nov. 28, 2014)
`
`(citing ZTE v. Contentguard Holdings, Inc., IPR2013-00139, Paper 27 at 3 (PTAB
`
`July 30, 2013)); Redline Detection, LLC v. Star Envirotech, Inc., IPR2013-00106,
`
`Paper 24 at 4 (PTAB Aug. 5, 2013), aff’d, 811 F.3d 435 (Fed. Cir. 2015)). In
`
`particular, the Board has denied motions where Petitioners seek to use
`
`supplemental information to “bolster” the challenges originally presented in the
`
`Petition based on feedback gleaned from the institution decision. Redline
`
`Detection, Paper 24 at 4; see also ZTE, Paper 27 at 3.
`
`Additionally, the Board denies supplemental submissions when they are
`
`responsive to a POPR, which is not permitted. VTech Commc’ns, Inc. v. Spherix
`
`2
`
`
`
`Inc., IPR2014-01432, Paper 12 at 3 (PTAB, Jan. 21, 2015). The Petitioner cannot
`
`use supplemental evidence as a vehicle to respond to a possible position the Patent
`
`Owner may make in the Patent Owner Response. See Medtronic, Inc. v. Endotach
`
`LLC, IPR2014-00100, Paper No. 18 at 4 (PTAB Apr. 21, 2014). Instead, the
`
`Petitioner may bring additional evidence to the Board’s attention in the Reply,
`
`assuming it is responsive to the Patent Owner’s Response. See Medtronic, Paper
`
`18 at 4.
`
`III. The Board Should Deny Authorization to Submit the Final Office
`Action
`
`Mylan’s request to introduce the Final Office Action that cites Mylan’s
`
`Petition should be denied because (1) Mylan is attempting to respond to the POPR,
`
`(2) the decision is not relevant, and (3) Mylan is seeking to improperly bolster the
`
`Petition.
`
`A. Mylan Is Attempting to Respond to the Patent Owner’s
`Preliminary Response
`
`Mylan seeks to rely on the Final Office Action primarily to rebut the
`
`argument made by Aventis in its POPR that the Examiner allowed the claims of
`
`the ’592 patent over the references in Mylan’s Grounds. Motion at 9-10 (citing
`
`extensively to the POPR). But that is an improper basis for supplementation.
`
`“Because the proposed submission is intended to address the content of Patent
`
`Owner’s Preliminary Response, Petitioner in effect is asking for authorization to
`
`3
`
`
`
`file a reply to the Preliminary Response.” Wireless Seismic, Inc. v. Fairfield
`
`Indus., Inc., IPR2014-01113, Paper 8 at 2 (PTAB Oct. 28, 2014). However, the
`
`rules for inter partes review do not provide for such reply. Id.; VTech, Paper 12 at
`
`3.
`
`Nor is supplemental evidence permitted to preemptively respond to a
`
`position Aventis may or may not take in the Patent Owner Response. See
`
`Medtronic, Paper No. 18 at 4. In particular, Aventis may not choose to use the
`
`same argument regarding the ’592 patent Examiner’s allowance of the claims that
`
`was set forth in the POPR in its forthcoming Patent Owner Response.1 See
`
`Macronix Int’l Co. v. Spanison LLC, IPR2014-00104, Paper 18 at 3 (PTAB Jul. 1,
`
`2014) (denying motion to submit supplemental information where alleged
`
`relevancy was based on arguments in POPR, but the patent owner had not filed its
`
`full response). Mylan will have an opportunity to respond to arguments that are
`
`actually made in the Patent Owner Response in a Reply and will be able to cite
`
`new evidence so long as that evidence responds to Aventis’s arguments.
`
`Medtronic, Paper 18 at 4. Mylan does not explain why supplemental evidence is
`
`necessary here instead of the usual course of filing a Reply to the Patent Owner’s
`
`Response.
`
`1 Similarly, to the extent Aventis objected to exhibits as being cumulative to those
`considered by the Examiner (Motion at 10), there have been no motions to exclude.
`In the event Aventis files a motion to exclude exhibits on those grounds, Mylan
`will be permitted to respond accordingly.
`
`4
`
`
`
`B.
`
`The Final Office Action Is Not Relevant
`
`Mylan argues that the Final Office Action is relevant because it concerns
`
`narrower claims than those of the ’592 patent and allegedly shows the same
`
`Examiner rejecting Patent Owner’s and Dr. Sartor’s arguments. Motion at 10-12.
`
`Mylan, however, repeatedly misrepresents what occurred in the Final Office
`
`Action, what evidence the Examiner was considering, and the weight of the
`
`Examiner’s decision. The Final Office Action is not relevant because (1) it is not a
`
`final determination of the patentability of the claims at issue in that application or
`
`of the instituted claims, (2) the Examiner has not received Patent Owner’s
`
`arguments or the declaration of Dr. Sartor submitted with the POPR, and (3) the
`
`Examiner is not the finder of fact in this proceeding.
`
`1.
`
`The Examiner’s Rejection Is Not a Final Determination
`
`The Final Office Action is part of an ongoing dialogue between the applicant
`
`and the Examiner in a different application. See Phillips v. AWH Corp., 415 F.3d
`
`1303, 1317 (Fed. Cir. 2005). Aventis has multiple avenues of overcoming the
`
`Final Office Action such as submitting further amendments and arguments in a
`
`request for continued examination, filing a continuation, and appealing the
`
`Examiner’s decision. The Board should reject this supplemental information as it
`
`is not a final determination of the claims at issue in the corresponding application,
`
`let alone of the instituted claims.
`
`5
`
`
`
`2.
`
`The Examiner Has Not Considered Patent Owner’s
`Arguments
`
`Pursuant to its duty of candor, Aventis submitted Mylan’s Petition and
`
`expert declaration (Seth Declaration (Exh. 1002)) to the Examiner in the
`
`prosecution of the ’566 application. Aventis, however, has not submitted the
`
`POPR, supporting declaration of Dr. Sartor (Exh. 2001), or other supporting
`
`evidence that rebut Mylan’s submissions. Thus, contrary to Mylan’s assertions,
`
`the Examiner did not have the opportunity to “evaluate Patent Owner’s and Dr.
`
`Sartor’s arguments against the testimony of Dr. Seth and against the Petition in this
`
`IPR proceeding.” Motion at 10. Accordingly, the Examiner could not have
`
`rejected Aventis’s and Dr. Sartor’s arguments regarding a reasonable expectation
`
`of success that have and will be made in this IPR. Contra Motion at 12. The
`
`Examiner also was not able to consider deposition testimony by Drs. Seth and
`
`Sartor that will occur in this proceeding, or any other arguments Aventis will
`
`make. Thus, the Examiner’s statements are based on a limited record, and it would
`
`be prejudicial to Sanofi for the Board to credit such statements.
`
`3.
`
`The Examiner Is Not the Finder of Fact in This Proceeding
`
`Mylan argues that that the Examiner’s discussion is relevant to the factual
`
`issues underlying obviousness in this proceeding. Motion at 13. However, as
`
`discussed above, the Examiner has not made final factual findings, and any
`
`determinations he has made were based on an incomplete record without the
`
`6
`
`
`
`benefit of Aventis’s POPR and related expert declaration, Aventis’s Patent Owner
`
`Response, or the cross examination that will take place in the IPR. More
`
`importantly, the Examiner is not an administrative law judge or a factfinder in this
`
`proceeding. The Board has rejected attempts to use proceedings that are not
`
`binding on it, including its own decisions. See Nestle Healthcare Nutrition, Inc. v.
`
`Steuben Foods, IPR2015-00249, Paper 37 at 9 (PTAB Jul. 20, 2015) (“Although
`
`the Board seeks consistency, the facts of each case are different, and Board
`
`decisions from other proceedings are not binding.”). Such an admonishment is
`
`particularly applicable to a preliminary opinion of an examiner, which is not a final
`
`factual determination.
`
`C. Mylan’s Use of the Final Office Action Is Improper Bolstering
`
`Even if the Board finds that the Final Office Action is relevant, Mylan’s
`
`request should be denied because the submission is an improper attempt to “bolster
`
`the challenges presented originally in the Petition, based on feedback gleaned from
`
`the institution decision.” Mitsubishi Plastics, Paper 30 at 5.
`
`In the decision instituting this IPR, the Board stated that the parties currently
`
`“present sharply divergent testimonial and documentary evidence of whether a
`
`POSA would have had a reasonable expectation of successfully treating prostate
`
`cancer patients.” Motion at 12-13 (quoting Paper 9 at 13). Based on that
`
`feedback, Mylan’s motion seeks to strengthen its Petition and supporting
`
`7
`
`
`
`declaration of Dr. Seth by asserting that the Examiner has endorsed Mylan’s
`
`arguments over Aventis’s. See Motion at 10. Thus, Mylan is effectively seeking
`
`to change the evidence it relied upon in making its original challenge to claims 1-5
`
`and 7-30. See Mitsubishi Plastics, Paper 30 at 5-6. Accordingly, the Board should
`
`deny the motion to submit the Final Office Action as supplemental information.
`
`IV. The Board Should Deny Authorization to Submit the Claim
`Construction Order
`
`Mylan’s request to introduce the Claim Construction Order should be denied
`
`because the decision is not relevant, and Mylan is seeking to improperly bolster the
`
`Petition.
`
`A.
`
`The Claim Construction Order Is Not Relevant
`
`The Claim Construction Order is not relevant because (1) the Claim
`
`Construction Order is not binding on the Board, and (2) the district court’s
`
`construction is not final.
`
`The district court decision is not binding on the Board. Applying its own
`
`standard, the Board should and has reached its own interpretation of the claims
`
`based on the evidence before it in this proceeding. See Nestle USA, Inc. v. Steuben
`
`Foods, Inc., IPR2015-00023, Paper 17 at 3 (PTAB June 29, 2015) (denying
`
`rehearing request based on construction in other proceedings because “Petitioner
`
`does not cite any statute, regulation, rule or case law requiring that our construction
`
`of a specific claim term be identical in every proceeding”); Innolux Corp. v.
`
`8
`
`
`
`Semiconductor Energy Lab. Co., IPR2013-00028, Paper 27 at 10 (PTAB Apr. 30,
`
`2013) (denying rehearing request based on a district court claim construction
`
`because “such a claim construction was performed under a different standard, with
`
`different considerations and constraints.”).
`
`Furthermore, the Claim Construction Order is not a final decision. District
`
`courts are permitted to and have altered their claim constructions during the course
`
`of litigation. Conoco, Inc. v. Energy & Envtl. Int'l, L.C., 460 F.3d 1349, 1359
`
`(Fed. Cir. 2006); Jack Guttman, Inc. v. Kopykake Enter., Inc., 302 F.3d 1352, 1361
`
`(Fed. Cir. 2002). And, even if a district court’s decision is not altered, the parties
`
`often appeal construction issues to the Federal Circuit, which reviews the district
`
`court’s ultimate claim construction de novo, with factual underpinnings reviewed
`
`for clear error. Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841
`
`(2015). In the district court litigation here, the claim construction issues were
`
`briefed and argued to the court before fact discovery was completed or expert
`
`discovery had taken place. Exh. 2141 at 5. Furthermore, trial is scheduled to
`
`begin on September 18, 2017, and thus any such appeal will be decided after the
`
`Board issues its final written decision. Id. Therefore, the Board should deny
`
`Mylan’s request for relying on too preliminary a determination.
`
`9
`
`
`
`B. Mylan’s Use of the Claim Construction Order Is Improper
`Bolstering
`
`Even if the Board finds that the Claim Construction Order is relevant, which
`
`it is not, the Board should deny Mylan’s request because it is an improper attempt
`
`to bolster the challenges originally presented in the Petition. Here, Mylan seeks to
`
`supplement the record with the Claim Construction Order because it “includes,
`
`inter alia, constructions of the preambles of claims 1 and 27 of the ’592 patent that
`
`confirm and support the constructions proposed by Petitioner and adopted by the
`
`Board.” Motion at 7 (emphasis added). Similarly, in Mitsubishi Plastics, Inc. v.
`
`Celgard, LLC, the Board refused to permit supplemental submission of new expert
`
`declarations that were concededly used to “bolster and corroborate” an expert’s
`
`assertions to give them “additional probative weight.” IPR2014-00524, Paper 30,
`
`at 5-6 (emphasis added). Thus, like in Mitsubishi Plastics, Mylan has conceded
`
`that it is bolstering the evidence by submitting the Claim Construction Order as
`
`additional confirmatory evidence. Because this is an improper modification of the
`
`evidence Mylan relies on to challenge the instituted claims, the Board should deny
`
`the motion to submit the Claim Construction Order as supplemental evidence.
`
`V.
`
`CONCLUSION
`
`For the reasons discussed above, Aventis respectfully requests that the Board
`
`deny Mylan’s motion to submit supplemental evidence in full.
`
`10
`
`
`
`November 4, 2016
`
`Respectfully submitted,
`
`/Dominick A. Conde/
`
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`11
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the PATENT OWNER’S OPPOSITION TO
`
`PETITIONER’S MOTION TO SUBMIT SUPPLEMENTAL INFORMATION
`
`was served on November 4, 2016 by causing it to be sent by email to counsel for
`
`Petitioner at the following email addresses:
`
`sparmelee@wsgr.com
`
`mrosato@wsgr.com
`
`jmills@wsgr.com
`
`November 4, 2016
`
`Respectfully submitted,
`
`/Dominick A. Conde/
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`12
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