Trials@uspto.gov Paper 20
`Tel: 571-272-7822
`
`Entered: November 30, 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.
`
`
`
`ORDER
`Conduct of the Proceeding
`Filing of Supplemental Information
`37 C.F.R. § 42.5; 37 C.F.R. § 42.123(a)
`
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`Entered: November 30, 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.
`
`
`
`ORDER
`Conduct of the Proceeding
`Filing of Supplemental Information
`37 C.F.R. § 42.5; 37 C.F.R. § 42.123(a)
`
`
`
`
`
`
`
`
`
`
`IPR2016-00712
`Patent 8,927,592 B2
`
`
`
`
`I.
`INTRODUCTION
`On March 15, 2016, 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.”). On
`June 24, 2016, Aventis Pharma S.A. (“Patent Owner”) filed a Preliminary
`Response to the Petition. Paper 7 (“Prelim. Resp.”). We issued our
`Decision to Institute on September 22, 2016. Paper 9 (“Decision” or
`“Dec.”).
`On October 21, 2016, by email within one month of our Decision,
`Petitioner renewed its request to file a motion to submit supplemental
`information pursuant to 37 C.F.R. § 42.123(a). On October 28, 2016,
`Petitioner filed a Motion to File Supplemental Information pursuant to 37
`C.F.R. § 42.123(a), as authorized by the Board. Paper 14, 5–6 (“Motion” or
`“Mot.”). Petitioner filed the proposed supplemental information as Exhibits
`1039 and 1040, for our consideration with the Motion. Mot. 1. Patent
`Owner filed an Opposition to the Motion. Paper 15 (“Opposition” or
`“Opp.”). Petitioner filed a Reply to Patent Owner’s Opposition. Paper 17
`(“Mot. Reply”). For the reasons expressed below, Petitioner’s Motion is
`granted-in-part and denied-in-part.
`
`
`II. ANALYSIS
` 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
`
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`2
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`IPR2016-00712
`Patent 8,927,592 B2
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`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.
`
`Satisfaction of the above-listed requirements for filing the motion,
`however, does not mean the Board will 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.
`There is no question that Patent Owner made its request within one
`month of the date trial was instituted. The relevance of proffered Exhibits
`1039 and 1040, however, is disputed. We address each exhibit in turn.
`
`A. Judge Shipp’s Claim Construction Opinion (Exhibit 1039)
`
`Exhibit 1039 is an Amended Memorandum Opinion authored by
`District Court Judge Michael A. Shipp of the District of New Jersey, in
`which Judge Shipp construes certain limitations in the ’592 patent claims.
`Ex. 1039 (“Opinion”). Judge Shipp’s Opinion is dated October 7, 2016,
`approximately two weeks after we issued our Decision on September 22,
`2016. Id. A portion of Judge Shipp’s Opinion addresses the same issue we
`addressed in our Decision regarding whether the preamble phrases, “a
`method for treating a patient” (claim 1) and “a method of increasing the
`
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`3
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`IPR2016-00712
`Patent 8,927,592 B2
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`survival of a patient” (claim 27), are claim limitations or merely statements
`of intended use. Compare Ex. 1039, 8–14 with Dec., 7–10. Although we
`apply the broadest reasonable interpretation standard to construe claims in
`unexpired patents undergoing an inter partes review, this “‘does not include
`giving claims a legally incorrect interpretation.’” Microsoft Corp. v.
`Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015) (quotation omitted).
`Just as we should consult the patent specification and the patent’s
`prosecution history when a patent “has been brought back to the agency for a
`second review” (id.), we would be remiss in failing to consider a District
`Court’s analysis of the same patent claim language, specification, and
`prosecution history under review. While not binding, such a District Court
`claim construction analysis is a valuable and relevant resource for
`consideration during an inter partes review proceeding. Patent Owner’s
`citations to additional Federal Circuit and PTAB decisions are not to the
`contrary. Opp. 8–9.
`We further note Judge Shipp’s Opinion issued approximately two
`weeks after our Decision. Petitioner’s effort to bring the Opinion to our
`attention was prompt. Patent Owner will have the opportunity to address the
`preamble claim construction issue, and our Decision and Judge Shipp’s
`Opinion regarding that issue, in Patent Owner’s Response. Petitioner may
`Reply.1 Under such circumstances, we do not agree with Patent Owner that
`Petitioner’s reliance on Exhibit 1039 is “improper bolstering.” Id. at 10.
`
`
`1 Pursuant to stipulation of the parties, Patent Owner’s Response is currently
`scheduled to be filed on December 23, 2016, and Petitioner’s Reply on
`March 14, 2017. Paper 18.
`
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`IPR2016-00712
`Patent 8,927,592 B2
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`For the reasons given above, Petitioner’s motion to file Exhibit 1039
`is granted.
`
`B. Examiner’s Final Office Action in Continuation Application
`(Exhibit 1040)
`
`The ’592 patent, titled “Antitumoral Use of Cabazitaxel,” issued
`January 6, 2015, from an application filed April 26, 2012. Ex. 1001.
`Exhibit 1040 is a Final Office Action dated June 9, 2016 from the file
`history of a continuation application based on the application that issued as
`the ’592 patent (the “continuation case”). By definition, the claims in the
`continuation case are different from the claims issued in the ’592 patent. We
`also note that examination of the claims in the continuation case remains
`pending and is not yet concluded. Ex. 1040, 43–44.
`Petitioner argues for the relevance of the Final Office Action based on
`Patent Owner’s Preliminary Response argument that relied on the
`Examiner’s actions taken during examination of the ’592 patent application.
`Mot. 9–10. In our Decision, we did not accept Patent Owner’s contention
`that because substantially the same arguments made in the Petition were
`overcome during Examination of the ’592 patent application, we should
`exercise our discretion and deny institution under 35 U.S.C. § 325(d). Dec.,
`22–23; Prelim. Resp. 52–53. Therefore, the issue raised by Patent Owner in
`the Preliminary Response in reliance on the Examiner’s actions has been
`decided, and Patent Owner has not requested a rehearing of the issue.
`Of greater significance, Patent Owner has filed Petitioner’s IPR
`Petition and the supporting Declaration of Dr. Seth from this proceeding in
`the continuation case in accordance with its duty of candor and good faith in
`
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`IPR2016-00712
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`dealing with the Office. Opp. 6; see 37 C.F.R. § 1.56(a) (“Each individual
`associated with the filing and prosecution of a patent application has a duty
`of candor and good faith in dealing with the Office.”). Patent Owner has not
`submitted its Preliminary Response, Dr. Sartor’s supporting Declaration (Ex.
`2001), or other evidence supporting Patent Owner’s contentions in the
`continuation case. Opp. 6. Petitioner is attempting to use the Examiner’s
`view of Dr. Seth’s Declaration, based on a partial record in the still-pending
`continuation case, weighed against the Rule 132 Declaration submitted by
`Patent Owner’s expert, Dr. Sartor, to Petitioner’s advantage in this trial
`proceeding. Mot. 10-11. Having considered the matter, we agree with
`Patent Owner that any relevance the Final Office Action may have in the
`present inter partes review proceeding is diminished because (1) it is not a
`final determination of the patentability of the claims at issue in the
`continuation case, which differ from the instituted claims, (2) the Examiner
`has not received Patent Owner’s arguments or the declaration of Dr. Sartor
`submitted with Patent Owner’s Preliminary Response, and (3) the Examiner
`is not the finder of fact in this proceeding. Opp. 5–7. We will not allow
`Petitioner to use the Examiner’s views in the continuation case as a shadow
`proceeding to bolster its Petition in the present trial proceeding. Mot. 11–13.
`For the reasons given above, Petitioner’s Motion with respect to
`Exhibit 1040 is denied, and Exhibit 1040 will be expunged. Petitioner will
`have the opportunity to Reply to Patent Owner’s Response and submit new
`
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`IPR2016-00712
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`evidence, such as Ex. 1040, if the evidence is responsive to Patent Owner’s
`arguments and evidence in the Response.2
`III. ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s Motion is granted with respect to Exhibit
`1039, and Exhibit 1039 will be accepted as an exhibit in this proceeding;
`FURTHER ORDERED that Petitioner’s Motion is denied with respect
`to Exhibit 1040, and Exhibit 1040 will be expunged from the record.
`
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`2 Patent Owner’s objections to ten exhibits submitted by Petitioner on the
`basis that the references were previously considered by the Examiner is duly
`noted. Mot. 10. If Patent Owner files a motion to exclude any of the
`exhibits, Petitioner will have an opportunity to respond and submit
`supporting evidence in accordance with the Scheduling Order. Paper 10, 6–
`8; Opp. 4 n.1.
`
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`7
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`IPR2016-00712
`Patent 8,927,592 B2
`
`
`FOR PETITIONER:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`
`FOR PATENT OWNER:3
`
`Dominic A. Conde
`Whitney L. Meier
`FITZPATRICK CELLA HARPER & SCINTO
`dconde@fchs.com
`wmeier@fchs.com
`
`
`
`
`
`3 In Patent Owner’s Mandatory Notices, Patent Owner indicates an intent to
`file a motion for the pro hac vice admission of Messrs. William E. Solander
`and Jason A. Leonard. Paper 6. Our review of the docket does not indicate
`that such a motion with supporting declarations has been filed in this
`proceeding.
`
`
`
`8
`
`
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