Paper No. 75
`Trials@uspto.gov
`571-272-7822 Entered: September 25, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`____________
`
`Case IPR2017-015261 (Patent 7,476,652 B2)
`Case IPR2017-01528 (Patent 7,713,930 B2)
`____________
`
`
`Before ERICA A. FRANKLIN, ROBERT A. POLLOCK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`ANKENBRAND, Administrative Patent Judge.
`
`
`
`ORDER
`Conduct of the Proceeding
`Authorizing Sur-reply and Sur-sur-reply
`37 C.F.R § 42.5
`
`
`
`
`
`
`
`1 We exercise our discretion to issue one order to be entered in both cases.
`The parties are not authorized to use this style heading for subsequent papers
`without prior Board approval.
`
`
`Trials@uspto.gov
`571-272-7822 Entered: September 25, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`____________
`
`Case IPR2017-015261 (Patent 7,476,652 B2)
`Case IPR2017-01528 (Patent 7,713,930 B2)
`____________
`
`
`Before ERICA A. FRANKLIN, ROBERT A. POLLOCK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`ANKENBRAND, Administrative Patent Judge.
`
`
`
`ORDER
`Conduct of the Proceeding
`Authorizing Sur-reply and Sur-sur-reply
`37 C.F.R § 42.5
`
`
`
`
`
`
`
`1 We exercise our discretion to issue one order to be entered in both cases.
`The parties are not authorized to use this style heading for subsequent papers
`without prior Board approval.
`
`
`
`IPR2017-01526 (Patent 7,476,652 B2)
`IPR2017-01528 (Patent 7,713,930 B2)
`
`
`On September 24, 2018, the Board held a conference call between
`counsel for the parties and Judges Ankenbrand and Pollock. We scheduled
`the conference call to notify the parties that we were considering authorizing
`additional briefing regarding Petitioner’s argument, made in the Reply, that
`Lantus Label’s2 teaching of different in-use storage requirements would
`have indicated an aggregation problem that would have led a person of
`ordinary skill in the art to modify the Lantus formulation (the “in-use storage
`requirement argument”). Petitioner arranged for a court reporter to
`transcribe the conference call, and has filed a rough transcript as an exhibit
`in each proceeding (Ex. 1186, “Tr.”). Petitioner will file the final version of
`the transcript when it becomes available.
`BACKGROUND
`Previously, we authorized Patent Owner to file a motion to strike
`certain arguments Petitioner made in the Reply. See Ex. 2055, 43:3–20
`(Transcript of July 17, 2018 Teleconference).3 We also authorized Patent
`Owner to file a sur-reply, but not as to the in-use storage requirement
`argument. See id. at 42:13–43:2. In its motion, Patent Owner requested to
`strike, inter alia, Petitioner’s argument that “a [person of ordinary skill in
`the art] ‘would have understood the different storage requirements as
`suggesting a propensity for insulin glargine to aggregate.’” Paper 47, 2.
`During the oral hearing in these proceedings, Patent Owner argued
`that the way that Petitioner presented its case created a due process issue that
`
`
`2 Physicians’ Desk Reference, Lantus entry 709–713 (55th ed. 2001)
`(Ex. 1004).
`3 Unless otherwise noted, citations are to the papers and exhibits filed in
`IPR2016-01526.
`
`
`
`2
`
`
`
`IPR2017-01526 (Patent 7,476,652 B2)
`IPR2017-01528 (Patent 7,713,930 B2)
`
`the sur-reply and oral hearing could not remedy. Specifically, Patent Owner
`argued that it was unable to respond with its own evidence as to the issues it
`raised in the motion to strike, including Petitioner’s in-use storage
`requirement argument. After having considered Patent Owner’s due process
`assertion further, we were persuaded that additional briefing regarding the
`in-use storage requirement argument might be helpful in resolving the
`disputed issues in these proceedings.
`DISCUSSION
`During the conference, we explained that the panel contemplated
`authorizing further briefing according to the following parameters. Within
`one week, Patent Owner would file a six-page sur-reply limited to whether
`one of ordinary skill in the art would have understood the different storage
`requirements in the Lantus Label to suggest a propensity for insulin glargine
`to aggregate. See Tr. 3:3–4:14, 22:2–6. In support of its sur-reply, Patent
`Owner could file testimonial evidence from its declarant, Dr. Trout, but no
`other testimonial or documentary evidence. Id. at 4:14–17. Petitioner would
`respond one week later with a four-page sur-sur-reply. Id. at 4:23–25. We
`would not authorize additional evidence from Petitioner, but would allow
`Petitioner to reference Dr. Trout’s cross-examination testimony in the sur-
`sur-reply. Id. at 5:1–5.
`Although Patent Owner initially appeared inclined to reject the
`opportunity for further briefing unless the Board specifically was going to
`require it (Tr. 14:15–18:16), both parties were ultimately amenable to further
`briefing. See generally Tr. Patent Owner objected to limiting its supporting
`evidence to testimony from Dr. Trout and requested additional evidence
`including documents and potential testimony from fact witnesses related to
`
`
`
`3
`
`
`
`IPR2017-01526 (Patent 7,476,652 B2)
`IPR2017-01528 (Patent 7,713,930 B2)
`
`confidential documents. Id. at 5:12–24, 7:10–15, 9:6–11:5. Petitioner
`sought leave to introduce additional evidence, if necessary, to rebut Patent
`Owner’s evidence. Id. at 11:8–12:15. Both parties objected to the time
`limits suggested by the panel. Id. at 22:7–18.
`
`After considering the parties’ arguments, we concluded that we would
`authorize a six-page sur-reply for Patent Owner and a four-page sur-sur-
`reply for Petitioner. Id. at 20:14–21:3. We reconsidered the initial
`limitation on evidence that Patent Owner could submit (if it so desired) to
`support its sur-reply and determined that we would not limit such evidence
`to testimony from Dr. Trout. Id. at 21:4–11. We did not authorize Petitioner
`to file additional evidence supporting its sur-sur-reply, but invited Petitioner
`to renew its request at the appropriate time should such a request become
`necessary. Id. at 21:18–25.
`We took under advisement the timing of the parties’ briefing. Id. at
`22:25–23:6. Patent Owner requested two weeks to file its sur-reply and
`supporting evidence. Petitioner did not object and requested two weeks to
`file its sur-sur-reply. Id. at 22:7–18. The parties agreed that they would
`work together with respect to scheduling and completing depositions in a
`timely manner in order to fit within the timeline they proposed. Having
`further considered the requests, we determine that the four-week timeline
`that the parties proposed for completing the briefing is appropriate. Patent
`Owner’s sur-reply will be due by close of business on Tuesday, October 9,
`2018, and Petitioner’s sur-sur-reply will be due by close of business on
`Tuesday, October 23, 2018.
`
`It is
`
`
`
`4
`
`
`
`IPR2017-01526 (Patent 7,476,652 B2)
`IPR2017-01528 (Patent 7,713,930 B2)
`
`
`ORDERED that Patent Owner is authorized to file a six-page sur-
`reply and any supporting evidence, limited to addressing Petitioner’s in-use
`storage requirement argument, on or before close of business on Tuesday,
`October 9, 2018;
`FURTHER ORDERED that Petitioner is authorized to file a four-page
`sur-sur-reply, limited to addressing the in-use storage requirement argument,
`on or before close of business on Tuesday, October 23, 2018; and
`FURTHER ORDERED that Petitioner is not authorized at this time to
`file supporting evidence with its sur-sur-reply.
`
`
`
`
`
`5
`
`
`
`IPR2017-01526 (Patent 7,476,652 B2)
`IPR2017-01528 (Patent 7,713,930 B2)
`
`PETITIONER:
`Jeffrey W. Guise
`Douglas Carsten
`Richard Torczon
`Lorelei Westin
`Clark Lin
`Nancy Zhang
`WILSON SONSINI GOODRICH & ROSATI
`
`jguise@wsgr.com
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`lwestin@wsgr.com
`clin@wsgr.com
`nzhang@wsgr.com
`
`
`PATENT OWNER:
`Elizabeth Weiswasser
`Anish Desai
`elizabeth.weiswasser@weil.com
`anish.weiswasser@weil.com
`
`Aaron Pereira
`Aaron.pereira@bipc.com
`
`
`
`6
`
`
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