Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`Paper 15
`Date: December 7, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BOEHRINGER INGELHEIM INTERNATIONAL GMBH,
`Patent Owner.
`____________
`
`Cases: IPR2016-01563 (Patent 8,673,927)
` IPR2016-01564 (Patent 8,846,695)
` IPR2016-01565 (Patent 8,853,156)
` IPR2016-01566 (Patent 9,173,859)
`____________
`
`
`
`Before TONI R. SCHEINER, BRIAN P. MURPHY, and ZHENYU YANG
`Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`
`
`
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`571-272-7822
`
`
`
`
`
`
`
`Paper 15
`Date: December 7, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BOEHRINGER INGELHEIM INTERNATIONAL GMBH,
`Patent Owner.
`____________
`
`Cases: IPR2016-01563 (Patent 8,673,927)
` IPR2016-01564 (Patent 8,846,695)
` IPR2016-01565 (Patent 8,853,156)
` IPR2016-01566 (Patent 9,173,859)
`____________
`
`
`
`Before TONI R. SCHEINER, BRIAN P. MURPHY, and ZHENYU YANG
`Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`
`
`
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`IPR2016-01563 (Patent 8,673,927)
`IPR2016-01564 (Patent 8,846,695)
`IPR2016-01565 (Patent 8,853,156)
`IPR2016-01566 (Patent 9,173,859)
`
`
`On November 21, 2016, Mylan Pharmaceuticals Inc. (“Petitioner”)
`requested a teleconference with the Board for authorization to file a reply to the
`Preliminary Responses of Patent Owner Boehringer Ingelheim International GmbH
`(“Patent Owner”). On November 30, 2016, a conference call with the parties was
`convened by Judges Yang, Scheiner, and Murphy.
`The Petitions assert at least one ground of unpatentability in reliance on
`certain “FDA-approved” drug labels, and a meeting poster (IPR2016-01565), as
`prior art printed publications under 35 U.S.C. § 102. Pet. 21–29.1 Patent Owner
`argues that Petitioner has not made a threshold showing to establish the drug labels
`and meeting poster qualify as prior art printed publications. Prelim. Resp. 21–24.
`A decision on whether to institute a trial proceeding has not yet been made.
`During the conference call, Petitioner argued there was good cause for
`submission of a reply to address Patent Owner’s printed publication arguments,
`because Patent Owner cited a PTAB case that issued after the Petitions were filed,
`which addressed non FDA-approved drug labels. See Prelim. Resp. 21 (citing
`Frontier Therapeutics, LLC v. Medac Gesellschaft Fur Klinische Spezialpraparate
`MBH, Case IPR2016-00649, slip op. at 22 (PTAB September 1, 2016) (Paper 10)).
`Petitioner also represented it was not seeking to submit any new evidence to
`supplement the record, only to address Patent Owner’s arguments. Patent Owner
`argued that the Preliminary Responses challenged only the sufficiency of
`Petitioner’s evidence required to meet Petitioner’s burden in the Petition to
`establish the drug labels and meeting poster qualify as printed publications. Patent
`
`
`1 For ease of reference, all citations are to the papers in IPR2016-01563 as
`representative, unless otherwise stated.
`
`
`
`2
`
`
`
`IPR2016-01563 (Patent 8,673,927)
`IPR2016-01564 (Patent 8,846,695)
`IPR2016-01565 (Patent 8,853,156)
`IPR2016-01566 (Patent 9,173,859)
`
`Owner further noted the § 315(b) one-year bar date has passed, and, therefore, it
`would be improper to permit Petitioner to supplement the Petition now.
`Upon considering both parties’ positions, we agree with Patent Owner.
`Petitioner does not persuade us that good cause exists to allow Petitioner to file a
`reply to the Preliminary Responses to address the sufficiency of Petitioner’s
`evidence that the drug labels and meeting poster qualify as prior art printed
`publications. It is Petitioner’s burden to make such a showing in the Petitions. We
`can read the Frontier Therapeutics case without further input from the parties and
`assess the arguments and evidence presented on the current record. The passing of
`the § 315(b) bar date also militates against granting Petitioner’s request. See Teva
`Pharmaceuticals USA, Inc., v. Indivior UK Limited, Case IPR2016-00280 slip op.
`at 4 (PTAB May 27, 2016) (Paper 21) (“Petitioner essentially asks to significantly
`bolster its Petition with new substantive argument and evidence, well after a
`statutory bar date, in relation to an issue where it has the burden to make a
`threshold showing.”).
`With regard to IPR2016-01565, Petitioner also requested the opportunity to
`file a reply addressing Patent Owner’s evidence and argument in support of the
`asserted conception and reduction to practice of the claimed invention prior to the
`Mikhail reference. IPR2016-01565 Paper 11, 9–11. Petitioner emphasized that the
`evidence presented by Patent Owner consisted of internal company reports, and
`that Petitioner was entitled to address the substance of Patent Owner’s arguments
`after discovery. Patent Owner acknowledged its antedating claim and argued that
`Petitioner had received contention discovery in the co-pending district court
`proceeding, although discovery in the district court proceeding is not yet complete.
`
`
`
`3
`
`
`
`IPR2016-01563 (Patent 8,673,927)
`IPR2016-01564 (Patent 8,846,695)
`IPR2016-01565 (Patent 8,853,156)
`IPR2016-01566 (Patent 9,173,859)
`
`
`We agree with Petitioner. Patent Owner bears the burden of proof regarding
`its antedating contention. Petitioner is entitled to respond to the contention after
`discovery. It is premature at the institution stage to address the merits of Patent
`Owner’s antedating contention. Therefore, we see no reason for Petitioner to file a
`reply to that contention prior to a decision by the Board on whether to institute a
`trial proceeding.
`
`In consideration of the foregoing, it is:
`ORDERED that Petitioner’s request is denied;
`
`
`
`
`
`
`
`
`
`
`4
`
`
`
`IPR2016-01563 (Patent 8,673,927)
`IPR2016-01564 (Patent 8,846,695)
`IPR2016-01565 (Patent 8,853,156)
`IPR2016-01566 (Patent 9,173,859)
`
`FOR PETITIONER:
`Thomas J. Parker
`Ellen Y. Cheong
`Christopher L. McArdle
`Charles A. Naggar
`ALSTON & BIRD LLP
`thomas.parker@alston.com
`ellen.cheong@alston.com
`chris.mcardle@alston.com
`charles.naggar@alston.com
`
`FOR PATENT OWNER:
`Leora Ben-Ami
`Eugene Goryunov
`Mira Mulvaney
`KIRKLAND & ELLIS LLP
`leora.benami@kirkland.com
`eugene.goryunov@kirkland.com
`mira.mulvaney@kirkland.com
`
`
`
`
`
`
`
`
`
`5
`
`
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