Trials@uspto.gov
`571-272-7822
`
`
`
` Paper 66 (IPR2017-00378)
` Paper 66 (IPR2017-00380)
` Entered: February 6, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MERCK SHARP & DOHME CORP.,
`Petitioner,
`
`v.
`
`WYETH LLC,
`Patent Owner.
`____________
`
`IPR2017-00378
`IPR2017-00380
`Patent 8,562,999 B2
`____________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`
`ORDER1
`Conduct of Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
` 1
`
` This Order addresses issues common to each captioned case. Thus, we
`enter the same Order in each case. The parties are not authorized to use this
`format for filings.
`
`
`
`
`
`571-272-7822
`
`
`
` Paper 66 (IPR2017-00378)
` Paper 66 (IPR2017-00380)
` Entered: February 6, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MERCK SHARP & DOHME CORP.,
`Petitioner,
`
`v.
`
`WYETH LLC,
`Patent Owner.
`____________
`
`IPR2017-00378
`IPR2017-00380
`Patent 8,562,999 B2
`____________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`
`ORDER1
`Conduct of Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
` 1
`
` This Order addresses issues common to each captioned case. Thus, we
`enter the same Order in each case. The parties are not authorized to use this
`format for filings.
`
`
`
`
`
`
`IPR2017-00378; IPR2017-00380
`Patent 8,562,999 B2
`
`
`Introduction
`
`On January 24, 2020, a conference call was held by Judges Prats,
`
`Franklin, and Snedden, with counsel for the parties in attendance. A Final
`
`Written Decision was entered for each of the captioned proceedings on June
`
`8, 2018. IPR2017-00378, Paper 59 (PTAB June 8, 2018); IPR2017-00380,
`
`Paper 59 (PTAB June 8, 2018). On appeal, the Federal Circuit vacated and
`
`remanded those Decisions for further proceedings. See Merck Sharp &
`
`Dohme Corp. v. Wyeth LLC., Nos. 2018-2133 and 2018-2134, 2019 WL
`
`6320454, at *1–4. The Court entered the Mandate on January 2, 2020.
`
`Case: 18-2133 (Document 71). The purpose of the conference call was to
`
`discuss the parties’ proposals for a procedure on remand, as discussed in the
`
`Patent Trial and Appeal Board Standard Operating Procedure 9 (“SOP 9”),
`
`App’x 2, “Guidance for Parties Regarding Remand Procedures.”
`
`Remand Background
`
`In the Final Written Decision for IPR2017-00378, the Board
`
`determined that Petitioner established by a preponderance of the evidence
`
`that claims 1–6, 10, 11, 14, 17, 19, and 20 of U.S. Patent No. 8,562,999 B2
`
`(Ex. 1001, “the ’999 patent”) are unpatentable under 35 U.S.C. § 103 as
`
`obvious over Chiron, Smith, and Elan, and that claim 17 of the ’999 patent is
`
`also unpatentable over Chiron, Smith, Elan, and Peña. IPR2017-00378,
`
`Paper 59 at 48–49. However, the Board determined that Petitioner had not
`
`established that claim 18 of the ’999 patent is unpatentable as obvious over
`
`either combination of references. Id. at 40, 45, 48.
`
`Similarly, in the Final Written Decision for IPR2017-00380, the
`
`Board determined that Petitioner established by a preponderance of the
`
`evidence that claims 1–6, 10, 11, 14, 17, 19, and 20 of the ’999 patent are
`
`
`
`2
`
`
`
`IPR2017-00378; IPR2017-00380
`Patent 8,562,999 B2
`
`unpatentable under 35 U.S.C. § 103 as obvious over Prevenar and Chiron.
`
`IPR2017-00380, Paper 59 at 41. However, the Board determined that
`
`Petitioner had not established that claim 18 is unpatentable as obvious over
`
`the combination of Prevenar and Chiron, or the combination of Prevenar,
`
`Chiron, and Peña. Id. at 33–34, 37.
`
`Petitioner appealed to the Federal Circuit each Final Written Decision,
`
`only with respect to the Board’s determination that Petitioner had not shown
`
`by a preponderance of the evidence that claim 18 was obvious over any of
`
`the asserted combinations of prior art. See Merck Sharp & Dohme, 2019
`
`WL 6320454, at *1–2.
`
`The Federal Circuit found that the Board “did not address the
`
`evidence as to whether someone skilled in the art would have been
`
`motivated to combine the 13 serotypes into a CRM197 conjugate or whether
`
`the potential loss of immunogenicity would have dissuaded someone skilled
`
`in the art from making such combination.” Id. at *4. The Court vacated the
`
`Board’s obviousness findings with respect to claim 18, and remanded the
`
`Decisions “for further consideration of the parties’ arguments and evidence
`
`as to (1) motivation to combine and (2) reasonable expectation of success
`
`and, if the Board find sufficient motivation to combine and reasonable
`
`expectation of success, other issues such as secondary considerations.” Id.
`
`The Parties’ Positions
`
`Prior to the conference call, the parties met and conferred regarding a
`
`proposed remand procedure. During the conference call, the parties
`
`confirmed that they do not seek to file new evidence. Petitioner requested
`
`additional briefing to streamline for us the relevant arguments and evidence
`
`
`
`3
`
`
`
`IPR2017-00378; IPR2017-00380
`Patent 8,562,999 B2
`
`directed to claim 18 in each proceeding. Patent Owner’s position is that
`
`additional briefing is not warranted.
`
`Discussion
`
`The Federal Circuit Decision includes an explicit instruction for us to
`
`reconsider our obviousness determinations with respect to claim 18 of the
`
`’999 patent in each proceeding. See Merck Sharp & Dohme, 2019 WL
`
`6320454, at *4. In particular, the Court instructs us to further consider the
`
`parties’ arguments and evidence as to motivation to combine and reasonable
`
`expectation of success and, if appropriate, other issues such as secondary
`
`considerations. Id. In other words, we are instructed to consider further the
`
`parties’ arguments already of record regarding those issues.
`
`With its request, Petitioner does not allege that it has not previously
`
`had an adequate opportunity to brief those issues raised by the Court. Nor
`
`do we find such is the case. Rather, Petitioner seeks additional briefing to
`
`draw our attention to what has been argued. However, doing so in the form
`
`of additional briefing runs the risk of a party adding or incorporating
`
`arguments and/or evidence to the record with respect to what has previously
`
`been presented regarding the challenges to claim 18. To avoid that risk,
`
`while still allowing the parties to highlight arguments and evidence of record
`
`previously asserted regarding the challenge to claim 18 in each proceeding,
`
`we authorize the parties to file a concise table listing the pages of the papers
`
`and exhibits that they previously presented addressing that challenge. The
`
`table shall not include headings as to subject matter. Any listing of an
`
`exhibit must identify the paper and page of that paper referring to the
`
`exhibit.
`
`
`
`4
`
`
`
`IPR2017-00378; IPR2017-00380
`Patent 8,562,999 B2
`
`
`This listing is not an opportunity for the parties to incorporate by
`
`reference additional evidence or arguments to their previous submissions
`
`regarding claim 18 in either proceeding. Thus, the parties are cautioned not
`
`to attempt to do so here.
`
`
`
`ORDER
`
`Accordingly, it is
`
`ORDERED that in each of the above-captioned proceedings, each
`
`party is authorized to file a table listing the location, i.e., paper number and
`
`page, of its arguments and evidence previously submitted and directed to
`
`claim 18;
`
`FURTHER ORDERED that such table listing shall include only the
`
`paper numbers and pages of those arguments, and if relevant, the exhibit
`
`numbers and pages referenced within those arguments;
`
`FURTHER ORDERED that the table shall not include headings as to
`
`subject matter or any discussion or argument;
`
`FURTHER ORDERED that each party shall file the authorized table,
`
`wherein the filing is no more than 5 pages, on or before Friday, February 21,
`
`2020; and
`
`FURTHER ORDERED that no additional filings are authorized in
`
`these proceedings.
`
`
`
`
`
`5
`
`
`
`IPR2017-00378; IPR2017-00380
`Patent 8,562,999 B2
`
`PETITIONER:
`
`Arlene L. Chow
`Ernest Yakob
`HOGAN LOVELLS US LLP
`arlene.chow@hoganlovells.com
`ernest.yakob@hoganlovells.com
`
`PATENT OWNER:
`
`John Scheibeler
`Dimitrios T. Drivas
`Eric Krause
`WHITE & CASE LLP
`jscheibeler@whitecase.com
`ddrivas@whitecase.com
`eric.krause@whitecase.com
`
`
`
`6
`
`
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