Paper No. ___
`Date Filed: Dec. 2, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`––––––––––––––––––
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`––––––––––––––––––
`
`AMERIGEN PHARMACEUTICALS LIMITED and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`
`––––––––––––––––––
`
`Case No. IPR2016-002861
`U.S. Patent No. 8,822,438 B2
`
`––––––––––––––––––
`
`PATENT OWNER’S MOTION
`TO FILE EXHIBITS
`
`
`
`1 Case No. IPR2016-01317 has been joined with this proceeding.
`
`
`Date Filed: Dec. 2, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`––––––––––––––––––
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`––––––––––––––––––
`
`AMERIGEN PHARMACEUTICALS LIMITED and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`
`––––––––––––––––––
`
`Case No. IPR2016-002861
`U.S. Patent No. 8,822,438 B2
`
`––––––––––––––––––
`
`PATENT OWNER’S MOTION
`TO FILE EXHIBITS
`
`
`
`1 Case No. IPR2016-01317 has been joined with this proceeding.
`
`
`
`IPR2016-00286
`US Patent 8,822,438
`
`
`
`
`
`Patent Owner respectfully moves to file three exhibits that were mistakenly
`
`omitted from Patent Owner’s October 4, 2016 filing. These three exhibits,
`
`Exhibits 2033, 2034, and 2035, had previously been provided to Petitioners during
`
`the deposition of their own expert and were specifically relied on by one of Patent
`
`Owner’s experts in his declaration. The Board authorized this filing on November
`
`29. See Paper 48.
`
`A. Background
`
`ZYTIGA® is the commercial embodiment of the challenged claims. Paper
`
`33 at 1, 60-65. Exhibits 2033, 2034, and 2035 are copies of press releases
`
`reflecting annual U.S. net sales of ZYTIGA® for the years 2013-2015. See Ex.
`
`2111 at 28:17-35:23. During the September 1, 2016 deposition of Petitioners’
`
`expert, Dr. DeForest McDuff, Patent Owner introduced and marked Exhibits 2033,
`
`2034, and 2035, and provided courtesy copies to Petitioners’ counsel. See id.
`
`Patent Owner’s commercial success expert, Dr. Christopher A. Vellturo,
`
`expressly relied on Exhibits 2033, 2034, and 2035 in preparing his declaration.
`
`Ex. 2044 at App. A. Dr. Vellturo specifically relies on these exhibits when
`
`showing the annual net sales of ZYTIGA®, Ex. 2044 at App. B (citing Exs. 2033-
`
`35), which he then discusses in the body of his declaration, id. at ¶¶41, 51. Dr.
`
`Vellturo also relies on portions of Petitioners’ expert Dr. McDuff’s testimony
`
`discussing these exhibits. Id. at ¶37 (citing Ex. 2111 at 30:23-31:6).
`
`1
`
`
`
`IPR2016-00286
`US Patent 8,822,438
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`
`
`
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`Patent Owner’s Response relies extensively on Dr. Vellturo’s report to show
`
`the commercial success of ZYTIGA®. See, e.g., Paper 33 at 12, 60, 64-65.
`
`Clearly, Patent Owner had every intent to submit Exhibits 2033, 2034, and 2035 as
`
`part of its Response, but they were inadvertently omitted from Patent Owner’s
`
`updated exhibit list and neither filed nor served. See Paper 27.
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`Soon after Patent Owner’s Response was filed, Petitioners themselves
`
`recognized that the exhibits were missing and that an error had been made. On
`
`October 18, two weeks after the original filing, Petitioners contacted Patent Owner
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`inquiring about the exhibits. See Oct. 18, 2016 Olson Email (Ex. 2121). Patent
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`Owner promptly served copies on Petitioners that same day and requested their
`
`consent in filing this motion. Ex. 2121. On November 11, Petitioners informed
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`Patent Owner via telephone that they would likely oppose the motion.
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`B. Analysis
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`Patent Owner respectfully requests leave to file Exhibits 2033, 2034, and
`
`2035 because (1) Patent Owner’s mistake was inadvertent and clerical, (2)
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`Petitioners will not be prejudiced, and (3) it is in the public interest to maintain a
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`complete and understandable file history for public notice purposes.
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`First, Patent Owner’s mistake was inadvertent and clerical. Every other
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`Patent Owner exhibit relied on in Dr. Vellturo’s declaration was included on the
`
`exhibit list and filed and served on Petitioners. Compare Ex. 2044 at App. A. with
`
`2
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`IPR2016-00286
`US Patent 8,822,438
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`
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`Paper 27. Petitioners themselves recognized that an obvious error had been made
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`when they quickly contacted Patent Owner about the omission of the exhibits.
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`Second, correcting Patent Owner’s mistake in no way prejudices Petitioners.
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`Courtesy copies of each of the three exhibits, marked with the same exhibit
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`numbers referenced in the Vellutro Declaration, had been given to Petitioners
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`during Dr. McDuff’s September 1, 2016 deposition, over a month before Patent
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`Owner’s Response was filed. The Vellturo Declaration clearly identified the
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`exhibits as press releases reflecting ZYTIGA® sales. There could have been no
`
`reasonable doubt as to the identification of the inadvertently missing exhibits and,
`
`moreover, Patent Owner provided additional copies of the exhibits to Petitioners
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`two weeks after the Response was filed.
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`Third, Patent Owner respectfully submits that, even though the Rules
`
`provide for correction of clerical mistakes in a petition (37 C.F.R. § 42.104(c)) but
`
`not specifically in other papers, the Board has authority under 37 C.F.R. § 42.5(a)
`
`to grant the requested relief. See, e.g., CaptionCall, L.L.C. v. Ultratec, Inc.,
`
`IPR2015-01889, Paper No. 54 at 3 (August 1, 2016) (allowing changes to Patent
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`Owner Response). Since the error was inadvertent and there is no prejudice to
`
`Petitioner, the public interest would be served by granting the motion so that a full
`
`public record is maintained for notice purposes.
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`For these reasons, Patent Owner’s motion should be granted.
`
`3
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`IPR2016-00286
`US Patent 8,822,438
`
`
`
`
`
`Dated: December 2, 2016
`
`Respectfully Submitted,
`
`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Barbara L. Mullin (Reg. No. 38,250)
`bmullin@akingump.com
`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER &
`FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`Bindu Donovan (pro hac vice)
`S. Isaac Olson (pro hac vice)
`Alyssa B. Monsen (pro hac vice)
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`ZytigaIPRTeam@sidley.com
`Counsel for Patent Owner
`
`4
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`IPR2016-00286
`US Patent 8,822,438
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`
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Motion to File Exhibits and Exhibit 2121 were served on counsel of
`
`record on December 2, 2016 by filing this document through the End-to-End
`
`System, as well as delivering a copy via electronic mail to counsel of record for the
`
`Petitioners at the following addresses:
`
`William Hare - bill@miplaw.com
`Gabriela Materassi - materassi@miplaw.com
`
`Teresa Stanek Rea - TRea@Crowell.com
`Shannon M. Lentz - SLentz@Crowell.com
`
`
`
`
`
`
`
`
`
`
`
`
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`Respectfully submitted,
`
`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`
`
`Date: Dec. 2, 2016
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