IPR2017-01446
`U.S. Patent No. 7,049,328
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
`
`Case IPR2017-01446
`U.S. Patent No. 7,049,328
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S MOTION TO EXPUNGE
`
`
`
`
`U.S. Patent No. 7,049,328
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
`
`Case IPR2017-01446
`U.S. Patent No. 7,049,328
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S MOTION TO EXPUNGE
`
`
`
`
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`IPR2017-01446
`U.S. Patent No. 7,049,328
`
`
`I.
`
`Pursuant to 37 C.F.R. § 42.56, Patent Owner, Apotex Technologies, Inc.
`
`(“Apotex”), hereby requests that certain confidential information in the record be
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`expunged. Specifically, Apotex requests expungement of Exhibits 1037-1043 and
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`1047-1049 from the record in this proceeding.1
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`II.
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`STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`A.
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`Procedural Background
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`Petitioner, Taro Pharmaceuticals U.S.A., Inc. (“Taro”), filed a petition for
`
`Inter Partes Review of U.S. Patent No. 7,049,328 (“the ’328 patent”) on May 16,
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`2017. (Paper 1.) On September 11, 2017, Apotex filed its Preliminary Response
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`under 37 C.F.R. § 42.107. (Paper 6.) On September 28, 2017, the Board instituted
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`an inter partes review of certain claims of the ’328 patent. (Paper 7.)
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`On April 16, 2018, Taro filed a redacted Motion to Compel Routine
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`Discovery or, in the Alternative, for Additional Discovery relating to Exhibits
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`1037-1045 and 1047-1049 (Paper 22) along with a Motion to Seal (Paper 21). In
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`response, Apotex filed a redacted paper opposing Taro’s Motion to Compel
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`Routine Discovery or, in the Alternative, for Additional Discovery (Paper 30), and
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`also filed a Motion to Seal (Paper 31). On May 11, 2018, the Board denied
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`1 Petitioner, Taro Pharmaceuticals U.S.A., Inc., does not oppose this Motion.
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`
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`
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`without prejudice both Apotex’s and Taro’s Motion to Seal. (Paper 34 at 3.) The
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`Board, however, authorized each party to file a Second Motion to Seal for the
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`purpose of requesting to seal Exhibits 1037-1045 and 1047-1049. (Id. at 4.) On
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`May 25, 2018, Apotex filed an unopposed Second Motion to Seal (Paper 35),
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`which requested that Exhibits 1038-1043 and 1047-1049 be sealed, that certain
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`portions of Exhibit 1037 be sealed. Concurrently, Apotex filed a non-confidential,
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`redacted public version of Exhibit 1037, as Exhibit 2039. (Id.) On June 5, 2018,
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`the Board granted Apotex’s Second Motion to Seal in light of the “stated
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`confidentiality” of Exhibits 1037-1043 and 1047-1049. (Paper 37 at 4-5.)
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`On August 6, 2018, pursuant to 35 U.S.C. § 317(a) (and 37 CFR § 42.72),
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`the parties filed a Joint Motion to Terminate Inter Partes Review. (Paper 61.)
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`And, on August 7, 2018, the Board granted that Motion. (Paper 65.)
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`B. Applicable Legal Standards
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`Section 6 of the Office Trial and Practice Guide provides in pertinent part:
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`There is an expectation that information will be made
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`public where the existence of the information is referred
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`to in a decision to grant or deny a request to institute a
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`review or is identified in a final written decision following
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`a trial. A party seeking to maintain the confidentiality of
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`information, however, may file a motion to expunge the
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`3
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`information from the record prior to the information
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`becoming public.
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`37 C.F.R. § 42.56 provides that, “[a]fter denial of a petition to institute a trial or
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`after final judgment in a trial, a party may file a motion to expunge confidential
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`information in the record.”
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`C. Good Cause Exists to Expunge Exhibits 1037-1043 and 1047-1049
`from the Record in this Proceeding
`There is good cause to expunge Exhibits 1037-1043 and 1047-1049 from the
`
`record in this proceeding. While the public’s interest is served by maintaining a
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`complete and understandable file history, Exhibits 1037-1043 and 1047-1049 refer
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`to and include Apotex’s confidential research, development, and commercial
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`information. Such information is of the exact type that the Board has
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`acknowledged that it has an “interest in protecting . . . .” Office Trial and Practice
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`Guide at 48760 (stating that the “rules aim to strike a balance between the public’s
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`interest in maintaining a complete and understandable file history and the parties’
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`interest in protecting truly sensitive information” where confidential information is
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`identified as “confidential research, development, or commercial information.”)
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`(77 Fed. Reg. 48756, 48760 (Aug. 14, 2012)).
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`Provided below is a concise explanation of the confidential nature of
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`Exhibits 1038-1043 and 1047-1049, and portions of Exhibit 1037:
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` Ex. 1037: The redacted portions of Exhibit 1037 concern Apotex’s
`
`
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`4
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`
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`
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`confidential business information related to NDA No. 21-825 for Ferriprox®,
`
`including information related to the research and development of Ferriprox®,
`
`and the clinical testing of Ferriprox®. Additional redacted portions of
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`Ex. 1037 concern sensitive information related to a scientific dispute between,
`
`inter alia, Dr. Nancy Olivieri and Apotex concerning allegations made by Dr.
`
`Olivieri about the clinical efficacy of deferiprone, as well as the ownership,
`
`interpretation, and use of patient records and related data concerning the
`
`compassionate use of deferiprone at Toronto’s Hospital for Sick Children.
`
`This dispute between Dr. Olivieri and Apotex resulted in lawsuits filed by
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`both Dr. Olivieri and Apotex, including a libel suit filed by Dr. Olivieri against
`
`Apotex for defamation. These lawsuits were resolved pursuant to a settlement
`
`agreement, the terms of which are confidential. Therefore, in addition to the
`
`fact that these documents themselves are highly confidential, Apotex has
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`significant concerns that public disclosure of certain portions of Ex. 1037 may
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`be in violation of the terms of the confidential settlement agreement.
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` Exs. 1038-1041: These documents are confidential
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`internal email
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`communications between Apotex employees that relate to the scientific
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`dispute between Apotex and Dr. Nancy Olivieri concerning the long-term
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`efficacy and possible side-effects of deferiprone. These emails and
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`attachments concern the contemporaneous thoughts and mental impressions
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`5
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`of Dr. Michael Spino, an inventor of the ’328 patent, and his colleagues at
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`Apotex as they attempted to rebut allegations by Dr. Olivieri concerning the
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`safety and efficacy of deferiprone. As noted above, the dispute between Dr.
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`Olivieri and Apotex resulted in lawsuits filed by both Dr. Olivieri and Apotex,
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`including a libel suit filed by Dr. Olivieri against Apotex for defamation.
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`These lawsuits were resolved pursuant to a settlement agreement, the terms of
`
`which are confidential. Therefore, in addition to the fact that these documents
`
`themselves are highly confidential, Apotex has significant concerns that
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`public disclosure of Exhibits 1038-1041 may be in violation of the terms of
`
`the confidential settlement agreement. What is more, Ex. 1041 contains
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`personal information, including names and confidential phones numbers of
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`individuals purported to be knowledgeable of deferiprone and its clinical use.
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` Exs. 1042-1043: The Deposition Transcripts of Dr. Fernando Tricta (Nov. 7,
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`2017) and Dr. Michael Spino, the President of ApoPharma, Inc. (Nov. 8,
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`2017)
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`include
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`testimony
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`regarding Apotex’s confidential business
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`information, including, inter alia, information related to the research and
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`development of Ferriprox®, Apotex’s NDA No. 21-825, correspondence with
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`FDA regarding NDA No. 21-825, and internal Apotex emails concerning the
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`same. Further, these transcripts include testimony related to the above-
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`described scientific dispute between Dr. Olivieri and Apotex and the
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`6
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`subsequent lawsuits related thereto.
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` Exs. 1047-1049: These documents are part of the closed portions of Apotex’s
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`confidential NDA No. 21-825 that was filed with FDA. Information in these
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`documents concerns the design and execution of clinical studies as well as
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`other research and development information related to Ferriprox®. Apotex
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`made considerable investments in the research and development of Ferriprox®
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`and has taken considerable lengths to maintain the confidentiality of this
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`information. As such, the public disclosure of this information would be
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`highly damaging to Apotex’s competitive position.
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`For at least these reasons, Exhibits 1038-1043, 1047-1049, and portions of
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`Exhibit 1037 are confidential research and development information and other
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`highly sensitive confidential information. Moreover, Exhibits 1042 and 1043 are
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`deposition transcripts that include testimony from Apotex witnesses related to
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`confidential business information.
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`Finally, because this proceeding was terminated prior to the Board entering a
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`Final Decision, the Board never relied on the confidential information in Exhibits
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`1037-1043 and 1047-1049. Furthermore, these Exhibits were never referred to in
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`the Board’s Decision to Institute Inter Partes Review (Paper 7). As such, there is
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`little public interest in making these Exhibits public. Therefore, Patent Owner
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`submits that good cause exists to expunge Exhibits 1037-1043 and 1047-1049 from
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`7
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`the record.
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`III. CONCLUSION
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`For the aforementioned reasons, Apotex respectfully requests that the Board
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`expunge Exhibits 1037-1043 and 1047-1049 pursuant to 37 C.F.R. § 42.56.
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`Dated: December 12, 2018
`
`/s/ W. Blake Coblentz
`W. Blake Coblentz
`Reg. No. 57,104
`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, DC 20036
`(202) 912-4837
`
`8
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`
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`IPR2017-01446
`U.S. Patent No. 7,049,328
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on December 12, 2018, I caused a true and correct copy
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`of Patent Owner’s Motion to Expunge to be served via electronic mail on the
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`following attorneys of record:
`
`Huiya Wu
`Sarah Fink
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`HWu@goodwin.law.com
`SFink@goodwinlaw.com
`
`Date: December 12, 2018
`
`/s/ W. Blake Coblentz
`W. Blake Coblentz
`Reg. No. 57,104
`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, DC 20036
`(202) 912-4837
`
`
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