IPR2017-01446
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
`
`Case No. IPR2017-01446
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`U.S. Patent No. 7,049,328 B2
`
`Title: USE FOR DEFERIPRONE
`________________
`
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`PATENT OWNER’S SECOND MOTION TO SEAL
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`
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`
`
`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 No. IPR2017-01446
`
`U.S. Patent No. 7,049,328 B2
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S SECOND MOTION TO SEAL
`
`
`
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`IPR2017-01446
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`Pursuant to 37 C.F.R. §§ 42.14 and 42.54, Patent Owner, Apotex
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`Technologies, Inc. (“Apotex”), respectfully submits this Second Motion to Seal
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`Apotex’s sensitive and highly confidential business information contained and/or
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`discussed in Exhibits 1038-1043 and 1047-1049, and certain portions of Exhibit
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`1037 pursuant to the terms of the Protective Order in this matter (Exhibit 1051). A
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`non-confidential, redacted public version of Petitioner’s Exhibit 1037 is filed
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`herewith as IPR2017-01446, Exhibit 2039.
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`If the Board is not inclined to grant this Second Motion to Seal with respect
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`to Exhibits 1037-1043 and 1047-1049, then Apotex respectfully requests leave to
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`file a third motion to seal or, in the alternative, a motion to expunge such exhibits
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`from the record. Apotex agreed to Petitioner’s request to submit Exhibits 1037-
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`1043 and 1047-1049 with its Motion to Compel Routine Discovery (Paper 22)
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`solely to aid the Board in deciding Petitioner’s Motion and with the express
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`understanding that such exhibits would be sealed. To the extent such protection is
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`not available, Apotex would not have agreed to this Request and therefore would
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`seek to remove Exhibits 1037-1043 and 1047-1049 from the record through
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`expungement.
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`I.
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`GOOD CAUSE EXISTS FOR SEALING CERTAIN CONFIDENTIAL
`AND/OR SENSITIVE INFORMATION
`There is good cause to seal Exhibits 1038-1043 and 1047-1049, and portions
`
`of Exhibit 1037. While the public interest is served by maintaining a complete and
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`IPR2017-01446
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`understandable file history in these proceedings, Exhibits 1038-1043 and 1047-
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`1049 refer to and include Apotex’s confidential research, development, and
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`commercial information, which the Board has acknowledged that it has an “interest
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`in protecting [such] truly sensitive information.” Office Trial and Practice Guide
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`at 48760 (77 Fed. Reg. 48756, 48760 (Aug. 14, 2012)). Further, such protection
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`would be “in a manner consistent with Federal Rule of Civil Procedure
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`26(c)(1)(G), which provides for protective orders for trade secret or other
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`confidential research, development, or commercial information.” Id. (citing 37
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`C.F.R. § 42.54).
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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 this exhibit concern Apotex’s
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`confidential business information related to NDA No. 21-825 for
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`Ferriprox®, including information related to the research and
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`development of Ferriprox®, and the clinical testing of Ferriprox®.
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`Additional redacted portions of Ex. 1037 concern sensitive information
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`related to a scientific dispute between, inter alia, Dr. Nancy Olivieri and
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`Apotex concerning allegations made by Dr. Olivieri about the clinical
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`efficacy of deferiprone, as well as the ownership, interpretation, and use
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`of patient records and related data concerning the compassionate use of
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`IPR2017-01446
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`deferiprone at Toronto’s Hospital for Sick Children. This dispute
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`between Dr. Olivieri and Apotex resulted in lawsuits filed by both Dr.
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`Olivieri and Apotex, including a libel suit filed by Dr. Olivieri against
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`Apotex for defamation. These lawsuits were resolved pursuant to a
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`settlement agreement, the terms of which are confidential. Therefore, in
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`addition to the fact that these documents themselves are highly
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`confidential, Apotex has significant concerns that public disclosure of
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`certain portions of Ex. 1037 may be in violation of the terms of the
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`confidential settlement agreement.
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` Exs. 1038-1041: These documents are confidential 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
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`impressions of Dr. Michael Spino, an inventor of the ’328 patent, and his
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`colleagues at Apotex as they attempted to rebut allegations by Dr.
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`Olivieri concerning the safety and efficacy of deferiprone. As noted
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`above, the dispute between Dr. Olivieri and Apotex resulted in lawsuits
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`filed by both Dr. Olivieri and Apotex, including a libel suit filed by Dr.
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`Olivieri against Apotex for defamation. These lawsuits were resolved
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`IPR2017-01446
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`pursuant to a settlement agreement, the terms of which are confidential.
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`Therefore, in addition to the fact that these documents themselves are
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`highly confidential, Apotex has significant concerns that public
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`disclosure of Exhibits 1038-1041 may be in violation of the terms of the
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`confidential settlement agreement. What is more, Ex. 1041 contains
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`personal information, including names and confidential phones numbers
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`of individuals purported to be knowledgeable of deferiprone and its
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`clinical use.
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` Exs. 1042-1043: The Deposition Transcripts of Dr. Fernando Tricta
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`(Nov. 7, 2017) and Dr. Michael Spino, the President of ApoPharma, Inc.
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`(Nov. 8, 2017) include testimony regarding Apotex’s confidential
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`business information, including, inter alia, information related to the
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`research and development of Ferriprox®, Apotex’s NDA No. 21-825,
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`correspondence with FDA regarding NDA No. 21-825, and internal
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`Apotex emails concerning the same. Further, these transcripts include
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`testimony related to the above-described scientific dispute between Dr.
`
`Olivieri and Apotex and the subsequent lawsuits related thereto.
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` Exs. 1047-1049: These documents are part of the closed portions of
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`Apotex’s confidential NDA No. 21-825 that was filed with FDA.
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`Information in these documents concerns the design and execution of
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`IPR2017-01446
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`clinical studies as well as other research and development information
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`related to Ferriprox®. Apotex made considerable investments in the
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`research and development of Ferriprox® and has taken considerable
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`lengths to maintain the confidentiality of this information. As such, the
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`public disclosure of this information would be highly damaging to
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`Apotex’s competitive position.
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`For at least these reasons, Exhibits 1038-1043 and 1047-1049 and portions
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`of Exhibit 1037 are confidential research and development sensitive information
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`and Apotex’s confidential research and development information. Finally,
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`Exhibits 1042 and 1043 are deposition transcripts that include testimony from
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`Apotex witnesses related to confidential business information.
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`To the best of Patent Owner’s knowledge, Exhibits 1038-1043, 1047-1049,
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`and the redacted portions of Exhibit 1037 have never been made public. The
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`public’s interest in accessing this information for purposes of the patentability of
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`the challenged claims in this proceeding is far outweighed by the prejudicial effect
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`that such disclosure would have on Patent Owner. Broad unprotected disclosure of
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`this information would divulge the Patent Owner’s closely held strategic business
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`considerations, and internal deliberations concerning past litigation that was
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`subsequently settled under confidential terms. Such access would severely hinder
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`Patent Owner’s ability to compete in the market. Confidential information such as
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`IPR2017-01446
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`this is precisely the type of information to be protected pursuant to 37 C.F.R.
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`§ 42.54(a)(7). Further, disclosure of Apotex documents containing sensitive
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`information related to the dispute between Dr. Olivieri and Apotex—which was
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`the subject of litigation(s) (including a libel lawsuit)—could cause substantial harm
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`to Apotex. Accordingly, good cause exists to seal Exhibits 1038-1043, 1047-1049,
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`and the redacted portions of Exhibit 1037.
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`Finally, Exhibits 1037-1043 and 1047-1049 have been designated as
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`“HIGHLY CONFIDENTIAL INFORMATION – OUTSIDE COUNSEL ONLY”
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`in parallel proceedings before the U.S. District Court for the Eastern District of
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`Texas. While this designation alone does not establish that the information in
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`these Exhibits must be sealed, it is evidence that the parties consider the subject
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`matter to be confidential information entitled to protection. See Tandus Flooring,
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`Inc. v. Interface, Inc., IPR2013-00333, Paper 60 at 1 (PTAB Aug. 8, 2014). Based
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`on the explanation above, Patent Owner believes that it has shown good cause as to
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`why Exhibits 1038-1043, 1047-1049, and portions of Exhibit 1037 should be
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`treated as sensitive and confidential and sealed in this proceeding apart from the
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`entry of a Protective Order in the related district court litigation. See Instradent
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`USA, Inc. v. Nobel Biocare Servs. AG, IPR2015-01786, Paper 96 at 4 (PTAB Oct
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`11, 2016) (Patent Owner provided sufficient explanation as to why exhibits should
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`IPR2017-01446
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`be treated as confidential in the IPR beyond designation of the material as
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`confidential in a related litigation).
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`II.
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`CERTIFICATION OF NON-PUBLICATION
`Patent Owner’s undersigned counsel certifies that, to this best of his
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`knowledge, the information sought to be sealed by this motion has not been
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`published or otherwise made public.
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`III. CERTIFICATION OF CONFERENCE WITH OPPOSING PARTY
`PURSUANT TO 37 C.F.R. § 42.54
`Patent Owner has in good faith conferred with Petitioner and Petitioner does
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`not oppose the filing of Apotex’s sensitive and/or confidential business
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`information described above under seal.
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`THEREFORE, Patent Owner respectfully requests that the Board grant
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`Patent Owner’s Second Motion to Seal. If the Board is not inclined to grant this
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`Second Motion to Seal, then Apotex respectfully requests leave to file a third
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`motion to seal or, in the alternative, a motion to expunge Exhibits 1037-1043 and
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`1047-1049 from the record.
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`Dated: May 25, 2018
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`Respectfully submitted,
`/s/ W. Blake Coblentz
`W. Blake Coblentz (Reg. No. 57,104)
`COZEN O’CONNOR
`1200 19th Street, NW
`Washington, DC 20036
`Tel: (202) 912-4837
`Email: wcoblentz@cozen.com
`Lead Counsel for Patent Owner
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`IPR2017-01446
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`CERTIFICATE OF SERVICE
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` I hereby certify that, on May 25, 2018, I caused a true and correct copy of
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`the foregoing materials:
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`- PATENT OWNER’S SECOND MOTION TO SEAL
`- EXHIBIT 2039
`- REDACTED VERSION OF ORDER GRANTING PETITIONER’S
`MOTION FOR ADDITIONAL DISCOVERY (PAPER NO. 33)
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`to be served via electronic mail on the 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
`
`By: /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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