Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`Paper 61
` Entered: June 21, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-01099
`Patent 8,669,290 B2
`____________
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judge.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Denying Patent Owner’s Motion to Seal and Denying Entry of
`the Proposed Stipulated Protective Order
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`571-272-7822
`
`
`
`
`
`Paper 61
` Entered: June 21, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-01099
`Patent 8,669,290 B2
`____________
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judge.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Denying Patent Owner’s Motion to Seal and Denying Entry of
`the Proposed Stipulated Protective Order
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`IPR2015-01099
`Patent 8,669,290 B2
`
`
`INTRODUCTION
`I.
`Patent Owner filed a combined Motion to Seal and Motion to Enter
`Stipulated Protective Order. Paper 25 (“Mot.”). Patent Owner seeks to seal
`the following exhibits and papers: the entirety of excerpts from Patent
`Owner’s New Drug Application (“NDA”) (Exs. 2096, 2102, 2103, 2110,
`2251, and 2291–2293); three presentations related to Patent Owner’s
`research and development of the patented formulation (Exs. 2220, 2226, and
`2296); testimony related to the market share of Patent Owner’s product in a
`related district court case (Ex. 2258); testing reports and materials
`documenting the testing methods of third-party test companies (Exs. 2267–
`2278, 2286, 2294); the transcripts of the testimony in related Cases
`IPR2015-00902 and -00903 of Dr. Paul Laskar (Ex. 2114) and Dr. Jayne
`Lawrence (Ex. 2316), portions of Patent Owner’s Response (Papers 22 and
`23); and portions of the declarations of Drs. Adam C. Myers (Ex. 2126),
`Daryl S. Paulson (Ex. 2128), Robert O. Williams (Ex. 2082), Stephen G.
`Davies (Ex. 2105), William B. Trattler (Ex. 2116), and John C. Jarosz (Ex.
`2130) that cite or substantially describe the above categories of documents
`sought to be sealed. Mot. 1. Patent Owner asserts that Petitioner does not
`oppose the motion. Id. at 2.
`The Stipulated Protective Order (“proposed order”) differs from the
`Board’s default protective order set forth in the Office Patent Trial Practice
`Guide (“Trial Practice Guide”), 77 Fed. Reg. 48,756, 48,771 (Aug. 14, 2012)
`in a number of ways, such as including two additional categories of
`confidential information, i.e., “PROTECTIVE ORDER MATERIAL –
`BOARD’S EYES ONLY” and “PROTECTIVE ORDER MATERIAL –
`FED R. EVID 615.” Mot. 1, App’x A at 2; see Paper 32 (redlined version of
`
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`IPR2015-01099
`Patent 8,669,290 B2
`
`the proposed order showing modifications to the Board’s default protective
`order).
`For the reasons described in the following discussion, we deny the
`Motion to Seal and we deny entry of the proposed order without prejudice.
`II. DISCUSSION
`
`A. Proposed Order
`When a party seeks entry of a protective order that differs from the
`default protective order set forth in the Trial Practice Guide, it is essential
`that the modifications made and the effect of those modifications are clear.
`Based upon our review, the proposed order is not in an adequate form for
`entry. In particular, the proposed order recites variations of the term “party”
`with apparently different meanings. In some instances the term refers to
`either Petitioner or Patent Owner. For example, the proposed order states
`“Nothing in this Order prevents any Party from challenging a confidentiality
`designation to any Exhibit by raising the matter with the Board.” Id. at 5
`n.2. In other instances, the term is defined in a manner that apparently
`excludes the Petitioner in the captioned cases, i.e., “(A) Parties. Persons
`who are owners of a patent involved in the proceeding and other persons
`who are identified as a real party-in-interest in any Related Proceeding.” Id.
`at 4, 6. Those inconsistencies create an ambiguity in the proposed order that
`prevents us from entering it.
`Further, the proposed order includes a category of confidential
`information that may be marked as “PROTECTIVE ORDER MATERIAL –
`FED R. EVID. 615.” It is unclear whether that category of confidential
`information is necessary at this stage in the proceeding because the
`discovery phase has concluded. If the parties determine that such category is
`
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`IPR2015-01099
`Patent 8,669,290 B2
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`still necessary, that need should be explained. Also, the proposed order
`states that such disclosures shall not occur “until after such time as the Board
`has lifted the Rule on Witnesses under Fed. R. Evid. 615 ….” Id. at 3. We
`do not contemplate, however, “lift[ing] the Rule on Witnesses.” Rather, the
`proposed order should describe sufficiently when and/or under what
`circumstances the disclosure restriction shall expire, if that is the intent of
`the parties, without requiring an additional order by the panel. Similarly,
`after an expiration of the Fed. R. Evid. 615 disclosure restriction, any
`request to disclose such material to an expert should not be made contingent
`“upon the formal request of any Party to the Board or upon a joint request by
`the Parties to the Board’s administrative staff.” See id. at 4. Such requests,
`if required, should be directed to the party from whom the disclosure is
`sought.
`Additionally, rather than reciting that nothing in the proposed order
`“shall amend or alter the Stipulated Discovery Confidentiality Order” filed
`in the cited district court litigation, we recommend that provision state, more
`precisely, that the proposed order shall apply only to the captioned
`proceedings.
`The parties are reminded that information subject to a protective order
`will become public if identified in a final written decision in this proceeding,
`and that a motion to expunge the information will not necessarily prevail
`over the public interest in maintaining a complete and understandable file
`history. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,761
`(Aug. 14, 2012).
`
`
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`IPR2015-01099
`Patent 8,669,290 B2
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`
`B. Motion to Seal
`“There is a strong public policy for making all information filed in a
`quasi-judicial administrative proceeding open to the public, especially in an
`inter partes review which determines the patentability of claims in an issued
`patent and therefore affects the rights of the public.” Garmin Int’l v. Cuozzo
`Speed Techs., LLC, IPR2012-00001, slip op. at 1–2 (PTAB Mar. 14, 2013)
`(Paper 34). A motion to seal may be granted for good cause. 37 C.F.R. §
`42.54. The moving party bears the burden of showing that there is good
`cause for the relief requested, including why the information is appropriate
`to be filed under seal. 37 C.F.R. §§ 42.20, 42.54. The Office Patent Trial
`Practice Guide notes that 37 C.F.R. § 42.54 identifies confidential
`information in a manner consistent with Federal Rule of Civil Procedure
`26(c)(1)(G), which provides for protective orders for trade secret or other
`confidential research, development, or commercial information. 77 Fed.
`Reg. at 48,760. Until a motion to seal is decided, documents filed with the
`motion shall be sealed provisionally. 37 C.F.R. § 42.14.
`Patent Owner requests that we seal four categories of exhibits and
`portions of its Patent Owner Response and supporting declarations citing or
`describing those exhibits. Mot. 7.
`As discussed, we have denied entry of the proposed order without
`prejudice. Thus, the motion to seal is also denied without prejudice, as it is
`based upon an unacceptable protective order. Under the circumstances, we
`exercise our discretion to maintain the papers and exhibits cited by Patent
`Owner under a provisional seal, in the manner requested, through July 31,
`2016, to (a) permit Patent Owner and Petitioner to resolve the issues that we
`have identified regarding the proposed order in an amended proposed order,
`
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`IPR2015-01099
`Patent 8,669,290 B2
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`and (b) allow Patent Owner an opportunity to file a revised motion to seal
`after a protective order is entered in this proceeding or to withdraw
`provisionally sealed papers and exhibits. In a revised motion to seal, Patent
`Owner should consider and address the following:
`1. Patent Owner’s NDA and Filings Citing the NDA
`Patent Owner asserts that Exhibits 2096, 2102, 2103, 2110, 2251, and
`2291–2293 represent excerpts from Patent Owner’s NDA and should be
`sealed in their entirety as “PROTECTIVE ORDER MATERIAL –
`BOARD’S EYES ONLY.” Mot. 7. Patent Owner explains that its NDA
`was filed confidentially with the Food and Drug Administration. Id.
`According to Patent Owner, “public disclosure of the contents of these
`documents, or descriptions of those contents, would disclose confidential
`business terms in a highly competitive market.” Id. at 9. Patent Owner
`asserts also that “redaction of those exhibits would not be practical.” Id. at
`8.
`
`Patent Owner asserts that those exhibits containing excerpts of the
`NDA are cited or substantially described on pages 2, 3, 46–48, and 50 of the
`Patent Owner’s Response (Paper 22), in paragraphs 12, 15, 16, 18, and 22 of
`Dr. Myers declaration (Ex. 2126), paragraphs 60, 173, 174, 197, 198, 200,
`201, and 232–234 of Dr. Williams’ declaration (Ex. 2082), paragraphs 16,
`40, 49, and 50 of Dr. Trattler’s declaration (Ex. 2116), and paragraphs 18,
`50, 81, 84, and 148 of Dr. Jarosz’ declaration (Ex. 2130). Mot. 7–8. Thus,
`Patent Owner requests that those portions of the Patent Owner’s Response
`and supporting declarations be sealed as “PROTECTIVE ORDER
`MATERIAL – BOARD’S EYES ONLY.” Id. at 9.
`
`
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`IPR2015-01099
`Patent 8,669,290 B2
`
`We note that a portion of Exhibit 2096 contains material that Patent
`
`Owner has not established to be confidential. See Ex. 2096, 1. Although the
`exhibit represents an excerpt of Patent Owner’s NDA, page 1 does not
`appear to contain any confidential or proprietary information. Indeed, that
`page appears to contain information readily available to the public.
`Additionally, we note that the entirety of Exhibit 2293 lacks any content.
`Every page of that exhibit is essentially blank, containing only a portion of
`an empty grid. In a revised motion to seal, if Patent Owner continues to seek
`to have those exhibits sealed, those issues should be addressed.
`2. Research and Development Presentations and the Testimony of
`Ms. Valorie and Dr. Jarosz
`
`Patent Owner asserts that Exhibits 2220, 2226, and 2296 are
`presentations containing “Patent Owner’s proprietary information related to
`Patent Owner’s methods of conducting confidential discussion groups and
`market information for its commercial embodiment of the Patents-at-Issue”
`in this and related proceedings. Mot. 10. Patent Owner asserts that the
`testimony of Ms. Valorie, an officer of Patent Owner’s parent company
`(Ex. 2258) also “relate[s] to Patent Owner’s commercial embodiment of the
`patent at issue.” Id. Additionally, Patent Owner asserts that those materials
`are relied upon in the declaration of Dr. Jarosz (Exhibit 2130 ¶¶ 13, 40, 42,
`50, 68, 81, and 98–101) and in the Patent Owner Response. Thus, Patent
`Owner requests for those items to be sealed as “PROTECTIVE ORDER
`MATERIAL.” Id. at 11.
`We note that Patent Owner has not identified what portions of its
`Patent Owner’s Response contain the asserted confidential material, i.e., the
`portions of that filing that it seeks to seal. In that respect, the motion to seal
`
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`IPR2015-01099
`Patent 8,669,290 B2
`
`is deficient. Further, we note that Exhibit 2258 contains seven inconsecutive
`pages from a transcript of the deposition of Ms. Tracy Valorie. The first
`page of the exhibit is the cover sheet and the second page includes little
`more than an introduction of the counsel, the videographer, and the witness
`present at the deposition. In other words, Patent Owner has not established
`that the exhibit should be sealed in its entirety by asserting only that the
`testimony is “related to Patent Owner’s commercial embodiment of the
`patent at issue.” Mot. 10. In a revised motion to seal, if Patent Owner
`continues to seek to have those materials sealed, those issues should be
`addressed.
`3. Third Party Testing Reports and Test Methods
`Patent Owner seeks to seal Exhibits 2267–2278, 2286, and 2294 as
`“PROTECTIVE ORDER MATERIAL.” Mot. 12. Patent Owner asserts that
`those exhibits are “confidential materials of third parties BioScience and
`SSCI.” Mot. 11. According to Patent Owner, those exhibits “contain third
`party BioScience’s and SSCI’s proprietary information related to each
`company’s proprietary testing methods.” Id. Patent Owner asserts that “the
`public’s interest in the instant proceeding does not outweigh a third party’s
`interest in protecting this limited sensitive business information.” Id. Those
`assertions are insufficient. In particular, Patent Owner has neither
`demonstrated that the exhibits contain proprietary information nor
`established its standing to assert the “interest” of a non-party third party in
`this proceeding. Patent Owner’s request to seal portions of the declaration
`of Dr. Paulson (Ex. 2128 ¶¶ 10, 14, 17–18, and 20–25) that cite those
`exhibits to document preservative effectiveness testing that BioScience
`performed on samples of Patent Owner’s commercial product is problematic
`
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`IPR2015-01099
`Patent 8,669,290 B2
`
`for the same reason. In a revised motion to seal, if Patent Owner continues
`to seek to have those materials sealed, those issues should be addressed.
`4. The Testimony of Dr. Lawrence and Filings citing that Testimony
`Patent Owner requests that the transcript of Dr. Jayne Lawrence’s
`deposition testimony in this proceeding be sealed in its entirety under
`Federal Rule of Evidence 615 (“FRE 615”) “until such time as the cross
`examination of Petitioner InnoPharma’s expert Dr. Paul Laskar in
`connection with InnoPharma’s petitions in the Related IPR Proceedings have
`been concluded.” Mot. 12. As discussed with respect to the proposed order,
`this request appears to be moot at this stage in the proceeding, as discovery
`has concluded. Similarly, Patent Owner’s request to seal portions of Patent
`Owner’s Response and the declarations of Drs. Williams and Dr. Davies that
`cite or substantially describe Dr. Lawrence’s or Dr. Laskar’s testimony for
`the same duration appears to be moot. Mot. 13–14. In a revised motion to
`seal, if Patent Owner contends otherwise, it should explain that position.
`ORDER
`In accordance with the foregoing, it is hereby:
`ORDERED that Patent Owner’s Motion to Seal is denied without
`prejudice and entry of the Stipulated Protective Order is denied without
`prejudice;
`FURTHER ORDERED that Exhibits 2082, 2096, 2102, 2103, 2105,
`2110, 2114, 2116, 2126, 2128, 2130, 2220, 2226, 2251, 2267–2278, 2286,
`2291–2294, 2296, 2316, as well as, Papers 22 and 23 shall remain
`provisionally sealed until further notice by the Board;
`
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`IPR2015-01099
`Patent 8,669,290 B2
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`
`FURTHER ORDERED that Patent Owner may file a motion for entry
`of either the default protective order or an amended protective order
`addressing the issues set forth in this Decision on or before July 31, 2016;
`FURTHER ORDERED that Patent Owner may file a revised motion
`to seal addressing the issues set forth in this Decision, and/or withdraw
`provisionally sealed exhibits on or before July 31, 2016; and
`FURTHER ORDERED that any opposition to a proposed protective
`order and/or revised motion to seal shall be filed within 5 business days after
`the filing of the motion(s).
`
`
`PETITIONER:
`Deborah H. Yellin
`Jonathan Lindsay
`Teresa Rea
`Shannon Lentz
`CROWELL & MORING LLP
`DYellin@crowell.com
`JLindsay@crowell.com
`trea@crowell.com
`slentz@crowell.com
`
`PATENT OWNER:
`Bryan C. Diner
`Joshua L. Goldberg
`Justin J. Hasford
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`bryan.diner@finnegan.com
`joshua.goldberg@finnegan.com
`justin.hasford@finnegan.com
`
`
`
`
`10
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