Trials@uspto.gov
`571-272-7822
`
`
`
`
`
` Paper 77
` Entered: June 21, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`
`Patent Owner.
`____________
`
`Case IPR2015-00902 (Patent 8,669,290 B2)
`Case IPR2015-000903 (Patent 8,129,431 B2)1
`____________
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judge.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION2
`Denying Patent Owner’s Motion to Seal and
`Denying Entry of the Stipulated Protective Order
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
` 1
`
` IPR2015-01871 was joined with IPR2015-00903 after Patent Owner’s
`Motion was filed, adding Petitioner Lupin Ltd. and Lupin Pharmaceuticals
`Inc. That added Petitioner is not a party to the Motion or this Decision.
`2 This Decision relates to and shall be filed in each referenced case.
`
`
`571-272-7822
`
`
`
`
`
` Paper 77
` Entered: June 21, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`
`Patent Owner.
`____________
`
`Case IPR2015-00902 (Patent 8,669,290 B2)
`Case IPR2015-000903 (Patent 8,129,431 B2)1
`____________
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judge.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION2
`Denying Patent Owner’s Motion to Seal and
`Denying Entry of the Stipulated Protective Order
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
` 1
`
` IPR2015-01871 was joined with IPR2015-00903 after Patent Owner’s
`Motion was filed, adding Petitioner Lupin Ltd. and Lupin Pharmaceuticals
`Inc. That added Petitioner is not a party to the Motion or this Decision.
`2 This Decision relates to and shall be filed in each referenced case.
`
`
`
`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`INTRODUCTION
`I.
`In each of the captioned proceedings, Patent Owner filed a combined
`Motion to Seal and Motion to Enter Stipulated Protective Order. Paper 363
`(“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,) and Petitioner InnoPharma Licensing’s
`Abbreviated New Drug Application (“ANDA”) (Ex. 2109); two
`presentations related to Patent Owner’s research and development of the
`patented formulation (Exs. 2220 and 2226); the transcripts of the testimony
`of Dr. Paul Laskar (Ex. 2114); portions of Patent Owner’s Response (Papers
`33 and 34); and portions of the declarations of Drs. 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 84 in IPR2015-00902
`
`
`
` 3
`
` Cited Paper and exhibit numbers are the same in each captioned
`proceeding, except where indicated otherwise.
`2
`
`
`
`
`
`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
`
`and Paper 76 in IPR2015-00903 (redlined version of 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
`
`
`
`3
`
`
`
`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
`
`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).
`B. Motion to Seal
`
`
`
`4
`
`
`
`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`“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,
`(b) allow Patent Owner an opportunity to file a revised motion to seal after a
`
`
`
`5
`
`
`
`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
`
`protective order is entered in this proceeding or to withdraw provisionally
`sealed papers and exhibits, and (c) allow inclusion of joined Petitioner Lupin
`Ltd. and Lupin Pharmaceuticals Inc. to the filings. 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, and 2110
`represent excerpts from Patent Owner’s NDA and should be sealed in their
`entirety as “PROTECTIVE ORDER MATERIAL – BOARD’S EYES
`ONLY.” Mot. 9. Patent Owner asserts that Exhibit 2109 represents
`Petitioner InnoPharma Licensing’s ANDA and should similarly be sealed.
`Id. Patent Owner explains that the NDA and ANDA were filed
`confidentially with the Food and Drug Administration. Id. at 7. 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 7.
`Patent Owner asserts that those exhibits containing excerpts of the
`NDA or the ANDA are cited or substantially described in: the Patent
`Owner’s Response (Paper 34) on pages 3, 48, 49, and 51 in IPR2015-00902
`and on pages 3, 55–57, and 59 in IPR2015-00903; Dr. Williams’ declaration
`(Ex. 2082) at paragraphs 143, 144, 167, 168, 170, 171, 193, and 194 in
`IPR2015-00902 and at paragraphs 152, 153, 177, 178, 180, 181, 186, and
`187 in IPR2015-00903; Dr. Trattler’s declaration (Ex. 2116) at of
`paragraphs 16 and 41 of in IPR2015-00902 and at paragraphs 16, 41, and 49
`in IPR2015-00903; and Dr. Jarosz’ declaration (Ex. 2130) at paragraphs 17,
`56, 82, and 134 in IPR2015-00902 and at paragraphs 17, 56, 82, and 134 in
`
`
`
`6
`
`
`
`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
`
`IPR2015-00903. Mot. 6–7. Thus, Patent Owner requests that those portions
`of the Patent Owner’s Response and the cited declarations be sealed as
`“PROTECTIVE ORDER MATERIAL– BOARD’S EYES ONLY.” Id. at 9.
`
`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. In a revised
`motion to seal, if Patent Owner continues to seek to have the entirety of the
`exhibit sealed, that issue should be addressed.
`2. Research and Development Presentations
`
`Patent Owner asserts that Exhibits 2220 and 2226 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. 9. Patent Owner asserts that the information
`contained in those exhibits are relied upon in the declaration of Dr. Jarosz
`(Exhibit 2130 ¶¶ 44, 45 n.5, 47, 56, 82, 95, 96, and 97) and in the Patent
`Owner Response. Id. Thus, Patent Owner requests for those items to be
`sealed as “PROTECTIVE ORDER MATERIAL.” Id. at 10.
`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
`is deficient. In a revised motion to seal, if Patent Owner continues to seek to
`have portions of the Patent Owner’s Response sealed, that issues should be
`addressed.
`
`
`
`
`7
`
`
`
`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`3. The Testimony of Dr. Laskar and Filings citing that Testimony
`Patent Owner requests that the transcript of Dr. Paul Laskar’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 Lupin’s expert Dr. Lawrence in connection with
`Lupin’s petition in the Related IPR Proceedings has been concluded.” Mot.
`10. 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, Davies, and Trattler that
`cite or substantially describe Dr. Laskar’s testimony for the same duration
`appears to be moot. Mot. 11–12. 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,
`2109, 2110, 2114, 2116, 2130, 2220, 2226, , as well as, Papers 33 and 34
`shall remain provisionally sealed until further notice by the Board;
`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;
`
`
`
`8
`
`
`
`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`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).
`
`PETITIONERS:
`Jitendra Malik
`jitty.malik@alston.com
`Lance Soderstrom
`lance.soderstrom@alston.com
`Joseph Janusz
`joe.janusz@alston.com
`James Abe
`james.abe@alston.com
`
`Deborah Yellin
`dyellin@crowell.com
`Jonathan Lindsay
`jLindsay@Crowell.com
`Shannon Lentz
`SLentz@Crowell.com
`
`
`PATENT OWNER:
`Bryan Diner
`bryan.diner@finnegan.com
`Justin Hasford
`justin.hasford@finnegan.com
`Joshua Goldberg
`Joshua.goldberg@finnegan.com
`
`
`
`9
`
`
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