Trials@uspto.gov
`571-272-7822
`
`
`
` Paper: 92
` Entered: August 29, 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., MYLAN INC.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`_______________
`
`Case IPR2015-009031
`Patent 8,129,431 B2
`_______________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`ORDER
`Granting Petitioner’s Renewed Motion to Seal
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`1 Case IPR2015-1871 has been joined with this proceeding.
`
`
`571-272-7822
`
`
`
` Paper: 92
` Entered: August 29, 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., MYLAN INC.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`_______________
`
`Case IPR2015-009031
`Patent 8,129,431 B2
`_______________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`ORDER
`Granting Petitioner’s Renewed Motion to Seal
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`1 Case IPR2015-1871 has been joined with this proceeding.
`
`
`
`IPR2015-00903
`Patent 8,129,431 B2
`
`
`
`
`In an Order dated June 21, 2016, the Board denied Patent Owner’s
`
`request to enter a Stipulated Protective Order. Paper 77. That same day, the
`
`Board denied without prejudice all pending motions to seal documents.
`
`Papers 77–80. On July 29, 2016, Petitioner filed a Renewed Motion to Seal.
`
`Paper 88 (“Motion” or “Mot.”). This Order addresses that Motion. Patent
`
`Owner has “agreed not to oppose this Motion.” Mot. 6.
`
`Concurrently herewith, we enter an Order granting the parties’ joint
`
`request for entry of an Amended Stipulated Protective Order (Paper 81,
`
`App’x A (copy of Amended Stipulated Protective Order)), which governs
`
`disclosure of confidential information in this proceeding.
`
`
`
`
`
`Granting Motion to Seal Exhibit 2109 in its Entirety
`
`Exhibit 2109 was the subject of a prior request to seal filed by Patent
`
`Owner, which was denied because it was “based upon an unacceptable
`
`protective order.” Paper 77, 5; see Paper 36, 1 (Patent Owner’s request to
`
`seal Exhibit 2109). Petitioner now moves to seal Exhibit 2109, which
`
`Petitioner describes as an excerpt of Petitioner’s Abbreviated New Drug
`
`Application (“ANDA”). Mot. 1, 4. Petitioner states that the ANDA “was
`
`filed confidentially with the FDA in order to obtain FDA approval to market
`
`[Petitioner’s] generic pharmaceutical product,” which “has not yet been
`
`marketed and remains confidential.” Id. at 4. Petitioner also states that
`
`“Exhibit 2109 is only an excerpt of the much larger [] ANDA and redaction
`
`
`
`2
`
`
`
`IPR2015-00903
`Patent 8,129,431 B2
`
`
`of this excerpt would not be practical.” Id. On that basis, Petitioner
`
`contends that Exhibit 2109 should “be sealed in its entirety.” Id.
`
`
`
`The Board denied a prior request to seal certain documents because
`
`Petitioner did not describe properly the papers sought to be sealed.
`
`Paper 77, 2–3. Specifically, we denied Petitioner’s prior motion to seal
`
`because, among other things, it identified five documents sought to be sealed
`
`in their entirety that were not characterized even by title. Id.; Paper 50, 3.
`
`Based on the information presented in the instant Motion, by contrast, we
`
`are persuaded that Petitioner identifies Exhibit 2109 adequately. Mot. 4.
`
`Our review of the unredacted version of Exhibit 2109, furthermore,
`
`persuades us of the correctness of Petitioner’s view that redacting that
`
`document “would not be practical” and, therefore, Exhibit 2109 should be
`
`sealed in its entirety. Id. Accordingly, Petitioner’s request to seal
`
`Exhibit 2109 is granted.
`
`
`
`Granting Motion to Seal Two Paragraphs of Exhibit 2082
`
`Petitioner moves to seal two paragraphs of a declaration of Dr. Robert
`
`O. Williams, III (Ex. 2082). Mot. 6–7. Patent Owner previously moved to
`
`seal portions of Exhibit 2082, but that request was denied because it was
`
`“based upon an unacceptable protective order.” Paper 77, 5. Petitioner now
`
`requests sealing paragraphs 181 and 187, which are alleged to describe “the
`
`confidential information contained in the ANDA in connection with
`
`secondary considerations of non-obviousness.” Mot. 4. Petitioner states that
`
`“public disclosure of the contents” of paragraphs 181 and 187 of
`
`Exhibit 2082 “would disclose confidential business terms in a highly
`
`
`
`3
`
`
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`IPR2015-00903
`Patent 8,129,431 B2
`
`
`competitive market.” Id. at 5. Petitioner establishes good cause for sealing
`
`paragraphs 181 and 187 of Exhibit 2082. Accordingly, Petitioner’s request
`
`to seal paragraphs 181 and 187 of Exhibit 2082 is granted.
`
`
`
`Granting Motion to Seal Page 59 of Patent Owner’s Response
`
`Petitioner moves to seal page 59 of Patent Owner’s Response
`
`(Paper 32) because “the third sentence of the second full paragraph”
`
`discusses Petitioner’s “ANDA product and cites to paragraph 181 of
`
`[Exhibit 2082].” Mot. 5. Patent Owner previously moved to seal portions of
`
`Patent Owner’s Response, but that request was denied because it was “based
`
`on an unacceptable protective order.” Paper 77, 5. Petitioner now seeks to
`
`seal page 51 of that Response to protect “confidential business terms in a
`
`highly competitive market.” Mot. 5. Petitioner establishes good cause for
`
`sealing page 59 of Patent Owner’s Response. Accordingly, Petitioner’s
`
`request to seal page 59 of Patent Owner’s Response is granted.
`
`
`
`Requiring a Joint Stipulation and Counsel Certification
`
`By September 2, 2016, Patent Owner and Petitioner shall file a Joint
`
`Stipulation that identifies with particularity the exact portions (by page or
`
`paragraph number) of all sealed papers and exhibits that are cited in the
`
`Final Written Decision. The Joint Stipulation shall include a Counsel
`
`Certification attesting to the accuracy and completeness of the Joint
`
`Stipulation, including a statement verifying that the exact portion of each
`
`paper and exhibit cited in the Final Written Decision is identified (by page or
`
`paragraph number) in the Joint Stipulation.
`
`
`
`4
`
`
`
`IPR2015-00903
`Patent 8,129,431 B2
`
`
`
`We specifically provided the parties advance notice “that information
`
`subject to a protective order will become public if identified in a final
`
`written decision in this proceeding.” Paper 77, 4. Further, the Rules of
`
`Practice for Trial Before the Patent Trial and Appeal Board (“Rules of
`
`Practice”) provide that:
`
`Confidential information that is subject to a protective order ordinarily
`will become public 45 days after denial of a petition to institute a trial
`or 45 days after final judgment in a trial. There is an expectation that
`information will be made public where the existence of the information
`is referred to in a decision to grant or deny a request to institute a review
`or is identified in a final written decision following a trial. A party
`seeking to maintain the confidentiality of information, however, may
`file a motion to expunge the information from the record prior to the
`information becoming public.
`
`77 Fed. Reg. No. 157, Part V at Section I.E.6. (Aug. 14, 2012) (emphasis
`
`added). There is a presumption, therefore, that any confidential information
`
`cited in the Final Written Decision, entered July 28, 2016, shall become
`
`public on September 12, 2016.
`
`A strong public interest favors maintaining a complete and
`
`understandable record of the patent history, including the factual basis for
`
`the Board’s findings and the intelligibility of the Final Written Decision.
`
`Petitioner recognizes that public interest but fails to show sufficiently that it
`
`is outweighed by any private business interest in this case. Mot. 2–5. By
`
`placing confidential information before the Board, Petitioner accepted the
`
`risk that the information would become public if relied upon in the Final
`
`Written Decision. Rules of Practice, 77 Fed. Reg. No. 157, Part V at Section
`
`I.E.6. (Aug. 14, 2012) (“There is an expectation that information will be
`
`
`
`5
`
`
`
`IPR2015-00903
`Patent 8,129,431 B2
`
`
`made public where the existence of the information . . . is identified in a
`
`final written decision following a trial.”).
`
`Accordingly, all papers and exhibits identified in the Joint Stipulation
`
`shall be unsealed and made publicly available on September 12, 2016, unless
`
`a revised public version of the paper or exhibit, conforming to the following
`
`requirements, is filed by September 2, 2016 (that is, ten days prior to the
`
`date set for unsealing). Specifically, a party may prevent the unsealing of
`
`any paper or exhibit identified in the Joint Stipulation by filing, no later than
`
`September 2, 2016, a revised public version of the paper or exhibit in which
`
`each page or paragraph cited in the Final Written Decision is left unredacted.
`
`Material not cited in the Final Written Decision may be redacted in the
`
`revised public version.
`
`
`
`Other Matters
`
`Any request for reconsideration of this Order shall be filed no later
`
`than September 2, 2016.
`
`No further briefing is authorized at this time.
`
`Should the parties require assistance in complying with this Order, the
`
`Board is available for a teleconference during the week of August 29, 2016.
`
`Counsel may initiate a request for a teleconference by sending an email to
`
`Trials@USPTO.gov.
`
`
`
`It is
`
`ORDERED that Petitioner’s Motion to Seal is granted to the extent
`
`set forth in this Order;
`
`
`
`6
`
`
`
`IPR2015-00903
`Patent 8,129,431 B2
`
`
`
`FURTHER ORDERED that, by September 2, 2016, Patent Owner and
`
`Petitioner shall file a Joint Stipulation as described in this Order, which
`
`identifies with particularity the exact portions (by page or paragraph
`
`number) of all sealed papers and exhibits that are cited in the Final Written
`
`Decision;
`
`FURTHER ORDERED that the Joint Stipulation shall include a
`
`Counsel Certification attesting to the accuracy and completeness of the Joint
`
`Stipulation, including a statement verifying that the exact portion of each
`
`paper and exhibit cited in the Final Written Decision is identified (by page or
`
`paragraph number) in the Joint Stipulation;
`
`FURTHER ORDERED that all papers and exhibits identified in the
`
`Joint Stipulation shall be unsealed and made publicly available on
`
`September 12, 2016, unless a revised public version of the paper or exhibit,
`
`conforming to the requirements of this Order, is filed by September 2, 2016;
`
`FURTHER ORDERED that a party may prevent the unsealing of any
`
`paper or exhibit identified in the Joint Stipulation by filing, no later than
`
`September 2, 2016, a revised public version of the paper or exhibit in which
`
`each page or paragraph cited in the Final Written Decision is left unredacted;
`
`and
`
`FURTHER ORDERED that any request for reconsideration of this
`
`Order shall be filed no later than September 2, 2016.
`
`
`
`
`
`
`
`7
`
`
`
`IPR2015-00903
`Patent 8,129,431 B2
`
`
`PETITIONER:
`
`Jitendra Malik
`jitty.malik@alston.com
`Lance Soderstrom
`lance.soderstrom@alston.com
`Hidetada James Abe
`james.abe@alston.com
`Joseph Janusz
`joe.janusz@alston.com
`
`
`Deborah Yellin
`dyellin@crowell.com
`Jonathan Lindsay
`jLindsay@Crowell.com
`Shannon Lentz
`SLentz@Crowell.com
`
`
`PATENT OWNER:
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`Justin J. Hasford
`justin.hasford@finnegan.com
`Joshua L. Goldberg
`joshua.goldberg@finnegan.com
`
`
`
`8
`
`
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