Trials@uspto.gov
`571-272-7822
`
`Paper: 70
`
` Entered: September 15, 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 8,699,290 B2
`____________
`
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`ORDER
`Granting Petitioner’s Motion to Seal and
`Granting Petitioner’s Motion to Enter Default Protective Order
`37 C.F.R. §§ 42.14 and 42.54
`
`
`571-272-7822
`
`Paper: 70
`
` Entered: September 15, 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 8,699,290 B2
`____________
`
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`ORDER
`Granting Petitioner’s Motion to Seal and
`Granting Petitioner’s Motion to Enter Default Protective Order
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`IPR2015-01099
`Patent 8,699,290 B2
`
`In an Order dated June 21, 2016, the Board denied Patent Owner’s
`
`request to enter a Stipulated Protective Order. Paper 61. That same day, the
`Board denied without prejudice all pending motions to seal documents.
`Papers 57–61. We entered a Final Written Decision on September 12, 2016.
`Paper 69.
`On July 29, 2016, Petitioner filed a combined Motion to Seal and
`Motion to Enter Default Protective Orcer. Paper 63 (“Motion” or “Mot.”).
`This Order addresses that Motion.
`
`
`Granting Motion to Seal
`
`Petitioner seeks to seal Exhibit 2109, described as “Lupin’s ANDA
`[Abbreviated New Drug Application], which was filed confidentially with
`the FDA [Food and Drug Administration] in order to obtain FDA approval
`to market Lupin’s generic pharmaceutical product.” Mot. 5. Petitioner
`states that Exnibit 2109 “contains Lupin’s highly sensitive, confidential
`development information and technical, business information.” Id.
`Petitioner further states that if the asserted “confidential information is made
`public, Lupin’s competitors could exploit its confidential information and
`gain an unfair competitive advantage over Lupin.” Id. Petitioner further
`identifies Exhibit 2109 as “an excerpt of the much larger Lupin ANDA,”
`arguing that “redaction of this excerpt would not be practical.” Id.
`Petitioner, thus, requests “that Exhibit 2109 be sealed in its entirety.” Id.
`
`Petitioner also seeks to seal portions of a declaration of Dr. Robert O.
`Williams, III (Ex. 2082). Id. Specifically, Petitioner seeks to seal
`paragraphs 201 and 234, which are alleged to describe “the confidential
`information contained in the ANDA in connection with secondary
`
`
`
`2
`
`
`
`IPR2015-01099
`Patent 8,699,290 B2
`
`considerations of non-obviousness.” Id. Petitioner states that, in particular,
`paragraph 234 “shows the generic bromfenac product components described
`in Exhibit 2109,” discussed above. Id.
`
`In addition, Petitioner moves to seal page 50 of Patent Owner’s
`Response (Paper 24) because “the third sentence of the paragraph beginning
`on page 50” discusses “ Lupin’s ANDA product and cites to paragraph 201
`of [Exhibit 2082].” Mot. 6. Petitioner avers that sealing is necessary to
`protect “confidential business terms in a highly competitive market.” Id.
`
`We previously denied a joint motion to seal these same documents.
`Paper 58, 3. We denied that prior request because a protective order had not
`been entered, and the parties had not proposed an adequate proposed
`protective order. Id. We determined, however, that “the parties have
`established that” the materials sought to be sealed “represent or contain
`confidential information.” Id.
`As explained below, our prior concerns about the lack of an adequate
`protective order have been addressed. Specifically, upon Petitioner’s
`unopposed request, we enter a suitable protective order in this proceeding.
`Accordingly, based on our prior determination that the parties have
`established good cause for sealing the documents that are the subject of the
`instant request, we grant Petitioner’s request to seal Exhibit 2109 in its
`entirety, portions of Exhibit 2082 (namely, paragraph 201 and 234), and
`page 50 of Patent Owner’s Response.
`
`
`Granting Motion to Enter Default Protective Order
`Previously, the Board determined that a proposed Stipulated
`
`Protective Order jointly submitted by the parties was “not in an adequate
`
`
`
`3
`
`
`
`IPR2015-01099
`Patent 8,699,290 B2
`
`form for entry.” Paper 61, 3. In the instant Motion, Petitioner requests
`“entry of the Default Protective Order.” Mot. 3. Petitioner states that
`“Patent Owner does not oppose” the request. Id. Accordingly, we grant
`Petitioner’s request for entry of the Board’s Default Protective Order, which
`shall apply to confidential information filed in this proceeding. The parties
`are directed to enter a copy of the Board’s Default Protective Order as an
`exhibit in this proceeding within five (5) business days.
`
`
`Requiring a Joint Stipulation and Counsel Certification
`Within thirty five (35) days after entry of the Final Written Decision,
`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.
`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 61, 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
`
`
`
`4
`
`
`
`IPR2015-01099
`Patent 8,699,290 B2
`
`
`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. 48756, 48761, Section I.E.6. (Aug. 14, 2012) (emphasis
`added). There is a presumption, therefore, that any confidential information
`cited in the Final Written Decision shall become public forty five (45) days
`after entry of the Final Written Decision.
`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. By
`placing confidential information before the Board, Petitioner accepted the
`risk that the information will become public if relied upon in the Final
`Written Decision. Rules of Practice, 77 Fed. Reg. 48756, 48761, Section
`I.E.6. (Aug. 14, 2012) (“There is an expectation that information will be
`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 forty five (45) days after entry
`of the Final Written Decision, unless a revised public version of the paper or
`exhibit, conforming to the following requirements, is filed no later than
`thirty five (35) days (that is, ten days prior to the date set for unsealing) after
`entry of the Final Written Decision. Specifically, a party may prevent the
`unsealing of any paper or exhibit identified in the Joint Stipulation by filing,
`no later than thirty five (35) days after entry of the Final Written Decision, 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
`
`
`
`5
`
`
`
`IPR2015-01099
`Patent 8,699,290 B2
`
`not cited in the Final Written Decision may be redacted in the revised public
`version.
`
`
`It is
`ORDERED that Petitioner’s Motion to Seal is granted to the extent
`
`set forth in this Order;
`FURTHER ORDERED that Petitioner’s Motion to Enter Default
`Protective Order is granted;
`FURTHER ORDERED that the partes shall file a copy of the Board’s
`Default Protective Order as an exhibit in this proceeding within five (5)
`business days;
`FURTHER ORDERED that the Default Protective Order shall apply
`to confidential information filed in this proceeding;
`FURTHER ORDERED that, within thirty five (35) days after entry of
`the Final Written Decision, 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 forty five
`(45) days after entry of the Final Written Decision, unless a revised public
`
`
`
`6
`
`
`
`IPR2015-01099
`Patent 8,699,290 B2
`
`version of the paper or exhibit, conforming to the requirements of this Order,
`is filed no later than thirty five (35) days (that is, ten days prior to the date
`set for unsealing) after entry of the Final Written Decision;
`FURTHER ORDERED that a party may prevent the unsealing of any
`paper or exhibit identified in the Joint Stipulation by filing, no later than
`thirty five (35) days after entry of the Final Written Decision, a revised
`public version of the paper or exhibit in which each page or paragraph cited
`in the Final Written Decision is left unredacted.
`
`
`
`
`
`
`
`
`7
`
`
`
`IPR2015-01099
`Patent 8,699,290 B2
`
`
`
`PETITIONER:
`Deborah 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 Diner
`Justin Hasford
`Joshua Goldberg
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`bryan.diner@finnegan.com
`justin.hasford@finnegan.com
`joshua.goldberg@finnegan.com
`
`
`
`
`
`8
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