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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
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`AGILA SPECIALTIES INC.
`
`AND MYLAN PHARMACEUTICALS INC.,
`
`Petitioners,
`
`v.
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`CUBIST PHARMACEUTICALS, INC.,
`
`Patent Owner.
`____________________________________________
`
`Case IPR2015-00144
`
`Patent 8,058,238
`____________________________________________
`
`OPPOSITION TO MOTION TO CORRECT ACCORDED FILING DATE
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`
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`TABLE OF CONTENTS
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`Introduction ...................................................................................................... 1
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`The Petitions Did Not Meet the Statutory Requirements ................................ 1
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`
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`I.
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`II.
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`III. Granting Agila’s Motion Requires Waiver of Board Rules ............................ 3
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`IV. Agila’s Conduct Does Not Justify Waiver of Board Rules ............................. 6
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`V.
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`Conclusion ....................................................................................................... 9
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`
`
`
`i
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`TABLE OF AUTHORITIES
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`Page(s)
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`Federal Cases
`Baxter Int’l, Inc. v. McGaw, Inc.,149 F.3d 1321 (Fed. Cir. 1998) ............................ 1
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`Federal Statutes
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`35 U.S.C. § 312(a) ................................................................................................. 2, 3
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`35 U.S.C. § 312(a)(4) ................................................................................................. 2
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`35 U.S.C. § 312(a)(5) ......................................................................................... 2, 3, 4
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`35 U.S.C. § 315(b) ..................................................................................................... 1
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`Regulations
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`37 C.F.R. § 42.6 ......................................................................................................... 2
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`37 C.F.R. § 42.6(b)(1) ............................................................................................ 4, 5
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`37 C.F.R. § 42.6(b)(2)(i) ............................................................................................ 2
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`37 C.F.R. § 42.6(b)(2)(i)(A) ...................................................................................... 2
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`37 C.F.R. § 42.6(b)(2)(ii) ........................................................................................... 5
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`37 C.F.R. § 42.6(d) .................................................................................................... 4
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`37 C.F.R. § 42.6(e)(2) ................................................................................................ 4
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`37 C.F.R. § 42.20(b) .................................................................................................. 5
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`37 C.F.R. § 42.104 ..................................................................................................... 2
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`37 C.F.R. § 42.104(c) ................................................................................................. 8
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`Other Authorities
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012) ................. 7
`
`
`
`
`ii
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`
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`USPTO.gov, Patent Review Processing System (PRPS), available at
`http://www.uspto.gov/ip/boards/bpai/prps.jsp. ..................................................... 5
`
`
`
`USPTO.gov, Patent Review Processing System (PRPS), archived version dated
`Aug. 17, 2014, available at
`https://web.archive.org/web/20140817025907/http:/www.uspto.gov/ip/boards/b
`pai/prps.jsp ............................................................................................................ 5
`
`
`
`
`iii
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`
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`I.
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`Introduction
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`
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`Patent Owner (“Cubist”) respectfully opposes Petitioner’s Motion to Correct
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`Accorded Filing Date (Paper No. 11) (“Motion to Correct”). Both submitted
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`petitions—the electronic petition and the paper petition—violate statutory
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`requirements that the Board cannot waive. The petitions also violate regulations
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`that the Board should not waive. The Motion to Correct must therefore be denied.
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`II. The Petitions Did Not Meet the Statutory Requirements.
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`Petitioners (“Agila”) filed two petitions with the Board: an electronic
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`petition and a paper petition. Both petitions violate statutory provisions that cannot
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`be waived. Indeed, it is well-recognized that government agencies such as the
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`USPTO may not waive or modify statutory requirements, by regulation or
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`otherwise. See Baxter Int’l, Inc. v. McGaw, Inc., 149 F.3d 1321, 1334 (Fed. Cir.
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`1998) (finding that statutory requirements “may not be waived by the PTO”). The
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`Board is thus precluded from instituting an inter partes review based on either
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`petition and must deny the Motion to Correct.
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`First, the filing of Agila’s electronic petition was completed on October 24,
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`2014, one day after the statutory deadline under 35 U.S.C. § 315(b). See Exh.
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`1041; Petition for Inter Partes Review (Paper No. 1) at p. 4 (acknowledging
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`Cubist’s service of complaint on Agila on October 23, 2013); Exh. 1035, Proof of
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`Service of Agila (attesting to service of Agila on October 23, 2013). The Board
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`1
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`
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`therefore cannot institute an inter partes review based on the electronically-filed
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`
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`petition. Agila’s Motion to Correct does not suggest otherwise.
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`Second, Agila’s subsequently-filed paper petition also failed to comply with
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`statutory requirements. Pursuant to 35 U.S.C. § 312(a), “[a] petition filed under
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`section 311 may be considered only if,” inter alia, “the petitioner provides copies
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`of any of the documents required under paragraphs (2), (3), and (4) to the patent
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`owner . . . .” 35 U.S.C. § 312(a)(5). These statutorily required “documents”
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`include “such other information as the Director may require by regulation.” 35
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`U.S.C. § 312(a)(4). The regulations, incorporated by reference in the statute,
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`require that “[a] document filed by means other than electronic filing must . . . [b]e
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`accompanied by a motion requesting acceptance of the submission.” 37 C.F.R. §
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`42.6(b)(2)(i), (i)(A); 37 C.F.R. § 42.104 (stating that petition must comply with 37
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`C.F.R. § 42.6). Thus, 35 U.S.C. § 312(a)(5) requires that a petitioner serve on the
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`patent owner any motion requesting acceptance of a paper petition.
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`Agila failed to comply with this statutory requirement. Cubist did not
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`receive Agila’s motion to accept paper filing with the service copy of the petition.
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`Exh. 2001, Decl. of Henry H. Gu, at ¶ 3. In the Certificate of Service that
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`accompanied the petition, Agila’s counsel certified that she “caused to be served a
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`true and correct copy of the foregoing Petition for Inter Partes Review of U.S.
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`Patent No. 8,058,238, Exhibit Nos. 1001-1037 and Powers of Attorney by Network
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`2
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`
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`Global Logistics Next Day Service on the patent owner . . . .” Petition for Inter
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`
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`Partes Review (Paper No. 1) at p. 67 (emphasis omitted). Therefore, it is clear that
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`Agila did not serve the motion requesting acceptance of the paper petition on
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`Cubist as required by statute.
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`In fact, Agila has never served Cubist with a copy of the motion. Exh. 2001,
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`Decl. of Henry H. Gu, at ¶ 4. Cubist did not even become aware of the motion or
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`the alternative paper filing until the conference call held with Agila and the Board
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`on November 21, 2014. Id. at ¶ 4. Agila’s failure to comply with the statutory
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`service obligations of 35 U.S.C. § 312(a)(5) precludes the Board from accepting
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`Agila’s paper petition. 35 U.S.C. § 312(a).
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`Thus, the Board is prohibited by statute from instituting an inter partes
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`review based either on Agila’s electronic petition, which was filed after the
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`statutory deadline, or on Agila’s paper petition, which did not meet the statutory
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`service requirements.
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`III. Granting Agila’s Motion Requires Waiver of Board Rules.
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`In the Motion to Correct, Agila argues that acceptance of the paper petition
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`“does not require the waiver of any rule.” Motion to Correct at p. 4. To the
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`contrary, at least five different requirements of the Board’s rules would need to be
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`waived.
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`3
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`
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`First, 37 C.F.R. § 42.6(e)(2) (consistent with the service requirement under
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`35 U.S.C. § 312(a)(5)) requires service on the opposing party of each document
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`filed with the Board simultaneously with filing. As discussed above, Agila failed
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`to serve the Patent Owner with its motion to accept paper filing, and thus violated
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`this rule.
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`Second, 37 C.F.R. § 42.6(d) forbids the filing of multiple copies of the same
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`document: “[a] document already in the record of the proceeding must not be filed
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`again, not even as an exhibit or an appendix, without express Board authorization.”
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`This forbidden duplicate filing is exactly what Agila has attempted. Agila first
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`filed its petition and certain exhibits electronically. Realizing that the electronic
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`filing was a day late, Agila filed the same documents again by paper—without
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`requesting the Board’s authorization under this subsection. See Exh. 2002, Motion
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`to Request Acceptance of Mailed Petition, at p. 2 (failing to request authorization
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`for filing under 37 C.F.R. § 42.6(d)). Agila’s paper filing therefore also violates 37
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`C.F.R. § 42.6(d).
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`Third, 37 C.F.R. § 42.6(b)(1) states that, “[u]nless otherwise authorized,
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`submissions are to be made to the Board electronically via the Internet according to
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`the parameters established by the Board and published on the Web site of the
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`Office.” The Office’s website, prior to October 23, 2014, stated that “[p]aper filing
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`. . . is authorized only if both PRPS and the Board’s email address
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`4
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`[Trials@uspto.gov] are unavailable.” Exh. 2003, USPTO.gov, Patent Review
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`
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`Processing System (PRPS), archived version dated Aug. 17, 2014, at A2, available
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`at
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`https://web.archive.org/web/20140817025907/http:/www.uspto.gov/ip/boards/bpai
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`/prps.jsp (emphasis added).1 Neither of these conditions applied at the time of
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`Agila’s paper filing. PRPS was clearly available, given that it accepted all seven
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`inter partes review petitions that Agila filed that evening against Cubist’s patents,
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`including the late-filed electronic petition at issue here. Motion to Correct at pp. 6-
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`7. And there is no allegation that Agila tried to send its filing to the Board’s email
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`address. Agila’s paper filing therefore also violates 37 C.F.R. § 42.6(b)(1).
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`Fourth, 37 C.F.R. § 42.6(b)(2)(ii) requires that paper filings are to be
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`addressed to “Mail Stop PATENT BOARD, Patent Trial and Appeal Board . . . .”
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`Agila acknowledges that the paper filing instead was addressed to the
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`“Commissioner of Patents.” See Exh. 1043, Decl. of Adriana Serrano, at ¶ 11;
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`Exh. 1039. Agila’s paper filing therefore also violates 37 C.F.R. § 42.6(b)(2)(ii).
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`Fifth, 37 C.F.R. § 42.20(b) prohibits filing any motion without prior
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`authorization. Agila submitted its motion to accept paper filing without prior
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`Board authorization, and thus violated this rule as well.
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`1 This rule is still in place today. See USPTO.gov, Patent Review Processing
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`System (PRPS), available at http://www.uspto.gov/ip/boards/bpai/prps.jsp, at A2.
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`
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`5
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`In sum, contrary to Agila’s argument (Motion to Correct at pp. 4, 10), the
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`Board would have to waive at least five separate requirements to grant the
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`requested relief.
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`IV. Agila’s Conduct Does Not Justify a Waiver of Board Rules.
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`The Board should not waive compliance with these rules. Agila has not
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`shown good cause for such a waiver, nor would waiver be in the interests of
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`justice. While Agila characterizes the failure to timely file electronically as a
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`technical problem, the facts described in Agila’s own declarations indicate that
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`Agila simply filed its petition too late.
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`Despite having a year to file, Agila began the process of uploading its seven
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`inter partes review petitions against Cubist’s patents during the last six hours of
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`the last day permitted under the statute. Motion to Correct at p. 6. Agila’s counsel
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`waited until 45 minutes before this statutory deadline to ask a paralegal to file the
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`electronic petition at issue here on a separate computer—despite knowing that each
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`submission was taking approximately 35 minutes to file. Exh. 1044, Decl. of
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`Lorelei P. Westin, at ¶¶ 4-5. This paralegal then began uploading the petition at
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`8:26 p.m. Pacific Time, or 11:26 p.m. Eastern Time, cognizant of the deadline at
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`8:59 p.m. Pacific Time. Exh. 1043, Decl. of Adriana Serrano, at ¶¶ 7, 9. If
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`Agila’s acknowledged 35-minutes-per-filing pattern persisted, Agila should have
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`6
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`
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`expected this last filing to be completed at 12:01 a.m. Eastern Time—one minute
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`
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`after the statutory deadline.
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`The failure to timely file the petition was not, as Agila suggests, due to
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`“technical difficulties.” See, e.g., Motion to Correct at pp. 5-6. Agila admits that
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`PRPS was not only available, but working and able to accept all of Agila’s
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`petitions, including the one at issue here. See Motion to Correct at pp. 6-7. Agila
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`also provides no justification for not having attempted filing by email to the Board
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`as required according to the Board’s website as a pre-requisite to paper filing,
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`because this would not have remedied the timing problem. See Exh. 2003 at A2.
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`Agila simply attempted filing too close to the statutory deadline, and failed to meet
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`the deadline as a result.
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`After missing this deadline, Agila now seeks a second bite at the apple by
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`filing the same petition a second time by non-electronic means. Petitioners who
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`have already missed a statutory deadline should not be allowed to exploit the
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`Board’s filing provisions, and obtain waiver of five separate requirements in the
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`rules, to retroactively fix their own failure. The Board’s paper filing provisions are
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`available for those occasions when a petitioner cannot file its documents
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`electronically—not when it has already filed its documents electronically, but
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`wishes it had filed them earlier. See, e.g., Office Patent Trial Practice Guide, 77
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`Fed. Reg. 48756, 48758 (Aug. 14, 2012) (noting paper filing is appropriate “where
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`7
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`the Office’s electronic filing system is unable to accept filings”); Exh. 2003 at A2
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`(authorizing paper filing only when PRPS and email are unavailable).
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`Agila’s argument about the balance of prejudice is also incorrect. Agila
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`failed to meet a statutorily mandated deadline for filing the petition. The statutory
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`one-year deadline reflects a policy that there be a defined limit on the time in
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`which a plaintiff patent owner can be subjected to IPR petitions on its asserted
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`patents. Any prejudice to Agila is the direct result of its own conduct in failing to
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`meet deadlines. In addition, Agila overstates such prejudice, since they can pursue
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`the arguments presented in this inter partes review in the pending district court
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`action. In contrast, Cubist will be greatly prejudiced, for no fault of its own,
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`insofar as it will be required to defend its claims in this inter partes review, with
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`the attendant time, cost, and risk of loss of intellectual property rights.
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`Furthermore, Agila ignores the prejudice to the Board itself from granting Agila’s
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`motion. If the Board allows Agila to use the paper filing process as a de facto
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`electronic filing extension, it can expect to receive paper filings from other late
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`filers in the future.
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`Finally, Agila has not requested and is not entitled to relief under 37 C.F.R.
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`§ 42.104(c). Such relief would not be warranted, at least because Agila’s failures
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`were not the result of clerical errors, and are not even claimed as such by Agila.
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`8
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`V. Conclusion
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`
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`For the foregoing reasons, the Board should deny Agila’s Motion to Correct
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`Accorded Filing Date.
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`Date: December 8, 2014
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`Respectfully submitted,
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`By: /Henry H. Gu/
`Henry H. Gu
`Registration No. 55,227
`Cubist Pharmaceuticals, Inc.
`65 Hayden Ave.
`Lexington, MA 02421
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`9
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`CERTIFICATE OF SERVICE
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`I hereby certify that, on December 8, 2014, I caused a true and correct copy
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`of the foregoing materials:
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` Opposition to Motion to Correct Accorded Filing Date
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` Exhibits 2001-2003
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` Patent Owner’s Exhibit List
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`to be served via electronic mail on the following attorneys of record:
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`Peter R. Munson, Esq.
`Lorelei Westin, Ph.D, Esq.
`Wilson Sonsini Goodrich & Rosati PC
`12235 El Camino Real, Suite 200
`San Diego, CA 92130-3002
`pmunson@wsgr.com
`lwestin@wsgr.com
`
`
`/Henry H. Gu/
`Henry H. Gu
`Registration No. 55,227
`Cubist Pharmaceuticals, Inc.
`65 Hayden Ave.
`Lexington, MA 02421
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`PATENT OWNER’S EXHIBIT LIST
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`Description
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`Exhibit
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`
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`Declaration of Henry H. Gu in Support of Opposition to Motion
`to Correct Accorded Filing Date
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`Motion to Request Acceptance of Mailed Petition for Inter Partes
`Review of U.S. Patent No. 8,058,238 Under 37 C.F.R.
`§42.6(b)(2)(i)(A)
`
`USPTO.gov, Patent Review Processing System (PRPS), archived
`version dated Aug. 17, 2014, available at
`https://web.archive.org/web/20140817025907/http:/www.uspto.g
`ov/ip/boards/bpai/prps.jsp
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`2001
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`2002
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`2003
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`1
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