UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
`
`AGILA SPECIALTIES INC. AND
`MYLAN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`CUBIST PHARMACEUTICALS, INC.
`Patent Owner
`
`Patent No. 8,058,238
`
`________________________
`
`Case IPR2015-00144
`________________________
`
`MOTION TO CORRECT ACCORDED FILING DATE
`Under 37 C.F.R. §§ 1.10, 42.20 and 42.22
`
`

`
`i
`
`TABLEOFCONTENTS
`
`I.
`
`II.
`
`III.
`
`A.
`
`Statement and Summary of Reasons for Relief Requested............................ 1
`
`Brief Summary of Factual Background.......................................................... 1
`
`Statement of the Reasons for the Relief Requested ....................................... 2
`
`The Petition Was Timely Filed....................................................................... 2
`
`(i)
`
`The Petition Met the Statutory Requirements ........................... 2
`
`(ii) Agila Met the Non-Statutory Requirements .............................. 3
`
`B.
`
`Acceptance of the Non-Electronic Filing....................................................... 4
`
`(i)
`
`(ii)
`
`Standard and Conditions............................................................ 4
`
`Reasonable Good-Faith Efforts to File Electronically............... 6
`
`C.
`
`Agila Ensured an October 23, 2014 Filing Date by Filing Under
`§42.6(b)(2)............................................................................................ 7
`
`(i)
`
`No Legally Cognizable Prejudice Except to Agila.................... 8
`
`IV. CONCLUSION............................................................................................. 10
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`ii
`ii
`TABLE OF AUTHORITIES
`
`TABLE OF AUTHORITIES
`
`CASES
`
`CASES
`Burlington Truck Lines v. United States, 371 U.S. 156 (1962).................................5
`Burlington Truck Lines v. United States, 371 U.S. 156 (1962) ............................... ..5
`Foman v. Davis, 371 U.S. 178 (1962) .......................................................................9
`Foman v. Davis, 371U.S. 178 (1962) ..................................................................... ..9
`In re Bachler, 229 U.S.P.Q. 553 (Comm’r of Patents 1986).....................................6
`In re Bachler, 229 U.S.P.Q. 553 (COmm’r of Patents 1986) ................................... ..6
`In re Weiler, 790 F.2d 1576 (Fed. Cir. 1986)............................................................6
`In re Weiler, 790 F.2d 1576 (Fed. Cir. 1986) .......................................................... ..6
`STATUTES
`35 U.S.C. §312(a) ......................................................................................................2
`35 U.S.C. §312(a) .................................................................................................... ..2
`
`STATUTES
`
`RULES
`
`RULES
`37 C.F.R. §42.5(a)......................................................................................................3
`37 C.F.R. §42.5(a) .................................................................................................... ..3
`37 C.F.R. §42.6(b)(2).............................................................................2, 3, 4, 6, 7, 8
`37 C.F.R. §42.6(b)(2) ........................................................................... ..2, 3, 4, 6, 7, 8
`37 C.F.R. §§42.6(b) & (e)..........................................................................................3
`37 C.F.R. §§42.6(b) & (e) ........................................................................................ ..3
`37 C.F.R. §42.5(b) .....................................................................................................3
`37 C.F.R. §42.5(b) ................................................................................................... ..3
`37 C.F.R. §42.6(b)(1).................................................................................................3
`37 C.F.R. §42.6(b)(1) ............................................................................................... ..3
`37 C.F.R. §42.6(b)(i) .................................................................................................4
`37 C.F.R. §42.6(b)(i) ............................................................................................... ..4
`37 C.F.R. §1.10(a)..................................................................................................3, 8
`37 C.F.R. §1.10(a) ................................................................................................ ..3, 8
`37 C.F.R. §42.5(c)(2).................................................................................................5
`37 C.F.R. §42.5(c)(2) ............................................................................................... ..5
`37 C.F.R. §42.5(c)(3).................................................................................................5
`37 C.F.R. §42.5(c)(3) ............................................................................................... ..5
`37 C.F.R. §42.1(b) ...............................................................................................5, 10
`37 C.F.R. §42.1(b) ............................................................................................. ..5, 10
`37 C.F.R. §42.24 ........................................................................................................6
`37 C.F.R. §42.24 ...................................................................................................... ..6
`
`MISCELLANEOUS
`77 Fed. Reg. 48756, 4875 ..........................................................................................5
`77 Fed. Reg. 48756, 4875 ........................................................................................ ..5
`77 Fed. Reg. 48756, 48762 ......................................................................................10
`77 Fed. Reg. 48756, 48762 .................................................................................... ..1O
`
`MISCELLANEOUS
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`1
`Statement and Summary of Reasons for Relief Requested
`
`I.
`
`Petitioner (“Agila”) files this motion to correct the accorded filing date as it
`
`timely filed and served its petition on October 23, 2014 with the requisite
`
`supporting documents and appropriate fee. When faced with an electronic filing
`
`difficulty for the last of seven contemporaneously filed petitions, Agila diligently
`
`and timely pursued the alternative filing mechanism provided in the rules.
`
`Accepting the paper filing resulting from Agila’s prompt remedial action with the
`
`electronic filing creates no legally cognizable prejudice for the Patent Owner
`
`(“Cubist”) or for the Board. Conversely, if the Board refuses to accept Agila’s
`
`timely filed petition, the prejudice to Agila and to the public would be significant.
`
`II.
`
`Brief Summary of Factual Background
`On October 23, 2014, Agila filed seven petitions for the inter partes review
`
`(IPR) of four Cubist patents. Four of these petitions relate to U.S. Patent No.
`
`8,058,238 patent (‘238 patent), which boasts 192 overlapping and substantially
`
`similar claims. The petition that is the subject of this motion (IPR2015-00144; ‘144
`
`petition) requested review of certain claims of the ‘238 patent, many of which are
`
`similar to those in its three sister petitions. In fact, the declarations and exhibits of
`
`the ‘144 petition are identical to those of IPR petitions IPR2015-00141, -00142
`
`and -00143 for the ‘238 patent, which were filed electronically with the Board on
`
`October 23, 2014, and timely served on Cubist, along with IPR2015-00144.
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`2
`As detailed below, Agila began electronic filing of the ‘144 petition on
`
`October 23, 2014 on a separate computer, but encountered difficulties uploading
`
`documents and using the PRPS system. Agila filed the same ‘144 petition later that
`
`same evening by mail with a motion under §42.6(b)(2). The petition and exhibits
`
`were timely served on Cubist. The Board thus received two copies of the ‘144
`
`petition: the electronic copy, which the Board first granted a filing date of October
`
`23, 2014 via notice, subsequently expunged that notice without reason or hearing
`
`and replaced with a notice granting an October 24, 2014 filing date; and the paper
`
`copy, for which the Board has not issued a notice according a filing date.
`
`III.
`
`Statement of the Reasons for the Relief Requested
`
`A.
`
`The Petition Was Timely Filed
`
`(i) The Petition Met the Statutory Requirements
`
`The six statutory requirements for an IPR petition are for the petitioner to: 1)
`
`pay a fee; 2) identify real parties-in-interest; 3) identify the grounds for challenging
`
`each claim; 4) provide evidence supporting the grounds; 5) provide such other
`
`information required by the rules; and 6) serve the petition and evidence on the
`
`patent owner. 35 U.S.C. §312(a). Significantly, no mode of filing or service to the
`
`Patent Owner or the Board is specified in the statute. With every statutory
`
`requirement met on October 23, 2014, this case presents no question of waiving a
`
`statutory deadline. The statutory deadline was met.
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`3
`(ii) Agila Met the Non-Statutory Requirements
`
`The Director has provided rules specifying the mode of filing and service,
`
`e.g., §§42.6(b) & (e), but has also provided the Board authority to administer the
`
`application of the rules, §42.5(a), or to waive the rules entirely if the need arises,
`
`§42.5(b). The default method of filing is electronic, §42.6(b)(1), with the explicit
`
`option of filing by non-electronic means, accompanied by a motion requesting
`
`acceptance of the filing, §42.6(b)(2). There are no further requirements or specific
`
`directions on how the paper filing should be done (other than providing a mailing
`
`address), no conditions for when such filing is appropriate, and no standard for
`
`accepting such filings. The general rules for non-electronic filing should apply to
`
`IPR, in particular the rule which explains that “[a]ny correspondence received by
`
`the United States Patent and Trademark Office (USPTO)” that was delivered by
`
`Priority Mail Express® is accorded the date on which it was deposited with the
`
`United States Postal Service (USPS). §1.10(a).
`
`When Agila encountered difficulties with the electronic filing of its seventh
`
`petition, it promptly followed and met all of the requirements promulgated by the
`
`Director for paper filing. The Express Mail receipt shows a timely deposit with the
`
`USPS on October 23, 2014, and identifies the correct mailing address for paper
`
`filing. Exh.1039. Agila also contacted the Board shortly after the filing to notify
`
`the Board of the paper filing and to ensure the filing reached the correct
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`4
`department; Agila understood that the Board received the paper filed copy shortly
`
`thereafter. Westin Decl. Exh. 1044, ¶10. Thus, Agila filed a complete petition with
`
`the Board on October 23, 2014.
`
`Hence, the question facing the Board is not whether Agila timely filed the
`
`petition, but rather whether the Board will exercise its rule-based authority to
`
`accept the petition in paper form under §42.6(b)(i). Under the current rules, the
`
`Board has ample discretion to accept Agila’s petition and accord the filing date of
`
`October 23, 2014 evidenced by the Priority Mail Express receipt, reflecting receipt
`
`by the Patent Office of the full ‘144 petition. Cubist had a properly served copy of
`
`the petition. Exh. 1038. This exercise of authority does not require the waiver of
`
`any rule; but quite the opposite, it is the application of one.
`
`Agila’s good faith efforts and diligence to meet the statutory deadline, as
`
`well as the extreme prejudice to Agila justifies the application of the non-electronic
`
`filing rule, and acceptance of the paper filing of October 23, 2014.
`
`B.
`
`Acceptance of the Non-Electronic Filing
`
`(i)
`
`Standard and Conditions
`
`Agila unquestionably met the explicit requirements of the rule governing
`
`non-electronic filing, §42.6(b)(2). This rule, however, provides little information
`
`on the conditions for when the Board should accept such a filing.
`
`At the outset, it should be noted that the rule certainly does not set a high
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`5
`standard, e.g., unavoidability, and adopting such a high standard after the fact,
`
`when there was adequate opportunity to do so during the substantive notice and
`
`rulemaking process, would raise serious due process concerns. See Burlington
`
`Truck Lines v. United States, 371 U.S. 156, 168 (1962) (requiring an agency to
`
`articulate “a ‘rational connection between the facts found and the choice made’” if
`
`promulgating rules after the notice period has passed). In fact, related Board
`
`standards suggest a modest threshold should be applied. For example, the Board
`
`accepts untimely filings if “good cause” is shown, §42.5(c)(2), or if it determines
`
`that consideration on the merits would be in the interest of justice, §42.5(c)(3). By
`
`comparison, acceptance of non-electronic filings would not affect the Board’s
`
`deadlines, and thus, should, if anything, receive even more favorable treatment
`
`than untimely filings. See also §42.1(b) (requiring rule construction “to secure the
`
`just, speedy, and inexpensive resolution of every proceeding”).
`
`Finally, should the Board limit the availability of paper filing post hoc to the
`
`single situation where the “Office’s electronic filing system is unable to accept
`
`filings” (i.e., the nonexclusive example given in the Practice Guide, see 77 Fed.
`
`Reg. 48756, 4875) the Board would contradict its guidance that unavailability is
`
`just an example in an inclusive list. Everyone has known unexpected difficulties
`
`with electronic equipment. In the present case, the Board’s electronic system is
`
`reportedly incompatible, at least in part, with updated browsers, including one of
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`6
`Agila’s. See Westin Dec. (Exh. 1044) ¶9. Thus, the Board must exercise reasonable
`
`discretion when applying §42.6(b)(2) where technical difficulties are encountered.
`
`In the absence of a formally adopted standard, Agila respectfully submits
`
`that the right standard should balance a good-faith, reasonable effort to file
`
`electronically against any resulting prejudice for the inability to file electronically.
`
`See In re Bachler, 229 U.S.P.Q. 553, 554-55 (Comm’r Patents 1986); accord In re
`
`Weiler, 790 F.2d 1576, 1579 (Fed. Cir. 1986) (remedial provisions should be
`
`construed liberally). Agila easily satisfied this standard.
`
`(ii) Reasonable Good-Faith Efforts to File Electronically
`
`Agila filed seven petitions directed to four of Cubist’s patents, including the
`
`subject ‘238 patent, which required four petitions to cover its 192 claims within the
`
`60-page limit, §42.24. The total cost for requesting IPR on the ‘238 patent alone
`
`was $168,400.
`
`Agila took reasonable efforts to prepare exhibits and documents well ahead
`
`of the deadline by October 22nd. Serrano Dec. (Exh. 1043) ¶5. The petitions and
`
`declarations were signed, marked and ready for electronic filing between 3:30–
`
`4:00 pm PDT. Westin Dec. (Exh. 1044) ¶3. Agila filed the first two petitions
`
`(IPR2015-00131 and IPR2015-00132) by 5:00 pm PDT. Agila began filing the
`
`third petition (IPR2015-00140) at approximately 5:30 pm PDT. Westin Dec. (Exh.
`
`1044) ¶4. The sequential filing of the fourth (IPR2015-00141), fifth (IPR2015-
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`7
`00142) and sixth (IPR2015-00143) petitions followed. Id.
`
`During the filing of the sixth petition, Agila started the electronic filing of
`
`the seventh petition (IPR2015-00144) at 8:26 pm PDT on another computer.
`
`Serrano Dec. (Exh. 1043) ¶7; Westin Dec. (Exh. 1044) ¶5. Technical issues with
`
`the PRPS system occurred several times during this filing, requiring closing of the
`
`PRPS session and a new log-in. Serrano Dec. (Exh. 1043) ¶8. Despite these
`
`technical issues, Agila was able to upload the petition, supporting declarations,
`
`numerous exhibits, and other related court documents. Id. ¶9. Agila paid the
`
`petition fee of $42,400, and received a payment receipt by email dated October 23,
`
`2014, Exh. 1040, but received another receipt by email with a provisional filing
`
`date of October 24, 2014. Exh. 1041. Westin Dec. (Exh. 1044) ¶8.
`
`Agila had basis to believe it timely met the statutory requirements for filing
`
`the petition, which was confirmed by the Board’s notice according a filing date of
`
`October 23, 2014, Exh. 1042, and acted on the notice by filing a corrected petition
`
`as the notice required. While the Board later expunged the notice without comment
`
`on November 7th and posted a new notice according a filing date of October 24,
`
`2014, the Board has provided no explanation for the change, instead shifting the
`
`burden to Agila to ask the Board to restore the original notice.
`
`C.
`
`Agila Ensured an October 23, 2014 Filing Date by Filing Under
`§42.6(b)(2)
`
`Although Agila believed it timely filed its petition despite the technical
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`8
`issues, Agila further ensured a timely filing by paper filing a complete copy of the
`
`petition under §42.6(b)(2). Here, Agila took prompt and decisive action to comply
`
`with the paper filing rules and arranged for a complete copy of the petition
`
`(including payment authorization for the petition fee), exhibits and motion under
`
`§42.6(b)(2) to be printed in Palo Alto, California, sent by courier to the San
`
`Francisco International Airport Post Office, and then mailed via Priority Express
`
`Mail. See §1.10(a); Westin Decl. Exh. 1044, ¶¶6-7. A stamped Express Mail
`
`receipt with an October 23, 2014 date was received. Exh. 1039.
`
`Agila thus took reasonable measures to file seven IPR petitions with PRPS,
`
`and despite its diligence, encountered unexpected technical difficulties. Agila then,
`
`in good faith, completed its filing by Priority Mail Express despite geographical
`
`and timing hurdles, again exhibiting its diligence in ensuring that the petitions were
`
`timely filed with the Board. Agila should be accorded the filing date reflected on
`
`the Priority Mail Express receipt.
`
`(i) No Legally Cognizable Prejudice Except to Agila
`
`Both the Board and Cubist received the complete petition in a timely
`
`fashion. See Exh. 1038. And although there were issues with the default electronic
`
`format, the only possible prejudice arising therefrom falls on Agila and is readily
`
`addressed by accepting the paper filing under §42.6(b)(2).
`
`The Board suffers no cognizable prejudice. The existence of §42.6(b)(2)
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`9
`demonstrates that electronic filing is only a preference, and that physical receipt of
`
`the petition is not an insurmountable hardship. The rule is remedial and, thus,
`
`should not be used as a tool to retract a petitioner’s statutory rights. Further, the
`
`Board had a complete electronic set of the documents for the subject petition,
`
`given that the petition was uploaded on October 23 and all the exhibits were
`
`available in the sister petitions and subsequently in the record for this petition.
`
`Indeed, the most efficient process for Agila, the Board, Cubist and the public
`
`would be for these issues to be resolved together.
`
`Cubist also suffers no legally cognizable harm. Cubist was timely served (in
`
`paper). Moreover, Cubist has not been prejudiced by the paper filing as it has been
`
`able to use the co-existing electronic record ever since it received service. Cubist
`
`also has no stake in the administrative question between the Board and Agila
`
`regarding acceptance of the paper filing. The time and expense of trying a timely
`
`filed and served petition on the merits is not a harm that the law recognizes. See,
`
`e.g., Foman v. Davis, 371 U.S. 178, 181 (1962) (reversing dismissal for lack of
`
`prejudice in face of cure). Cubist also suffers little practical harm. It already faces
`
`three other Agila petitions on the same patent that included the same set of exhibits
`
`and declarations and recited substantially similar grounds. And again, Cubist was
`
`timely served all petitions, exhibits and declarations. Thus, there was no delay to
`
`Cubist receiving notice of the basis for relief and grounds of patentability
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`10
`described in the subject petition. See 77 Fed. Reg. 48756, 48762 (Aug. 14, 2012).
`
`Finally, the prejudice to Agila and other stakeholders would be considerable.
`
`Petitions are very expensive to file and should be resolved on the merits when
`
`possible. §42.1(b). A partial resolution of the patentability of the ‘238 patent would
`
`only shift the burden from the Board to another forum, such as the United States
`
`District Court, District of Delaware. This shift would impose substantial costs on
`
`the parties and the public for the largely tax-payer supported costs of the court. It
`
`would also impose greater uncertainty for a longer period on Agila and the public.
`
`In sum, the balance of prejudices weighs overwhelmingly in Agila’s favor.
`
`IV. CONCLUSION
`Agila’s address of each inquiry set forth by the Board (see Paper No. 9)
`
`leads to one conclusion: The Board should grant this motion because the only thing
`
`standing between normal consideration of the petition and dismissal is the Board’s
`
`decision to accept the paper petition. Agila made reasonable good-faith efforts to
`
`file electronically and then took prompt rule-based action to ensure timely filing.
`
`Finally the balance of prejudices is not even close. Thus, Agila respectfully
`
`requests the Board to accept its paper petition and suggests that the Board simply
`
`accord the paper-petition filing date to the parallel electronic record. The Board
`
`need not waive any statute or rule. It need only follow its existing rules.
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`Dated: December 1, 2014
`
`11
`Respectfully submitted,
`
`/Peter R. Munson/
`Peter R. Munson
`Lead Attorney for Petitioners, AGILA
`SPECIALTIES INC. AND MYLAN
`PHARMACEUTICALS INC.
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE
`
`

`
`12
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), I certify that I caused to be served a true
`
`and correct copy of Petitioner’s Motion to Correct Accorded Filing Date and
`
`Exhibits
`
`1038-1044
`
`by electronic mail
`
`on
`
`the
`
`patent owner Cubist
`
`Pharmaceuticals, Inc. at:
`
`William DeVaul: William.DeVaul@cubist.com
`Henry Gu: Henry.Gu@cubist.com
`
`Dated: December 1, 2014
`
`/Lorelei P. Westin/
`Lorelei P. Westin, Reg. No. 52,353
`
`Wilson Sonsini Goodrich & Rosati PC
`12235 El Camino Real, Suite 200
`San Diego, CA 92130-3002
`Tel.: (858) 350-2225
`Facsimile: (858) 350-2399
`E-mail: lwestin@wsgr.com
`
`AGILA’S MOTION TO CORRECT ACCORDED FILING DATE