`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
`
`BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC.,
`Patent Owners.
`
`
`U.S. Patent No. 9,326,945 to Patel et al.
`
`Inter Partes Review IPR2018-00892
`
`
`
`Before SHERIDAN K SNEDDEN, ZHENYU YANG, and
`KRISTI L. R. SAWERT, Administrative Patent Judges
`
`
`
`
`PETITIONER’S MOTION TO CORRECT A TYPOGRAPHICAL OR
`CLERICAL MISTAKE IN THE PETITION UNDER 37 C.F.R. § 42.104(c)
`
`
`
`
`
`
`
`
`
`I.
`
`
`
`INTRODUCTION AND RELIEF REQUESTED
`
`Pursuant to the Board’s November 20, 2018 Order (Paper No. 30), the Board
`
`authorized Petitioner to file a motion to correct inadvertent clerical/typographical
`
`errors in the Petition (Paper No. 2) and the Park Declaration (Ex. 1002) (“Park
`
`Decl.”) incorrectly referring to the Rudnic reference (Ex. 1010) as Chapter 10 of
`
`the fourth edition of the textbook Modern Pharmaceutics, rather than the third
`
`edition, and to file a separate motion (filed concurrently herewith) to submit
`
`supplemental information, that replaces Ex. 1010 with a clean copy of Rudnic (Ex.
`
`1042) thereby removing extraneous markings, the incorrect cover page and
`
`publishing information to the fourth edition and replacing it with the correct cover
`
`page and publishing information for the third edition. Therefore, pursuant to 37
`
`C.F.R. § 42.104(c), Petitioner requests that it be allowed to correct the
`
`typographical errors relating to Rudnic in both the Petition and the Park Decl. as
`
`proposed in APPENDIX A – PROPOSED CORRECTIONS attached hereto.
`
`II. DISCUSSION OF AUTHORITY AND MATERIAL FACTS
`
`The Board’s rules allow for correction of certain clerical and typographical
`
`mistakes. See Amkor Technology, Inc. v. Tessera, Inc., Case IPR2013-00242,
`
`2013 WL6907729, *2 (PTAB Aug. 29, 2013). Rule 42.104(c) provides:
`
`A motion may be filed that seeks to correct a clerical or typographical
`
`mistake in the petition. The grant of such a motion does not change the
`
`1
`
`
`
`
`
`filing date of the petition.
`
`37 C.F.R. § 42.104(c). Rule 42.104(c) is remedial in nature and has been liberally
`
`interpreted to allow not only the correction of clerical or typographical mistakes
`
`contained in a petition, but also for related documents filed in support of a petition.
`
`See, e.g., Amkor Technology, Inc., Case IPR2013-00242, 2013 WL6907729, at *3
`
`(granting motion to correct citation to wrong reference in petition); Emerson Elec.
`
`Co. v. Sipco, LLC, Case IPR2017–00260, 2017 WL 1952720, at *1 (PTAB May 9,
`
`2017) (granting motion to correct pinpoint citations in petition to corresponding
`
`exhibits); Abb Inc. v. Roy-G-Biv Corp., Case IPR2013-00063, 2013 WL 6907728,
`
`at *6 (PTAB Jan. 16, 2013) (granting motion to correct the uploading of incorrect
`
`exhibits in support of petition by replacing with correct exhibits)1; Syntroleum
`
`Corp. v. Nest Oil Oyj, Case IPR2013-00178, 2013 WL 5970108, at *3 (PTAB Jul.
`
`22, 2013) (same).
`
`Correction is especially appropriate here where no substantive changes are
`
`
`1 Petitioner understands that the Board has limited this motion to correcting the
`
`typographical errors in the Petition and the Park Decl. (see Order, Paper No. 30),
`
`but submits that 37 C.F.R. § 42.104(c) also provides for the correction of Rudnic
`
`(Ex. 1010) because the incorrect header portions (edition and publishing date) of
`
`Rudnic was due to a clerical error. Nevertheless, Petitioner limits this motion as
`
`ordered by the Board.
`
`2
`
`
`
`
`
`being proposed; therefore, the correction will not affect the notice function of the
`
`Petition in informing the Patent Owner or the Board of the grounds and
`
`supporting evidence for the petition. See Amkor Technology, Inc., Case IPR2013-
`
`00242, 2013 WL6907729, at *3-4 (finding no prejudice to patent owner by
`
`allowing petitioner to correct the disclosure of subject matter to a particular claim
`
`where the patent owner had notice of the substantive portions of a prior art
`
`reference relied on in the petition and had an opportunity to respond in its
`
`preliminary response).
`
`
`
`The Petition and the Park Decl. filed April 5, 2018 incorrectly refer to
`
`Rudnic (Ex. 1010) as Chapter 10 of the fourth edition of the textbook Modern
`
`Pharmaceutics published in 2002. (See generally, Second Supplemental Park
`
`Declaration (“Second Suppl. Park Decl.”) and Declaration of Karen L. Carroll
`
`(“Carroll Decl.”) submitted herewith). The citations should have instead referred
`
`to the third edition of Modern Pharmaceutics published in 1996 as the substantive
`
`portions of the Rudnic reference provided (i.e., Chapter 10) with the Petition were
`
`actually from the third edition of Modern Pharmaceutics rather than the fourth
`
`edition. (Id.) This clerical error occurred due to a third-party prior art search
`
`providing Petitioner with a copy of Chapter 10 of Modern Pharmaceutics from the
`
`third edition consisting of pages 333-359, without including a cover page,
`
`publication date information, or table of contents, but misidentifying that chapter
`
`3
`
`
`
`
`
`as coming from the fourth edition. (See Carroll Decl., ¶¶ 2-5; Second Suppl. Park
`
`Decl., ¶¶ 5-6). In reliance on the incorrect citation, Petitioner obtained the
`
`publication date information and cover from the fourth edition, combined those
`
`missing pages with Chapter 10 from the third edition, and filed that compilation as
`
`Ex. 1010.. (See Carroll Decl., ¶ 6; Second Suppl. Park Decl., ¶ 4). Accordingly,
`
`the substantive portions of Rudnic (i.e., Chapter 10), including all pinpoint page
`
`citations thereto, cited and discussed within the Petition and the Park Decl.
`
`correctly refer to Chapter 10 from the third edition submitted within Ex. 1010.
`
`(See Second Suppl. Park Decl., ¶ 5). Petitioner was unaware, however, of these
`
`errors until Patent Owners submitted a table of contents purporting to be from the
`
`fourth edition of Modern Pharmaceutics (Ex. 2019) with Patent Owners’
`
`Preliminary Response (Paper No. 18). (See Carroll Decl., ¶ 7). Thereafter,
`
`Petitioner investigated further by obtaining a complete copy of the fourth edition of
`
`Modern Pharmaceutics, comparing Chapter 10 from both editions, thereby
`
`discovering the error necessitating this motion. (See Carroll Decl., ¶ 8).
`
`
`
`Patent Owners will suffer no prejudice by the requested correction. First,
`
`the error did not prevent Patent Owners from addressing the substantive teachings
`
`of Rudnic in the Preliminary Response. (Prel. Resp., Paper No. 18, p. 16 and 23;
`
`Decision, Paper No. 24, p. 8). Second, Patent Owners have already admitted that
`
`“all prior art references relied on in Grounds 1–4 [including Rudnic] qualify as
`
`4
`
`
`
`
`
`
`
`prior art under the earliest possible priority date” and a POSA would understand
`
`that either edition of Rudnic predates the ’945 patent. (See Prel. Resp., Paper No.
`
`18, p. 9; Decision, Paper No. 24, p. 28; see also Second Suppl. Park Decl., ¶¶ 6-
`
`7). Thus, the error has not prejudiced Patent Owners, and neither would the
`
`proposed corrections, as there would be no change to the substantive teachings of
`
`Rudnic already addressed by Patent Owners. See Amkor Technology, Inc., Case
`
`IPR2013-00242, 2013 WL6907729, at*3-4 (granting motion to correct because
`
`“[t]he correction would not require [patent owner] to analyze or respond to any
`
`new citations or arguments in the Petition”); 37 C.F.R. § 42,1(b) (dictating that
`
`the Board’s rules “shall be construed to secure the just, speedy and inexpensive
`
`resolution of every proceeding”). Finally, Patent Owners can respond further in
`
`their Response due on January 15, 2019 (see Decision, Paper No. 24, p. 34;
`
`Sched. Order, Paper No. 25, p. 8). Accordingly, Petitioner respectfully requests
`
`that the Board grant the relief requested herein.
`
`Dated: November 26, 2018
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`5
`
`Respectfully submitted,
`
`/ Robert L. Florence /
`Robert L. Florence (Reg. No. 54,933)
`Karen L. Carroll (Reg. No. 50,748)
`Sharad K. Bijanki (Reg. No. 73,400)
`Micheal L. Binns (Reg. No. 65,836)
`
`
`
`
`
`APPENDIX A – PROPOSED CORRECTIONS
`
`Corrections to Petition: Correct the following typographical errors contained
`
`within citations to Rudnic in the Petition (Paper No. 2) as proposed with redlining
`
`below:
`
`
`
`Change the sentence in footnote 7 on page 28 to recite “Rudnic, E.M.
`
`and M.K. Kottke, “Tablet Dosage Forms,” in Modern Pharmaceutics, 4th
`
`ed.3rd ed., G.S. Banker and C.T. Rhodes, eds., Taylor & Francis Group,
`
`Boca Raton, FL, pp. 333-359 (20021996) (“Rudnic” or Ex. 1010), published
`
`in 20021996, . . . .”
`
`
`
`Change the description of the Rudnic reference on page 5 of
`
`APPENDIX B: LISTING OF EXHIBITS to similarly recite “Rudnic et al.,
`
`“Tablet Dosage Forms,” in Modern Pharmaceutics, 4th ed.3rd ed., G.S.
`
`Banker and C.T. Rhodes, eds., Taylor & Francis Group, Boca Raton, FL, pp.
`
`333-359 (20021996).”
`
`
`
`Corrections to Park Decl.: Correct the following typographical errors
`
`contained within references to Rudnic in the Park Decl. (Ex. 1002) as proposed
`
`with redlining below:
`
`
`
`Change the description of the Rudnic reference in header ii on page 58
`
`to correctly recite “Ex. 1010 – Rudnic et al., “Tablet Dosage Forms,” in
`
`Modern Pharmaceutics, 4th ed.3rd ed., G.S. Banker and C.T. Rhodes, eds.,
`
`i
`
`
`
`
`
`Taylor & Francis Group, Boca Raton, FL, pp. 333-359 (20021996)
`
`(“Rudnic” or Ex. 1010).”; and, change the first sentence of paragraph 140 to
`
`recite “Rudnic was published in 20021996, and . . . .”
`
`ii
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Petitioner’s Motion to Correct a Typographical or Clerical Mistake in the
`
`Petition Under 37 C.F.R. § 42.104(c) by email on this 26th day of November, 2018
`
`on the following attorneys of record:
`
`Heather M. Petruzzi
`Michael E. Nelson
`Amy K. Wigmore
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Ave, NW
`Washington, DC 20006
`E-mail: Heather.Petruzzi@wilmerhale.com
`E-mail: Michael.Nelson@wilmerhale.com
`E-mail: Amy.Wigmore@wilmerhale.com
`
`Timothy A. Cook
`Kevin M. Yurkerwich
`Kevin S. Prussia
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`E-mail: Tim.Cook@wilmerhale.com
`E-mail: Kevin.Yurkerwich@wilmerhale.com
`E-mail: Kevin.Prussia@wilmerhale.com
`
`Jason M. Okun
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`E-mail: JOkun@fchs.com
`
`Respectfully submitted,
`
`
`
`/ Robert L. Florence /
`Robert L. Florence, Lead Counsel
`Registration No. 54,933
`
`
`Dated: November 26, 2018
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
