Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`Paper 38
`Date: December 14, 2018
`
`
`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.
`
`
`
`Case IPR2018-00892
`Patent 9,326,945 B2
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN and KRISTI L. R. SAWERT,
`Administrative Patent Judges.
`
`
`SNEDDEN, Administrative Patent Judge.
`
`
`DECISION
`Granting Petitioner’s Motion to Correct a Typographical or Clerical Mistake
`37 C.F.R. § 42.104(c)
`
`
`571-272-7822
`
`
`
`
`
`
`
`Paper 38
`Date: December 14, 2018
`
`
`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.
`
`
`
`Case IPR2018-00892
`Patent 9,326,945 B2
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN and KRISTI L. R. SAWERT,
`Administrative Patent Judges.
`
`
`SNEDDEN, Administrative Patent Judge.
`
`
`DECISION
`Granting Petitioner’s Motion to Correct a Typographical or Clerical Mistake
`37 C.F.R. § 42.104(c)
`
`
`
`I.
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`INTRODUCTION
`On November 20, 2018, we authorized Petitioner to file a motion to
`correct a clerical error pursuant to 37 C.F.R. § 42.104(c). Paper 30. On
`November 26, 2018, Petitioner filed a Motion to Correct a Typographical or
`Clerical Mistake. Paper 31 (“Mot.”). Petitioner includes declarations from
`Dr. Kinam Park (Ex. 1044; “Second Suppl. Park Decl.”) and Karen L.
`Carroll (Ex. 1045; “Carroll Decl.”) in support of the Motion. Petitioner also
`provides a list of proposed corrections to fix alleged typographical errors
`contained within citations to Rudnic (Ex. 1010) in the Petition (Paper 2;
`“Pet.”) and in the Declaration of Dr. Park in support of the Petition (Ex.
`1002; “Park Declaration”). Mot, Appendix A.
`Petitioner proposes to correct certain citations referring to the Rudnic
`reference (Ex. 1010) as Chapter 10 of the fourth edition of the textbook
`Modern Pharmaceutics, published in 2002, rather than the third edition,
`published in 1996. Id. In its Motion, Petitioner explains that the
`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
`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).
`
`
`
`2
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`IPR2018-00892
`Patent 9,326,945 B2
`
`
`Id. at 3–4 (emphases omitted). Petitioner contends that correcting the
`citations of Rudnic in the Petition and Park Declaration are clerical and non-
`substantive, and that the corrections thereof would not prejudice Patent
`Owner. Mot. 4–5. In particular, Petitioner contends that the proposed
`changes do not affect the substantive teachings of Rudnic and that “the error
`did not prevent Patent Owners from addressing the substantive teachings of
`Rudnic in the Preliminary Response.” Id.
`On December 3, 2018, Patent Owners filed an Opposition to
`Petitioner’s Motion to Correct a Typographical or Clerical Mistake. Paper
`35 (“Opp.”). In its Opposition, Patent Owners contend that the “citation of
`the fourth edition in the Petition and Park Declaration was not the result of a
`typographical mistake—it was a substantive mistake.” Opp. 4. In this
`regard, Patent Owners contend that “Exhibit 1010 contained the cover and
`publication information for the fourth edition[,]” and as such, “[t]his is not a
`case where Petitioner intended to cite to the third edition of the text,
`mistyped the number, and clearly supplied the third edition in the exhibit.”
`Id. Patent Owners also contend that “Petitioner’s failure to adequately
`identify its reference has impaired Patent Owners’ ability to challenge the
`status of the Rudnic reference as a prior-art printed publication and to
`substantively respond to it.” Id. at 5.
`Upon consideration of the documents and the parties’ arguments, and
`for the reasons stated below, Petitioner’s motion is granted.
`
`II. ANALYSIS
`An inter partes review proceeding begins with the filing of a petition.
`37 C.F.R. § 42.104. A complete petition gives notice to the Patent Owner of
`
`
`
`3
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`IPR2018-00892
`Patent 9,326,945 B2
`
`the basis for relief by laying out the petitioner’s grounds and supporting
`evidence. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48756,
`48763 (Aug. 14, 2012). Where a party files an incomplete petition, no filing
`date is accorded. 37 C.F.R. § 42.106.
`The Board’s rules, however, make allowance for the correction of
`certain clerical mistakes. Thus, 37 C.F.R. § 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 filing date of the petition.
`
`This rule allows errors to be corrected in certain situations, without
`sacrificing the notice function of the petition in informing the patent owner
`of the “grounds and supporting evidence” for the petition. We have
`previously noted that this rule is remedial in nature and therefore is entitled
`to a liberal interpretation. ABB Inc. v. ROY-G-BIV Corp., Case IPR2013-
`00063, Paper No. 21 (Decision – Motion to Correct Petition), at 7 (citing
`Tcherepnin v. Knight, 389 U.S. 332, 336 (1967)).
`Based on our review of the facts as set forth in the declarations of Dr.
`Park and Ms. Carroll, we have determined that Petitioner has carried its
`burden of establishing that a clerical error led to the misidentification of Ex.
`1010 as Chapter 10 of the fourth edition of the textbook Modern
`Pharmaceutics, published in 2002, rather than the third edition, published in
`1996. Here, we credit the testimony of Ms. Carroll and find credible
`explanation as to how the wrong header pages were associated with Ex.
`1010. Ex. 1045 ¶¶ 3–6. We further credit the testimony of Dr. Park that his
`original declaration (Ex. 1002) is based on the Chapter 10 found in the third
`edition of Modern Pharmaceutics.
`
`
`
`4
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`IPR2018-00892
`Patent 9,326,945 B2
`
`We are not persuaded by Patent Owner’s arguments as to why the
`motion should be denied. Patent Owners had sufficient notice of the
`portions of Ex. 1010 relied upon in the challenges to the claims of the ’945
`patent, and was not prejudiced in that Patent Owners responded to the
`asserted grounds in its Patent Owner Preliminary Response. Paper 18, 16
`and 23. Furthermore, we do not agree with Patent Owners that its ability to
`challenge the status of the Rudnic reference as a prior-art printed publication
`has been impaired. Patent Owner will have the opportunity to address that
`issue in its Patent Owner Response due January 15, 2019, should it wish to
`do so. Paper 25. The correction would not require Patent Owners to analyze
`or respond to any new testimony from Dr. Park or any new arguments in the
`Petition. Rather, we find that correcting this error only serves to clarify the
`record by correctly identifying the substantive portion of Ex. 1010 as
`Chapter 10 of the third edition of the textbook Modern Pharmaceutics,
`published in 1996.
`Under the specific facts before us, we conclude that the errors related
`to the proper citation of Ex. 1010 identified in the Petition and Park
`Declaration are amenable to correction under § 42.104(c). Accordingly, the
`Motion is granted with no change in the filing date accorded to the Petition.
`37 C.F.R. § 42.104(c).
`
`III. ORDER
`For the reasons given:
`ORDERED that that Petitioner’s Motion to Correct a Typographical
`or Clerical Mistake (Paper 31) is granted.
`FURTHER ORDERED that the sentence in footnote 7 on page 28 of
`the Petition is corrected as follows:
`
`
`
`5
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`IPR2018-00892
`Patent 9,326,945 B2
`
`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, constitutes prior art under 35 U.S.C. § 102(b) to the
`’945 patent.
`
`FURTHER ORDERED that the description of the Rudnic reference
`identified as Ex. 1010 on page 5 of APPENDIX B: LISTING OF
`EXHIBITS in the Petition is corrected as follows:
`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).
`
`FURTHER ORDERED that the description of the Rudnic reference
`in header ii on page 58 of the Park Declaration (Ex. 1002) is corrected as
`follows:
`Ex. 1010 – 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) (“Rudnic” or Ex. 1010).
`
`FURTHER ORDERED that the first sentence of paragraph 140 on
`page 58 of the Park Declaration (Ex. 1002) is corrected as follows:
`Rudnic was published in 20021996, and constitutes prior art
`under 35 U.S.C. § 102(b) to the ’945 patent.
`
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`6
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`
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`For PETITIONER:
`
`Robert Florence
`Karen Carroll
`Micheal Binns
`Sharad Bijanki
`PARKER POE ADAMS & BERNSTEIN LLP
`robertflorence@parkerpoe.com
`karencarroll@parkerpoe.com
`michealbinns@parkerpoe.com
`sharadbijanki@parkerpoe.com
`
`For PATENT OWNER:
`
`Heather Petruzzi
`Timothy Cook
`Kevin Yurkerwich
`Michael Nelson
`WILMER CUTLER PICKERING HALE AND DORR LLP
`Heather.Petruzzi@wilmerhale.com
`Tim.Cook@wilmerhale.com
`Kevin.Yurkerwich@wilmerhale.com
`Michael.Nelson@wilmerhale.com
`
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`7
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