Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 76
`Date: Dec. 23, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., and
`SUN PHARMACEUTICALS INDUSTRIES LTD.
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`_____________
`
`IPR2020-000401
`Patent 7,326,708 B2
`_______________
`
`Before SHERIDAN K. SNEDDEN, ROBERT A. POLLLOCK, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`
`MAJORS, Administrative Patent Judge.
`
`
`
`
`ORDER
`Granting Patent Owner’s Motion to File Request for Certificate of
`Correction of Claims 5–7
`37 C.F.R. §§ 1.323, 42.20
`
`1 Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were
`joined as parties to this proceeding via a Motion for Joinder in IPR2020-
`01060; and Sun Pharmaceuticals Industries Ltd. was joined as a party to this
`proceeding via Motion for Joinder in IPR2020-01072.
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`
`
`I.
`BACKGROUND
`Mylan Pharmaceuticals Inc. (“Mylan”), on October 30, 2019, filed a
`Petition to institute inter partes review of claims 1–4, 17, 19, and 21–23 of
`U.S. Patent No. 7,326,708 B2 (Ex. 1001, “the ’708 patent”). Paper 1. On
`May 12, 2020, after considering a Preliminary Response (Paper 10) by
`Patent Owner Merck Sharp & Dohme Corp. (“Patent Owner” or “Merck”)
`(as well as other pre-institution papers that we authorized for filing), we
`instituted trial. Paper 21. Other parties were later joined as petitioners
`(supra n.1) and we refer to all petitioners, including Mylan, collectively as
`“Petitioner” in this Order.
`On November 6, 2020, the Board held a conference call with the
`parties to discuss Merck’s request for authorization to file a motion seeking
`leave to petition the Director for a certificate of correction related to certain
`claims of the ’708 patent. More specifically, Merck seeks to file a request
`for a certificate of correction on claims 5–7, which claims Merck contends
`include a mistake by the patent applicant correctable under 35 U.S.C. § 255.
`Claims 5–7 are not challenged in this IPR. Although the patentability of
`claims 5–7 is not at issue in this proceeding, Merck is not permitted to file
`its request for a certificate of correction of those claims absent the Board’s
`permission. 37 C.F.R. § 1.323; Honeywell Int’l Inc. v. Arkema Inc., 939
`F.3d 1345, 1349–50 (Fed. Cir. 2019) (explaining the steps required by a
`patent owner seeking the Board’s leave to petition the Director for a
`certificate of correction for a patent undergoing post-grant proceedings
`
`2
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`before the Board).2 After hearing from the parties at the conference, we
`allowed Merck to file the present motion. Ex. 2275 (transcript of
`conference); Paper 63 (“Mot.”). Petitioner opposed, and Merck filed a reply
`in support of its motion. Paper 70 (“Opp.”); Paper 71 (“Mot. Reply”).
`
`II. DISCUSSION
`The Federal Circuit explains that a patent owner seeking a certificate
`of correction on a patent undergoing post-grant review must take three steps.
`Honeywell, 939 F.3d at 1349. Those steps are:
`(1) seek authorization from the Board to file a motion, 37 C.F.R.
`§ 42.20(b);
`(2) if authorization is granted, file a motion with the Board,
`asking the Board to cede its exclusive jurisdiction so that the
`patentee can seek a Certificate of Correction from the
`Director, 37 C.F.R. § 1.323; MPEP § 1485; and
`(3) if the motion is granted, petition the Director for a Certificate
`of Correction under 35 U.S.C. § 255.
`Id. (citing Plastic Dev. Grp., LLC v. Maxchief Investments, Ltd., IPR2017-
`00846, Paper 16 at 2 (PTAB Nov. 13, 2017)). Merck completed steps (1)
`and (2). What remains is Board authorization for Merck to take step (3) and
`to petition the Director for the desired certificate correcting claims 5–7,
`which Board authorization is the subject of this motion.
`
`
`2 Because claims 5–7 are not at issue in this IPR, the parties agree that,
`whether the Board grants Merck’s motion to file a request for certificate of
`correction of those claims and cedes jurisdiction over the patent for that
`limited purpose, the present IPR will otherwise be unaffected and will
`remain on its existing schedule. Ex. 2275, 20:14–21:17.
`
`3
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`The Board’s inquiry in resolving the present motion is limited. The
`inquiry does not, as the Federal Circuit instructs, include deciding the merits
`of whether a certificate of correction should issue under 35 U.S.C. § 255.
`Honeywell, 939 F.3d at 1348–50 (holding the Board abused its discretion in
`(i) requiring patent owner to show the requirements of § 255 have been met
`before authorizing the motion and (ii) assuming the authority reserved for
`the Director in deciding the merits of patent owner’s request for the
`certificate).3 To the contrary, the question for the Board is “‘whether there is
`sufficient basis supporting Patent Owner’s position that the mistake may be
`correctable.’” Id. at 1349 (quoting Plastic Dev. Grp., Paper 16 at 2 (with the
`court’s emphasis)) (“We hold that this standard of review is appropriate and
`consistent” with, inter alia, § 255 and the relevant regulations). In resolving
`that limited question, the Board is not permitted to decide whether, for
`example, the alleged mistake is of a “minor character” or “occurred in good
`faith” as recited under § 255—those questions are for the Director. 35
`U.S.C. § 255; Honeywell, 939 F.3d at 1349.4
`
`
`3 “[W]e conclude that the Board abused its discretion by assuming the
`authority that 35 U.S.C. § 255 expressly delegates to the Director: to
`determine when a Certificate of Correction is appropriate.” Honeywell, 939
`F.3d at 1348.
`4 Other Board decisions have, in determining if a “sufficient basis” exists,
`assessed if “there appears to be a legitimate question as to whether the
`issuance of a Certificate of Correction is an appropriate course of action.”
`Intuitive Surgical, Inc. v. Ethicon LLC, IPR2020-00051, Paper 13, 4–5
`(PTAB Feb. 26, 2020) (“[W]ith the recognition of that legitimate question is
`the logical conclusion that Patent Owner has shown a sufficient basis in
`support of its position and that the matter should be considered by the
`appropriate official charged with answering the question, namely, the
`Director.”).
`
`4
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`Under 35 U.S.C. § 255, the Director may correct “a mistake of a
`clerical or typographical nature, or of minor character,” which “appears in a
`patent and a showing has been made that such mistake occurred in good
`faith.”
`Merck argues that claims 5–7 of the ’708 patent contain such a
`mistake and that it should be permitted to request that the Director make an
`appropriate correction. Mot. 1–3. Merck contends that claim 5–7 relate to
`particular crystalline monohydrate forms of a dihydrogenphosphate salt of
`sitagliptin, characterized by X-ray powder diffraction or “XRPD.” Id.
`Claim 5 recites the following and is illustrative of the alleged mistake in
`each of claims 5–7: “The salt of claim 4 characterized by characteristic
`absorption bands obtained from the X-ray powder diffraction pattern at
`spectral d-spacings of 7.42, 5.48, and 3.96 angstroms.” Ex. 1001, 16:49–52
`(emphases added).
`According to Merck, claims 5–7 should not have referred to
`“absorption bands” or “spectral” d-spacings. Id. at 4–6. Merck argues that
`such “obviously mistaken wording” makes no sense in the context of XRPD,
`which produces “diffraction peaks,” not “absorption bands” with “spectral”
`characteristics. Id. Moreover, Merck contends, the mistake and how it
`should be corrected would have been “clearly evident” to an ordinarily
`skilled person reading the intrinsic evidence, which does not refer to
`“absorption bands” and instead describes XRPD using the allegedly correct
`terminology—“diffraction peaks.” Id. at 6 (citing Specification (Ex. 1001,
`13:31–33): “[t]he monohydrate exhibited characteristic diffraction peaks
`corresponding to d-spacings of 7.42, 5.48, and 3.96 angstroms”).
`
`5
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`Although Merck concedes that the district court in related litigation
`where claims 5–7 are (or were) at issue determined that it could not fix the
`mistake and held those claims indefinite, Merck contends that does not stop
`the Patent Office from fixing the claims by certificate of correction. Mot. 3,
`5–6, 8–10. Merck cites Novo Indus., LP v. Micro Molds Corp., 350 F.3d
`1348, 1356 (Fed. Cir. 2003) for the proposition that “an error that ‘makes a
`claim indefinite’ can be fixed via a certificate.” Id. at 5–6. Further to this
`point, Merck contends that, while the court may have believed it could not
`interpret the claims to correct them, the Patent Office has a different or
`broader authority under the statute to correct errors in a patent. Id. at 9
`(citing the court’s discussion in Novo, 350 F.3d at 1356, that “we do not
`think that Congress intended that the district courts have authority to correct
`any and all errors that the PTO would be authorized to correct under sections
`254 and 255”).5
`Merck also argues that the mistake in claim language occurred in
`good faith. Mot. 7. According to Merck (and its declarant, named inventor
`Robert M. Wenslow, Ph.D.), “absorption bands” is a different “concept from
`spectrographic techniques . . . [that was] incorrectly imported into the claims
`when they were drafted” and the mistake went unnoticed upon review of the
`application and during prosecution. Ex. 2281 ¶ 6; Mot. 7.
`
`
`5 The Novo court “conclude[d] that the district court can correct only Essex-
`type errors” where “the correction is not subject to reasonable debate based
`on consideration of the claim language and the specification” and “the
`prosecution history does not suggest a different interpretation of the claims.”
`Novo, 350 F.3d at 1357; see also id. at 1354 (discussing the Supreme
`Court’s holding in I.T.S. Rubber Co. v. Essex Rubber Co., 272 U.S. 429
`(1926)).
`
`6
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`Finally, Merck contends that fixing the claims adds no new matter
`because the proposed change to “diffraction peaks” finds support in the
`Specification. Mot. 7–8. Merck also argues that reexamination of the
`claims with the corrected language is not required and, even if were, that is
`not for the Board to decide. Mot. 7–8; Mot. Reply 3.
`Petitioner raises several arguments in opposition. Petitioner contends
`that the claim language includes no mistake of a clerical or typographical, or
`otherwise minor character. Opp. 2–3, 4–5 (citing case law, the MPEP, and
`other decisions on petitions for a certificate of correction). The problem for
`Petitioner, relative to the relief Merck requests from the Board in this
`motion, is that Petitioner’s argument goes directly to whether Merck satisfies
`the elements of § 255 and is entitled to a certificate on the merits. As
`explained above, we are not authorized to decide that question. Merck has
`provided a reasonably detailed analysis of what it regards as the allegedly
`obvious mistake, accompanied by facts and law that Merck alleges supports
`its position. Merck might (or might not) prevail in showing that the mistake
`is “minor” and correctable. On that, however, we must defer to the
`Director’s judgment.
`Petitioner argues that Merck cites no authority permitting the Patent
`Office to correct claims found to be indefinite in court, as Merck requests
`the Office do now. Opp. 3–4. According to Petitioner, the reference in
`Nova to correcting indefinite claims through a certificate of correction is
`dicta. Id. at 3 (citing Novo, 350 F.3d 1348, 1356 (Fed. Cir. 2003)).
`Petitioner criticizes Merck’s alleged lack of authority, but Petitioner
`provides no authority that persuades us the type of relief Merck is requesting
`is necessarily foreclosed. Even if we agreed that the excerpt in Novo quoted
`
`7
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`by Merck is dicta, the decision still suggests that indefinite claims may be
`corrected by the Office under its § 255 authority. In its more complete
`context, the sentence including the quoted excerpt stands for the proposition
`that even courts might sometimes correct errors that would render a claim
`indefinite. Novo, 350 F.3d at 1356 (noting that “if we were to hold that the
`district court was powerless to correct any and all errors when construing the
`patent, every patent containing an error that makes a claim indefinite would
`be invalid until and unless corrected by the PTO,” then rejecting that
`holding). We see no basis in the cited authority to conclude that courts
`might correct an indefinite claim term, but the Patent Office could not. In
`any event, Merck identifies cases where the Office has, in fact, done just that
`through the certificate of correction process—together, with Merck’s
`discussion of what the error is, why it is allegedly minor, and how it should
`be fixed, raising a legitimate question of whether correction is appropriate.
`Mot. Reply 2 (citing, e.g., ipDataTel, LLC v. ICN Acquisition, IPR2018-
`01822, Paper 19 at 13–14 (PTAB Apr. 22, 2019)).6 Whether the Office will
`do so here is, again, a matter for the Director.
`Petitioner argues that Merck’s and the patent applicant’s “inattentive
`review” of the ’708 patent’s claims does not show good faith. Opp. at 8–10.
`According to Petitioner, the notion that the error is so “obvious” and
`“apparent” is at odds with Merck’s explanation for why the error was not
`caught during prosecution, or in the twelve years since the patent’s issuance.
`
`
`6 In ipDataTel, after a petition for inter partes review was filed, a district
`court found in October 2018 that claims of the patent challenged in the IPR
`were indefinite, a certificate of correction for the indefinite claims was filed
`in January 2019, and a certificate correcting the claims was issued in March
`2019. ipDataTel, Paper 19 at 13–14.
`
`8
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`Opp. 8–9. Instead, as Petitioner highlights, it took Merck more than a year
`into the related litigation, and a finding of indefiniteness by the district court,
`before Merck approached the Patent Office about a possible correction. Id.
`at 9. Those strike us as fair points raised by Petitioner. Whether and how
`such points factor into the “good faith” or other inquiry under § 255 is,
`however, a matter better left for the Director.
`Petitioner also contends that the corrected claims would add new
`matter and require reexamination. Opp. 5–7. But Petitioner does not
`address the disclosures cited by Merck that purport to provide explicit
`descriptive support for the “diffraction peaks” language when characterizing
`the relevant compounds according to XRPD. See Mot. 1 (citing Ex. 1001,
`13:29–36). Even if there is written description support for the proposed
`corrections, Petitioner argues there are other conditions for patentability
`(e.g., novelty) that will require reexamination because the newly claimed
`subject matter was never actually examined during prosecution. Opp. 6.
`And, Petitioner contends, there is “nothing from the prosecution history”
`itself showing any recognition of the alleged error or how it should be
`corrected.7 As there was little or no substantive discussion of claims 5–7
`
`
`7 Insofar as Petitioner reads Arthrocare Corp. v. Smith & Nephew, Inc., 406
`F.3d 1365, 1374–75 (Fed. Cir. 2005) as requiring something explicit in the
`prosecution history that makes an error in the claims “clearly evident,” that
`overstates the reasoning and holding of Arthrocare. Based on the claim
`language itself, which made no sense in the original form, and the language
`of the specification, the Arthrocare court concluded “[t]hat evidence
`indicates that it was clear how the typographical error in the original claims
`should have been corrected.” Id. at 1375. The fact that the court continued,
`remarking that the prosecution history “further support[ed]” patentee’s
`position on the error does not mean the court would have ruled against
`patentee if the prosecution history shed no light, either way, on whether the
`
`9
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`during the original examination, it is not apparent to us that the prosecution
`history favors or disfavors Merck’s allegations that the claims are
`correctable as proposed or that such corrected claims need not be
`reexamined. Mot. 7–8. Heeding the Federal Circuit’s guidance, we leave
`such a determination to the Director.
`Finally, Petitioner argues that, if Merck’s motion is granted, Merck
`should include Petitioner’s Opposition with any request for certificate of
`correction submitted to the Director. Opp. 10. We agree. Like other panels
`in similar situations, “we discern that Petitioner’s Opposition may be . . .
`useful to the Director in determining whether the issuance of a Certificate of
`Correction is appropriate.” Intuitive Surgical, IPR2020-00051, Paper 13, at
`4–5. We also agree with Merck, however, that it should provide “all the
`briefing” on this issue, not just the Petitioner’s Opposition. Mot. Reply 3;
`Arkema Inc. v. Honeywell Int’l Inc., PGR2016-00011, Paper 77 at 13 (PTAB
`Apr. 27, 2020) (requiring patent owner to submit, with request for certificate
`of correction, copies of all documents submitted to or generated from the
`Board in connection with patent owner’s motion). Thus, Merck is instructed
`to provide with its request for certificate of correction the full briefing on
`this motion (including exhibits), as well as the Board’s decision on the
`motion.
`
`
`
`
`claims included an error. Rather, we understand the court as indicating that
`an error to the claims may be correctable when it is clearly evident based on
`the totality of the relevant intrinsic evidence.
`
`10
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`
`III. ORDER
`In consideration of the foregoing, it is:
`ORDERED that Patent Owner’s Motion for Leave to File Request for
`Certificate of Correction of Claims 5–7 (Paper 63) is granted; we cede
`jurisdiction but only for the limited purpose of Patent Owner seeking
`correction of claims 5–7, which are not at issue in this proceeding, and this
`proceeding will therefore continue on its existing schedule;
`FURTHER ORDERED that Patent Owner will file, within ten (10)
`days of the entry of this Order, its Request for a Certificate of Correction,
`and also file a copy of that request as an exhibit in this proceeding;
`FURTHER ORDERED that Patent Owner must include with its
`Request for Certificate of Correction the briefing and other related
`documents on this motion as provided above; and
`FURTHER ORDERED that when a decision is rendered on Patent
`Owner’s request for a Certificate of Correction, Patent Owner will file,
`within ten (10) days of such decision, a copy of the decision as an exhibit in
`this proceeding.
`
`
`
`
`
`
`
`
`11
`
`

`

`IPR2020-00040
`Patent 7,326,708 B2
`
`FOR PETITIONER:
`Jitendra Malik
`Alissa M. Pacchioli
`Christopher W. West
`Heike S. Radeke
`Lance Soderstrom
`KATTEN MUCHIN ROSEMAN LLP
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`christopher.west@katten.com
`heike.radeke@katten.com
`lance.soderstrom@kattenlaw.com
`
`
`FOR PATENT OWNER:
`Stanley E. Fisher
`Jessamyn S. Berniker
`Shaun P. Mahaffy
`Anthony H. Sheh
`WILLIAMS & CONNOLLY LLP
`sfisher@wc.com
`jberniker@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`12
`
`