`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., WATSON LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., and
`SUN PHARMACEUTICALS INDUSTRIES LTD.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-000401
`U.S. Patent 7,326,708
`__________________
`
`PATENT OWNER’S MOTION TO FILE
`REQUEST FOR CERTIFICATE OF CORRECTION OF CLAIMS 5–7
`
`
`
`1 Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. were joined as
`parties to this proceeding via Motion for Joinder in IPR2020-01045; 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.
`
`
`
`
`
`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`
`
`TABLE OF CONTENTS
`
`
`BACKGROUND ....................................................................................................... 2
`
`ARGUMENT ............................................................................................................. 3
`
`I.
`
`Merck Should Be Permitted to Request a Certificate of Correction
`Because There Is a Sufficient Basis Supporting Its Position That the
`Mistake May Be Correctable. .......................................................................... 4
`
` Merck’s Proposed Correction Is a “Clerical” or “Minor” Error
`that Can Be Corrected via a Certificate of Correction. ......................... 5
`
` Merck’s Error Occurred in “Good Faith.” ............................................ 7
`
` Merck’s Correction Will Not Add “New Matter” or “Require
`Re-examination.” ................................................................................... 7
`
`II.
`
`The District Court Has Not Decided Whether the PTO Can Issue a
`Certificate of Correction. ................................................................................. 8
`
`CONCLUSION ........................................................................................................ 10
`
`
`
`
`
`
`
`
`
`i
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`
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`
`
`TABLE OF AUTHORITIES
`
`Allen Eng’g Corp. v. Bartell Indus., Inc.,
`299 F.3d 1336 (Fed. Cir. 2002) ............................................................................ 8
`
`Arthrocare Corp. v. Smith & Nephew, Inc.,
`406 F.3d 1365 (Fed. Cir. 2005) .................................................................... 1, 6, 9
`
`Chef Am., Inc. v. Lamb-Weston, Inc.,
`358 F.3d 1371 (Fed. Cir. 2004) ............................................................................ 8
`
`Cubist Pharms., Inc. v. Hospira Inc.,
`805 F.3d 1112 (Fed. Cir. 2015) .......................................................................... 10
`
`Honeywell Int’l, Inc. v. Arkema Inc.,
`939 F.3d 1345 (Fed. Cir. 2019) .................................................................... 1, 4, 5
`
`Novo Indus., LP v. Micro Molds Corp.,
`350 F.3d 1348 (Fed. Cir. 2003) ........................................................................ 6, 9
`
`Arkema Inc. v. Honeywell Int’l Inc.,
`PGR2016-00011, Paper 77 (P.T.A.B. Apr. 27, 2020) ...................................... 7, 8
`
`ASML Netherlands B.V. v. Energetiq Tech., Inc.,
`IPR2015-01375, Paper 11 (P.T.A.B. Oct. 14, 2015) ............................................ 4
`
`Intuitive Surgical, Inc. v. Ethicon LLC,
`IPR2020-00050, Paper 13 (P.T.A.B. Feb. 26, 2020) ........................................ 5, 6
`
`United Servs. Auto. Ass’n v. Asghari-Kamrani, No. CBM2016-00063, Paper
`No. 10 (P.T.A.B. Aug. 4, 2016) ............................................................................ 5
`
`35 U.S.C. § 255 .................................................................................................passim
`
`37 C.F.R. § 1.323 ....................................................................................................... 3
`
`ii
`
`
`
`
`
`Pursuant to the Board’s Order of November 9, 2020, Paper 61, Patent Owner
`
`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`Merck hereby moves for leave to request a certificate of correction of claims 5–7
`
`of U.S. Patent No. 7,326,708 (“the ’708 patent”), which contain undisputedly
`
`mistaken language. Because these claims are not at issue in the IPR, there is no
`
`risk of affecting this proceeding or duplicating efforts across different parts of the
`
`PTO. The issue for the Board is thus a narrow, threshold question: “whether there
`
`is sufficient basis supporting Patent Owner’s position that the mistake may be
`
`correctable” when the merits of the request are considered by the Director.
`
`Honeywell Int’l, Inc. v. Arkema Inc., 939 F.3d 1345, 1349 (Fed. Cir. 2019).
`
`Merck’s request readily meets that threshold. Claims 5–7 refer to
`
`“absorption bands obtained from the X-ray powder diffraction pattern at spectral”
`
`d-spacings of particular sizes. EX1001 (’708 Patent). As the district court in the
`
`co-pending infringement action put it, the reference to “absorption bands” is “just a
`
`mistake.” EX2277 at 94:14. The claims should have referred to “diffraction
`
`peaks,” which is the correct term, and the term the specification uses, for the X-ray
`
`powder diffraction (XRPD) data that determine the claimed d-spacings. EX1001
`
`at 13:29–36; EX2281 ¶¶ 3–6.
`
`A certificate of correction can fix such a mistake when it is “clearly evident
`
`from the specifications, drawings, and prosecution history how the error should
`
`appropriately be corrected to one of skill in the art.” Arthrocare Corp. v. Smith &
`
`1
`
`
`
`
`
`Nephew, Inc., 406 F.3d 1365, 1374–75 (Fed. Cir. 2005) (internal quotation marks
`
`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`omitted). Here, the patent’s specification describes the claimed crystal form,
`
`characterized by the exact same claimed d-spacings, using the correct
`
`terminology—“diffraction peaks corresponding to” the d-spacings. EX1001 at
`
`13:31–36. The person of ordinary skill would have understood that a correction to
`
`the claims should employ this same language.
`
`The Board should grant leave and permit the Director to consider Merck’s
`
`request on the merits.
`
`BACKGROUND
`
`The claims of the ’708 patent are directed generally to novel forms of the
`
`compound sitagliptin, which are used in Merck’s successful Januvia® family of
`
`diabetes drugs. Independent claim 1 is directed to a dihydrogenphosphate salt of
`
`sitagliptin with a 1:1 stoichiometric ratio; claim 4, on which claims 5–7 depend, is
`
`directed to a crystalline monohydrate form of that salt.
`
`Claims 5–7, the claims Merck seeks to correct, limit claim 4 to a particular
`
`form of the crystalline monohydrate characterized using XPRD. Petitioners did
`
`not challenge these claims before the Board, and they are not at issue in this IPR.
`
`Each of claims 5–7 recites “absorption bands obtained from the X-ray powder
`
`diffraction pattern at spectral” d-spacings of different sizes. As all parties agree,
`
`that language is incorrect. The specification of the patent does not refer to
`
`2
`
`
`
`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`
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`“absorption bands,” and the features of a diffraction pattern that characterize
`
`particular crystal forms are “diffraction peaks,” not “absorption bands.” See
`
`EX2277 at 84:09–15; EX2281 ¶¶ 3–6. Where the specification of the ’708 patent
`
`describes a form of crystalline monohydrate characterized by XRPD, it refers to
`
`“diffraction peaks corresponding to” the same d-spacings listed in the claims.
`
`EX1001 at 13:29–36.
`
`Petitioners in this IPR also are defendants in a multi-district infringement
`
`litigation. In re Sitagliptin Phosphate (’708 & ’921) Patent Litigation, 1:19-md-
`
`02902 (D. Del.). Each petitioner seeks FDA approval to make a generic version of
`
`one or more Merck products protected by the ’708 patent. Merck has asserted
`
`infringement of claims 5–7 in district court. During Markman proceedings,
`
`Petitioners (other than Mylan, which did not join in the other defendants’ position)
`
`argued that the term “absorption bands” is indefinite because of the wording error,
`
`and the district court agreed. See EX2277 at 94–95; EX2276; EX2282 at 7. It also
`
`concluded that it lacked the power to fix the mistake. EX2277 at 94; EX2276.
`
`ARGUMENT
`
`35 U.S.C. § 255 permits the PTO to correct “a mistake of a clerical or
`
`typographical nature, or of minor character” that “occurred in good faith” upon a
`
`request by the patent owner. When an IPR is pending, however, the patent owner
`
`must seek leave from the Board before requesting such a certificate. 37 C.F.R.
`
`3
`
`
`
`
`
`§ 1.323. That is for good reason; a certificate of correction to a claim that is at
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`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`issue, or that affects some other overall aspect of the patent like the priority claim,
`
`might “impact th[e] review.” ASML Netherlands B.V. v. Energetiq Tech., Inc.,
`
`IPR2015-01375, Paper 11, at 3 (P.T.A.B. Oct. 14, 2015). Here, however,
`
`Petitioners have not alleged any such impact. Claims 5–7 are not in the IPR, nor is
`
`claim 8 (which depends from claim 7). And all parties agree that Merck’s request
`
`for a certificate will not affect the schedule. EX2275 at 21:4–17.
`
`Instead, Petitioners oppose Merck’s certificate request because they claim
`
`that Merck is not entitled to a certificate of correction on the merits and because
`
`the district court has already concluded that it cannot correct the error. The former
`
`is incorrect and not for the Board to determine in plenary fashion. The latter has
`
`no bearing on whether the PTO can correct the error.
`
`I. Merck Should Be Permitted to Request a Certificate of Correction
`Because There Is a Sufficient Basis Supporting Its Position That the
`Mistake May Be Correctable.
`
`The Federal Circuit has held that 35 U.S.C. § 255 expressly “authorizes the
`
`Director—not the Board—to determine whether a Certificate of Correction should
`
`be issued.” Honeywell, 939 F.3d at 1349–50 (emphasis added). Review of a
`
`patentee’s motion for leave to petition for a certificate of correction therefore does
`
`not involve a decision of the merits of the patentee’s petition, only whether the
`
`patent owner is to be granted “authorization for filing such a request.” See, e.g.,
`
`4
`
`
`
`
`
`United Servs. Auto. Ass’n v. Asghari-Kamrani, No. CBM2016-00063, Paper No.
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`10 at 6 (P.T.A.B. Aug. 4, 2016).
`
`The question of whether to grant such authorization involves only a
`
`threshold inquiry into “whether there is sufficient basis supporting Patent Owner’s
`
`position that the mistake may be correctable.” Honeywell, 939 F.3d at 1349. The
`
`Board has ruled that there is a “sufficient basis,” and leave should be granted, if
`
`there is at least 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, IPR2020-00050, Paper 13, at 4–5 (P.T.A.B. Feb. 26, 2020).
`
`Merck amply meets every requirement of § 255. It is not even a close
`
`question whether it clears the lower bar for the Board to grant leave.
`
` Merck’s Proposed Correction Is a “Clerical” or “Minor” Error
`that Can Be Corrected via a Certificate of Correction.
`
`Merck seeks to fix obviously mistaken wording in the claims by replacing it
`
`with the correct wording used in the specification to describe the same aspect of
`
`the invention. That is a “mistake of a clerical or typographical nature, or of minor
`
`character” under 35 U.S.C. § 255. Even the district court defendants (including
`
`Joinder Petitioners) and their claim construction expert acknowledged that this
`
`error “could be seen as a mistake or typographical error.” EX2277 at 92:20–23;
`
`EX2279 ¶ 46. And contrary to Petitioners’ suggestion, EX2275 at 14, an error that
`
`5
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`
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`“makes a claim indefinite” can be fixed via a certificate. Novo Indus., LP v. Micro
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`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`Molds Corp., 350 F.3d 1348, 1356 (Fed. Cir. 2003).
`
`A clerical, typographical, or minor error can be corrected via certificate “if it
`
`is clearly evident from the specifications, drawings, and prosecution history how
`
`the error should appropriately be corrected to one of skill in the art.” Arthrocare,
`
`406 F.3d at 1374–75 (Fed. Cir. 2005) (internal quotation marks omitted). Merck’s
`
`proposed certificate meets this standard. Other than the erroneous claims, the
`
`patent does not mention the terms “absorption bands” or “spectral.” The POSA
`
`would know, and the patent explains, that X-ray powder diffraction produces
`
`diffraction peaks corresponding to specific d-spacing values, not absorption bands.
`
`EX2278 ¶¶ 69–71; EX2280 ¶¶ 14–17; EX2281 ¶¶ 4–5. And column 13 of the
`
`patent identifies exactly the same d-spacings that characterize the crystal form of
`
`claims 5–7, and describes them using the terminology Merck seeks to include in a
`
`certificate of correction. EX1001 at 13:29–36. For example, where claim 5 recites
`
`the crystalline monohydrate characterized by “characteristic absorption bands . . .
`
`at spectral d-spacings of 7.42, 5.48, and 3.96 angstroms,” column 13 states that
`
`“[t]he monohydrate exhibited characteristic diffraction peaks corresponding to d-
`
`spacings of 7.42, 5.48, and 3.96 angstroms.” Id. at 13:31–33, claim 5.
`
`Given the clarity in the intrinsic record, the POSA would have understood
`
`what the claim means: a crystalline monohydrate form characterized by diffraction
`
`6
`
`
`
`
`
`peaks corresponding to the specified d-spacing values. The appropriate correction
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`is “clearly evident” and may be made via a certificate of correction.
`
` Merck’s Error Occurred in “Good Faith.”
`
`The mistaken use of the term “absorption bands . . . at spectral” d-spacings
`
`was made in “good faith,” and Petitioners have made no suggestion to the contrary.
`
`The incorrect language was inadvertently imported from spectroscopic analyses
`
`(which, unlike XRPD, involve absorption) and then overlooked. EX2281 ¶ 6. The
`
`correction fixes the claims to recite what they plainly were intended to cover all
`
`along. There is no argument that the use of the mistaken language somehow could
`
`have been intended to provide some benefit or strategic advantage to Merck. And
`
`in this threshold posture, the Board “lack[s] authority to determine” whether a
`
`mistake “occurred in good faith.” Arkema Inc. v. Honeywell Int’l Inc., PGR2016-
`
`00011, Paper 77, at 11 (P.T.A.B. Apr. 27, 2020).
`
` Merck’s Correction Will Not Add “New Matter” or “Require Re-
`examination.”
`
`Granting Merck’s proposed correction also will not add “new matter” or
`
`“require re-examination.” 35 U.S.C. § 255. The change is fully supported by the
`
`original specification and does not alter the scope of the claims. There is no
`
`ambiguity as to what term was intended or how it should be used; if there had
`
`been, the mistake presumably would have been addressed during the original
`
`7
`
`
`
`
`
`prosecution. Rather, the proposed certificate simply replaces erroneous language
`
`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`with correct language from the specification that describes the same subject matter.
`
` Once again, moreover, whether re-examination is required is a question for
`
`the Director rather than the Board. Arkema, PGR2016-00011, Paper 77, at 11–12.
`
`II. The District Court Has Not Decided Whether the PTO Can Issue a
`Certificate of Correction.
`
`Petitioners also argue that leave should be denied because Merck already
`
`sought to correct the claims in district court. EX2275 at 12–13. That is a red
`
`herring. The district court concluded that the district court could not correct the
`
`claims through claim construction. That has no bearing whatsoever on whether the
`
`PTO can correct them with a certificate.
`
`The issue in district court was whether Claims 5–7, as currently worded, are
`
`indefinite, based on an argument that “absorption is akin to an opposite process of
`
`diffraction,” and that it was improper to construe the claim to mean something
`
`other than what they say. EX2277 at 91. The focus was thus on cases like Chef
`
`America, where claims to a cookie-baking process recited baking “to” 400°F to
`
`850°F where they should have said “at” those temperatures, and Allen Engineering,
`
`where claims recited “perpendicular” instead of “parallel.” See Chef Am., Inc. v.
`
`Lamb-Weston, Inc., 358 F.3d 1371, 1374–75 (Fed. Cir. 2004); Allen Eng’g Corp. v.
`
`Bartell Indus., Inc., 299 F.3d 1336, 1349 (Fed. Cir. 2002). Under those cases, the
`
`8
`
`
`
`
`
`district court ruled that it had to construe Merck’s claims to mean what they said,
`
`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`rather than “wholesale changing” the language Merck drafted. EX2277 at 94–95.
`
`But the district court’s conclusion that it could not re-interpret the existing
`
`claim language has no bearing on whether the Patent Office can change that claim
`
`language using a certificate of correction. Petitioners will no doubt highlight that
`
`Merck argued that the district court possessed the power to correct obvious
`
`drafting mistakes. However, while the district court disagreed, it did not purport to
`
`decide whether the mistaken language was a “mistake of a clerical or typographical
`
`nature, or of minor character” correctable under 35 U.S.C. § 255. The court
`
`merely concluded that “it is not a ‘typographical error’ that I can correct.”
`
`EX2276 (emphasis added). It is no accident that the district court did not decide
`
`whether a certificate of correction could issue, because, as the Federal Circuit has
`
`stated, “we do not think that Congress intended that the district courts have the
`
`authority to correct any and all errors that the PTO would be authorized to correct
`
`under sections 254 and 255.” Novo, 350 F.3d at 1356. The district court’s ruling,
`
`in fact, supports Merck’s contention that the error is correctable by a certificate.
`
`The district court agreed with Merck that the person of ordinary skill would
`
`“figure out what the inventors wanted to do”—in other words, how the error
`
`should be corrected. EX2277 at 94–95; see Arthrocare, 406 F.3d at 1374–75. It
`
`just concluded that it could not fix the problem. EX2276; EX2277 at 95.
`
`9
`
`
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`
`
`That is irrelevant to whether Merck should be allowed to request a certificate
`
`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`of correction from the Director. Should the Director issue a certificate, Petitioners
`
`will have the opportunity to ask the district court to rule on its validity. Cubist
`
`Pharms., Inc. v. Hospira Inc., 805 F.3d 1112, 1118 (Fed. Cir. 2015). There is no
`
`basis to deny Merck the opportunity even to make the request.
`
`CONCLUSION
`
`For the foregoing reasons, the Board should grant Merck’s motion and
`
`authorize it to petition the Director for a certificate of correction.
`
`
`Date: November 17, 2020
`
`
`
`
`
`Respectfully submitted,
`
`/Stanley E. Fisher/
`Stanley E. Fisher (Reg. No. 55,820)
`Bruce R. Genderson (Pro Hac Vice)
`David M. Krinsky (Reg. No. 72,339)
`Elise M. Baumgarten (Pro Hac Vice)
`Alexander S. Zolan (Pro Hac Vice)
`Shaun P. Mahaffy (Reg. No. 75,534)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`sfisher@wc.com
`bgenderson@wc.com
`dkrinsky@wc.com
`ebaumgarten@wc.com
`azolan@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`
`10
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`
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`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
`
`11
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`
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`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`CERTIFICATION UNDER 37 C.F.R. § 42.24(d)
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
`
`and correct copy of the foregoing was served on November 17, 2020, by delivering
`
`a copy via electronic mail on the following attorneys of record:
`
`Jitendra Malik
`Alissa M. Pacchioli
`Christopher W. West
`Heike S. Radeke
`KATTEN MUCHIN ROSEMAN LLP
`550 South Tryon, Street Suite 2900
`Charlotte, NC 28202-4213
`(704) 444-2000
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`christopher.west@katten.com
`heike.radeke@katten.com
`
`Russell W. Faegenburg
`Tedd W. Van Buskirk
`Michael H. Teschner
`LERNER, DAVID, LITTENBERG,
`KRUMHOLZ & MENTLIK, LLP
`20 Commerce Drive
`Cranford, New Jersey 07016
`(908) 518-6367
`Rfaegenburg.ipr@ldlkm.com
`Tvanbuskirk@lernerdavid.com
`litigation@lernerdavid.com
`MTeschner.ipr@ldlkm.com
`
`
`
`
`Keith A. Zullow
`Sarah J. Fischer
`Emily L. Rapalino
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eight Avenue
`New York, NY 10018
`kzullow@goodwinprocter.com
`sfischer@goodwinprocter.com
`erapalino@goodwinprocter.com
`
`Jovial Wong
`Charles B. Klein
`Claire A. Fundakowski
`Zachary B. Cohen
`WINSTON & STRAWN LLP
`1901 L. Street, N.W.
`Washington, D.C. 20036
`(202) 282-5000
`Sunipr@winston.com
`
`
`
`/Stanley E. Fisher/
`Stanley E. Fisher
`Reg. No. 55,820
`
`12
`
`
`
`
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