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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`__________________
`
`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
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`
`
`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.
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`
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`TABLE OF CONTENTS
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`BACKGROUND ....................................................................................................... 2
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`ARGUMENT ............................................................................................................. 3
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`I.
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`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
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` Merck’s Error Occurred in “Good Faith.” ............................................ 7
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` Merck’s Correction Will Not Add “New Matter” or “Require
`Re-examination.” ................................................................................... 7
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`II.
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`The District Court Has Not Decided Whether the PTO Can Issue a
`Certificate of Correction. ................................................................................. 8
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`CONCLUSION ........................................................................................................ 10
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`i
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`TABLE OF AUTHORITIES
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`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
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`37 C.F.R. § 1.323 ....................................................................................................... 3
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`ii
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`
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`Pursuant to the Board’s Order of November 9, 2020, Paper 61, Patent Owner
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`Merck hereby moves for leave to request a certificate of correction of claims 5–7
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`of U.S. Patent No. 7,326,708 (“the ’708 patent”), which contain undisputedly
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`mistaken language. Because these claims are not at issue in the IPR, there is no
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`risk of affecting this proceeding or duplicating efforts across different parts of the
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`PTO. The issue for the Board is thus a narrow, threshold question: “whether there
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`is sufficient basis supporting Patent Owner’s position that the mistake may be
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`correctable” when the merits of the request are considered by the Director.
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`Honeywell Int’l, Inc. v. Arkema Inc., 939 F.3d 1345, 1349 (Fed. Cir. 2019).
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`Merck’s request readily meets that threshold. Claims 5–7 refer to
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`“absorption bands obtained from the X-ray powder diffraction pattern at spectral”
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`d-spacings of particular sizes. EX1001 (’708 Patent). As the district court in the
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`co-pending infringement action put it, the reference to “absorption bands” is “just a
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`mistake.” EX2277 at 94:14. The claims should have referred to “diffraction
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`peaks,” which is the correct term, and the term the specification uses, for the X-ray
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`powder diffraction (XRPD) data that determine the claimed d-spacings. EX1001
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`at 13:29–36; EX2281 ¶¶ 3–6.
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`A certificate of correction can fix such a mistake when it is “clearly evident
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`from the specifications, drawings, and prosecution history how the error should
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`appropriately be corrected to one of skill in the art.” Arthrocare Corp. v. Smith &
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`1
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`
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`Nephew, Inc., 406 F.3d 1365, 1374–75 (Fed. Cir. 2005) (internal quotation marks
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`omitted). Here, the patent’s specification describes the claimed crystal form,
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`characterized by the exact same claimed d-spacings, using the correct
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`terminology—“diffraction peaks corresponding to” the d-spacings. EX1001 at
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`13:31–36. The person of ordinary skill would have understood that a correction to
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`the claims should employ this same language.
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`The Board should grant leave and permit the Director to consider Merck’s
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`request on the merits.
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`BACKGROUND
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`The claims of the ’708 patent are directed generally to novel forms of the
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`compound sitagliptin, which are used in Merck’s successful Januvia® family of
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`diabetes drugs. Independent claim 1 is directed to a dihydrogenphosphate salt of
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`sitagliptin with a 1:1 stoichiometric ratio; claim 4, on which claims 5–7 depend, is
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`directed to a crystalline monohydrate form of that salt.
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`Claims 5–7, the claims Merck seeks to correct, limit claim 4 to a particular
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`form of the crystalline monohydrate characterized using XPRD. Petitioners did
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`not challenge these claims before the Board, and they are not at issue in this IPR.
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`Each of claims 5–7 recites “absorption bands obtained from the X-ray powder
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`diffraction pattern at spectral” d-spacings of different sizes. As all parties agree,
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`that language is incorrect. The specification of the patent does not refer to
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`2
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`
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`“absorption bands,” and the features of a diffraction pattern that characterize
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`particular crystal forms are “diffraction peaks,” not “absorption bands.” See
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`EX2277 at 84:09–15; EX2281 ¶¶ 3–6. Where the specification of the ’708 patent
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`describes a form of crystalline monohydrate characterized by XRPD, it refers to
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`“diffraction peaks corresponding to” the same d-spacings listed in the claims.
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`EX1001 at 13:29–36.
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`Petitioners in this IPR also are defendants in a multi-district infringement
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`litigation. In re Sitagliptin Phosphate (’708 & ’921) Patent Litigation, 1:19-md-
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`02902 (D. Del.). Each petitioner seeks FDA approval to make a generic version of
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`one or more Merck products protected by the ’708 patent. Merck has asserted
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`infringement of claims 5–7 in district court. During Markman proceedings,
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`Petitioners (other than Mylan, which did not join in the other defendants’ position)
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`argued that the term “absorption bands” is indefinite because of the wording error,
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`and the district court agreed. See EX2277 at 94–95; EX2276; EX2282 at 7. It also
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`concluded that it lacked the power to fix the mistake. EX2277 at 94; EX2276.
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`ARGUMENT
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`35 U.S.C. § 255 permits the PTO to correct “a mistake of a clerical or
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`typographical nature, or of minor character” that “occurred in good faith” upon a
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`request by the patent owner. When an IPR is pending, however, the patent owner
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`must seek leave from the Board before requesting such a certificate. 37 C.F.R.
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`3
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`
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`§ 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
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`issue, or that affects some other overall aspect of the patent like the priority claim,
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`might “impact th[e] review.” ASML Netherlands B.V. v. Energetiq Tech., Inc.,
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`IPR2015-01375, Paper 11, at 3 (P.T.A.B. Oct. 14, 2015). Here, however,
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`Petitioners have not alleged any such impact. Claims 5–7 are not in the IPR, nor is
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`claim 8 (which depends from claim 7). And all parties agree that Merck’s request
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`for a certificate will not affect the schedule. EX2275 at 21:4–17.
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`Instead, Petitioners oppose Merck’s certificate request because they claim
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`that Merck is not entitled to a certificate of correction on the merits and because
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`the district court has already concluded that it cannot correct the error. The former
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`is incorrect and not for the Board to determine in plenary fashion. The latter has
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`no bearing on whether the PTO can correct the error.
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`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.
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`The Federal Circuit has held that 35 U.S.C. § 255 expressly “authorizes the
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`Director—not the Board—to determine whether a Certificate of Correction should
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`be issued.” Honeywell, 939 F.3d at 1349–50 (emphasis added). Review of a
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`patentee’s motion for leave to petition for a certificate of correction therefore does
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`not involve a decision of the merits of the patentee’s petition, only whether the
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`patent owner is to be granted “authorization for filing such a request.” See, e.g.,
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`4
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`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).
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`The question of whether to grant such authorization involves only a
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`threshold inquiry into “whether there is sufficient basis supporting Patent Owner’s
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`position that the mistake may be correctable.” Honeywell, 939 F.3d at 1349. The
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`Board has ruled that there is a “sufficient basis,” and leave should be granted, if
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`there is at least a “legitimate question as to whether the issuance of a Certificate of
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`Correction is an appropriate course of action.” Intuitive Surgical, Inc. v. Ethicon
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`LLC, IPR2020-00050, Paper 13, at 4–5 (P.T.A.B. Feb. 26, 2020).
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`Merck amply meets every requirement of § 255. It is not even a close
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`question whether it clears the lower bar for the Board to grant leave.
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` Merck’s Proposed Correction Is a “Clerical” or “Minor” Error
`that Can Be Corrected via a Certificate of Correction.
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`Merck seeks to fix obviously mistaken wording in the claims by replacing it
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`with the correct wording used in the specification to describe the same aspect of
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`the invention. That is a “mistake of a clerical or typographical nature, or of minor
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`character” under 35 U.S.C. § 255. Even the district court defendants (including
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`Joinder Petitioners) and their claim construction expert acknowledged that this
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`error “could be seen as a mistake or typographical error.” EX2277 at 92:20–23;
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`EX2279 ¶ 46. And contrary to Petitioners’ suggestion, EX2275 at 14, an error that
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`5
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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
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`Molds Corp., 350 F.3d 1348, 1356 (Fed. Cir. 2003).
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`A clerical, typographical, or minor error can be corrected via certificate “if it
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`is clearly evident from the specifications, drawings, and prosecution history how
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`the error should appropriately be corrected to one of skill in the art.” Arthrocare,
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`406 F.3d at 1374–75 (Fed. Cir. 2005) (internal quotation marks omitted). Merck’s
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`proposed certificate meets this standard. Other than the erroneous claims, the
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`patent does not mention the terms “absorption bands” or “spectral.” The POSA
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`would know, and the patent explains, that X-ray powder diffraction produces
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`diffraction peaks corresponding to specific d-spacing values, not absorption bands.
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`EX2278 ¶¶ 69–71; EX2280 ¶¶ 14–17; EX2281 ¶¶ 4–5. And column 13 of the
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`patent identifies exactly the same d-spacings that characterize the crystal form of
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`claims 5–7, and describes them using the terminology Merck seeks to include in a
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`certificate of correction. EX1001 at 13:29–36. For example, where claim 5 recites
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`the crystalline monohydrate characterized by “characteristic absorption bands . . .
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`at spectral d-spacings of 7.42, 5.48, and 3.96 angstroms,” column 13 states that
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`“[t]he monohydrate exhibited characteristic diffraction peaks corresponding to d-
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`spacings of 7.42, 5.48, and 3.96 angstroms.” Id. at 13:31–33, claim 5.
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`Given the clarity in the intrinsic record, the POSA would have understood
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`what the claim means: a crystalline monohydrate form characterized by diffraction
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`6
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`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.
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` Merck’s Error Occurred in “Good Faith.”
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`The mistaken use of the term “absorption bands . . . at spectral” d-spacings
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`was made in “good faith,” and Petitioners have made no suggestion to the contrary.
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`The incorrect language was inadvertently imported from spectroscopic analyses
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`(which, unlike XRPD, involve absorption) and then overlooked. EX2281 ¶ 6. The
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`correction fixes the claims to recite what they plainly were intended to cover all
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`along. There is no argument that the use of the mistaken language somehow could
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`have been intended to provide some benefit or strategic advantage to Merck. And
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`in this threshold posture, the Board “lack[s] authority to determine” whether a
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`mistake “occurred in good faith.” Arkema Inc. v. Honeywell Int’l Inc., PGR2016-
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`00011, Paper 77, at 11 (P.T.A.B. Apr. 27, 2020).
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` Merck’s Correction Will Not Add “New Matter” or “Require Re-
`examination.”
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`Granting Merck’s proposed correction also will not add “new matter” or
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`“require re-examination.” 35 U.S.C. § 255. The change is fully supported by the
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`original specification and does not alter the scope of the claims. There is no
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`ambiguity as to what term was intended or how it should be used; if there had
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`been, the mistake presumably would have been addressed during the original
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`7
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`prosecution. Rather, the proposed certificate simply replaces erroneous language
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`with correct language from the specification that describes the same subject matter.
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` Once again, moreover, whether re-examination is required is a question for
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`the Director rather than the Board. Arkema, PGR2016-00011, Paper 77, at 11–12.
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`II. The District Court Has Not Decided Whether the PTO Can Issue a
`Certificate of Correction.
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`Petitioners also argue that leave should be denied because Merck already
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`sought to correct the claims in district court. EX2275 at 12–13. That is a red
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`herring. The district court concluded that the district court could not correct the
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`claims through claim construction. That has no bearing whatsoever on whether the
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`PTO can correct them with a certificate.
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`The issue in district court was whether Claims 5–7, as currently worded, are
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`indefinite, based on an argument that “absorption is akin to an opposite process of
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`diffraction,” and that it was improper to construe the claim to mean something
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`other than what they say. EX2277 at 91. The focus was thus on cases like Chef
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`America, where claims to a cookie-baking process recited baking “to” 400°F to
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`850°F where they should have said “at” those temperatures, and Allen Engineering,
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`where claims recited “perpendicular” instead of “parallel.” See Chef Am., Inc. v.
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`Lamb-Weston, Inc., 358 F.3d 1371, 1374–75 (Fed. Cir. 2004); Allen Eng’g Corp. v.
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`Bartell Indus., Inc., 299 F.3d 1336, 1349 (Fed. Cir. 2002). Under those cases, the
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`8
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`district court ruled that it had to construe Merck’s claims to mean what they said,
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`rather than “wholesale changing” the language Merck drafted. EX2277 at 94–95.
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`But the district court’s conclusion that it could not re-interpret the existing
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`claim language has no bearing on whether the Patent Office can change that claim
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`language using a certificate of correction. Petitioners will no doubt highlight that
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`Merck argued that the district court possessed the power to correct obvious
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`drafting mistakes. However, while the district court disagreed, it did not purport to
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`decide whether the mistaken language was a “mistake of a clerical or typographical
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`nature, or of minor character” correctable under 35 U.S.C. § 255. The court
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`merely concluded that “it is not a ‘typographical error’ that I can correct.”
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`EX2276 (emphasis added). It is no accident that the district court did not decide
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`whether a certificate of correction could issue, because, as the Federal Circuit has
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`stated, “we do not think that Congress intended that the district courts have the
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`authority to correct any and all errors that the PTO would be authorized to correct
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`under sections 254 and 255.” Novo, 350 F.3d at 1356. The district court’s ruling,
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`in fact, supports Merck’s contention that the error is correctable by a certificate.
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`The district court agreed with Merck that the person of ordinary skill would
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`“figure out what the inventors wanted to do”—in other words, how the error
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`should be corrected. EX2277 at 94–95; see Arthrocare, 406 F.3d at 1374–75. It
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`just concluded that it could not fix the problem. EX2276; EX2277 at 95.
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`9
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`That is irrelevant to whether Merck should be allowed to request a certificate
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`of correction from the Director. Should the Director issue a certificate, Petitioners
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`will have the opportunity to ask the district court to rule on its validity. Cubist
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`Pharms., Inc. v. Hospira Inc., 805 F.3d 1112, 1118 (Fed. Cir. 2015). There is no
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`basis to deny Merck the opportunity even to make the request.
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`CONCLUSION
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`For the foregoing reasons, the Board should grant Merck’s motion and
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`authorize it to petition the Director for a certificate of correction.
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`
`Date: November 17, 2020
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`
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`
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`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
`
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
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`11
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`CERTIFICATION UNDER 37 C.F.R. § 42.24(d)
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
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`and correct copy of the foregoing was served on November 17, 2020, by delivering
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`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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