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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`ACERTA PHARMA B.V.,
`Patent Owner
`_________________________________________________
`
`
`Case IPR 2023-00478
`Patent No. 10,272,083
`
`_________________________________________________
`
`PATENT OWNER’S MOTION FOR LEAVE TO FILE REQUEST FOR
`CERTIFICATE OF CORRECTION
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`
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`i
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`Case IPR2023-00478 | U.S. Patent 10,272,083
`
`TABLE OF AUTHORITIES
`
`
`Cases
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`Arkema Inc. and Arkema France v. Honeywell International Inc.,
`
`
`
`PGR2016-00011, Paper 77 (P.T.A.B Apr. 27, 2020) ................................... 2,6
`
`Commonwealth Sci. and Indus. Research Org. v. Basf Plant Sci. Gmbh,
`PGR2020-00033, Paper 26, Paper 33 (P.T.A.B. Mar. 18, 2021) ................ 2, 5
`
`Honeywell Int’l, Inc. v. Arkema Inc.,
`
`
`
`939 F.3d 1345, 1349 (Fed. Cir. 2019) .......................................................... 1.4
`
`Intuitive Surgical, Inc. v. Ethicon LLC,
`
`
`
`IPR2020-00050, Paper 13 (P.T.A.B. Feb. 26, 2020) ...................................... 5
`
`United Servs. Auto. Ass’n v. Asghari-Kamrani,
`
`CBM2016-00063, Paper 10 (P.T.A.B. Aug. 4, 2016) ..................................... 5
`
`
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`
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`Statutes and Other Authority
`
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`35 U.S.C. § 102(b)(2)(C) ........................................................................................... 3
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`35 U.S.C. § 102(c) ..................................................................................................... 3
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`35 U.S.C. § 255 ....................................................................................................... 4,5
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`37 C.F.R. § 1.71(g)(3) .......................................................................................... 1,5,6
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`37 C.F.R. § 1.9(e) .................................................................................................... 4,5
`
`MPEP §§ 717.02(a)(II) (June 2020) ....................................................................... 1,6
`
`MPEP 717.02(b)(IV) (June 2020)........................................................................... 1,6
`
`
`
`ii
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`
`
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`Pursuant to the Board’s authorization, EX3002, Patent Owner Acerta Pharma
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`B.V. (“Acerta”) moves for leave to request a certificate of correction from the
`
`Director. Acerta seeks to correct U.S. Patent No. 10,272,083 (“the ’083 patent”) to
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`reference a written joint research agreement (the “JRA”) between Acerta’s
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`predecessor-in-interest and a third party, MSD Oss BV (“Merck”)1. The JRA was
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`effective by January 21, 2014, which is the ’083 patent’s earliest effective filing date.
`
`The issue for the Board is the narrow, threshold question: “whether there is sufficient
`
`basis supporting Patent Owner’s position that the mistake may be correctable” when
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`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).
`
`Here, the claimed invention disclosed in the ’083 patent is the subject of a
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`timely, written joint research agreement, EX2004, but the patent mistakenly does
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`not reference it. A patent’s failure to identify parties to a joint research agreement
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`is a correctable mistake that the Director has the authority to correct. 37 C.F.R.
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`§ 1.71(g)(3); see also MPEP §§ 717.02(a)(II), 717.02(b)(IV) (“If the patent as issued
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`does not include the names of the parties to the joint research agreement, the patent
`
`must be corrected to include the names of the parties to the joint research agreement
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`by a certificate of correction.”). In line with these authorities, the Board has
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`1 MSD Oss BV is the predecessor-in-interest to Merck Sharp & Dohme B.V.
`EX2010.
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`
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`1
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`
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`Case IPR2023-00478 | U.S. Patent 10,272,083
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`previously permitted leave to seek such a correction from the Director. See
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`Commonwealth Sci. and Indus. Research Org. v. Basf Plant Sci. Gmbh, PGR2020-
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`00033, Paper 26 at 5 (P.T.A.B. Mar. 18, 2021). Likewise, the Director has issued
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`certificates to correct a patent’s specification that omitted reference to a joint
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`research agreement. Id., Paper 33 at 1, Ex. 2043.
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`Petitioner Sandoz Inc. (“Sandoz”) will not be prejudiced by Acerta’s
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`requested relief.2 The Board has already authorized Sandoz to file a response to this
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`motion, EX3002, so Sandoz will have an opportunity to present its position. Further,
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`this proceeding was only recently initiated and the Board has not determined whether
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`to institute trial. Accordingly, it is unlikely that any deadlines set by the Board will
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`be affected by a certificate of correction. On the other hand, the Board has
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`previously found that a patent owner is prejudiced when denied an opportunity to
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`seek a certificate of correction. See Arkema Inc. and Arkema France v. Honeywell
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`International Inc., PGR2016-00011, Paper 77 at 12 (P.T.A.B Apr. 27, 2020).
`
`Acerta respectfully requests that the Board grant leave and cede jurisdiction
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`to the Director to consider Acerta’s request on the merits.
`
`
`2 The relevant prejudice, if any, to consider is that caused by “granting Patent
`Owner’s Motion,” not that caused by a certificate of correction should the Director
`issue one. Arkema Inc. and Arkema France v. Honeywell International Inc.,
`PGR2016-00011, Paper 77 at 5 (P.T.A.B Apr. 27, 2020).
`
`2
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`
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`Case IPR2023-00478 | U.S. Patent 10,272,083
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`BACKGROUND
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`The claims of the ’083 patent are directed to novel methods of treating various
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`lymphomas using acalabrutinib, a targeted inhibitor of Bruton’s tyrosine kinase,
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`using specified doses and dosing regimens. The correction Acerta seeks bears on
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`whether art cited in the Petition could qualify as prior art to the ’083 patent. Sandoz’s
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`challenge relies on three references, including U.S. Patent No. 9,758,524 (EX1005)
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`(“Barf”). Barf issued on September 12, 2017, and on its face is assigned to Merck.
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`Sandoz claims that Barf is prior art under 35 U.S.C. § 102(a)(2) and, in combination
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`with another reference, renders the challenged claims obvious.
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`Barf is not prior art because it falls within the joint research exception under
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`35 U.S.C. § 102(b)(2)(C) and § 102(c). On August 20, 2012, Merck and Covalution
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`Pharma B.V., which is Acerta’s predecessor-in-interest, EX2008; EX2009, entered
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`into an agreement for the development and commercialization of BTK inhibitor
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`compounds. EX2004 at 2. Merck provided know-how (§ 4.01) and a license (§
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`2.01) to intellectual property, including Barf and related patents (§§ 2.01, 1.25;
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`Schedule 1.25 (listing PCT application to which Barf claims priority)) for the
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`purpose of allowing Acerta to research and develop such compounds as a treatment
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`for cancer (§ 2.01, 1.11). EX2004 at 3, 5, 7–8, 10–11, 43. Further evincing the
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`collaborative intent of the JRA, the agreement required Acerta to use reasonable
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`efforts to develop acalabrutinib (§ 1.08), provide reports to Merck on progress (§
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`3
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`Case IPR2023-00478 | U.S. Patent 10,272,083
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`3.03), and contemplated that any new patent applications from that work would be
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`filed and owned by Acerta (§§ 8.01, 8.02, 1.18). EX2004 at 4, 14–15.3 The
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`specification of the ’083 patent mistakenly does not reference the JRA between
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`Merck and Acerta (the developers of Barf and the ’083 patent respectively).
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`Accordingly, Acerta seeks a certificate of correction to fix that mistake and
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`insert the following text at the beginning of the ’083 patent:
`
`The subject matter disclosed herein was developed and the claimed
`invention was made by or on behalf of one or more of the following
`parties to a joint research agreement: Covalution Pharma B.V. (a/k/a
`Acerta Pharma B.V.) and MSD Oss BV (a predecessor-in-interest to
`Merck Sharp & Dohme B.V.). The joint research agreement was in
`effect on and before the effective filing date of the claimed invention
`and the date the claimed invention was made, and the claimed invention
`was made as a result of activities undertaken within the scope of the
`joint research agreement.
`
`
`ARGUMENT
`
`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. The Federal Circuit has held that 35 U.S.C. § 255
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`expressly “authorizes the Director—not the Board—to determine whether a
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`Certificate of Correction should be issued.” Honeywell, 939 F.3d at 1349–50
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`3 See 37 C.F.R. § 1.9(e) (explaining that “[t]he term joint research
`agreement . . . means a written contract, grant, or cooperative agreement entered
`into by two or more . . . entities for the performance of experimental,
`developmental, or research work in the field of the claimed invention”).
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`4
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`Case IPR2023-00478 | U.S. Patent 10,272,083
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`(emphasis added). Review of a patentee’s motion for leave to petition for a
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`certificate of correction therefore does not involve a decision on the merits of the
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`patentee’s petition, only whether the patent owner is to be granted “authorization for
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`filing such a request.” See, e.g., United Servs. Auto. Ass’n v. Asghari-Kamrani, No.
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`CBM2016-00063, Paper 10 at 6 (P.T.A.B. Aug. 4, 2016). The Board has found a
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`“sufficient basis,” and that 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
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`13, at 4–5 (P.T.A.B. Feb. 26, 2020).
`
`Acerta’s request amply meets every requirement of § 255. As such, the Board
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`should grant that authorization. See Commonwealth, PGR2020-00033, Paper 26 at
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`2, 5 (granting leave to seek a certificate of correction to amend specification to list a
`
`joint research agreement).
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`“Clerical” or “Minor” Error. Acerta seeks to correct the omission of the
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`details of the JRA in the specification of the ’083 patent. That is a “mistake of a
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`clerical . . . nature, or of minor character” under 35 U.S.C. § 255. Rule 1.71 expressly
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`provides that “[t]he specification may disclose or be amended to disclose the names
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`of the parties to a joint research agreement as defined in § 1.9(e).” 37 C.F.R. §
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`1.71(g)(1). It goes on to state:
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`If the patent as issued does not include the names of the
`parties to the joint research agreement, the patent must be
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`5
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`Case IPR2023-00478 | U.S. Patent 10,272,083
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`corrected to include the names of the parties to the joint
`research agreement by a certificate of correction under 35
`U.S.C. 255 and § 1.323 . . . .
`
`
`37 C.F.R. § 1.71(g)(3); see also MPEP §§ 717.02(a)(II), 717.02(b)(IV).
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`“Good Faith.” The mistaken omission of any reference to the joint research
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`agreement was inadvertent and made in “good faith.” However, in this threshold
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`posture, the Board “lack[s] authority to determine” whether a mistake “occurred in
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`good faith.” Arkema, PGR2016-00011, Paper 77, at 11.
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`“New Matter.” Granting Acerta’s proposed correction also will not add “new
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`matter” or “require re-examination.” 35 U.S.C. § 255. The correction would only
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`be a reference to a joint research agreement and would not include the addition of
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`substantive material. The MPEP specifically indicates that such a correction does
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`not require reexamination. (MPEP § 717.02(a)(II) (“It is unnecessary to file a reissue
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`application or request for reexamination of the patent to submit the amendment and
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`other information necessary to establish that the prior art exception under 35 U.S.C.
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`102(b)(2)(C) applies in view of a joint research agreement..”). Once again,
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`moreover, whether re-examination is required is a question for the Director rather
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`than the Board. Arkema, PGR2016-00011, Paper 77, at 11.
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`
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`CONCLUSION
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`For the foregoing reasons, the Board should grant Acerta’s motion and
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`authorize it to petition the Director for a certificate of correction.
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`6
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`Case IPR2023-00478 | U.S. Patent 10,272,083
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`Date: May 24, 2023 Respectfully submitted,
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`/Stanley E. Fisher/
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`
`Stanley E. Fisher (Reg. No. 55,820)
`David I. Berl (Reg. No. 72,751)
`Williams & Connolly LLP
`680 Maine Avenue SW,
`Washington, D.C., 20024
`T: (202) 434-5000
`F: (202) 434-5029
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`7
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`Case IPR2023-00478 | U.S. Patent 10,272,083
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true and correct
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`copy of the foregoing was served on May 24, 2023, by delivering a copy via electronic mail on the
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`following counsel of record for the Petitioner:
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`May 24, 2023
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`Jovial Wong (Reg. No. 60,115)
`WINSTON & STRAWN LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: (202) 282-5867
`Facsimile: (202) 282-5100
`Email: jwong@winston.com
`
`Charles B. Klein
`WINSTON & STRAWN LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: (202) 282-5000
`Facsimile: (202) 282-5100
`Email: cklein@winston.com
`
`Eimeric Reig-Plessis
`WINSTON & STRAWN LLP
`101 California Street
`San Francisco, CA 94111
`Telephone: (415) 591-1000
`Facsimile: (415) 591-1400
`Email: ereigplessis@winston.com
`
`Sharon Lin
`WINSTON & STRAWN LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: (202) 282-5000
`Facsimile: (202) 282-5100
`Email: slin@winston.com
`
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`/Stanley E. Fisher/
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`Stanley E. Fisher (Reg. No. 55,820)
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`8
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