Trials@uspto.gov
`571-272-7822
`
`
`Paper 7
` Date: July 20, 2023
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APOTEX INC.,
`Petitioner,
`
`v.
`
`CELLGENE CORPORATION,
`Patent Owner.
`____________
`
`IPR2023-00512
`Patent 8,846,628 B2
`____________
`
`
`
`Before TINA E. HULSE, RYAN H. FLAX, and
`DEVON ZASTROW NEWMAN, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Instituting Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`

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`IPR2023-00512
`Patent 8,846,628 B2
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`
`INTRODUCTION
`I.
`Celgene Corporation (“Patent Owner”) is the owner of U.S. patent
`8,846,628 B2 (“the ’628 patent”). Paper 5, 1. On February 10, 2023,
`Apotex Inc. (“Petitioner”) filed a Petition for inter partes review challenging
`the patentability of claims 1, 2, 6–9, 11–28, 32–36, and 38–43 of the ’628
`patent (claims 3–5, 10, 29–31, and 37 are not challenged). Paper 1, 1, 6
`(“Pet.”). On May 15, 2023, Patent Owner filed a Preliminary Response to
`the Petition. Paper 6 (“Prelim. Resp.”). No further briefing was requested
`or authorized.
`Under 37 C.F.R. § 42.4(a), we have authority to determine whether to
`institute trial in an inter partes review. We may institute an inter partes
`review if the information presented in the petition filed under 35 U.S.C.
`§ 311, and any preliminary response filed under § 313, shows that there is a
`reasonable likelihood that Petitioner would prevail with respect to at least
`one of the claims challenged in the petition. 35 U.S.C. § 314.
`After reviewing the parties’ submissions, we conclude Petitioner
`demonstrates a reasonable likelihood it will prevail in showing that at least
`one challenged claim of the ’628 patent is unpatentable under the presented
`grounds. Therefore, we grant institution of inter partes review. Our
`reasoning is discussed below.
`A. REAL PARTIES-IN-INTEREST
`Petitioner lists Apotex Inc., Apotex Corp, Apotex Pharmaceutical
`Holdings Inc, and Aposherm Delaware Holdings Corp., as well as SK
`Capital Partners, LP, as real parties-in-interest. Pet. 4. Patent Owner
`identifies itself and Bristol-Myers Squibb Company as real
`parties-in-interest. Paper 5, 1.
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`Patent 8,846,628 B2
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`B. RELATED MATTERS
`Petitioner identifies Celgene Corp. v. Accord Healthcare Inc.,
`1-21-cv-01795 (D. Del.) as a related matter. Pet. 4. Patent Owner identifies
`the same matter as related. Paper 5, 1.
`THE ’628 PATENT
`C.
`The ’628 patent issued on September 30, 2014, from U.S. Application
`12/466,213, which was filed on May 14, 2009. Ex. 1001, codes (45), (21),
`(22). The ’628 patent ultimately indicates priority to U.S. Provisional
`Applications 61/053,609, filed on May 15, 2008, 61/201,145, filed on
`December 5, 2008, and 61/157,857, filed on March 5, 2009. Id. at code
`(60), 1:5–12. Petitioner asserts that, for priority, the ’628 patent is entitled to
`no earlier than the December 5, 2008, filing date of provisional 61/201,145.
`See, e.g., Pet. 19. At this point, Patent Owner does not dispute this and
`applies the December 5, 2008, date to the challenged claims. 1 Prelim. Resp.
`5 n.1.
`The ’628 patent’s abstract states:
`The present disclosure provides pharmaceutical compositions
`comprising cytidine analogs, for example, 5-azacytidine or
`decitabine, for oral administration, wherein the compositions
`release the cytidine analog, for example, 5-azacytidine or
`decitabine, substantially in the stomach. Also provided are
`methods of treating diseases and disorders using the oral
`formulations provided herein.
`Id. at Abstract.
`
`
`1 Regardless of which, if any, provisional application affords an earlier
`effective filing date for the ’628 patent for priority purposes, on this record,
`it appears that each asserted reference has an earlier publication date,
`making each reference prior art and any potential disagreement over the ’628
`patent’s priority immaterial to our decision. See infra Section II.D.
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`Patent 8,846,628 B2
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`
`As Background, the ’628 patent identifies that “[c]ancer is a major
`worldwide public health problem” and specifically discusses
`myelodysplastic syndromes (MDS), which may progress and convert into
`leukemia, one form being acute myelogenous leukemia (AML). Id. at 1:28–
`67. The Background section of the ’628 patent further describes that
`“[n]ucleoside analogs have been used clinically for the treatment of viral
`infections and cancer. Most nucleoside analogs are classified as anti-
`metabolites. After they enter the cell, nucleoside analogs are successively
`phosphorylated to nucleoside 5'-mono-phosphates, di-phosphates, and tri-
`phosphates.” Id. at 2:27–32. The Background describes “5-Azacytidine,
`also known as azacytidine, AZA, or 4-amino-1-β-D-ribofuranosyl-1,3,5-
`triazin-2(1H)-one, is currently marketed as the drug product VIDAZAR®”
`and that “5-Azacytidine is a nucleoside analog, more specifically a cytidine
`analog.” Id. at 2:33–39. The molecular structure of 5-azacytidine is shown
`to be:
`
`
`
`Id. at 2:44–62. The image above shows 5-Azacytidine (or just Azacytidine)
`as being a two-ring molecule (one 5-membered ring and one 6-membered
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`Patent 8,846,628 B2
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`ring) of molecular formula C8H12N4O5 and, of particular note, having a
`nitrogen rather than carbon at position 5 of a cytosine ring. Id. at 2:39–46.
`Citing to prior publications, the Background of the ’628 patent
`describes that “5-Azacytidine [has] been tested in clinical trials and showed
`significant anti-tumor activity, such as, for example, in the treatment of
`myelodysplastic syndromes (MDS), acute myelogenous leukemia (AML),
`chronic myelogenous leukemia (CML), acute lymphocytic leukemia (ALL),
`and non-Hodgkin’s lymphoma (NHL),” and that the drug is “approved for
`subcutaneous (SC) or intravenous (IV) administration to treat various
`proliferative disorders,” but that “[o]ral dosing of cytidine analogs would be
`more desirable and convenient.” Id. at 3:28–51.
`As to such oral dosing, the ’628 patent states that
`oral delivery of cytidine analogs has proven difficult due to
`combinations of chemical instability, enzymatic instability,
`and/or poor permeability. For example, cytidine analogs have
`been considered acid labile and unstable in the acidic gastric
`environment. Previous attempts to develop oral dosage forms
`of cytidine analogs have required enteric coating of the drug
`core to protect the active pharmaceutical ingredient (API) from
`what was understood and accepted to be therapeutically
`unacceptable hydrolysis in the stomach, such that the drug is
`preferably absorbed in specific regions of the lower
`gastrointestinal tract, such as the jejunum in the small intestine.
`Id. at 3:54–65.
`Upon turning to describing its invention, the ’628 patent states that
`“[p]rovided herein are pharmaceutical compositions comprising cytidine
`analogs, wherein the compositions release the API substantially in the
`stomach upon oral administration.” Id. at 4:21–23. The ’628 patent
`describes embodiments having non-enteric-coated tablets comprising the
`cytidine analog. Id. at 4:44–48. The ’628 patent describes such
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`formulations as including 5-azacytidine doses of about 40–1,000 mg, to
`achieve, upon oral administration and substantial release in the stomach, an
`area-under-the-curve (AUC) value of at least about 200–400 ng-hr/mL, a
`maximum plasma concentration (Cmax) of at least 100 ng/mL, and a time to
`maximum plasma concentration (Tmax) of less than about 90 minutes. Id. at
`5:48–6:10, 33:35–38:6.
`The ’628 patent describes that known and conventional methods can
`be used to make the 5-azacytidine formulations and describes a variety of
`embodiments, including those with coatings that can be applied to a tablet or
`capsule comprising 5-azacytidine, so that it is released substantially in the
`stomach, for example a sugar layer coating. Id. at 37:20–40:44. The ’628
`patent also describes that the 5-azacytidine dose in the oral formulations can
`be adjusted based on the patient’s characteristics, e.g., age, weight, prior
`treatment regimens, and other variables, as known in the art, or to increase
`the drug’s beneficial effect, but not cause toxicity. Id. at 76:66–77:20.
`The ’628 patent includes Section VI.A titled “DEFINITIONS,” and
`expressly provides several definitions for terms used in the Specification and
`claims. The ’628 patent defines that:
`The term “about” or “approximately” means an
`acceptable error for a particular value as determined by one of
`ordinary skill in the art, which depends in part on how the value
`is measured or determined. In certain embodiments, the term
`“about” or “approximately’ means within 1, 2, 3, or 4 standard
`deviations. In certain embodiments, the term “about” or
`“approximately” means within 30%, 25%, 20%, 15%, 10%,
`9%, 8%, 7%, 6%. 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, or 0.05%
`of a given value or range.
`Id. at 9:57–65. The ’628 patent also defines that:
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`Patent 8,846,628 B2
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`
`the terms “therapeutically effective amount” and “effective
`amount” of a compound mean an amount sufficient to provide a
`therapeutic benefit in the treatment or management of a disease
`or disorder, or to delay or minimize one or more symptoms
`associated with the disease or disorder. A “therapeutically
`effective amount” and “effective amount” of a compound mean
`an amount of therapeutic agent, alone or in combination with
`one or more other agent(s), which provides a therapeutic benefit
`in the treatment or management of the disease or disorder. The
`terms “therapeutically effective amount” and “effective
`amount” can encompass an amount that improves overall
`therapy, reduces or avoids symptoms or causes of disease or
`disorder, or enhances the therapeutic efficacy of another
`therapeutic agent.
`Id. at 10:43–57. The ’628 patent further defines that:
`The term “non-enteric-coated,” when used herein, refers
`to a pharmaceutical composition, formulation, or dosage form
`that does not comprise a coating intended to release the active
`ingredient(s) beyond the stomach (e.g., in the intestine). In
`certain embodiments, a non-enteric-coated composition,
`formulation, or dosage form is designed to release the active
`ingredient(s) substantially in the stomach.
`Id. at 11:42–48. The ’628 patent also defines that:
`The term “substantially in the stomach,” when used
`herein in reference to a composition, formulation, or dosage
`form provided herein, means that at least about 99%, at least
`about 95%, at least about 90%, at least about 85%, at least
`about 80%, at least about 75%, at least about 70%, at least
`about 65%, at least about 60%, at least about 55%, at least
`about 50%, at least about 45%, at least about 40%, at least
`about 35%, at least about 30%, at least about 25%, at least
`about 20%, at least about 15%, or at least about 10% of the
`cytidine analog is released in the stomach. The term “released
`in the stomach” and related terms as used herein refer to the
`process whereby the cytidine analog is made available for
`uptake by or transport across cells lining the stomach and then
`made available to the body.
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`Id. at 11:49–62. The ’628 patent also defines that:
`The term “subject” is defined herein to include animals
`such as mammals, including, but not limited to, primates (e.g.,
`humans), cows, sheep, goats, horses, dogs, cats, rabbits, rats,
`mice and the like. In specific embodiments, the subject is a
`human.
`Id. at 11:63–67.
`Nowhere in the ’628 patent’s written description does it expressly
`describe specifically how its invention overcame the professed difficulty in
`developing a therapeutically effective oral formulation of azacytidine related
`to the indicated chemical instability (acid lability and instability in the acidic
`gastric environment), enzymatic instability, and/or poor permeability, noting
`only that formulations could be prepared by conventional methods known to
`those skilled in the field. See generally id.
`The ’628 patent concludes with 43 claims, of which claims 1 and 28
`are independent claims. Ex. 1001, 81:55–84:23. Claim 1 is illustrative and
`reproduced below:
`1. [1a ]A pharmaceutical composition for oral
`administration comprising [1b] a therapeutically effective
`amount of 5-azacytidine and [1c] at least one pharmaceutically
`acceptable excipient, [1d] wherein the composition is a non-
`enteric coated tablet.
`Ex. 1001, 81:55–58 (adding sub-numbers as used by Petitioner).
`Independent claim 28 is similar to claim 1 in reciting the same drug,
`formulated as a non-enteric coated (NEC)2 tablet, but is directed to a method
`of using that drug composition to treat myelodysplastic syndrome (MDS) or
`acute myelogenous leukemia (AML). Id. at 82:61–83:2. The dependent
`
`2 NEC refers to non-enteric coatings/coated and EC refers to enteric
`coatings/coated.
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`claims further define the composition of the 5-azacytidine NEC tablet, the
`dose of 5-azacytidine, or the resultant pharmacokinetic (PK) measurements
`(area under the curve value (AUC), maximum plasma concentration (Cmax),
`and time to maximum plasma concentration (Tmax) upon oral administration
`(pharmacokinetics addresses how the body interacts with administered
`substances). See id. at 81:59–61, 82:5–60, 83:12–84:23.
`D. ASSERTED GROUNDS FOR UNPATENTABILITY
`Petitioner asserts the following grounds for the unpatentability of
`claims 1, 2, 6–9, 11–28, 32–36, and 38–43 of the ’628 patent:
`
`
`Ground Claims Challenged 35 U.S.C. §3
`1, 2, 6–8, 11, 13–18,
`20–23, 28, 32–35,
`38, 40, 42, 43
`1, 2, 6–9, 11–28, 32–
`36, 38–43
`1, 2, 6–9, 11–28, 32–
`36, 38–43
`
`Reference(s)/Basis
`
`Ionescu4
`
`Ionescu, Atadja, 5
`Gibson6
`Ionescu, Atadja,
`Gibson, Pharmion-PR7
`
`1
`
`2
`
`3
`
`102(b)
`
`103(a)
`
`103(a)
`
`
`3 The ’628 patent has a priority date no later than its actual filing date of
`May 14, 2009, which is before the AIA revisions to 35 U.S.C. §§ 102 and
`103 took effect on March 16, 2013. 35 U.S.C. § 100 (note). Therefore, pre-
`AIA §§ 102 and 103 apply. However, our decision is not impacted by which
`version of the statute applies.
`4 WO 2004/082619 A2, published Sept. 30, 2004 (Ex. 1004, “Ionescu”).
`5 WO 2004/103358 A2, published Dec. 2, 2004 (Ex. 1005, “Atadja”).
`6 TAYLOR & FRANCIS GROUP, PHARMACEUTICAL PREFORMULATION AND
`FORMULATION, A PRACTICAL GUIDE FROM CANDIDATE DRUG SELECTION TO
`COMMERCIAL DOSAGE FORM (Mark Gibson ed. 2001) (Ex. 1006, “Gibson”).
`7 Pharmion, News Release, Clinical Data Presented on Pilot
`Pharmacokinetic Study of Oral Azacitidine, Bioavailability data from First
`Oral Demethylating Agent in Clinical Trials, (July 9, 2007) (“Presented at
`the American Society of Clinical Oncology 43rd Annual Meeting”)
`(Ex. 1010, “Pharmion-PR”). Petitioner and affiant assert Pharmion-PR was
`
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`
`See Pet. 6.
`In support of these grounds for unpatentability, Petitioner submits,
`inter alia, the Declarations of Graham Buckton, PhD (Ex. 1002) and Hanna
`K. Batchelor, PhD (Ex. 1003). In response, Patent Owner submits, inter
`alia, the Declaration of Cory Berkland, PhD. Ex. 2001. In the absence of
`evidence to the contrary, we find Drs. Buckton, Batchelor, and Berkland
`competent to testify on the subject matter of their declarations. See infra
`Section II.A; see Ex. 1002 ¶¶ 3, 5–13, 15–19, Exhibit A; Ex. 1003 ¶¶ 3, 5–
`13, 15–17, Exhibit A; Ex. 2001 ¶¶ 2–15, 17, 28–30, App’x A.
`II. DISCUSSION
`LEVEL OF ORDINARY SKILL IN THE ART
`In determining the level of ordinary skill in the art, we consider the
`types of problems encountered in the art, the prior art solutions to those
`problems, the rapidity with which innovations are made, the sophistication
`of the technology, and the educational level of active workers in the field.
`Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962
`(Fed. Cir. 1986).
`We do not discern that Petitioner expressly advocates for any specific
`definition of the ordinarily skilled artisan, which is a reading of the Petition
`that Patent Owner confirms. See generally Pet.; Prelim. Resp. 17. However,
`as identified by Patent Owner (see Prelim. Resp. 17), each of Petitioner’s
`witnesses, Drs. Buckton and Batchelor, states,
`
`A.
`
`
`published at https://web.archive.org/web/2007079161226/
`http:/investor.pharmion.com/phoenix.zhtml?c=142045&p=irol-
`newsArticle&ID=1010376&highlight=. See Ex. 1010 (Affidavit of
`Nathaniel E Frank-White regarding “the Wayback Machine”).
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`
`A POSA relating to the subject matter of the ʼ628 patent
`would have had (1) a Pharm.D., or a Ph.D. in pharmaceutical
`sciences, chemical engineering, chemistry, or related discipline;
`and (2) at least two to four years of experience with
`pharmaceutical design, formulation, development, and/or
`manufacturing of oral dosage forms. A POSA may also work
`as part of a multidisciplinary team and draw upon not only his
`or her own skills, but also take advantage of certain specialized
`skills of others in the team to solve a given problem. To the
`extent necessary, this person would have worked in
`collaboration with others with the requisite education and
`experience in candidate drug selection, clinical use, clinical
`testing, design, formulation, development, and/or
`manufacturing of pharmaceutical oral dosage forms.
`Ex. 1002 ¶ 17; Ex. 1003 ¶ 16. 8 As does Patent Owner, we understand this to
`be Petitioner’s proposed definition of the person of ordinary skill in the art
`and to what it refers when addressing a POSA throughout the Petition.
`Patent Owner neither contests this proposed definition of the
`ordinarily skilled artisan nor offers its own. Prelim. Resp. 17–18.
`For the purposes of this Decision, we accept the above quoted
`definition of the person of ordinary skill in the art (or ordinarily skilled
`artisan), which appears to be consistent with the level of skill in the art
`reflected in the prior art of record and the disclosure of the ’628 patent. See
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art
`itself [may] reflect[]” evidence of the ordinary level of skill in the art)
`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`163 (Fed. Cir. 1985)).
`
`
`8 The parties and their witnesses use “POSA” to refer to the person of
`ordinary skill in the art.
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`B. CLAIM CONSTRUCTION
`The Board interprets claim terms in an inter partes review using the
`same claim construction standard that is used to construe claims in a civil
`action in federal district court. 37 C.F.R. § 42.100(b). In construing claims,
`district courts and the Board here, by default, give claim terms their ordinary
`and customary meaning, which is “the meaning that the term would have to
`a person of ordinary skill in the art in question at the time of the invention.”
`Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc).
`Should claim terms require express construction, sources for claim
`interpretation include “the words of the claims themselves, the remainder of
`the specification, the prosecution history [i.e., the intrinsic evidence], and
`extrinsic evidence concerning relevant scientific principles, the meaning of
`technical terms, and the state of the art.” Id. at 1314 (quoting Innova/Pure
`Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed.
`Cir. 2004)). “[T]he claims themselves [may] provide substantial guidance as
`to the meaning of particular claim terms.” Id. However, the claims “do not
`stand alone,” but are part of “‘a fully integrated written instrument’ . . .
`consisting principally of a specification that concludes with the claims,” and,
`therefore, the claims are “read in view of the specification.” Id. at 1315
`(quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 978–79 (Fed.
`Cir. 1995) (en banc)). Any special definition for a claim term must be set
`forth in the specification “with reasonable clarity, deliberateness, and
`precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Without
`such a special definition, however, limitations may not be read from the
`specification into the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed.
`Cir. 1993).
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`“[W]e need only construe terms ‘that are in controversy, and only to
`the extent necessary to resolve the controversy.’” Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999)).
`Our claim construction positions herein are necessarily preliminary,
`by the nature of the proceeding. Further argument by the parties is
`permitted.
`Regarding claim construction, Petitioner states, “[t]he ʼ628 patent
`defines several claim terms including, for example, ‘about,’ ‘therapeutically
`effective amount,’ ‘non-enteric-coated,’ and ‘subject.’ (EX-1001 at 9:57-65,
`10:43-48, 11:42-38, 11:63-67[).] Petitioner applies the definitions set forth
`in the ʼ628 patent (id. at 9:51-13:9) unless otherwise noted [in the Petition].”
`Pet. 20; see supra Section I.C (identifying that the ’628 patent expressly
`defines certain relevant terms).
`We note that the terms “therapeutically effective amount” and “non-
`enteric-coated tablet” (we add “tablet” to this claim phrase for full context)
`appear in claims 1 and 28. Ex. 1001, 81:55–58, 82:61–83:2. Further,
`“about” appears in claims 5, 8–12, 18–22, 24–27, 31, and 35–43. Id. at
`82:1–84:23. The term “subject” appears in claims 11, 12, 18–22, 28, and
`38–43. Id. at 82:15–84:23.
`Patent Owner, similar to Petitioner, urges we apply the ’628 patent’s
`Specification’s expressly-provided definition of “non-enteric-coated” (“non-
`enteric-coated tablet,” contextually, as noted above). Prelim. Resp. 18.
`The Federal Circuit in Phillips states, “our cases recognize that the
`specification may reveal a special definition given to a claim term by the
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`patentee that differs from the meaning it would otherwise possess. In such
`cases, the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316
`(citing CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir.
`2002)). Moreover, “[w]hen the specification explains and defines a term
`used in the claims, without ambiguity or incompleteness, there is no need to
`search further for the meaning of the term.” Multiform Dessicants, Inc. v.
`Medzam Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). We agree with the
`parties that the ’628 patent expressly defines this term in stating “[t]he term
`‘non-enteric-coated,’ when used herein, refers to a pharmaceutical
`composition, formulation, or dosage form that does not comprise a coating
`intended to release the active ingredient(s) beyond the stomach (e.g., in the
`intestine),” and we adopt this express definition herein with regard to “non-
`enteric coated tablet.”9 Ex. 1001, 11:42–48 (emphasis added).
`Regarding the scope of this claim term, we note that this definition of
`“non-enteric coated,” urged by each party and expressly set forth in the
`Specification, only requires what the pharmaceutical composition,
`formulation, or dosage, i.e., the “tablet” recited by claims 1 and 28, does not
`include––“does not comprise a coating intended to release the active
`ingredient(s) beyond the stomach (e.g., in the intestine)” (emphasis added);
`that is, the limitation does not require any coating be applied to the tablet.
`Nothing in claims 1 or 28 expressly requires any coating whatsoever. A
`requirement for a coating is introduced at dependent claim 13, which recites
`
`
`9 We note that, when used in the claims, this term does not include a hyphen
`between the words enteric and coated where, in the written description of the
`’628 patent, such a hyphen is included; however, we discern no substantive
`difference between the two phrases and none is asserted by the parties.
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`“the tablet [of claim 1] further comprises a sugar coating, a film coating, or a
`compression coating.” Ex. 1001, 82:21–23, cert. of correction.
`Our understanding and interpretation of this aspect of the claims is
`supported by the Specification, which states, inter alia, “[i]n particular
`embodiments, the tablet contains a drug core that comprises a cytidine
`analog, and [only] optionally further contains a coating of the drug core,”
`and “embodiments provide the aforementioned compositions, which: are
`immediate release compositions; do not have an enteric coating (i.e., are
`non-enteric-coated); are tablets,” and “[i]n certain embodiments, coatings
`and/or shells may be employed in the formulation to control the release of
`the cytidine analog . . . substantially in the stomach,” and, further, describes
`a variety of tablet designs for controlling drug delivery to occur in the
`stomach. Id. at 4:65–5:1, 5:52–55, 34:48–50, 38:41–41:62 (emphasis
`added). This description makes clear that some embodiments have a coating
`and some do not.
`Our understanding of this claim language is also reinforced by Patent
`Owner’s (then Applicant) statements to the Office during prosecution of the
`’628 patent. See Ex. 1022. Applicant argued in its last Response (dated
`February 27, 2017) to an office action before the allowance and issuance of
`the claims that “[a] novel and unique element of the claimed composition is
`the absence of an enteric coating, i.e., a coating that is designed to release
`the active ingredient beyond the acidic environment of the stomach when
`orally administered.” Id. at 2072–73. This crystallizes the Patent Owner’s
`understanding of the claim term “non-enteric coated tablet” before the
`Office, i.e., it is a tablet without an enteric coating.
`
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`Thus, per the claim language itself, the Specification as a whole, and
`the prosecution history, “non-enteric coated tablet” refers to the recited
`“tablet” itself as omitting an enteric coating and does require any specific
`coating be included in the tablet.
`Patent Owner also argues that the term “test subject” (which is similar
`to, and sometimes associated with, but not identical to the claim term
`“subject”), which appears in claims 11, 12, 18–22, and 38–43, means “a
`human or other animal who received the recited pharmaceutical composition
`in connection with a test of the recited parameter.” Prelim. Resp. 18–19
`(also asserting Petitioner does not appear to dispute this construction).
`We first note that the term “test subject” appears in the ’628 patent
`only in the claims. See generally Ex. 1001. However, we find Patent
`Owner’s definition comports with the Specification’s express definition of
`“subject,” a term the Specification appears to use synonymously with the
`claim term “test subject” and the word patient, and that Patent Owner’s
`definition adds that the subject received the pharmaceutical composition in
`connection with a test of the recited parameter, which we find to be a
`reasonable interpretation of the claim term “test subject,” in accordance with
`the plain language of the claims on their face, and as supported by the
`relevant portions of the Written Description that describe testing parameters
`relating to drug administration. Ex. 1001, 35:45–36:62, 67:61–81:48. We
`adopt Patent Owner’s definition herein.
`Patent Owner also argues that the language of claim 14, and claim 15
`that depends from 14, does further limit the scope of the subject matter of
`claim 13 from which claim 14 depends. Prelim. Resp. 19. Patent Owner
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`provides no support for this position. Id. We need not resolve this matter at
`this stage of the proceeding.
`We determine that no other express construction of any claim term is
`necessary for purposes of rendering this Decision. See Nidec Motor Corp.,
`868 F.3d at 1017.
`If either party intends to further argue claim construction at trial they
`should do so in a clearly designated section of their briefing so as to
`expressly identify such arguments. See, e.g., 37 C.F.R. § 42.104(b)(3)
`(content of petition); see also Board’s Consolidated Trial Practice Guide
`(CTPG), 84 FR 64280, 46, 48–45 (Nov. 2019) (available at
`https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL=).
`Critical claim construction arguments should not be relegated to or hidden
`within patentability arguments on the facts.
`LEGAL STANDARDS FOR ANALYZING PATENTABILITY
`C.
`“In an IPR, the petitioner has the burden from the onset to show with
`particularity why the patent it challenges is unpatentable.” Harmonic Inc. v.
`Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C.
`§ 312(a)(3) (requiring inter partes review petitions to identify “with
`particularity . . . the evidence that supports the grounds for the challenge to
`each claim”)). This burden of persuasion never shifts to Patent Owner. 10
`See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
`(Fed. Cir. 2015) (discussing the burden of proof in inter partes review).
`
`
`10 Although we refer herein to certain of Patent Owner’s arguments as being
`not persuasive, we do not shift the ultimate burden of proof from Petitioner.
`Such non-persuasiveness is in the context of the parties’ arguments and the
`record as a whole.
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`An inter partes review may be instituted if the information presented
`by Petitioner in the Petition, in view of Patent Owner’s Preliminary
`Response and the preliminary record, shows that there is a reasonable
`likelihood that Petitioner would prevail with respect to at least one of the
`claims challenged in the Petition. 35 U.S.C. § 314.
`“Anticipation requires that all of the claim elements and their
`limitations are shown in a single prior art reference.” In re Skvorecz, 580
`F.3d 1262, 1266 (Fed. Cir. 2009). To anticipate “it is not enough that the
`prior art reference discloses part of the claimed invention, which an ordinary
`artisan might supplement to make the whole, or that it includes multiple,
`distinct teachings that the artisan might somehow combine to achieve the
`claimed invention.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359,
`1371 (Fed. Cir. 2008). “However, a reference can anticipate a claim even if
`it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as
`in the claim, if a person of skill in the art, reading the reference, would ‘at
`once envisage’ the claimed arrangement or combination.” Kennametal, Inc.
`v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (quoting
`In re Petering, 301 F.2d 676, 681 (CCPA 1962)).
`A prior art reference without express reference to a claim limitation
`may anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d
`1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior
`art necessarily functions in accordance with, or includes, the claimed
`limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v.
`Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)).
`Regarding obviousness, the Supreme Court in KSR Int’l Co. v.
`Teleflex Inc., 550 U.S. 398 (2007), reaffirmed the framework for
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`determining obviousness set forth in Graham v. John Deere Co., 383 U.S. 1
`(1966). The KSR Court summarized the four factual inquiries set forth in
`Graham (383 U.S. at 17–18) that are applied in determining whether a claim
`is unpatentable as obvious under 35 U.S.C. § 103 as follows: (1) determining
`the scope and content of the prior art; (2) ascertaining the differences
`between the prior art and the claims at issue; (3) resolving the level of
`ordinary skill in the art;11 and (4) considering objective evidence indicating
`obviousness or non-obviousness. 12 KSR, 550 U.S. at 406.
`“The combination of familiar elements according to known methods
`is likely to