`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`CATALENT PHARMA SOLUTIONS, INC.
`Petitioner
`
`v.
`
`PATHEON SOFTGELS INC.
`Patent Owner
`
`_____________________
`
`Case IPR2018-00422
`Patent 9,693,979
`_____________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`UNDER 37 C.F.R. § 42.107(a)
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
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`

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`IPR2018-00422
`Patent No. 9,693,979
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`TABLE OF CONTENTS
`
`I. 
`II. 
`
`B. 
`
`Introduction ...................................................................................................... 1 
`The Board should deny the petition because its grounds for unpatentability
`rely on a faulty and unreasonably broad claim construction. .......................... 6 
`The petition relies on an unreasonably broad and faulty construction
`A. 
`of “about 5%.” ....................................................................................... 6 
`The Petition relies on a flawed construction of “liquid matrix.” ........ 12 
`B. 
`III.  Catalent has not articulated its reasons behind the multiple grounds asserted
`in the petition. ................................................................................................ 12 
`IV.  Ground 1: Catalent has not met its burden of establishing a reasonable
`likelihood that any of the challenged claims is anticipated by Chen or
`obvious in view of Chen. ............................................................................... 14 
`The Petition fails to show that Chen anticipates any of the challenged
`A. 
`claims. .................................................................................................. 14 
`1.  Chen does not disclose all of the elements of the challenged
`claims, expressly or inherently. ................................................ 14 
`2.  Chen does not disclose all the elements of the challenged claims,
`arranged as claimed. .................................................................. 21 
`3.  Chen fails to disclose all the elements of the challenged claims,
`as evidenced by the Petition’s resort to additional references to
`purportedly meet the claim limitations. .................................... 26 
`4.  Catalent’s anticipation arguments for dependent claims also fail.
` ................................................................................................... 28 
`The Petition fails to show that Chen renders obvious any of the
`challenged claims ................................................................................ 30 
`The Petition fails to explain why or how the artisan would have
`1. 
`purportedly modified Chen to arrive at the compositions and
`methods as claimed. .................................................................. 31 
`The Petition fails to explain why the artisan would have had a
`reasonable expectation of success. ............................................ 33 
`The Petition fails to demonstrate that the claimed invention
`could have been generated through routine optimization. ........ 35 
`The Petition fails to address previously asserted objective indicia
`of nonobviousness. .................................................................... 36 
`
`2. 
`
`3. 
`
`4. 
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`IPR2018-00422
`Patent No. 9,693,979
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`2. 
`
`3. 
`
`4. 
`
`B. 
`
`C. 
`
`V.  Ground 2: Catalent has not met its burden of establishing a reasonable
`likelihood that any of the challenged claims would have been obvious in
`view of Kim or in view of Kim and Chen. .................................................... 42 
`The Petition fails to show that Kim renders obvious any of the
`A. 
`challenged claims. ............................................................................... 42 
`1.  Kim does not disclose or suggest all the elements of the
`challenged claims. ..................................................................... 43 
`The Petition fails to explain why or how a skilled artisan would
`have modified Kim to arrive at the compositions as claimed. .. 44 
`The Petition fails to show why a skilled artisan would have had
`a reasonable expectation of success. ......................................... 50 
`The Petition fails to demonstrate that the claimed invention
`could have been generated through routine optimization. ........ 50 
`5.  Catalent’s obviousness arguments for dependent claims also fail.
` ................................................................................................... 51 
`The Petition fails to show that Kim in view of Chen renders obvious
`any of the challenged claims. .............................................................. 53 
`The Petition fails to address previously asserted objective indicia of
`nonobviousness. .................................................................................. 54 
`VI.  Ground 3: Catalent has not met its burden of establishing a reasonable
`likelihood that any of the challenged claims are obvious in view of
`Schoenhard or obvious in view of Schoenhard and Chen. ............................ 54 
`The Petition fails to show that Schoenhard renders obvious any of the
`A. 
`challenged claims. ............................................................................... 54 
`Schoenhard does not disclose or suggest all the elements of the
`1. 
`challenged claims. ..................................................................... 55 
`The Petition fails to explain why or how the artisan would have
`purportedly modified Schoenhard to arrive at the compositions
`and methods as claimed. ........................................................... 60 
`The Petition fails to explain why the artisan would have had a
`reasonable expectation of success. ............................................ 61 
`The Petition fails to demonstrate that the claimed invention
`would have been generated through routine optimization. ....... 62 
`5.  Catalent’s obviousness arguments for dependent claims also fail.
` ................................................................................................... 63 
`
`2. 
`
`3. 
`
`4. 
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`IPR2018-00422
`Patent No. 9,693,979
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`B. 
`
`C. 
`
`The Petition fails to show that Schoenhard in view of Chen renders
`obvious any of the challenged claims. ................................................ 64 
`The petition fails to address known objective indicia of
`nonobviousness. .................................................................................. 65 
`VII.  Mr. Draper’s declaration provides biased and unsubstantiated testimony—
`the Board should accord it no weight. ........................................................... 66 
`VIII.  Conclusion ..................................................................................................... 69 
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`IPR2018-00422
`Patent No. 9,693,979
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`Patent Owner Patheon Softgels Inc. (“Patheon”) provides this Preliminary
`
`Response to the Petition for inter partes review (“IPR”) of claims 1-19 of U.S.
`
`Patent No. 9,693,979 (“the ’979 Patent”; EX1003) filed by Petitioner Catalent
`
`Pharma Solutions, Inc. (“Catalent”).
`
`I.
`
`Introduction
`
`Catalent is attempting to knock out Patheon’s claims protecting novel and
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`commercially successful softgel capsule naproxen formulations. But to even be
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`instituted, a petition for inter partes review must meet its burden to establish a
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`reasonable likelihood that it could prevail against at least one challenged claim—a
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`requirement that Catalent’s petition fails to meet because it neither complies with
`
`the Board’s filing requirements under 37 C.F.R. § 42.104 nor addresses key
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`elements of anticipation and obviousness necessary to prevail on the merits.
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`Catalent’s Petition fails to comply with the Board’s filing requirements on
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`several levels. First, the Petition does not identify the challenged claims with
`
`particularity, but instead presents a vague and conclusory series of attorney
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`arguments. See 37 C.F.R. § 42.104(b). Second, the grounds in the Petition each
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`include an alternative argument, essentially doubling the number of asserted
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`grounds, and the Petition fails to explain Catalent’s reasoning behind the multiple
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`IPR2018-00422
`Patent No. 9,693,979
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`grounds or alternative grounds. See generally 37 C.F.R. § 1.104. Third, the Petition
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`improperly incorporates by reference extensive arguments from the Draper
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`declaration that is not presented in the Petition. See 37 C.F.R. §42.6(a)(3).
`
`Catalent’s Petition fails on the merits as well because its art-based
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`challenges are premised on faulty claim construction and it misapplies the laws of
`
`anticipation and obviousness. Catalent provides an unreasonably broad and faulty
`
`construction of the term “about 5%” with complete disregard for the plain
`
`language of the claims and the intrinsic evidence in the ’979 patent specification
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`and its file history.
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`The Petition then proceeds to misapply controlling law of anticipation and
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`obviousness. Notably, Catalent’s anticipation argument relies on alleged inherent
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`disclosures in its lead reference, U.S. Patent No. 6,383,471 (“Chen,” EX1009).
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`Yet, the law is clear: inherent anticipation requires that the missing descriptive
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`material is necessarily present, not merely probably or possibly present, in the
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`prior art. Catalent’s inherent anticipation arguments impermissibly rely on the
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`arbitrary selection from myriad variables relating to dosage amount, capsule size,
`
`and liquid matrix density―in an attempt to fabricate the claimed invention from
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`the prior art. For each variable, Catalent contrives a specific value, then performs
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`IPR2018-00422
`Patent No. 9,693,979
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`calculations apparently preordained to establish anticipatory disclosure of the claim
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`limitations of the ’979 patent. But none of Chen, Kim, or Schoenhard discloses any
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`naproxen sodium dosage amounts, any softgel capsule sizes, or any particular
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`density of the liquid matrix. For example, Catalent does not explain why its
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`declarant chose an oblong capsule said to hold 880 milliliters of liquid and does
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`not explain why its declarant chose a 220 mg naproxen dosage. Nor does Catalent
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`explain why the liquid matrix density is arbitrarily set to the density of water. The
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`cited references do not expressly or inherently guide any of the above parameters,
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`nor are any of the selections a “necessary consequence of what was deliberately
`
`intended” by the disclosures such that the “about 5%” claim limitation is
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`necessarily met. MEHL/Biophile Intern. Corp. v. Milgraum, 192 F. 3d 1362, 1366
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`(Fed. Cir. 1999). This is not inherent anticipation.
`
`Moreover, Catalent’s anticipation arguments pick and choose elements from
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`long and disparate lists of compounds in Chen. An anticipatory reference,
`
`however, must disclose each and every element arranged as claimed, without any
`
`need for picking, choosing, and combining disparate disclosures in the reference.
`
`In re Arkley, 455 F.2d 586, 587 (C.C.P.A. 1972). Catalent’s anticipation arguments
`
`therefore fail on multiple levels.
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`IPR2018-00422
`Patent No. 9,693,979
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`Catalent’s obviousness arguments suffer similar deficiencies. The Petition
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`saddles the Board and Patheon with guessing Catalent’s arguments as to why and
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`how a person of ordinary skill in the art allegedly would have combined or
`
`modified the cited art with a reasonable expectation of success. These deficiencies
`
`relate to the core fundamentals of an obviousness analysis and prove fatal to the
`
`Petition’s obviousness arguments. Further, Catalent’s Petition fails to address
`
`publicly-available objective indicia evidence, particularly evidence of unexpected
`
`results. Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc., IPR2015-
`
`01792, Paper 14, at 18 (March 11, 2016).
`
`Patheon submits expert testimony from Mansoor Khan, Ph.D., a renowned
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`pharmaceutical formulations expert with over 25 years of experience in the field,
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`explaining that Catalent’s declarant’s analysis of the art is riddled with errors,
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`mischaracterizations of the art, and gaps in scientific logic. Catalent’s declarant,
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`Mr. Draper—who is employed by a Catalent subsidiary company—makes several
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`improper assertions. For example, Mr. Draper improperly equates disclosures of
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`“naproxen” in the art with disclosures of “naproxen sodium.” EX1001, ¶ 41. As
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`Dr. Khan explains, a skilled artisan would have considered these compounds to be
`
`two different drugs, not simply different formulations of the same drug. PSG2001,
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`IPR2018-00422
`Patent No. 9,693,979
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`¶¶29-31, 51. Mr. Draper also improperly asserts that citric acid and lactic acid are
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`“functional equivalents or substitutable in naproxen softgel formulations.”
`
`EX1001, ¶ 39. But Dr. Khan shows that the art contradicts Mr. Draper’s assertions:
`
`citric acid and lactic acid were known to be different compounds with different
`
`properties when used in pharmaceutical formulations. PSG2001, ¶¶43-50, 67.
`
`Mr. Draper’s analysis also fails to account for the state of the art in softgel
`
`capsule formulations before the ’979 patent. Though artisans generally understood
`
`that soft gelatin capsule formulations could offer certain advantages over
`
`conventional tablet dosage forms, the art nonetheless failed to provide softgel
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`capsule formulations of naproxen sodium, as provided in the ’979 patent.
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`PSG2001, ¶¶32-34; PSG2010, at 62; PSG2023, at 395–396.
`
`Despite the known advantages of liquid softgel capsule formulations over
`
`solid tablets for other active ingredients, artisans found that dissolving naproxen
`
`sodium in non-aqueous solvents like polyethylene glycol (“PEG”) resulted in the
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`formation of naproxen-PEG esters, which were considered unacceptable impurities
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`that reduced bioavailability. PSG2001, ¶¶35-36; PSG2005, at 4:1–6; 7:9–12;
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`11:21–24; PSG2006, at 147; EX1010, ¶[0061]. Thus, before March 8, 2005, there
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`was an unmet need for a liquid softgel formulation that offered good active
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`IPR2018-00422
`Patent No. 9,693,979
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`pharmaceutical ingredient solubility, stability, and bioavailability, such as a
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`naproxen sodium liquid softgel formulation. PSG2001, ¶37. The inventors of the
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`’979 patent solved this problem for naproxen by developing novel, liquid softgel
`
`formulations.
`
`Indeed, before the ’979 patent’s invention, naproxen sodium was formulated
`
`as a solid tablet for nearly 30 years until 2006 when the FDA approved Banner
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`Pharmacaps’ naproxen sodium softgel formulation (which is encompassed by the
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`’979 patent) under NDA application no. 21-920. PSG2001, ¶31; PSG2016-
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`PSG2020.
`
`In sum, the Board should deny institution because the information presented
`
`in the Petition and in this Preliminary Response demonstrates that there is not a
`
`reasonable likelihood that the Petitioner would prevail on even one of its
`
`challenges to claims 1–19.
`
`II. The Board should deny the petition because its grounds for
`unpatentability rely on a faulty and unreasonably broad claim
`construction.
`A. The petition relies on an unreasonably broad and faulty construction of
`“about 5%.”
`
`Catalent argues that the broadest reasonable interpretation of the phrase
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`IPR2018-00422
`Patent No. 9,693,979
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`“about 5% lactic acid by weight” in the challenged claims “includes at least from 2
`
`to 8% lactic acid by weight.” Pet., at 12-13 (emphasis added). Catalent’s
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`construction of “about 5%” is unreasonably broad, ignores intrinsic evidence in the
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`’979 patent’s specification and prosecution history, and ultimately provides a
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`faulty premise for each of the unpatentability grounds asserted in the Petition.
`
`Claim terms of the ’979 patent are interpreted according to their broadest
`
`reasonable interpretation (“BRI”). 37 C.F.R. § 42.100(b). Under the BRI1, “claims
`
`should always be read in light of the specification and teachings in the underlying
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`patent.” In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010).
`
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`1 On May 9, 2018, the U.S. Department of Commerce proposed changing
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`the claim construction standard in IPRs from the BRI to construing the claim in
`
`accordance with the ordinary and customary meaning of the claim as understood
`
`by one of ordinary skill in the art and the prosecution history pertaining to the
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`patent—i.e., the standard set forth in Phillips v. AWH Corp., 415 F.3d 1303 (Fed.
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`Cir. 2005) (en banc). See 83 FED. REG. 21221 (proposed May 9, 2018). Catalent’s
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`construction of “about5%” is faulty and unreasonably broad under the Phillips
`
`standard for the same reasons discussed herein under the BRI standard.
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`IPR2018-00422
`Patent No. 9,693,979
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`Moreover, “the prosecution history, while not literally within the patent document,
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`serves as intrinsic evidence for purposes of claim construction. This remains true
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`in construing patent claims before the PTO.” Tempo Lighting Inc. v. Tivoli LLC,
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`742 F.3d 973, 977 (Fed. Cir. 2014) (emphasis added). While the Board “must give
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`the terms their broadest reasonable construction, the construction cannot be
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`divorced from the specification and the record evidence.” In re NTP, Inc., 654 F.3d
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`1279, 1288 (Fed. Cir. 2011) (emphasis added) (citing Suitco, 603 F.3d at 1259).
`
`Here, Catalent’s construction of “about 5%” is entirely divorced from the
`
`plain language of the claims. Under Catalent’s construction, “about 5%” can mean
`
`“at least” up to 60% higher (i.e., 8%) or “at least” 60% lower (i.e., 2%) than 5%.
`
`As Dr. Khan explains, a skilled artisan would not have considered “about 5%” to
`
`include a range extending “at least” up to 60% higher or 60% lower than the
`
`middle point of 5%. PSG2001, ¶¶20-28. This does not reflect the plain and
`
`ordinary meaning of “about.” Id. To the contrary, a skilled artisan would have
`
`considered the plain and ordinary meaning of the term “about 5%” to be:
`
`“approximately 5%.” Id.; see, e.g., Merck & Co. v. Teva Pharmaceuticals USA,
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`395 F.3d 1364, 1372 (Fed. Cir. 2005) (“the term ‘about’ should be given its
`
`ordinary and accepted meaning of ‘approximately’”).
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`IPR2018-00422
`Patent No. 9,693,979
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`Catalent’s construction is flawed for several reasons. First, Catalent bases its
`
`construction on a single formulation disclosed in Example 8 of the ’979 patent.
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`Pet., at 12-13. Catalent makes the legally unfounded argument that the BRI of
`
`about 5% “must include” a range of lactic acid amounts that encompasses the
`
`formulation of Example 8. Id. (emphasis added). But Catalent provides no
`
`authority for such a principle. To the contrary, it is well-established law that the
`
`claims need not encompass every alternative embodiment in the patent. “[T]o
`
`construe the claim term to encompass the alternative embodiment in this case
`
`would contradict the language of the claims. Indeed, read in the context of the
`
`specification, the claims of the patent need not encompass all disclosed
`
`embodiments.” TIP Sys., LLC v. Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364,
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`1373 (Fed. Cir. 2008) (emphasis added).
`
`Second, Catalent assumes in its purported calculations that a skilled artisan
`
`would have interpreted the disclosed amount of lactic acid in Example 8 (“0.24-
`
`0.35M”) to mean “0.24–0.35 mole equivalents of lactic acid per mole equivalent of
`
`naproxen sodium,” Pet., at 12. Using this interpretation, the amount of lactic acid
`
`present in the formulation of Example 8 would be between 2.1–3.1% lactic acid by
`
`weight of the matrix, which is not “about 5%.” PSG2001, ¶¶23-24.
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`IPR2018-00422
`Patent No. 9,693,979
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`As Dr. Khan explains, a skilled artisan would recognize that the Examples in
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`the ’979 patent related to “about 5% lactic acid” are Examples 7 (5.27% lactic
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`acid) and Examples 9–12 (5.00% lactic acid). PSG2001, ¶¶22-24. The skilled
`
`artisan would have understood that the examples in the specification provide
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`specific percentages of lactic acid by weight of the matrix, calculated to the
`
`hundredths of a percent. PSG2001, ¶24; EX1003, Example 7 (disclosing a
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`composition comprising 5.27% lactic acid by weight of the matrix); Examples 9–
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`12 (disclosing compositions comprising 5.00% lactic acid by weight of the matrix).
`
`Thus, Dr. Khan explains that the artisan would not have considered a formulation
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`comprising 2.1–3.1% lactic acid to be “about 5%” lactic acid by weight of the
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`matrix as claimed. PSG2001, ¶24. It is of no moment that the formulation of
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`Example 8 discloses an alternative embodiment that is not be encompassed by the
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`claims, because the law does not require construction of claim terms to encompass
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`all disclosed embodiments. See TIP Systems, 529 F.3d at 1373.
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`Third, Catalent’s construction of “about 5%” to mean “at least from 2 to
`
`8%” is unreasonable because it is nearly the same scope of original claim 10,
`
`ignoring the fact that the claims were amended during prosecution. EX1008, at
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`121, 195 During prosecution of the ’979 patent, the Applicant pursued independent
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`IPR2018-00422
`Patent No. 9,693,979
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`claim 10 directed to a pharmaceutical composition comprising “naproxen sodium”
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`and “about 0.2 to about 1.0 mole equivalents of lactic acid per mole of naproxen
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`sodium.” See EX1008, at 121. And dependent claim 15 at the time, which
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`depended from claim 10 and thus was narrower than claim 10, was directed to the
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`composition of claim 10 “wherein the weight percentage of lactic acid is about
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`5%.” EX1008, at 121. Thus, “about 5%” lactic acid by weight is narrower than
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`“0.2 to about 1.0 mole equivalents per mole of naproxen sodium.” “[W]here … the
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`claims describe the same relationship using different terms, the assumption is that
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`the term in the dependent claim has a narrower scope.” American Piledriving
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`Equipment, Inc. v. Geoquip, Inc., 637 F.3d 1324, 1335 (Fed. Cir. 2011).
`
`Examples 8-12 of the ’979 patent use formulations comprising 25%
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`naproxen sodium by weight. If a POSA were to include lactic acid in such
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`formulations in an amount from “about 0.2 to about 1.0 mole equivalents per mole
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`of naproxen sodium,” converting the amount of lactic acid to a percentage by
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`weight results in about 1.8% to 8.9% lactic acid by weight of the matrix. PSG2001,
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`¶¶25-28. Catalent’s construction of “about 5%” to mean “at least from 2 to 8%” is
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`unreasonable because it is nearly the same scope as original claim 10, ignoring the
`
`fact that the claims were amended during prosecution. EX1008, at 121, 195.
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`IPR2018-00422
`Patent No. 9,693,979
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`In view of the plain language of the claims and the intrinsic evidence in the
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`’979 patent’s specification and prosecution history, the Board should reject
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`Catalent’s construction of “about 5%” as being unreasonably broad. Instead, the
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`term “about 5%” should be given its plain and ordinary meaning: “approximately
`
`5%.” PSG2001, ¶¶20-28.
`
`B. The Petition relies on a flawed construction of “liquid matrix.”
`The Petition construes “liquid matrix” to be synonymous with “fill
`
`material,” and asserts that it means “the material for filling the soft gelatin capsule
`
`prepared by mixing the claimed ingredients in the claimed amounts prior to
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`encapsulation.” Pet., at 13-14. Patheon does not concede that Catalent’s
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`construction of “liquid matrix” or “fill material” is correct. Nonetheless, Patheon
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`submits that construction of either term is unnecessary for the Board to resolve the
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`issues in this proceeding.
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`III. Catalent has not articulated its reasons behind the multiple grounds
`asserted in the petition.
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`As discussed below in Sections IV–VI, the Board should deny institution on
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`all grounds because Catalent’s Petition fails to show a reasonable likelihood of
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`prevailing on the merits in any of Grounds 1–3, which are six grounds disguised as
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`IPR2018-00422
`Patent No. 9,693,979
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`three. Notwithstanding the Supreme Court’s recent decision in SAS Institute Inc. v.
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`Iancu, 138 S.Ct. 1348 (2018), Catalent still carries the burden to articulate its
`
`reasoning behind each ground of unpatentability—a burden the Petition fails to
`
`meet. See 37 C.F.R. § 42.104.
`
`Here, Catalent’s Petition asserts six grounds for unpatentability without
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`providing any meaningful distinction between the grounds: (i) anticipation by
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`Chen; (ii) obviousness over Chen; (iii) obviousness over U.S. Patent Application
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`Publication no. US 2004/0157928 A1 (“Kim,” EX1010); (iv) obviousness over
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`Kim and Chen; (v) obviousness over U.S. Patent Application Publication no. US
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`2004/0224020 A1 (“Schoenhard,” EX1011); and (vi) obviousness over Schoenhard
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`and Chen. Pet., at 4. Catalent fails to identify the relative strengths and weaknesses
`
`of its arguments. For example, Catalent alleges in Ground 1 that Chen discloses all
`
`the elements of the claims, and then attempts to argue in Ground 2 that the
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`challenged claims would have been obvious over the combination of Kim and
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`Chen without explaining why Kim is more preferred for allegedly satisfying some
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`elements, while Chen is more preferred for allegedly satisfying other elements.
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`Catalent failed to meet its burden of articulating the reasons behind its different
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`grounds in the Petition. See Oracle Corp. v. Clouding IP, LLC, IPR2013-00088,
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`IPR2018-00422
`Patent No. 9,693,979
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`Paper 13, at 3 (June 13, 2013).
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`As to the merits (discussed below), this Preliminary Response shows that the
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`Petition fails on numerous levels to establish a reasonable likelihood of prevailing
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`on the merits in any of the arguments in Grounds 1–3.
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`IV. Ground 1: Catalent has not met its burden of establishing a reasonable
`likelihood that any of the challenged claims is anticipated by Chen or
`obvious in view of Chen.
`A. The Petition fails to show that Chen anticipates any of the
`challenged claims.
`
`Under 35 U.S.C. § 314(a), the petitioner must establish in the petition “a
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`reasonable likelihood that the petitioner would prevail with respect to at least 1 of
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`the claims challenged in the petition.” Id.; see also, 37 C.F.R. § 42.108(c).
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`Catalent’s Petition fails to make this threshold showing for at least two reasons: (i)
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`Chen does not disclose all of the elements of the challenged claims and the Petition
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`fails to show that Chen inherently discloses the missing elements; and (ii) even if
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`Chen did disclose elements of the claims, the disclosures are not arranged as
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`claimed in the ’979 patent.
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`1. Chen does not disclose all of the elements of the challenged
`claims, expressly or inherently.
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`Catalent first fails to show that Chen expressly or inherently discloses all the
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`elements of the challenged claims of the ’979 patent. Claim 1 of the ’979 patent
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`recites:
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`IPR2018-00422
`Patent No. 9,693,979
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`A pharmaceutical composition comprising a soft gelatin
`capsule encapsulating a liquid matrix comprising:
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`(a) naproxen sodium;
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`(b) about 5% lactic acid by weight of the matrix;
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`(c) one or more polyethylene glycols; and
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`(d) one or more solubilizers comprising
`polyvinylpyrrolidone, propylene glycol, or a
`combination thereof.
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`EX1003, Claim 1. The pharmaceutical compositions of independent claims 8 and
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`17 are similar to that of claim 1, and both claim 8 and claim 17 cover compositions
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`comprising “about 25% naproxen sodium by weight of the matrix,” “about 5%
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`lactic acid by weight of the matrix,” “polyethylene glycol 600,” and “about 1% to
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`about 10% of one or more solubilizers comprising polyvinylpyrrolidone, propylene
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`glycol, or a combination thereof by weight of the matrix.”
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`Chen fails to expressly or inherently disclose compositions or methods
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`comprising “about 5% lactic acid” by weight of the matrix, as recited in
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`Patent No. 9,693,979
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`independent claims 1, 8, and 17. The Petition relies on Chen’s disclosure of
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`compositions comprising an ionizing agent present in an amount of “at least about
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`0.5 mole equivalents per mole of ionizable functional group.” EX1009, 12:30-35;
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`Pet., at 19. In other words, the Petition relies on Chen’s disclosure of a ratio: for
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`every 1.0 mole of ionizable functional group present in the active pharmaceutical
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`ingredient, Chen teaches to include 0.5 moles of an ionizing agent. EX1009, 12:30-
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`35. But without knowing how much of the active pharmaceutical ingredient is
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`present in Chen’s formulation, one cannot determine the actual amount of ionizing
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`agent present in Chen’s formulation. PSG2001, ¶¶54-55. This is neither an express
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`nor inherent disclosure of “about 5% lactic acid by weight” because Chen does not
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`disclose any dosage amounts for naproxen sodium. Id. Unable to show where in
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`Chen each element of the challenged claims is purportedly disclosed, Catalent
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`concocts a flawed inherent anticipation argument based on a series of arbitrary
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`assumptions to arrive at “about 5% lactic acid.”
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`To begin, the art taught a wide range of naproxen dosages not limited to 220
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`mg or 250 mg as Catalent would have the Board believe. For example, Shapiro
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`disclosed a naproxen dosage range from 125 mg to 1.25 g daily, from 0.5 mg/kg to
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`25 mg/kg daily, or from 50 mg to 1.5 g daily; and naproxen sodium dosage range
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`from 50 mg to 1.65 g daily. PSG2007, at 61, lines 13–14; 70, lines 2–3; 71, lines
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`29–30; 96, lines 23–26; PSG2001, ¶¶40-42, 55. And even the FDA-approved
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`naproxen and naproxen sodium solid tablet formulations at the time included a
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`wide range of dosage amounts, ranging from 220 mg to 825 mg doses. PSG2001,
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`¶¶40-42, 55. From among these vast possibilities, Catalent contrived doses of 220
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`mg and 250 mg to support its inherent anticipation arguments. Pet., at 19-20, 25,
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`26, 30; EX1001, ¶93, p. 40-41. Moreover, even if 220 mg and 250 mg were among
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`the dosage possibilities from which a skilled artisan could have chosen, Chen does
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`not disclose these dosages. Inherency “may not be established by probabilities or
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`possibilities. The mere fact that a certain thing may result from a given set of
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`circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir.
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`1999) (quotation omitted); see also, In re Montgomery, 677 F.3d 1375, 1384 (Fed.
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`Cir. 2012)
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`The petition is also defective because Catalent and Mr. Draper arbitrarily
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`select an “880 ml capsule (i.e., a nominal size 14 Oblong capsule)” as the size
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`capsule an artisan purportedly would have used “to encapsulate 220 mg naproxen
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`sodium.” Pet., at 19-20; EX1001, ¶93. Catalent and Mr. Draper also arbitrarily
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`select a “conventional 800 ml capsule” size to encapsulate a “conventional dosage
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`of 250 mg.” Pet., at 19-20; EX1001, ¶ 93. Again, this disclosure is nowhere in
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`Chen. Chen does not disclose an “880 ml” capsule, an “800 ml” capsule, or any
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`other size capsule.2 The art taught numerous varieties of soft gelatin capsule shapes
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`and sizes, none of which are disclosed or suggested in Chen. PSG2001, ¶¶57-58;
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`PSG2023, at 400; PSG2021, at 611. Thus, the mere possibility of the artisan
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`selecting Catalent’s particular capsule size falls well short of inherency. Robertson,
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`169 F.3d at 745.
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`Further, Catalent and Mr. Draper admittedly assume that Chen’s liquid
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`matrix has a “density of 1g/ml.” Pet., at 20. Indeed, Mr. Draper testified that his
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`calculations were “assuming a density of 1 g/ml for the ‘liquid matrix.’” EX1001,
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`2 The petition and Mr. Draper’s declaration repeatedly mention an “880 ml
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`[milliliter] capsule” as part of their calculations. Pet., at 19-20, 50, 53; EX1001,
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`¶¶93, 110, 112, p. 83. A pharmaceutical softgel capsule of “880 ml” would be
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`extremely large (nearly one liter in volume) and impractical for human
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`consumption. PSG2001, ¶57. Even if “880 ml” were a typographical error (despite
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`its repeated use), the fact remains that Chen does not disclose compositions
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`comprising about 5% lactic acid by weight of the matrix.
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`¶93 (emphasis added). Chen makes no such disclosure regarding the density of his
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`liquid matrix, and there were numerous possibilities for density of