UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`DR. REDDY’S LABORATORIES, INC.
`Petitioner
`
`v.
`
`POZEN INC.
`Patent Owner
`______________
`
`Case No. IPR2015-00802
`Patent No. 8,557,285
`______________
`
`PRELIMINARY PATENT OWNER RESPONSE
`37 C.F.R. § 42.107
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`Lupin Exh. 1012
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`

`
`Table of Contents
`
`
`2.
`
`3.
`
`Page
`INTRODUCTION .......................................................................................... 1
`I.
`BACKGROUND ............................................................................................ 2
`II.
`III. ARGUMENT .................................................................................................. 4
`A. Ground 1 Should Be Denied Because The Plachetka
`Publication Is Not Prior Art ................................................................. 4
`1.
`Petitioner Has Not Provided Any Evidentiary Support
`Regarding the Priority Analysis ................................................. 5
`Claim Construction .................................................................... 6
`a.
`“Comprising . . . Naproxen Surrounded by a
`Coating” ........................................................................... 7
`“inhibits” .......................................................................... 9
`b.
`“at least a portion of said esomeprazole” ...................... 10
`c.
`“enteric coating” ............................................................ 10
`d.
`“unit dosage form” ......................................................... 11
`e.
`The Claims of The ’285 Patent Are At Least Entitled to
`The Same Filing Date as The ’216 Application ...................... 12
`a.
`The ’216 Application Discloses The “Coordinated
`Release” Recited in The ’285 Patent Claims ................. 15
`Petitioner Ignores Express Teaching in The ’216
`Application of “A Portion” of Acid Inhibitor
`Subject to Immediate-Release ....................................... 18
`Coatings that “Inhibit” Release Have Written
`Description Support in The ’216 Application ............... 20
`d. When Properly Construed The Claims of The ’285
`Are Limited To Oral Dosage Forms .............................. 24
`e. When Properly Construed The Claims of The ’285
`Are Entitled to At Least the Filing Date of the ‘216
`Application .................................................................... 24
`
`b.
`
`c.
`
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`-i-
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`Table of Contents
`(continued)
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`Page
`
`4.
`
`2.
`
`3.
`
`4.
`
`5.
`
`3.
`
`4.
`
`B.
`
`C.
`
`Petitioner’s Ground 1 Has No Likelihood of Success and
`Should Be Denied .................................................................... 25
`The Claims of The ’285 Patent Are Non-Obvious ............................ 26
`Petitioner Fails To Set Forth A Prima Facie Case of
`1.
`Obviousness ............................................................................. 27
`The Petition Fails To Demonstrate a Motivation To
`Combine or a Reasonable Expectation of Success .................. 29
`Petitioner’s References Have Been Repeatedly
`Considered During Examination ............................................. 39
`The Formulations Claimed in the ’285 Patent Exhibit
`Unexpected Results .................................................................. 41
`Petitioner’s Ground 2 Has No Likelihood of Success and
`Should Be Denied .................................................................... 42
`The Petition Should Be Denied For Failing To Identify All
`Real-Parties-In-Interest ...................................................................... 43
`1.
`Legal Standard ......................................................................... 44
`2.
`The Unnamed Co-Defendants Have the Ability to Exert
`Control Over This Proceeding ................................................. 44
`Tacit Permission to use Dr. Kibbe Should Act as an
`Estoppel .................................................................................... 48
`The Petition’s Filing Date Should Be Vacated and the
`Petition Dismissed as Untimely ............................................... 48
`IV. CONCLUSION ............................................................................................. 50
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`-ii-
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`

`
`Table of Authorities
`
`
`Page(s)
`
`Cases
`In re Abbott Diabetes Care Inc.,
`696 F.3d 1142 (Fed. Cir. 2012) ............................................................................ 6
`
`Anova Food, LLC., v. Sandau & Kowalski,
`No. IPR2013-00114 (LMG), Paper No. 11 (P.T.A.B. June 25,
`2013) ................................................................................................................... 33
`
`Capon v. Eshhar,
`418 F.3d 1349 (Fed. Cir. 2005) .......................................................................... 23
`
`CIAS, Inc. v. Alliance Gaming Corp.,
`504 F.3d 1356 (Fed. Cir. 2007) ............................................................................ 8
`
`Eiselstein v. Frank,
`52 F.3d 1035 (Fed. Cir. 1995) ............................................................................ 23
`
`Galderma S.A. v. Allergan Indus., SAS,
`IPR2014-01422, 2015 WL 1022410 (P.T.A.B. Mar. 5, 2015) ........................... 49
`
`Gen. Foods Corp. v. Mass. Dep’t of Pub. Health,
`648 F.2d 784 (1st Cir. 1981) ............................................................................... 48
`
`In re Haruna,
`249 F.3d 1327 (Fed. Cir. 2001) .......................................................................... 36
`
`In re Hedges,
`783 F.2d 1038 (Fed. Cir. 1986) .......................................................................... 26
`
`Hill-Rom Servs., Inc. v. Stryker Corp.,
`755 F.3d 1367 (Fed. Cir. 2014) ............................................................................ 6
`
`Karsten Mfg. Corp. v. Cleveland Golf Co.,
`242 F.3d 1376 (Fed. Cir. 2001) .......................................................................... 37
`
`In re Kaslow,
`707 F.2d 1366 (Fed. Cir. 1983) .......................................................................... 23
`
`
`
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`Table of Authorities
`(continued)
`
`Page(s)
`
`
`
`LizardTech, Inc. v. Earth Res. Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) .......................................................................... 23
`
`McGinley v. Franklin Sports, Inc.,
`262 F.3d 1339 (Fed. Cir. 2001) .......................................................................... 36
`
`Outside the Box Innovations, LLC v. Travel Caddy, Inc.,
`695 F.3d 1285 (Fed. Cir. 2012) ............................................................................ 8
`
`PowerOasis, Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008) .......................................................................... 13
`
`Purdue Pharma LP v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) .......................................................................... 12
`
`RPX Corp. v. Virnetx Inc.,
`IPR2014-00171, Paper No. 49 (P.T.A.B. June 5, 2014) .................................... 47
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) .......................................................................... 31
`
`In re Skvorecz,
`580 F.3d 1262 (Fed. Cir. 2009) ........................................................................ 8, 9
`
`In re Suitco Surface, Inc.,
`603 F.3d 1255 (Fed. Cir. 2010) ........................................................................ 7, 8
`
`Taylor v. Sturgell,
`553 U.S. 880 (2008) ............................................................................................ 44
`
`Tec Air, Inc. v. Denso Mfg. Mich. Inc.,
`192 F.3d 1353 (Fed. Cir. 1999) .......................................................................... 31
`
`Yorkey v. Diab,
`601 F.3d 1279 (Fed. Cir. 2010) ............................................................................ 5
`
`
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`Table of Authorities
`(continued)
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`Page(s)
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`
`
`Zerto, Inc. v. EMC Corp.,
`IPR2014-01254, 2015 WL 981664 (P.T.A.B. Mar. 3, 2015) ....................... 44, 49
`
`Zoll Lifecor Corp. v. Philips Elecs. N.A. Corp.,
`IPR2013-00607, 2014 WL 1253105 (P.T.A.B. Mar. 20, 2014) ................... 44, 49
`
`Statutes
`
`35 U.S.C.
`§ 120 .................................................................................................................... 12
`§ 312(a)(3) .................................................................................................... 29, 44
`§ 313 ...................................................................................................................... 1
`§ 315(b) ............................................................................................................... 49
`
`Other Authorities
`
`37 C.F.R.
`§ 42.8(b)(1) ......................................................................................................... 44
`§ 42.106 ............................................................................................................... 49
`§ 42.106(a) .......................................................................................................... 49
`§ 42.106(b) .......................................................................................................... 49
`§ 42.107(c) .......................................................................................................... 33
`
`Bell & Hunt, Progress with Proton Pump Inhibition, Yale J. Biology
`& Med., 65:649-57 (1992) .................................................................................. 34
`
`Changes to Implement Inter Partes Review Proceedings, Post-Grant
`Review Proceedings, and Transitional Program for Covered
`Business Method Patents,
`77 Fed. Reg. 48,680 (Aug. 14, 2012) ................................................................. 49
`
`Horn & Howden, Review article: similarities and differences among
`delayed-release proton-pump inhibitor formulations, Aliment
`Pharmacol. Ther. 22(Suppl. 3):20-24 (2005) ..................................................... 32
`
`
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`Table of Authorities
`(continued)
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`Page(s)
`
`
`
`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48,756 (Aug. 14, 2012) ................................................................. 44
`
`The Official Compendia of Standards, USP 24-NF 19,
`U.S. Pharmacopeia & National Formulary (1999) ............................................. 22
`
`Norman & Hawkey, What you need to know when you prescribe a
`proton pump inhibitor, Frontline Gastroenterology (2011), 1-7 ........................ 42
`
`Pilbrant, Formulation of proton pump inhibitors, Current status on
`targeted drug delivery to the gastrointestinal tract, Capsugel
`Library ................................................................................................................. 35
`
`Proton Pump Inhibitors (L. Olbe ed.) (1999), 161-169 ........................................... 35
`
`Stedman & Barclay, Review article: comparison of the
`pharmacokinetics, acid suppression and efficacy of proton pump
`inhibitors, Aliment Pharmacol. Ther. 14:963-78 (2000) .................................... 34
`
`www.merriam-webster.com/dictionary/portion....................................................... 10
`
`
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`-iv-
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`
`Case No. IPR2015-00802
`Patent No. 8,557,285
`
`I.
`
`INTRODUCTION
`
`Horizon Pharmaceuticals, Inc. and Pozen Inc. (hereinafter, “Patent Owner”)
`
`submit this preliminary response under 35 U.S.C. § 313 to Dr. Reddy’s
`
`Laboratories, Inc.’s (“Petitioner”) request for inter partes review (“IPR”) of claims
`
`1-4 of U.S. Patent No. 8,557,285 (“the ’285 patent”).
`
`Petitioner’s request for inter partes review is both substantively meritless
`
`and procedurally defective. Specifically, the Petition should be denied because it
`
`does not demonstrate a likelihood of success on the two asserted grounds.
`
`Ground 1 fails to justify review because the Petitioner has failed to show that the
`
`’285 patent is not entitled to the relevant priority date. As such, the Plachetka
`
`Publication is not prior art and cannot be a basis for invalidity. With regard to
`
`Ground 2, the combined references asserted by the Petitioner in its Petition fail to
`
`disclose, teach, or suggest key elements of the ’285 patent’s claims. Moreover, the
`
`teachings of those references have been repeatedly considered and rejected as
`
`invalidating during prosecution.
`
`The Petition should also be denied for failing to identify all real-parties-in
`
`interest (“RPI”)—a threshold requirement for IPR. Omitted from the RPI
`
`identification are Petitioner’s co-defendants in district court litigation in the
`
`District of New Jersey involving this same patent. Although the Board denied
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`Patent Owner’s motion for discovery directly related to this issue, (Decision Paper
`
`1
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`

`
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`No. 22), Patent Owner addresses the issue here in order to preserve the challenge
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`to the identification of RPI when complete review of the evidentiary record on the
`
`issue is available to the Board.
`
`II. BACKGROUND
`
`The Petitioner is a defendant in a Hatch-Waxman lawsuit involving the ’285
`
`patent; the Petitioner is seeking approval of two separate Abbreviated New Drug
`
`Applications (“ANDAs”) to make different proposed generic versions of
`
`VIMOVO® which are covered by the ’285 patent.
`
`VIMOVO is a unique drug product. VIMOVO is specifically formulated to
`
`reduce the potential for damage to the gastroduodenal mucosal tissue through
`
`adverse events induced by nonsteroidal anti-inflammatory drugs (“NSAIDs”).
`
`VIMOVO consists of an immediate-release esomeprazole magnesium (proton
`
`pump inhibitor [PPI]) layer surrounding an enteric-coated naproxen (NSAID) core.
`
`Naproxen, like other NSAIDs, may increase the chance of stomach and intestinal
`
`problems, such as bleeding or ulcers. Esomeprazole, however, is a known
`
`gastroprotective PPI agent that works by decreasing the amount of acid in the
`
`stomach. By surrounding the naproxen component with a delayed-release enteric
`
`coating, VIMOVO is designed to release its esomeprazole significantly before
`
`release of naproxen. This allows the gastroprotective effects of esomeprazole to
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`2
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`

`
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`take hold before the release of naproxen, thus reducing the potential for gastric
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`ulcers.
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`The inventions disclosed in the ’285 patent are directed to pharmaceutical
`
`compositions, such as VIMOVO, that provide for the coordinated release of a
`
`gastroprotective agent, esomeprazole, and an NSAID, naproxen, within a single
`
`oral dosage form that reduce the risk of GI injury that arises from NSAID
`
`treatment. (Pet. Ex. 1001 at 1:20-26.) “Coordinated release” refers to the
`
`sequential release of the proton pump inhibitor (“PPI”) followed by the NSAID.
`
`(Id. at 6:20-23.) By releasing the PPI before the NSAID, the PPI provides
`
`gastroprotection by elevating the gastric pH (i.e., lowering the acidity) to reduce
`
`the toxic effects of NSAID that occur when NSAID is released during a time when
`
`the stomach has low pH (i.e., high acidity). (E.g., id. at 3:14-20.) Although co-
`
`administrations of NSAIDs with acid inhibitors were attempted in the prior art,
`
`none of those efforts utilized or suggested single oral dosage forms with the
`
`specific structural features and functional properties that provide for coordinated
`
`delivery of an immediate-release PPI and a coated, delayed-release NSAID. (Id. at
`
`2:26-37.) Indeed, the prior art taught PPIs must be protected with a delayed
`
`release enteric coat and taught away from using immediate release PPIs. (See infra
`
`§ III.B.)
`
`3
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`

`
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`No prior art disclosed, taught, or suggested pharmaceutical compositions
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`providing coordinated release of naproxen and esomeprazole, as claimed in the
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`’285 patent. Indeed, the ’285 patent issued over several references cited by the
`
`Petitioner, including Depui. And, in the Notice of Allowance for the grandparent
`
`application to the ’285 patent, the Examiner correctly recognized that Depui, was
`
`one of “the closest prior art [references] of record.” Petitioner does not address
`
`why Depui or any of the other references thoroughly considered by the Examiner
`
`warrants reconsideration by the Board now. As discussed below, the ’285 patent’s
`
`inventions are not taught or suggested by the prior art.
`
`III. ARGUMENT
`
`A. Ground 1 Should Be Denied Because The Plachetka Publication Is
`
`Not Prior Art
`
`In Ground 1, Petitioner has built a house of cards based on an unreasonably
`
`broad claim interpretation. Petitioner first unreasonably interprets the claims of the
`
`’285 patent and, based on that unreasonably broad interpretation, opines that the
`
`claims cannot look to the ’216 application for priority as there allegedly is no
`
`written description for the ’285 claims in the ’216 application. Without the benefit
`
`of that priority, Petitioner argues that the Plachetka Publication (which is itself the
`
`’216 application) anticipates and/or renders obvious the claims of the ’285 patent.
`
`However, as discussed below, Petitioner has not provided any evidentiary support
`
`4
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`
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`for its claim constructions and furthermore, as properly construed, the ’285 patent
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`claims are entitled to a priority date of at least the ’216 application. Ground 1
`
`should be denied.
`
`1.
`
`Petitioner Has Not Provided Any Evidentiary Support
`
`Regarding the Priority Analysis
`
`Petitioner has built an elaborate house of cards based on an unreasonably
`
`broad interpretation of the ’285 patent claims, which Petitioner uses as a basis for
`
`concluding that the ’285 patent claims do not have written description support in
`
`the ’216 application. However, Petitioner has not provided any factual support to
`
`demonstrate why the ’285 patent is not entitled to claim priority to the ’216
`
`application. “The test for sufficiency of support in a parent application is whether
`
`the disclosure of the parent application reasonably conveys to the artisan that the
`
`inventor had possession at that time of the later claimed subject matter.” Yorkey v.
`
`Diab, 601 F.3d 1279, 1283 (Fed. Cir. 2010) (internal quotations & citation
`
`omitted). Outside of a single statement in the Kibbe IPR Declaration that “[he]
`
`understand[s] that the ’285 patents claims the benefit of priority to the U.S.
`
`Provisional Patent Application No. 60/294,588 (“the ’588 application”), filed on
`
`June 1, 2001,” the Kibbe IPR Declaration is entirely devoid of any discussion of
`
`the priority allegations made in the Petition. (See Pet. Ex. 1036.)
`
`5
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`

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`That is fatal to Petitioner’s arguments. Petitioner’s attorney arguments
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`cannot demonstrate a lack of written description support in the ’216 application
`
`because the inquiry must be evaluated from the perspective of one of ordinary skill
`
`in the art, who evaluates the sufficiency of the supporting disclosure with
`
`knowledge of that which is “known in the art.” Hill-Rom Servs., Inc. v. Stryker
`
`Corp., 755 F.3d 1367, 1373 (Fed. Cir. 2014) (“a patent specification need not
`
`disclose or teach what is known in the art”).
`
`Without a demonstration of lack of written description support, there is no
`
`basis for casting doubt on the ’285 patent’s priority claim. The Plachetka
`
`Publication is therefore not prior art to the ’285 patent. Ground 1 should be denied
`
`on that basis.
`
`2.
`
`Claim Construction
`
`Petitioner has unreasonably interpreted the claims of the ’285 patent in an
`
`attempt to undermine the priority claim of the ’285 patent. Those claim
`
`interpretations are contrary to their plain language, the specification, and the
`
`understanding of one of ordinary skill in the art under a broadest reasonable
`
`interpretation standard. In re Abbott Diabetes Care Inc., 696 F.3d 1142, 1149
`
`(Fed. Cir. 2012) (“‘Although the PTO emphasizes that it was required to give all
`
`claims their broadest reasonable construction, . . . this court has instructed that any
`
`such construction be consistent with the specification, and that claim language
`
`6
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`

`
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`should be read in light of the specification as it would be interpreted by one of
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`ordinary skill in the art.’” (quoting In re Suitco Surface, Inc., 603 F.3d 1255, 1260
`
`(Fed. Cir. 2010))).
`
`a.
`
`“Comprising . . . Naproxen Surrounded by a Coating”
`
`Petitioner maintains
`
`that
`
`the broadest
`
`reasonable
`
`interpretation of
`
`“‘comprising…naproxen surrounded by a coating’ in claim 1 allows additional
`
`naproxen not surrounded by a release inhibiting coating in the ‘unit dosage.’” (Pet.
`
`at 26.)
`
`As an initial matter, Claim 1 of the ’285 patent straightforwardly recites that
`
`it is a “therapeutically effective amount[] of . . . naproxen” that is “surrounded by a
`
`coating.” (Pet. Ex. 1001 at Claim 1.) The specification teaches that a
`
`“therapeutically effective amount” of NSAID is “an amount effective to reduce or
`
`eliminate pain or inflammation.” (Id. at 3:66-4:1.) The specification further
`
`discloses that “[t]he most preferred NSAID is naproxen in an amount of between
`
`50 mg and 1500 mg, and more preferably, in an amount of between 200 mg and
`
`600 mg.” (Id. at 4:11-14.) Thus, the specification describes and supports the
`
`ranges of naproxen that are “therapeutically effective.”
`
`The claim also unquestionably recites the requirement that there be a
`
`“coating” that surrounds the therapeutically effective amount of naproxen.
`
`Petitioner’s expansive interpretation that “coating” includes “uncoated,” relies on
`
`7
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`
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`the open transition “comprising” as an attempt to justify expanding the claim to
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`reach extraneous matter that is not part of the expressly recited limitations. But it
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`is long established that the signal “‘comprising’ means that additional components
`
`may be present in the device, but does not change the elements that are stated in
`
`the claim.” Outside the Box Innovations, LLC v. Travel Caddy, Inc., 695 F.3d
`
`1285, 1305 (Fed. Cir. 2012). See also In re Skvorecz, 580 F.3d 1262, 1268 (Fed.
`
`Cir. 2009) (“comprising” “simply means that the device may contain elements in
`
`addition to those explicitly mentioned in the claim”). For a proper construction,
`
`“the term ‘comprising’ is well understood to mean including but not limited to.”
`
`CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007)
`
`(internal quotations and citation omitted).
`
`Thus, Petitioner’s view is contrary to the plain requirements of this claim
`
`limitation because uncoated naproxen is the antithesis of “naproxen surrounded by
`
`a coating.” Accordingly, while other components may be present in a unit dosage
`
`form that includes but is not limited to the recited therapeutically effective amount
`
`of coated naproxen, Petitioner cannot expand this claim term to include uncoated
`
`naproxen—or any other hypothetical additional components that do not satisfy the
`
`expressly recited coated naproxen requirements—within this claim limitation.
`
`Suitco Surface, 603 F.3d at 1260–61 (“The broadest-construction rubric coupled
`
`with the term ‘comprising’ does not give the PTO an unfettered license to interpret
`
`8
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`

`
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`claims to embrace anything remotely related to the claimed invention.”). The
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`Board must reject Petitioner’s unreasonably expansive construction of this claim
`
`term.
`
`Patent Owner maintains that the broadest reasonable interpretation of the
`
`term “comprising…naproxen surrounded by a coating” is that “a therapeutically
`
`effective amount of naproxen is surrounded by a coating.”
`
` Any other
`
`interpretation would be an incorrect interpretation directly contrary to the plain
`
`language of the claims. Skvorecz, 580 F.3d at 1267 (“The protocol of giving
`
`claims their broadest reasonable interpretation during examination does not include
`
`giving claims a legally incorrect interpretation.”).
`
`b.
`
`“inhibits”
`
`Patent Owner agrees with Petitioner that “inhibits” should be given its
`
`ordinary meaning, but disagrees with Petitioner’s definition of that plain meaning.
`
`The claims recite “inhibits” in the context of “naproxen surrounded by a coating
`
`that inhibits its release from said unit dosage form . . . .” The ordinary meaning of
`
`“inhibits” applied within the context of the specification and claims is that the
`
`coating prevents, hinders, or restrains the release of NSAID. This ordinary
`
`meaning construction is derived directly from dictionary definitions. (Pet. Exs.
`
`1027, 1038.)
`
`9
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`
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`Petitioner’s construction—to stop or slow down—is imprecise because it
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`implies a preexisting ongoing action that is being slowed down. The claims,
`
`however, refer to inhibiting release from the outset—i.e., it is not a preexisting
`
`action that is being slowed down. In this context, the more appropriate ordinary
`
`meaning for “inhibits” is prevents, hinders, or restrains.
`
`c.
`
`“at least a portion of said esomeprazole”
`
`Claim 1 of the ’285 patent recites “at least a portion of said esomeprazole is
`
`not surrounded by an enteric coating” and that such esomeprazole “is released
`
`regardless of the pH in the medium.” (Pet. Ex. 1001 at Claim 1.) Patent Owner
`
`agrees that “portion” should be construed under its ordinary meaning. A proper
`
`dictionary definition of “portion” is “a part of a larger amount.” (See
`
`www.merriam-webster.com/dictionary/portion, Ex. 2008.) Patent Owner believes
`
`this definition, which is similar to Petitioner’s construction, is a more precise
`
`construction than Petitioner’s in the context of the claims of the ’285 patent.
`
`d.
`
`“enteric coating”
`
`While Petitioner did not explicitly state that it was construing the term
`
`“enteric coating”, Petitioner implicitly did so by accepting the definition of the
`
`term, as construed by Judge Pisano in the litigation, as meaning “a delayed release
`
`coating.” Patent Owner agrees with Petitioner that the proper construction of
`
`“enteric coating” is “a delayed release coating,” as that term was construed by the
`
`10
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`

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`district court in the context of the ’907 patent (to which the ’285 patent claims
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`priority). (Pet. Ex. 1019 at 11-12; Pet. at 11 n.1.) However, with regard to
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`Petitioner’s statement that the court recognized that it is “commonly and perhaps
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`frequently pH-dependent,” Patent Owner maintains that the district court further
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`explained that:
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`While the evidence shows that an enteric coating is commonly and
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`perhaps frequently pH-dependent, the evidence shows other types of
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`enteric coatings are utilized in the field. There is nothing in the patent
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`or otherwise that directs a construction that limits the term “enteric
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`coating” in claim 1 of the ’907 patent to strictly a pH-dependent form.
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`(Pet. Ex. 1019 at 12.) That is, under the broadest reasonable interpretation,
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`“enteric coating” should not be construed as “strictly a pH-dependent form.”
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`e.
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`“unit dosage form”
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`Petitioner did not offer a construction of the term “unit dosage form,”
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`possibly because a proper interpretation of that term undermines Petitioner’s house
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`of cards. It is clear from the specification and claims of the ’285 patent, that “unit
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`dosage form,” as recited in the claims, should be interpreted as a “unit dosage form
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`suitable for oral administration to a patient.” (Pet. Ex. 1001 at 3:27-29; Pet Ex.
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`1021 at [0011].) The specification further states that “[a]ll of the dosage forms are
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`designed for oral delivery and provide for the coordinated release of therapeutic
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`agents, i.e., for the sequential release of acid inhibitor followed by analgesic.”
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`(Pet. Ex. 1001 at 6:20-23; Pet Ex. 1021 at [0020].) Accordingly, the term is at the
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`core of the “invention” and should be construed, consistent with the specification,
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`as directed solely to oral delivery.
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`In addition, the claims themselves demonstrate that the unit dosage form is
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`intended for oral delivery. Petitioner gives no examples of any administration of a
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`combined unit dosage from containing naproxen and esomeprazole according to
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`the claims that could be used in non-oral administration. Nor does Petitioner
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`explain how any other potential non-oral route of administration would expose the
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`unit dosage to the anticipated pH variations described by the claims and the
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`specification other than the stomach and intestinal tract. That is because there are
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`none. Any administration route other than oral simply makes no sense in the
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`context of the ’285 patent.
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`3.
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`The Claims of The ’285 Patent Are At Least Entitled to The
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`Same Filing Date as The ’216 Application
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`Under 35 U.S.C. § 120, claims are granted the benefit of the filing date of an
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`earlier-filed application unless the earlier application does not provide written
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`description support for the later claims. See 35 U.S.C. § 120. “In order to satisfy
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`the written description requirement, the disclosure as originally filed does not have
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`to provide in haec verba support for the claimed subject matter at issue.” Purdue
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`Pharma LP v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000); see also
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008) (“a
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`prior application need not contain precisely the same words as are found in the
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`asserted claims”).
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`The ’285 patent has priority to its provisional application 60/294,588 (“the
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`’588 application”), filed on June 1, 2001, through non-provisional application
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`10/158,216 (“the ’216 application”) filed on May 31, 2002, published as 2003-
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`0069255 (“the Plachetka publication”) and issued as U.S. Patent No. 6,926,907
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`(“the ’907 patent”), and continuation-in-part application 11/129,320 (“the ’320
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`application”), issued as U.S. Patent No. 8,206,741 (“the ’741 patent”). (Pet. Ex.
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`1001 at 1:7-16.) The ’285 patent is a divisional of an abandoned application that
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`was itself a divisional application of the ’320 patent. (Id.) The relationship
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`between the ’285 patent and the ’558 provisional application and ’216 non-
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`provisional application is illustrated as follows:
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`As Petitioner accurately acknowledges, the specifications of all of these
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`applications are extremely similar. (See Pet. at 12.) And, Petitioner has identified
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`no new matter in the ’285 patent relevant to priority that is not identical to the text
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`of the priority ’216 application. That is because, as evident in a comparison
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`between the text of the priority ’216 application and the ’285 patent, no relevant
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`new matter has been added. (See Ex. 2009 (redline comparison between ’216
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`application (the Plachetka Publication) and the ’285 patent).)
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`Despite that lack of substantial differences in the specifications, Petitioner
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`argues that, the ’285 patent claims are not supported by its priority applications
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`because the claims, as construed by Petitioner, are broad enough to encompass
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`formulations with features that Petitioner alleges are not found in those
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`applications. Specifically, Petitioner argues that the Plachetka Publication does not
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`disclose a unit dosage form that (1) lacks coordinated release by releasing some of
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`its naproxen before reaching a pH of 3.5; (2) delays release of a portion of its
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`esomeprazole based upon pH; (3) permits slowed naproxen release at a pH below
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`3.5; or (4) is suitable for an administration other than oral. However, such features
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`are either not part of the claims as properly interpreted or are described in the
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`priority ’216 application.
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`a.
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`The ’216 Application Discloses The “Coordinated
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`Release” Recited in The ’285 Patent Claims
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`Claim 1 of the ’285 patent recites a unit dosage form that provides for
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`coordinated release of esomeprazole and naproxen. That coordinated release is a
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`direct result of the claim limitations, which include esomeprazole that “is not
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`surrounded by an enteric coating” and “naproxen surrounded by a coatin