UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`COALITION FOR AFFORDABLE DRUGS VII LLC
`Petitioner
`
`v.
`
`POZEN INC.
`Patent Owner
`______________
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`______________
`
`PRELIMINARY PATENT OWNER RESPONSE
`37 C.F.R. § 42.107
`(REDACTED VERSION)
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`TABLE OF CONTENTS
`
`V.
`
`B.
`
`C.
`
`INTRODUCTION .........................................................................................1
`I.
`BACKGROUND ............................................................................................3
`II.
`LEVEL OF ORDINARY SKILL IN THE ART ...........................................6
`III.
`IV. CLAIM INTERPRETATION .......................................................................7
`A.
`The Petition Incorrectly Interprets “Unit Dosage Form”.....................7
`B.
`The Petition Incorrectly Interprets “Acid Inhibitor”............................8
`C.
`“Coordinated Release” Does Not Require Further Interpretation .....12
`THE BOARD SHOULD DENY CFAD’S PETITION BECAUSE IT
`FAILS TO DEMONSTRATE A REASONABLE LIKELIHOOD OF
`SUCCESS ....................................................................................................13
`A.
`Ground 1: Petitioner Has Not Established a Reasonable
`Likelihood that Claims 1, 7, 8, 12, 13, 22, and 23 Are Obvious
`over Gimet in View of Chiverton ......................................................13
`Ground 2: Petitioner Has Not Established a Reasonable
`Likelihood that Claims 1-5 and 7-23 Are Obvious over Gimet
`in View of Goldman in Further View of Remington.........................15
`Ground 3: Petitioner Has Not Established a Reasonable
`Likelihood that Claims 1-5, 7-18, 21, and 23 Are Obvious over
`Goldman in View of Remington in Further View of Abe .................22
`Ground 4: Petitioner Has Not Established a Reasonable
`Likelihood that Claims 1, 5, and 6 Are Obvious over Goldman
`in View of Remington in Further View of Fitton .............................23
`Petitioner Fails to Offer Evidence Refuting Objective Indicia of
`Nonobviousness .................................................................................25
`1.
`Long Felt But Unresolved Need ..............................................30
`2.
`Surprising and Unexpected Results ........................................31
`3.
`Licensing..................................................................................33
`4.
`Copying ...................................................................................34
`
`D.
`
`E.
`
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`F.
`G.
`
`Each of Grounds 1-4 Should Be Denied............................................34
`Each of Grounds 2 and 3 Should Be Denied as to Claims 5 and
`15; Ground 4 Should Be Denied as to Claim 5..................................35
`THE BOARD SHOULD DENY CFAD’S PETITION BECAUSE IT
`WAS FILED FOR AN IMPROPER PURPOSE .........................................40
`VII. CONCLUSION.............................................................................................48
`
`VI.
`
`ii
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`
`TABLE OF AUTHORITIES
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`Page(s)
`
`Cases
`In re Abbott Diabetes Care Inc.,
`696 F.3d 1142 (Fed. Cir. 2012) ..........................................................................11
`
`Beckman Instruments, Inc. v. LKB Produkter AB,
`892 F.2d 1547 (Fed. Cir. 1989) ..........................................................................39
`
`Bumble Bee Foods, LLC v. Kowalski,
`IPR2014-00224, Paper No. 18 (P.T.A.B. June 5, 2014) ...................................15
`
`Cisco Sys., Inc. v. C-Cation Techs., LLC,
`IPR2014-00454, Paper No. 12 (P.T.A.B. Aug. 29, 2014) .................................27
`
`Coalition For Affordable Drugs V LLC v. Biogen IDEC Int’l GmbH,
`IPR2015-01086, Paper No. 11 (P.T.A.B. July 3, 2015) ....................................42
`
`Coalition For Affordable Drugs VI LLC v. Celgene Corp.,
`IPR2015-01169, Paper No. 18 (P.T.A.B. Sept. 2, 2015) ...................................46
`
`Consumer Watchdog v. Wis. Alumni Research Found.,
`753 F.3d 1258 (Fed. Cir. 2014) ..........................................................................43
`
`Crocs, Inc. v. Int’l Trade Comm’n,
`598 F.3d 1294 (Fed. Cir. 2010) ..........................................................................25
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litig., 676 F.3d 1063 (Fed. Cir. 2012) ....................................................27
`
`Excelsior Med. Corp. v. Lake,
`IPR2013-00494, Paper No. 10 (P.T.A.B. Feb. 6, 2014) ....................................22
`
`Fid. Nat’l Info. Servs., Inc. v. DataTreasury Corp.,
`IPR2014-00489, Paper No. 9 (P.T.A.B. Aug. 13, 2014) .............................28, 29
`
`In re Haruna,
`249 F.3d 1327 (Fed. Cir. 2001) ..........................................................................39
`
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`Heart Failure Techs., LLC v. Cardiokinetix, Inc.,
`IPR2013-00183, Paper No. 12 (P.T.A.B. July 31, 2013) ..................................15
`
`In re Huai-Hung Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ....................................................................25, 27
`
`Hulu LLC v. Intertainer, Inc.,
`IPR2014-01456, Paper No. 8 (P.T.A.B. Mar. 6, 2015) .....................................21
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...........................................................................................16
`
`Liberty Mut. Ins. Co. v. Progressive Cas. Inc., Co.,
`CBM2012-00003, Paper No. 7 (P.T.A.B. Oct. 25, 2012) .................................24
`
`McGinley v. Franklin Sports, Inc.,
`262 F.3d 1339 (Fed. Cir. 2001) ..........................................................................34
`
`Micron Tech., Inc. v. Bd. of Trs. of the Univ. of Ill.,
`IPR2013-00005, Paper No. 54 (P.T.A.B. Mar. 10, 2014) .................................31
`
`Moses Lake Indus., Inc. v. Enthone, Inc.,
`IPR2014-00243, Paper No. 6 (P.T.A.B. June 18, 2014) ...................................16
`
`Prism Pharma Co. v. Choongwae Pharma Corp.,
`IPR2014-00315, Paper No. 14 (P.T.A.B. July 8, 2014) ....................................22
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) ..........................................................................25
`
`In re Payne,
`606 F.2d 303 (C.C.P.A. 1979)............................................................................39
`
`In re Rouffet,
`149 F.3d 1350 (Fed. Cir. 1998) ..........................................................................33
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) ..........................................................................38
`
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`SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc.,
`242 F.3d 1337 (Fed. Cir. 2001) ..........................................................................12
`
`Stratoflex, Inc. v. Aeroquip Corp.,
`713 F.2d 1530 (Fed. Cir. 1983) ....................................................................26, 27
`
`Tec Air, Inc. v. Denso Mfg. Mich. Inc.,
`192 F.3d 1353 (Fed. Cir. 1999) ..........................................................................39
`
`TRW Auto. US LLC v. Magna Elecs. Inc.,
`Nos. IPR2014-00293 & IPR 2014-00294,
`Paper No. 19 (P.T.A.B. July 1, 2014)...........................................................16, 27
`
`Zetec, Inc. v. Westinghouse Elec. Co.,
`IPR2014-00384, Paper No. 10 (P.T.A.B. July 23, 2014) ..................................42
`
`Statutes
`
`35 U.S.C. § 103(a) ...................................................................................................16
`
`35 U.S.C. § 311(a) ...................................................................................................43
`
`35 U.S.C. § 313..........................................................................................................1
`
`35 U.S.C. § 314(a) .........................................................................................3, 42, 47
`
`35 U.S.C. § 316(b) ...................................................................................................43
`
`35 U.S.C. § 325(d) ...................................................................................................21
`
`Other Authorities
`
`37 C.F.R. § 42.6(a)(3)........................................................................................27, 29
`
`37 C.F.R. § 42.107 .....................................................................................................1
`
`153 Cong. Rec. E774 (Apr. 18, 2007) .....................................................................44
`
`157 Cong. Rec. S5319-03 (Sept. 6, 2011) ...............................................................44
`
`157 Cong. Rec. S5411 (Sept. 8, 2011).....................................................................44
`
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`157 Cong. Rec. S952 (Feb. 28, 2011)......................................................................44
`
`H.R. Rep. No. 112-98, pt. 1 (2011)..........................................................................44
`
`S. Rep. No. 110-259 (2008).....................................................................................44
`
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`Case No. IPR2015-01241
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`Patent No. 6,926,907
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`TABLE OF EXHIBITS
`
`DESCRIPTION
`
`License Agreement between Patent Owner Pozen Inc. and
`exclusive licensee Horizon Phanna, Inc.
`
`Norman & Hawkey. What you need to know when you prescribe a
`proton pump inhibitor, Frontline Gastroenterology, 1-7 (2011)
`(“Norman”)
`
`Comprehensive Pharmacy Review, Chapter 17: Drug Metabolism,
`Prodrugs, and Pharmacogenetics, 398-420 (Leon Shargel et al. eds.,
`2010) “Shar0el”
`
`C ederberg et al., 0mepra:ole.' Pharmacokinetics and llletabolism in
`Alan, Scand. J. of Gastroenterology 24:33-40 (1989) (“Cederberg”)
`
`Opinion in Astrazeneca AB v. Dr. Reddy ’s Laboratories Inc.. Nos. 1 1-
`23l7 (JAP), 11-4275 (JAP), 11-6348 (JAP). filed on May 1, 2013
`“Claim Construction Order”
`
`Fallingborg. Intraluminal pH of the human gastrointestinal tract, Danish
`(DP- Ws::= AOx/‘\ ~13 we I—‘ 00 t’ \O Ox f'\ |—‘ \O \’> VD%/ P: H-193I11::5 Q o"'1Q
`D
`D”)
`Wolfe et al_, Gastrointestinal TOA‘lCll_1‘0flVOI1SleI'0ld(llA1’lTll1’IflaI11I11(If0I:l’
`Drugs, New England Journal of Medicine, 340(24):l888—99 (1999)
`“Wolfe”
`
`Stedman & Barclay, Review article: comparison of the
`pharmacolcinetics, acid suppression and efficacy ofproton pump
`inhibitors, Aliment Pharmacol. Ther. 141963-78 2000) “Stedman”
`
`to.9‘
`
`on J‘! on-F‘‘P J‘! \I
`
`if‘ \o \o l\.)
`
`Sachs et al.. Review article: the control ofgastric acid and Helicobacter
`pylori eradication, Aliment Pharmacol. Ther. 14: 1383-401 (2000)
`(“Sachs”)
`
`Sega], Has Patent, Will Sue: An Alert to Corporate America, N.Y.
`Times (July 13, 2013), available at
`http zl/wwwnytimes.com/20 1 3 l07l 14.»/business/has-patent-wi11-sue-an-
`orate-americahtml? r=1 (“NY Times”
`
`vii
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`

`
`2015
`
`2016
`
`2017
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`2014
`
`2013 Walker & Copeland, New Hedge Fund Strategy: Dispute the Patent,
`Short the Stock, Wall Street Journal (Apr. 7, 2015), available at
`http://www.wsj.com/articles/hedge-fund-manager-kyle-bass-challenges-
`jazz-pharmaceuticals-patent-1428417408 (“WSJ”)
`La Roche, Kyle Bass’ war against the US pharmaceutical industry has
`officially begun, Business Insider (Feb. 10, 2015), available at
`http://www.businessinsider.com/kyle-bass-files-first-ipr-petition-2015-2
`(“Bus. Insider”)
`Hayman Capital Management, L.P., Form ADV Part 2A Brochure (June
`1, 2015) (“ADV”)
`Quinn, Senator Coons – Patents are about the American Dream,
`IPWatchdog.com (Mar. 5, 2015), available at
`http://www.ipwatchdog.com/2015/03/05/senator-coons-patents-are-
`about-the-american-dream/id=55442/ (“IPWatchdog”)
`Bio Statement Following Kyle Bass’ IPR Petition, Biotechnology
`Industry Organization (Feb. 11, 2015), available at
`https://www.bio.org/media/press-release/bio-statement-following-kyle-
`bass-ipr-petition-0 (“Bio Statement 1”)
`America Invents Act, 157 Cong. Rec. S5319-03 (2011)
`H.R. Rep. No. 112-98, pt. 1 (2011)
`157 Cong. Rec. S5402-43 (Sept. 8, 2011)
`153 Cong. Rec. E773-75 (Apr. 18, 2007)
`112 Cong. Rec. S936-53 (Feb. 28, 2011)
`S. Rep. No. 110-259 (2008)
`Kyle Bass Continues Abuse of Patent Challenge System, Biotechnology
`Industry Organization (Sept. 3, 2015), available at
`https://www.bio.org/media/press-release/kyle-bass-continues-abuse-
`patent-challenge-system (“Bio Statement 2”)
`
`2018
`2019
`2020
`2021
`2022
`2023
`2024
`
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`Pursuant
`
`to 35 U.S.C. § 313 and 37 C.F.R. § 42.107, Horizon
`
`Pharmaceuticals, Inc. (“Horizon”) and Pozen Inc. (“Pozen”) (collectively, “Patent
`
`Owner”)1
`
`submit
`
`this Patent Owner’s Preliminary Response (“Preliminary
`
`Response”) to the Petition for Inter Partes Review (“Petition”) of claims 1-23 of
`
`U.S. Patent No. 6,926,907 (“the ’907 patent”), filed by Coalition for Affordable
`
`Drugs VII LLC (“CFAD” or “Petitioner”). This Response is timely under 35
`
`U.S.C. § 313 and 37 C.F.R. § 42.107.2
`
`I.
`
`INTRODUCTION
`
`The Petition seeking inter partes review of the ’907 patent should be denied.
`
`The Petition fails to demonstrate a reasonable likelihood that any of the challenged
`
`claims are obvious. The Petition relies on an overly broad construction of the term
`
`“acid inhibitor,” fails to provide any motivation to combine references with a
`
`
`
`1 As explained in Patent Owner’s Mandatory Notices, Paper No. 7, Pozen is
`
`the assignee of the ’907 patent and Horizon is its exclusive licensee.
`
`2 In a September 4, 2015 e-mail, the Board stated that it would grant Patent
`
`Owner’s Motion for Extension of Time to File Preliminary Response, Paper No.
`
`10, amending the due date for Patent Owner’s Preliminary Response to September
`
`19, 2015.
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`reasonable expectation of success, and asserts substantially the same grounds of
`
`unpatentability that were asserted by the Examiner during prosecution and
`
`overcome by the Patent Owner. Furthermore, the Petition fails to address the
`
`objective indicia of nonobviousness, even though hornbook law states that such
`
`evidence must always be considered and is often the most probative.
`
`In addition to the present petition, the Petitioner has filed three additional
`
`petitions targeting patents that, like the ’907 Patent, cover Patent Owner’s product,
`
`Vimovo.3 These Petitions are among the 32 petitions for inter partes review filed
`
`by eleven related shell companies (Coalition For Affordable Drugs I-XI)4 against
`
`patents held by innovator pharmaceutical companies. The goal of filing these
`
`petitions is to manipulate the stock prices of the targeted pharmaceutical
`
`companies and generate profits for the Petitioner and his investors. This misuse of
`
`the inter partes review process should not be encouraged. In order to preserve the
`
`
`
`3 IPR2015-01344; IPR2015-01680; IPR2015-01718.
`
`4 Coalition for Affordable Drugs XII – XV have also been registered with
`
`the SEC, but as of the date of this Preliminary Response have not filed any
`
`petitions.
`
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`Office’s resources and stem this abusive practice, the Board should exercise its
`
`discretion under 35 U.S.C. § 314(a) to deny institution of CFAD’s Petition.
`
`II.
`
`BACKGROUND
`
`Non-steroidal anti-inflammatory drugs (“NSAIDs”) are valuable agents in
`
`the treatment of arthritis and other musculoskeletal disorders and are one of the
`
`most widely used classes of drugs in the United States. The use of NSAIDs,
`
`however, has been associated with mucosal injury to the upper gastrointestinal (GI)
`
`tract, including the development of peptic ulcer disease, upper gastrointestinal
`
`hemorrhage, and perforation. Vimovo® is a unique drug product specifically
`
`designed to reduce the potential for gastric mucosal tissue damage due to NSAID
`
`use. Vimovo consists of a delayed-release, enteric-coated NSAID core (naproxen)
`
`surrounded by an immediate-release acid inhibitor (esomeprazole magnesium).
`
`The acid inhibitor is released before the NSAID, allowing its gastroprotective
`
`effects to take hold before naproxen is released, thus reducing the potential for
`
`gastric damage.
`
`The ’907 patent is one of nine patents listed in the FDA’s Approved Drug
`
`Products with Therapeutic Equivalence Evaluations (the “Orange Book”) that
`
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`cover Vimovo.5 As described in more detail below, the ’907 patent claims
`
`pharmaceutical compositions that provide for the coordinated release of an
`
`immediate-release acid inhibitor and a delayed-release NSAID within a single oral
`
`dosage form that reduce the risk of GI injury arising from NSAID therapy. (Ex.
`
`1001 at 1:10-18.) The ’907 patent also claims methods of treating a patient for
`
`pain or inflammation with said pharmaceutical compositions.
`
`The immediate-release acid inhibitor in Vimovo is a proton pump inhibitor
`
`(“PPI”). In contrast to Vimovo’s immediate-release PPI, it was—and remains—
`
`widely accepted that PPIs must be administered with an enteric coating to protect
`
`the drug from gastric acid degradation. (Norman 2011, Ex. 2002 at 1.) For
`
`example, in 2010, Petitioner’s declarant, Dr. Leon Shargel, wrote that “[e]nteric
`
`
`
`5 Vimovo is also protected by U.S. Patent No. 8,858,996, at issue in
`
`IPR2015-01344 (filed by Petitioner) and IPR2015-01773; U.S. Patent No.
`
`8,557,285, at issue in IPR2015-00802; U.S. Patent No. 8,852,636, at issue in
`
`IPR2015-1680 (filed by Petitioner) and IPR2015-01774; U.S. Patent No.
`
`8,945,621, at issue in IPR2015-01718 (filed by Petitioner) and U.S. Patent Nos.
`
`5,714,504, 5,900,424, 6,369,085, 7,411,070, and 7,745,466.
`
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`coated formulations can protect acid-sensitive drugs as they pass through the acidic
`
`environment of the stomach. . . . [O]meprazole [a PPI] [is an] example[] of acid-
`
`sensitive agents that are available as enteric-coated preparations.” (Shargel 2010,
`
`Ex. 2003 at 15.) While this enteric coating protects acid-labile PPIs from acid
`
`degradation, it also reduces the PPI’s rate of absorption into the systemic
`
`circulation. (Cederberg 1989, Ex. 2004 at 6-7.)
`
`No prior art disclosed, taught, or suggested pharmaceutical compositions
`
`providing coordinated release of a delayed-release NSAID and an immediate-
`
`release acid inhibitor, as claimed in the ’907 patent. Indeed, the ’907 patent issued
`
`over several references cited by the Petitioner, including Goldman. And, in the
`
`Notice of Allowance for the ’907 patent, the Examiner correctly recognized that
`
`Goldman, was one of “the closest prior art [references] of record.” (3/29/05 Notice
`
`of Allowance, Ex. 1002 at 45.) Petitioner does not address why Goldman or any of
`
`the other
`
`references
`
`thoroughly considered by
`
`the Examiner warrants
`
`reconsideration by the Board now. As discussed below, the ’907 patent’s claimed
`
`inventions are not taught or suggested by the prior art.
`
`Although co-administrations of NSAIDs with acid inhibitors were attempted
`
`in the prior art, none of those efforts utilized or suggested unit dosage forms with
`
`the specific structural features and functional properties that provide for
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`coordinated delivery of an immediate-release acid inhibitor and a delayed-release
`
`NSAID. (Ex. 1001 at 2:20-30.)
`
`III. LEVEL OF ORDINARY SKILL IN THE ART
`
`Patent Owner proposes the following definition of a person of ordinary skill
`
`in the art (“POSA”): “a person with at least a graduate degree in pharmacy,
`
`chemistry, chemical engineering, pharmaceutics, or a comparable field, and some
`
`relevant pharmaceutical formulation work experience in industry.” While that
`
`definition is similar to the first definition provided by the Petitioner, i.e., “a
`
`pharmacist, medical doctor, or pharmaceutical scientist having a doctor of
`
`medicine degree, a doctor of pharmacy degree, or a Ph.D. degree, or equivalent
`
`training or degree, and at least two years of practical experience or clinical research
`
`in pharmaceutical formulations,” (Pet. at 10), the Petition’s definition of a POSA
`
`does not extend to a person having a graduate degree in chemistry or chemical
`
`engineering.
`
`Petitioner’s alternative definition also misses the mark. Petitioner describes
`
`the “alternative” POSA as “a pharmacologist or pharmacokineticist having a Ph.D.
`
`degree or equivalent training or degree and at least two years of practical
`
`experience or clinical research in pharmacology or pharmacokinetics.” (Id.) The
`
`study of pharmacokinetics is concerned with drug absorption, bioavailabilty,
`
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`distribution, metabolism, and excretion. The disciplines of pharmaceutical
`
`formulation and pharmacokinetics are not co-extensive and petitioner fails to
`
`distinguish or explain how a POSA from either discipline would understand and
`
`interpret the prior art.
`
`IV. CLAIM INTERPRETATION
`
`A.
`
`The Petition Incorrectly Interprets “Unit Dosage Form”
`
`The Petitioner’s proposed definition of the term “unit dosage form” found in
`
`claims 1, 4, 6, 12, 14, and 21 is “a single entity for drug administration,” taken in
`
`isolation with no limitation on route of administration. It is clear from the
`
`specification and claims of the ’907 patent that “unit dosage form” should be
`
`interpreted as a “unit dosage form suitable for oral administration to a patient.”
`
`(Ex. 1001 at 3:19-21.) The specification states that “[a]ll of the dosage forms are
`
`designed for oral delivery and provide for the coordinated release of therapeutic
`
`agents, i.e., for the sequential release of acid inhibitor followed by analgesic.” (Ex.
`
`1001 at 5:16-19.) Accordingly, the term is at the core of the “invention” and
`
`should be construed, consistent with the specification, as directed solely to oral
`
`delivery.
`
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`B.
`
`The Petition Incorrectly Interprets “Acid Inhibitor”
`
`Patent Owner disagrees with Petitioner’s proposed construction of the term
`
`“acid inhibitor,” found in claims 1, 2, 5, 12, 14, 15, and 18. “Acid inhibitor” is
`
`defined in the specification: “[t]he term ‘acid inhibitor’ refers to agents that inhibit
`
`gastric acid secretion and increase gastric pH.” (Ex. 1001 at 3:26-28.) Petitioner
`
`attempts to characterize that statement as something other than an explicit
`
`definition and tries to instead substitute the definition: “agents that hinder[],
`
`prevent[], or reduce[] the amount of gastric acid.” (Pet. at 11 (citing Ex. 1003, ¶
`
`56).) Petitioner provides no rationale why the express definition should be
`
`disregarded and provides no basis for its interpretation, other than citing to the
`
`Shargel Declaration, without any further explanation.
`
`Petitioner also suggests that the appropriate construction of “acid inhibitor”
`
`would include “prostaglandins, H2 blockers, and PPIs.” (Id.) Patent Owner
`
`disagrees. As explained below, the broadest reasonable interpretation of “acid
`
`inhibitor” excludes prostaglandins. Expanding the scope to include prostaglandins,
`
`as suggested by Petitioner, is simply not supported by the specification or file
`
`history; such an interpretation would not be reasonable.
`
`The specification of the ’907 patent plainly distinguishes H2-blockers and
`
`PPIs, describing them as “acid inhibitors,” from synthetic prostaglandins,
`
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`describing them as “cytoprotective agents.” (Compare Ex. 1001 at 1:40-44 (“In
`
`general, more potent and longer lasting acid inhibitors, such as proton pump
`
`inhibitors, are thought to be more protective during chronic administration of
`
`NSAIDs than shorter acting agents, e.g., histamine H2 receptor antagonists . . . .”)
`
`with id. at 2:45-51 (“Other attempts to produce an NSAID therapy with less
`
`gastrointestinal toxicity have involved the concomitant administration of a
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`cytoprotective agent” including ArthrotecTM which “contains misoprostol (a
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`cytoprotective prostaglandin) and the NSAID diclofenac.”).)
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`Furthermore, the specification provides examples of acceptable acid
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`inhibitors, listing specific H2-blockers and PPIs. (Ex. 1001 at 3:26-38.) And as
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`noted above,
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`the specification distinguishes Arthrotec (a combination of
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`misoprostol, a cytoprotective prostaglandin, and diclofenac, an NSAID) from the
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`claimed invention. (Ex. 1001 at 2:46-56.)
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`The file history of the ’907 patent also supports an interpretation of “acid
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`inhibitor” that excludes prostaglandins. Specifically, during prosecution, an
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`“attempt was made to restrict certain claims to either dosage forms containing H2
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`blockers or [PPIs].” (11/22/04 Amendment and Response, Ex. 1002 at 62.)
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`Furthermore, there is no evidence in the file history that the Examiner ever
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`considered synthetic prostaglandin art to be particularly relevant to the pending
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`claims. The Examiner never rejected the pending claims of the ’907 patent over
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`any reference disclosing misoprostol or any other prostaglandin. Indeed, the
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`Examiner characterized the closest prior art as Goldman and Depui, each of which
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`relates to H1 or H2-blockers and PPIs, respectively. (3/29/05 Notice of
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`Allowance, Ex. 1002 at 45.)
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`To be sure, original claim 2, which depended from claim 1, recited that the
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`“acid inhibitor is selected from: a proton pump inhibitor and an H2 blocker.”
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`(5/31/02 Claims, Ex. 1002 at 597.) From the doctrine of claim differentiation, it
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`can be inferred that claim 1’s recitation of “acid inhibitor” is thus broader in scope
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`than a PPI and an H2 blocker. However, that doesn’t necessitate that “acid
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`inhibitor” include prostaglandins, which are cytoprotective agents and are clearly
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`distinguished from “acid inhibitors.” Rather other known “acid inhibitors” include
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`H1-blockers, as taught by, e.g., Goldman, and muscarinic anticholinergic agents,
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`such as mepenzolate bromide and glycopyrrolate, each of which, inter alia, reduce
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`gastric acid secretion and are approved for the treatment of peptic ulcers, such as
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`gastric ulcers and duodenal ulcers.
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`Even the art cited in the Petition supports the fact that misoprostol, a
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`synthetic prostaglandin, only has a “very weak” effect on gastric acid secretion.
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`(Chiverton 1989, Ex. 1007 at 1-2.) Chiverton presents data showing that
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`misoprostol, a synthetic prostaglandin, has little to no effect on pH. (Id. at 406,
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`Table 1.) That is compelling evidence that prostaglandins, such as misoprostol, are
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`not “acid inhibitors” as they do not significantly inhibit gastric acid secretion or
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`increase gastric pH.
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`Given that the Board is required to apply the “broadest reasonable
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`construction,” the Board should construe “acid inhibitor” consistent with the
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`specification to mean “an agent that inhibits gastric acid secretion and increases
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`gastric pH,” and excludes prostaglandins. See In re Abbott Diabetes Care Inc., 696
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`F.3d 1142, 1149 (Fed. Cir. 2012) (“Although the PTO emphasizes that it was
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`required to give all claims their broadest reasonable construction, . . . this court has
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`instructed that any such construction be consistent with the specification, and that
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`claim language should be read in light of the specification as it would be
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`interpreted by one of ordinary skill in the art.”) (internal citation omitted).
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`Further, to the extent that a prostaglandin may be considered an acid
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`inhibitor, the patent has disclaimed formulations that combine an NSAID with a
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`cytoprotective prostaglandin. As explained above, the specification of the patent
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`distinguished the claimed invention from formulations such as Arthrotec that
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`involve the concomitant administration of a prostaglandin with an NSAID. (Ex.
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`1001 at 2:57-63.) By distinguishing the invention from prior art use of
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`prostaglandins, the patent has disclaimed these formulations and they do not fall
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`within the scope of the claims. See SciMed Life Sys., Inc. v. Advanced
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`Cardiovascular Sys., Inc., 242 F.3d 1337, 1341 (Fed. Cir. 2001) (“Where the
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`specification makes clear that the invention does not include a particular feature,
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`that feature is deemed to be outside the reach of the claims of the patent, even
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`though the language of the claims, read without reference to the specification,
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`might be considered broad enough to encompass the feature in question.”).
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`C.
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`“Coordinated Release” Does Not Require Further Interpretation
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`Patent Owner does not believe “coordinated release” requires further
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`construction because the claim itself specifically recites what “coordinated release”
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`means with regard to the ’907 patent:
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`said unit dosage form provides for coordinated release such that
`i) said NSAlD is surrounded by a coating that, upon ingestion of said
`unit dosage form by said patient, prevents the release of essentially
`any NSAlD from said dosage form unless the pH of the
`surrounding medium is 3.5 or higher;
`ii) at least a portion of said acid inhibitor is not surrounded by an
`enteric coating and, upon ingestion of said unit dosage form by
`said patient, is released regardless of whether the pH of the
`surrounding medium is below 3.5 or above 3.5.
`(Ex. 1001 at Claim 1.)
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`However, to the extent that the broadest reasonable interpretation is other
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`than that expressly recited in the claims, Patent Owner requests that the phrase be
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`interpreted consistent with the court’s construction of the phrase in the related
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`district court litigation. In that proceeding, the court concluded that a POSA would
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`understand the phrase to mean “sequential release of acid inhibitor followed by
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`NSAID” based in part on the claim language recited above. (5/1/13 Claim
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`Construction Order, Ex. 2005 at 9.)
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`V.
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`THE BOARD SHOULD DENY CFAD’S PETITION BECAUSE IT
`FAILS TO DEMONSTRATE A REASONABLE LIKELIHOOD OF
`SUCCESS
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`Each of the proposed grounds in the Petition alleges that the challenged
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`claims are unpatentable as obvious. As discussed below, each ground is legally
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`deficient and should be denied.
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`A.
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`Ground 1: Petitioner Has Not Established a Reasonable
`Likelihood that Claims 1, 7, 8, 12, 13, 22, and 23 Are Obvious over
`Gimet in View of Chiverton
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`Petitioner cannot establish a reasonable likelihood that it would prevail on
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`Ground 1.
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`Ground 1 is based on a combination of two references, each of which relates
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`to synthetic prostaglandins and more particularly, misoprostol. Gimet describes a
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`pharmaceutical composition comprising an NSAID core that may be enteric
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`coated, surrounded by a layer of a synthetic prostaglandin, misoprostol. (Gimet,
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`Ex. 1004 at 12:10-19.) Gimet does not state that the prostaglandin is capable of
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`raising the gastric pH of a patient to at least 3.5. Consequently, Gimet does not
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`disclose a dosage form comprising an acid inhibitor in an amount effective to raise
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`the gastric pH of a patient to at least 3.5.
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`The Petition cites Chiverton in an attempt to rectify that deficiency.
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`Chiverton, however, shows that the doses of prostaglandin taught by Gimet are
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`insufficient to raise the gastric pH to 3.5. Gimet teaches that the prostaglandin
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`misoprostol “is present in an amount from about 50 to about 500 mcg and
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`preferably from about 100 to about 200 mcg.” (Gimet, Ex. 1004 at 6:20-23.)
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`Chiverton shows in Table 1 that none of the tested doses of misoprostol raised the
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`mean pH to at least 3.5. (Chiverton 1989, Ex. 1007 at 4, Table 1.) Even the 600
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`mcg and 800 mcg doses, doses greater than those taught by Gimet, failed to raise
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`the mean pH to at least 3.5. Thus, neither Gimet nor Chiverton, either alone or in
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`combination, provides any rationale for a dosage form comprising an acid inhibitor
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`in an amount effective to raise the gastric pH of a patient to at least 3.5.
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`As the foregoing demonstrates, the Petition cannot demonstrate a likelihood
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`of success that the prior art combination of Gimet and Chiverton renders obvi