Amneal Pharmaceuticals, LLC
`Petitioner
`v.
`Supernus Pharmaceuticals, Inc.
`Patent Owner
`
`Case IPR2013-00368
`Case IPR2013-00371
`Case IPR2013-00372
`
`US Patent No. 8,206,740
`US Patent No. 8,394,405
`US Patent No. 8,394,406
`
`
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`Patents at issue
`
`US Patent No. 8,206,740 (IPR2013-00368)
`US Patent No. 8,394,405 (IPR2013-00371)
`US Patent No. 8,394,406 (IPR2013-00372)
`
`Title:
`
`Inventors:
`
`
`
`
`
`Assignee:
`
`Licensee:
`
`
`
`Once daily formulations of tetracyclines
`
`Rong-Kun Chang
`Arash Raoufinia
`Niraj Shah
`
`Supernus Pharmaceuticals, Inc.
`
`Galderma Laboratories, Inc. (a real party in interest)
`
`2
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`‘740 Patent (Ex. 1001)
`1. An oral pharmaceutical
`composition of doxycycline,
`
`which at a once-daily dosage
`will give steady state blood
`levels of doxycycline of a
`minimum of 0.1 µg/ml and a
`maximum of 1.0 µg/ml,
`the composition consisting of (i)
`an immediate release (IR)
`portion comprising 30 mg
`doxycycline;
`
`
`(ii) a delayed release (DR)
`portion comprising 10 mg
`doxycycline;
`
`
`
`and optionally, (iii) one or more
`pharmaceutically acceptable
`excipients.
`
`Claim 1
`‘405 Patent (Ex. 1007)
`1. An oral pharmaceutical
`composition comprising about
`40 mg of total doxycycline,
`
`which at a once-daily dosage
`will give steady state blood
`levels of doxycycline of a
`minimum of 0.1 µg/ml and a
`maximum of 1.0 µg/ml,
`wherein the composition
`consists of 70 to 80 percent of
`the doxycycline formulated as
`an immediate release (IR)
`formulation and
`
`20 to 30 percent of the
`doxycycline formulated as a
`delayed release (DR)
`formulation.
`
`3
`
`‘406 Patent (Ex. 1009)
`1. An oral pharmaceutical
`composition comprising less
`than 50 mg of total doxycycline,
`
`which at a once-daily dosage
`will give steady state blood
`levels of the doxycycline
`between 0.1 µg/ml and 1.0
`µg/ml,
`and a Cmax of the doxycycline
`between 0.4 µg/ml and 0.8
`µg/ml,
`
`the composition consisting of (i)
`an immediate release (IR)
`formulation of the doxycycline,
`(ii) a delayed release (DR)
`formulation of the doxycycline
`comprising at least one enteric
`polymer,
`and (iii) one or more
`pharmaceutically acceptable
`excipients,
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`“Amneal has demonstrated a reasonable likelihood that [claims 1
`and 19 are] unpatentable for obviousness over Ashley ’932 and
`Sheth.”
`
`“Amneal has demonstrated also a reasonable likelihood that the
`challenged dependent claims are unpatentable for obviousness
`over Ashley ’932 and Sheth…one or both of these references
`disclose all limitations of the challenged dependent claims.”
`
`See Decision, Paper 8, at 13; see also, IPR2013-00371, Paper 11, at 12-13;
`IPR2013-00372, Paper 8, at 13
`
`4
`
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`
`

`

`Prior Art at Issue:
`
`
`• WO 2002/080932 (“Ashley '932 Publication”)
`• US Application No. 60/281,854 (“Ashley ‘854”),
`incorporated by reference
`
`
`• US Patent No. 5,348,748 (“Sheth ‘748 Patent”)
`
`See Petition, Paper 2, at 19-30
`
`5
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`The challenged claims are obvious over the prior art
`
`1. An oral pharmaceutical composition
`of doxycycline,
`
`
`
`which at a once-daily dosage
`
`
`
`
`
`will give steady state blood levels of
`doxycycline of a minimum of 0.1 μg/ml
`and a maximum of 1.0 μg/ml,
`
`
`the composition consisting of (i) an
`immediate release (IR) portion
`comprising 30 mg doxycycline; (ii) a
`delayed release (DR) portion
`comprising 10 mg doxycycline;
`and optionally, (iii) one or more
`pharmaceutically acceptable
`excipients.
`
`“In a preferred embodiment, the tetracycline is doxycycline.”
`(Ashley ‘854, Ex. 1003 at 5:21)
`
`“[T]he composition of the invention allows the patient to administer the
`tetracycline compound one or two times a day.”
`(Ashley ‘854, Ex. 1003 at 6:28-29)
`
`“[The invention] provides a once-a-day delivery system which maintains
`therapeutic blood level concentrations of the medicament in a patient.”
`(Sheth ‘748, , Ex. 1005 at 1:13-16)
`
`“In general, the blood serum level will be between about 0.1 and 1.0 µg/ml”
`(Ashley ‘854, Ex. 1003 at 5:17)
`
`“For example, 40 milligrams of doxycycline may be administered….”
`(Ashley ‘932, Ex. 1002 at 16:1)
`
`“The composition also can include a controlled-release agent selected from
`the group consisting of an instantaneous-release agent, a sustained-
`release agent, a delayed-release agent, and combinations thereof.”
`(Ashley ‘854, Ex. 1003 at 5:24-26)
`
`“[F]rom 51 to 80 parts by weight per 100 parts by weight of…quick release
`granules…and (B) from 20 to 49 parts by weight per 100 parts by weight of
`…secondary loading [delayed release]…blended polymer coated spherical
`granules…."
`(Sheth ‘748, Ex. 1005 at 4:33-56)
`6
`See Petition, Paper 2, at 21-23; 1st Van Buskirk dec., Ex. 1022 at pp. 87-91
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`“The present invention provides methods of treating acne…For the
`purposes of this specification, acne includes all known types of acne. Some
`types of acne include, for example,…acne rosacea.”
`(Ashley ‘932, Ex. 1002 at 6:34-7:3)
`
`In a preferred embodiment, the tetracycline is doxycycline.
`(Ashley ‘854, Ex. 1003 at 5:21)
`
`The challenged claims are obvious over the prior art
`19. A method for treating rosacea in a
`mammal in need thereof, comprising
`administering
`
`
`an oral pharmaceutical composition of
`doxycycline comprising,
`
`
`which at a once-daily dosage will give
`steady state blood levels of
`doxycycline of a minimum of 0.1 μg/ml
`and a maximum of 1.0 μg/ml,
`
`
`
`
`the composition consisting of (i) an
`immediate release (IR) portion
`comprising 30 mg doxycycline; (ii) a
`delayed release (DR) portion
`comprising 10 mg doxycycline;
`and optionally, (iii) one or more
`pharmaceutically acceptable
`excipients.
`
`[T]he composition of the invention allows the patient to administer the
`tetracycline compound one or two times a day.
`(Ashley ‘854, Ex. 1003 at 6:28-29)
`[The invention] provides a once-a-day delivery system which maintains
`therapeutic blood level concentrations of the medicament in a patient
`(Sheth ‘748, , Ex. 1005 at 1:13-16)
`
`In general, the blood serum level will be between about 0.1 and 1.0 µg/ml
`(Ashley ‘854, Ex. 1003 at 5:17)
`
`For example, 40 milligrams of doxycycline may be administered….
`(Ashley ‘932, Ex. 1002 at 16:1)
`
`The composition also can include a controlled-release agent selected from
`the group consisting of an instantaneous-release agent, a sustained-
`release agent, a delayed-release agent, and combinations thereof.
`(Ashley ‘854, Ex. 1003 at 5:24-26)
`
`[F]rom 51 to 80 parts by weight per 100 parts by weight of…quick release
`granules…and (B) from 20 to 49 parts by weight per 100 parts by weight of
`…secondary loading…blended polymer coated spherical granules…."
`(Sheth ‘748, Ex. 1005 at 4:33-56)
`7
`See Petition, Paper 2, at 28-30; 1st Van Buskirk dec., Ex. 1022 at pp. 151-155
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`Reason to combine Ashley ‘932 and Sheth ‘748
`Reasonable expectation of success
`
`Ashley ‘932:
`expressly teaches
`minocycline
`
`“Examples of the maximum non-antibiotic doses of tetracyclines based on
`steady-state pharmacokinetics are as follows: 20 mg/twice a day for
`doxycycline; 38 mg of minocycline one, two, three or four times a day; and
`60 mg of tetracycline one, two, three or four times a day.”
`(Ashley ‘932, Ex. 1002 at 9:12-15.)
`
`“Some examples of the plasma antibiotic threshold levels of tetracyclines
`based on steady-state pharmacokinetics are as follows: 1.0 μg/ml for
`doxycycline; 0.8 μg/ml for minocycline; and 0.5 μg/ml for tetracycline.”
`(Ashley ‘932, Ex. 1002 at 11:1-3.)
`
`“Preferred antimicrobial tetracyclines include tetracycline, doxycycline,
`demeclocycline, minocycline, and lymecycline.”
`(Ashley ‘854, Ex. 1003 at 9:10-11.)
`
`Dr. Van Buskirk:
`comparable in “structure,
`function, and utility”
`
`“A person of ordinary skill in the art would have generally understood that
`minocycline and doxycycline are comparable tetracycline drugs with
`structure, function, and utility.”
`(Van Buskirk 1st declaration, Ex. 1022 at ¶ 185; Van Buskirk 2nd declaration, Ex. 1066 at ¶ 56.)
`
`“[T]he otherwise close relatedness of these two drugs in structure and
`Board: “close
`function makes information about formulation of one relevant to
`formulation of the other.”
`relatedness”
`(Decision, Paper 8, at 12.)
`See Petition, Paper 2, at 26-27; Reply, Paper 57, at 4; 2nd Van Buskirk dec. at ¶ 58 and Table 1 8
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`Reason to combine Ashley ‘932 and Sheth ‘748
`Reasonable expectation of success
`
`(G.F. Webster, "Treatment of Rosacea," Seminars in Cutaneous Medicine
`& Surgery 20(3): 207-208 (2001), Ex. 1018 at 208)
`
`(G.F. Webster, "Acne Vulgaris and Rosacea: Evaluation and
`Management," Clinical Cornerstone. 4: 15-22 (2001), Ex. 1041 at 18)
`
`(G.F. Webster, "Acne Vulgaris and Rosacea: Evaluation and
`Management," Clinical Cornerstone. 4: 15-22 (2001), Ex. 1041 at 19)
`
`See Petition, Paper 2, at 7, 26; Reply, Paper 57, at 4
`
`9
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`Reason to combine Ashley ‘932 and Sheth ‘748
`Reasonable expectation of success
`“Antibacterial dose” disclosures in Sheth “are of no moment”
`
`Board: antibacterial
`dose “is of no
`moment”
`
`“That Sheth happens to have made this disclosure in
`the context of an antibacterial dose instead of a sub-
`antibacterial dose is of no moment, on the present
`record.”
`(Decision, Paper 8, at 12.)
`
`Sheth: minocycline
`doses as low as 25 mg
`
`(Sheth, Ex. 1005 at 8:11-13)
`
`See Petition, Paper 2, at 37; 2nd Van Buskirk dec. at ¶ 59
`
`10
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`A POSA would have tried an IR/DR formulation (i.e., no SR)
`
`Drugs with long half-
`lives are “inherently
`sustained”
`
`(Chang et al., Ex. 2020 at 201.)
`
`Dr. Rudnic: a POSA
`would have considered
`DR as a possibility
`
`See Reply, Paper 57, at 5-6; 2nd Van Buskirk dec., Ex. 1066 at ¶¶ 67-69
`
`11
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`(Rudnic depo, Ex. 1052 at 126:11-22.)
`
`

`

`Dr. Rudnic’s testimony is contradicted by his own patent
`
`Dr. Rudnic:
`“counterintuitive”
`
`“[H]ad one of ordinary skill in the art been aware of the narrow absorption
`window of doxycycline, it would have been counterintuitive to formulate
`a drug composition as a DR drug product or with a DR component.”
`(Rudnic declaration, Ex. 2016 at ¶ ¶ 55, 136, 139, 140, 145.)
`
`But see Dr. Rudnic’s own patent:
`
`(Rudnic et al., Ex. 1032.)
`
`See Reply, Paper 57, at 5; 2nd Van Buskirk dec., Ex. 1066 at ¶¶ 70-71
`
`(Rudnic et al., Ex. 1032.)
`
`12
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`The claimed IR/DR ratio is not critical
`
`‘740 patent presents
`the
`“Figure 4 of
`simulated data indicating that 40 mg doses of
`doxycycline formulated in IR:DR ratios of
`100:0 (40 mg IR only), 70:30, and 80:20 all
`achieve
`steady-state blood
`levels
`of
`doxycycline within the claimed range of 0.1
`μg/ml to 1.0 μg/ml.” (Ex. 1022, ¶ 180.)
`
`(‘740 patent, Ex. 1001)
`
`See Petition, Paper 2, at 16; Reply, Paper 57, at 8
`
`13
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`The art does not “teach away”
`
`Dr. Rudnic: teaching away means “teaching something different”
`
`(Rudnic depo, Ex. 1052 at 66:13-16)
`
`(Rudnic depo, Ex. 1052 at 68:11-22)
`
`See Reply, Paper 57, at 6-7; 2nd Van Buskirk dec., Ex. 1066 at ¶ 29
`
`14
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`(Rudnic depo, Ex. 1052 at 64:2-3)
`
`(Rudnic depo, Ex. 1052 at 65:18-22)
`
`See Reply, Paper 57, at 6-7; 2nd Van Buskirk dec., Ex. 1066 at ¶ 29
`
`15
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`(Rudnic depo, Ex. 1052 at 68:2-10)
`
`

`

`Formulations of Ashley ‘854 do not “require”
`a sustained release component
`
`Express language in
`Ashley ‘854:
`“combinations
`thereof”
`
`“The composition also can include a controlled-release agent
`selected from the group consisting of an instantaneous-release
`agent, a sustained-release agent, a delayed-release agent, and
`combinations thereof.”
`(Ashley ‘854, Ex. 1003 at 5:24-26)
`
`Galderma: claimed a
`formulation with only
`IR and DR
`
`(‘240 Reply to Office Action, Ex. 1020 at 4.)
`
`See Petition, Paper 2, at 12; Reply, Paper 57, at 2-3
`
`16
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`The claimed IR/DR ratios are subsumed
`by disclosures in Sheth ‘748
`
`‘740 patent
`
`‘405 patent
`
`‘406 patent
`
`30 mg doxycycline IR
`10 mg doxycycline DR
`
`40 mg total doxycycline
`70-80% IR
`20-30% DR
`
`50 mg total doxycycline
`Comprising an IR and DR formulation
`
`Sheth ‘748:
`51-80 parts IR
`20-49 parts DR
`
`See Petition, Paper 2, at 7, 20
`
`(Ex. 1005 at 4:33-56)
`
`17
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`Objective indicia do not support
`patentability
`
`18
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`There was no long-felt need
`
`Dr. Gilmore:
`No actual evidence of a
`long-felt need recognized
`in the art
`
`Dr. Gilmore:
`If there were a need, it was
`met by disclosures in
`Ashley ‘932
`
`(Gilmore dec., Ex. 1056 at ¶¶ 36-37)
`
`“In his declaration (Ex2018), Dr. Webster does not
`provide any supporting evidence of a long-felt need
`for a once-daily, sub-antimicrobial dose of doxycycline
`for the treatment of rosacea…Dr. Webster does not
`provide any actual evidence of a long-felt need for a
`once-daily sub antimicrobial dose of doxycycline that
`was recognized in the prior art by those in the art.”
`(Gilmore dec., Ex. 1056 at ¶ 27)
`
`“In an especially preferred embodiment, doxycycline
`hyclate is administered at a 20 milligram dose twice
`daily. Such a formulation is sold…under the trademark
`Periostat ®.”
`(Ashley ‘932, Ex1002 at 9:21-25)
`
`“Second, the controlled release composition of the
`invention increases patient compliance…allows the
`patient to administer the tetracycline one or two
`times a day. The controlled release of the tetracycline
`creates the desired dose profile below that which is
`necessary for an antimicrobial response in the host.”
`(Ashley ‘854, Ex. 1003 at 6:26-31)
`
`See Petition, Paper 2, at 50-52; Reply, Paper 57, at 8-10
`
`19
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`There was no long-felt need
`
`Dr. Webster: No head-to-head studies
`comparing adverse events for Oracea®
`and generic doxycycline
`
`Dr. Webster: No head-to-head
`studies comparing compliance for
`Oracea® and Periostat®
`
`(Webster depo, Ex. 1054 at 76:11-21)
`
`Dr. Webster: No articulated need in the art
`
`(Webster depo, Ex. 1054 at 84:25-85:17)
`
`(Webster depo, Ex. 1054 at 113:2-11)
`
`See Reply, Paper 57, at 8-10
`
`20
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`There is no commercial success
`The features of Oracea® are found in the prior art
`
`See Reply, Paper 57, at 10-11; Table appears in Green declaration, Ex. 1071 at p. 48
`
`21
`
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`
`

`

`1) There is no nexus
`
`There is no commercial success
`Mr. Green:
`“It is my opinion that there is no nexus between this once-daily
`feature of Oracea® and its sales because there is no evidence
`to show that the once daily feature is driving sales.”
`Green dec., Ex. 1071 at ¶ 41
`
`2) Oracea® enjoys
`“marketing monopoly”
`due to FDA approval
`
`“Oracea®’s exclusive FDA-approved status allows it to enjoy
`a marketing monopoly in the field of oral rosacea treatment.
`This exclusive status is critical to Oracea®’s sales.”
`Green dec., Ex. 1071 at ¶ 51
`
`3) Oracea® marketing
`is driving sales
`•
`Marketing
`•
`Rebate cards
`•
`Free samples
`
`“Oracea®’s sales are driven in large part by Galderma’s
`marketing and promotional activities.”
`Green dec., Ex. 1071 at ¶ 58
`
`4) Dr. Grabowski did
`not consider prior art
`disclosures in his
`analysis
`See Reply, Paper 57, at 10-11
`
`“Dr. Grabowski’s declaration appears to ignore aspects of
`Oracea® that existed in the prior art, and he admitted as much
`during his deposition.”
`Green dec., Ex. 1071 at ¶ 40
`
`22
`
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`
`

`

`There is no commercial success
`
`Dr. Grabowski failed to consider the prior art in his analysis of
`commercial success
`
`Grabowski depo, Ex. 1055 at 76:24-77:7
`
`Grabowski depo, Ex. 1055 at 78:6-17
`
`Grabowski depo, Ex. 1055 at 201:15-202:2
`
`See Reply, Paper 57, at 11; Green dec., Ex. 1071 at ¶¶ 32, 47
`
`23
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
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`

`

`There is no commercial success
`
`Dr. Grabowski admitted that the once-daily dosing regimen of
`Oracea® is not the key driver of sales
`
`Grabowski depo, Ex. 1055 at 72:7-12
`
`Grabowski depo, Ex. 1055 at 73:10-21
`
`See Reply, Paper 57, at 11; Green dec., Ex. 1071 at ¶¶ 39, 40
`
`24
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`The Faulding Study was not a failure of others
`
`Dr. Van Buskirk:
`Faulding formulations
`achieved claimed steady
`state blood levels
`
`“[A]t least one of the once-daily doxycycline
`formulations of Faulding achieved steady-state blood
`levels within the claimed range of 0.1 μg/ml to 1.0
`μg/ml.”
`(2nd Van Buskirk dec., Ex. 1066 at ¶ 78; Ex. 2034 at Fig. 1)
`
`Dr. Van Buskirk:
`Chang patent claims do
`not require a certain
`level of “bioavailability”
`
`“I disagree that the purported lower bioavailability of the
`Faulding formulations constitutes a "failure" because the
`claims of the ‘740 patent do not require a certain level of
`bioavailability or even recite the term, ‘bioavailability.’”
`(2nd Van Buskirk dec., Ex. 1066 at ¶ 80; Ex. 1001; Ex. 1007; Ex. 1009)
`
`Dr. Van Buskirk:
`Drugs with lower
`bioavailability are not
`necessarily a “failure”
`
`“[T]here are numerous examples of well-known,
`effective drugs with bioavailability levels of 50% or less.”
`(2nd Van Buskirk dec., Ex. 1066 at ¶ 84)
`
`See Petition, Paper 2, at 51-52; Reply, Paper 57, at 10
`
`25
`
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`
`

`

`Supernus fails to establish copying
`
`Dr. Rudnic: relies on Amneal Paragraph IV notice letter, page 1 (see Ex. 2016 at ¶ 200)
`
`(Ex. 2053 at 1)
`
`See Petition, Paper 2, at 52-53; Reply, Paper 57, at 12
`
`26
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`Ashley ‘932 incorporates Ashley
`‘854 by reference in its entirety
`
`27
`
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`
`

`

`Ashley ‘854 application is incorporated by
`reference in its entirety in the ‘932 publication
`
`Ashley ‘932:
`
`“Further description of methods of delivering, tetracycline compounds by
`sustained release can be found in the patent application, "Controlled Delivery
`of Tetracycline and Tetracycline Derivatives," filed on April 5, 2001 and
`assigned to CollaGenex Pharmaceuticals, Inc. of Newtown, Pennsylvania. The
`aforementioned application is incorporated herein by reference in its
`entirety.”
`(Ex. 1002, at 15:26-30.)
`
`Petition:
`
`“The '932 incorporates by reference, in its entirety, U.S. Appl. No.
`60/281,854, filed April 5, 2001, titled "Controlled Delivery of Tetracycline and
`Tetracycline Derivatives" ("the '854 application")….”
`(Petition, Paper 2, at 9)
`
`Dr. Van
`Buskirk:
`
`“It is my understanding that the '932 publication incorporates the '854
`application by reference in its entirety, which I understand to mean that the
`'932 publication is generally treated as though the full text of the ‘854
`application were included within the '932 publication.”
`(1st Van Buskirk dec., Ex. 1022 at ¶ 41)
`
`See Petition, Paper 2, at 9; 1st Van Buskirk dec., Ex. 1022 at ¶ 41
`
`28
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`

`

`Ashley ‘854 application is incorporated by reference in its
`entirety in the ‘932 publication
`
`Board: no evidence to
`suggest identification was
`ambiguous
`
`“For of this decision, we determine that the incorporation-by-
`reference was effective, because there is no evidence of
`record to suggest that the identification was ambiguous.”
`(Decision, Paper 8, at n. 1.)
`
`Mr. Doll: “sufficient
`information for a POSA”
`
`“The title and application filing date provide sufficient
`information for a POSA to identify the Ashley '854 application
`without ambiguity….”
`(Doll declaration, Ex. 1049 at ¶ 31.)
`
`Dr. Van Buskirk:
`“unambiguously referred
`to the ‘854 application”
`
`“A POSA who considered the above incorporation statement in
`the '932 publication would have understood that it described the
`incorporated application with sufficient particularity that it
`unambiguously referred to the ‘854 application.”
`(2nd Van Buskirk declaration, Ex. 1066 at ¶ 107.)
`
`Mr. Kunin:
`not qualified to offer opinion
`on a POSA’s understanding
`
`See Petition, Paper 2, at 9; Reply, Paper 57, at 12-13
`
`29
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`(Kunin depo, Ex. 1051 at 29:25-30:3)
`
`

`

`Supernus’ attempts to sidestep the
`prior art fail
`
`30
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`Supernus’ attempts to sidestep the prior art fail
`
`1) Ashley ‘932 incorporates Ashley ‘854 by reference
`in its entirety (see slides 27-29)
`
`
`2) Supernus fails to show an actual reduction to
`practice (ARTP) of the claimed invention
`
`
`3) Supernus fails to provide credible evidence of
`conception and diligence
`
`
`4) Supernus’ attempt to invoke the CREATE Act fails
`
`
`
`
`See Reply, Paper 57, at 12-15
`
`31
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`Supernus fails to show an actual reduction to
`practice (ARTP) of the claimed invention
`
`MPEP § 2138.05: ARTP
`1)
`inventors made an embodiment of the claimed invention and
`2) demonstrated that it works for its intended purpose
`
`Dr. Van Buskirk:
`1) Supernus did not make or test formulations containing IR/DR
`2) Supernus did not make or test formulations that give steady-
`state blood levels within claimed range
`
`(2nd Van Buskirk dec., Ex. 1066 at ¶¶ 101-102)
`
`Supernus: inventors only “contemplated” in silico modeling
`
`(POR, Paper 39, at 58)
`
`Dr. Van Buskirk: “contemplating” in silico modeling is not ARTP
`
`(2nd Van Buskirk dec., Ex. 1066 at ¶¶ 103-104)
`
`See Reply, Paper 57, at 14-15
`
`32
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`Supernus fails to provide credible evidence of
`conception and diligence
`Supernus: no inventor testimony
`
`Dr. Bryan: non-inventor, substantial gaps in activity during the critical period
`
`(Bryan depo, Ex. 1107 at 64:17-20)
`
`(Bryan depo, Ex. 1107 at 63:1-4)
`
`“Dr. Bryan had no personal knowledge of the facts and events. And he did not explain
`the many substantial gaps in activity during the critical period…(more than a month of
`inactivity)….” (Reply, Paper 57, at 14-15)
`
`(Bryan depo, Ex. 1107 at 62:9-22)
`
`See Reply, Paper 57, at 14-15
`
`33
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`

`

`Supernus’ attempt to invoke the CREATE Act
`must fail
`35 U.S.C § 255
`Whenever a mistake of a clerical or typographical nature, or of minor character, which was not
`the fault of the Patent and Trademark Office, appears in a patent and a showing has been
`made that such mistake occurred in good faith, the Director may, upon payment of the required
`fee, issue a certificate of correction, if the correction does not involve such changes in
`the patent as would constitute new matter or would require reexamination. Such patent,
`together with the certificate, shall have the same effect and operation in law on the trial of
`actions for causes thereafter arising as if the same had been originally issued in such
`corrected form.
`
`Supernus’ Certificate of Correction cannot be used to
`amend the specification because it would necessitate re-
`examination
`
`If Supernus’ CREATE Act claim were to disqualify Ashley
`‘932 as prior art, Chang patents should be examined for
`obviousness-type double patenting over patents arising
`from Ashley ‘932
`
`See Reply, Paper 57, at 15
`
`34
`
`© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.
`
`