Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 13
`Entered: September 1, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`INTELGENX CORPORATION,
`Petitioner,
`
`v.
`
`ICOS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00678
`Patent 6,943,166 B1
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, SUSAN L. C. MITCHELL, and
`ZHENYU YANG, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`Paper 13
`Entered: September 1, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`INTELGENX CORPORATION,
`Petitioner,
`
`v.
`
`ICOS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00678
`Patent 6,943,166 B1
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, SUSAN L. C. MITCHELL, and
`ZHENYU YANG, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`IPR2016-00678
`Patent 6,943,166 B1
`
`
`INTRODUCTION
`IntelGenX Corporation (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
`to institute an inter partes review of claims 112 of U.S. Patent No.
`6,943,166 B1 (Ex. 1001, “the ’166 patent”). ICOS Corporation (“Patent
`Owner”) timely filed a Preliminary Response. Paper 11 (“Prelim. Resp.”).
`Based on this record, we determine Petitioner has not established a
`reasonable likelihood that it would prevail in showing the unpatentability of
`at least one challenged claim. See 35 U.S.C. § 314(a). Therefore, we deny
`institution of an inter partes review.
`Related Proceedings
`According to the parties, there are no related matters that would affect
`or be affected by this proceeding. Pet. 59; Paper 8, 2.
`The ’166 Patent
`The ’166 patent relates to a highly selective phosphodiesterase (PDE)
`enzyme inhibitor and its use in a pharmaceutical unit dosage form.
`Ex. 1001, Abstract, 1:14–16.
`Type 5 cGMP-specific PDE (PDE5) is an attractive target in the
`treatment of sexual dysfunction. Id. at 1:34–39. Before the ’166 patent
`invention, a pharmaceutical product, which provides a PDE5 inhibitor, was
`available and marketed for treating male erectile dysfunction (“ED”) under
`the trademark VIAGRA®. Id. at 1:41–43. The active ingredient in
`VIAGRA® is sildenafil. Id. at 1:43–44. According to the ’166 patent,
`however, “[w]hile sildenafil has obtained significant commercial success, it
`has fallen short due to its significant adverse side effects.” Id. at 1:58–60.
`The ’166 patent discloses a pharmaceutical unit dosage composition
`comprising about 1 to about 20 mg of compound tadalafil, which has the
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`IPR2016-00678
`Patent 6,943,166 B1
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`following structure:
`
`
`Id. at 3:11–28. The ’166 patent discloses that the pharmaceutical unit
`dosage is suitable for oral administration, and is useful for treating sexual
`dysfunction. Id. at 3:29–31.
`
`Illustrative Claim
`Claim 1 is the sole independent claim challenged in the Petition. It
`reads:
`1. A method of treating sexual dysfunction in a patient in need
`thereof comprising orally administering one or more unit dose
`containing about 1 to about 20 mg, up to a maximum total dose
`of 20 mg per day, of a compound having the structure [of formula
`(I)].
`
`Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds, each of which challenges the
`patentability of claims 1–12:
`Basis
`§ 103
`§ 103
`
`References
`Daugan1
`Daugan and SNDA2
`
`
`1 Daugan, WO 97/03675, published Feb. 6, 1997 (Ex. 1002, “Daugan”).
`2 Center for Drug Evaluation and Research, Approval Package for
`VIAGRA®, Approval Date March 27, 1998 (Ex. 1003, “SNDA”).
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`IPR2016-00678
`Patent 6,943,166 B1
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`In support of its patentability challenges, Petitioner relies on the
`Declaration of Drs. Wayne J.G. Hellstrom (Ex. 1005) and Douglas Reid
`Patterson (Ex. 1007).
`
`ANALYSIS
`Claim Construction
`In an inter partes review, the Board interprets a claim term in an
`unexpired patent according to its broadest reasonable construction in light of
`the specification of the patent in which it appears. 37 C.F.R. § 42.100(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under
`that standard, and absent any special definitions, we assign claim terms their
`ordinary and customary meaning, as would be understood by one of ordinary
`skill in the art at the time of the invention, in the context of the entire patent
`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007).
`Claim terms need only be construed to the extent necessary to resolve
`the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361
`(Fed. Cir. 2011). On this record and for purposes of this Decision, we see no
`need to construe any term expressly.
`Prior Art Disclosures
`
`Daugan
`Daugan identifies (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-
`(3,4-methylene-dioxyphenyl)pyrazino[2',1':6.1] pyrido[3,4-b]indole-1,4-
`dione, also known as compound (A), as a compound of the invention.
`Ex. 1002, 3:24–25. Compound (A) is the same as the compound of formula
`(I) in the ’166 patent, i.e., tadalafil.
`Daugan teaches that tadalafil is useful for treating male or female
`
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`IPR2016-00678
`Patent 6,943,166 B1
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`sexual dysfunction. Id. at 4:2528. According to Daugan, tadalafil may be
`administered orally to treat erectile dysfunction. Id. at 3:3032. It also
`teaches that “for a typical adult patient, individual tablets or capsules contain
`from 0.2-400mg of active compound, in a suitable pharmaceutically
`acceptable vehicle or carrier, for administration in single or multiple doses,
`once or several times per day.” Id. at 5:47. Specifically, Daugan teaches
`preparing tablets with 50 mg active compound. Id. at 12:1514:16.
`SNDA
`SNDA teaches sildenafil is a potent PDE5 inhibitor and is useful for
`treating ED. Ex. 1003, 35. Sildenafil is therapeutically effective for treating
`ED at doses of 25, 50, and 100 mg. Id. at 127–28, 215, 217–19. According
`to SNDA, in some patients, doses as low as 5 and 10 mg are therapeutically
`effective over placebo. Id. SNDA states that the “maximum recommended
`dosing frequency is once per day.” Id. at 50.
`Obviousness Grounds
`Petitioner contends that claims 1–12 would have been obvious over
`the teachings of Daugan, either alone or in combination with SNDA.
`Pet. 20–46. In both obviousness grounds, Petitioner relies on both Daugan
`and SNDA for suggesting tadalafil dose recited in claim 1. Based on the
`current record, we determine Petitioner has not established a reasonable
`likelihood that it would prevail in this assertion.
`Specifically, Petitioner points to Daugan for teaching tadalafil
`formulations comprising individual tablets or capsules containing “from 0.2-
`400mg of active compound.” Id. at 22, 25 (citing Ex. 1002, 5). According
`to Petitioner, while Daugan provides examples of 50 mg dosage forms for
`oral administration, it teaches that “other strengths” and “other doses” may
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`IPR2016-00678
`Patent 6,943,166 B1
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`be prepared, and that “lower dose ranges may be merited.” Id. at 23, 25
`(citing Ex. 1002, 12–16). In addition, Petitioner refers to SNDA for
`teaching that sildenafil is therapeutically effective in treating ED at doses of
`25, 50, and 100 mg. Id. at 39 (citing Ex. 1003, 127–28, 215, 217–19). In
`some patients, Petitioner asserts, sildenafil is therapeutically effective in
`dosages as low as 5 to 10 mg. Id. at 26, 39 (citing Ex. 1003, 127–28, 215,
`217–19).
`According to Petitioner, because tadalafil is a more potent and highly
`selective PDE5 inhibitor, an ordinary artisan would have had a reason to use
`doses lower than the 50 mg dose exemplified in Daugan, including doses
`lower than the known effective doses of sildenafil, and would have had a
`reasonable expectation of success in doing so. Id. at 26–28, 42–44. As a
`result, Petitioner contends, one of ordinary skill in the art would have arrived
`at the method of claim 1 either by following the express teachings and
`guidance in Daugan, or through routine optimization. Id. at 29, 44.
`In its Preliminary Response, Patent Owner does not address the “unit
`dose containing about 1 to about 20 mg” limitation. Patent Owner, instead,
`emphasizes that Petitioner fails to account for another essential claim
`limitation—“a maximum total dose of 20 mg per day.” Prelim. Resp. 13–22.
`We agree with Patent Owner.
`In an inter partes review, the petition must specify where each
`element of the claim is found in the prior art. 37 C.F.R. § 42.104(b)(4).
`Claim 1 recites “orally administering one or more unit dose containing about
`1 to about 20 mg, up to a maximum total dose of 20 mg per day.” In
`general, all patent claim terms are presumed to have meaning. Bicon, Inc. v.
`Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006). Petitioner, however,
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`IPR2016-00678
`Patent 6,943,166 B1
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`paraphrases the claim as “recit[ing] a method of treating sexual dysfunction
`comprising administering a tadalafil dose range of ‘about 1 to about 20
`mg.’” Pet. 21. In other words, Petitioner appears to ignore the maximum-
`total-dose requirement. Petitioner’s analysis reflects this omission.
`Assuming, without deciding, that tadalafil would have been expected to be
`therapeutically effective at doses from “about 1 to about 20 mg,” Petitioner
`does not point to the asserted prior art or otherwise explain why an ordinary
`artisan would limit the tadalafil dose to 20 mg per day.
`As a result, based on the current record, we conclude Petitioner has
`not established a reasonable likelihood it would prevail in showing that
`claim 1 would have been obvious over Daugan, either alone or in
`combination with SNDA.
`
`CONCLUSION
`On this record, Petitioner has not demonstrated a reasonable
`likelihood of prevailing on its challenges to the patentability of any
`challenged claim of the ’166 patent on the grounds asserted in the Petition.
`ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s request for an inter partes review of
`claims 1–12 of the ’166 patent is denied and no inter partes review is
`instituted.
`
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`IPR2016-00678
`Patent 6,943,166 B1
`
`PETITIONER:
`Patrick A. Doody
`Bryan P. Collins
`Pillsbury Winthrop Shaw Pittman, LLP
`patrick.doody@pillsburylaw.com
`bryan.collins@pillsburylaw.com
`
`PATENT OWNER:
`Mark J. Feldstein
`Joshua L. Goldberg
`Yieyie Yang
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
`mark.feldstein@finnegan.com
`joshua.goldberg@finnegan.com
`yieyie.yang@finnegan.com
`
`Mark J. Stewart
`Dan L. Wood
`Eli Lilly and Company
`stewart_mark@lilly.com
`wood_dan_l@lilly.com
`
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