Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 25
`Entered: October 5, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC. and APOTEX CORP.,
`Petitioner,
`
`v.
`
`ALCON RESEARCH, LTD.,
`Patent Owner.
`
`Case IPR2016-01640
`Patent 8,791,154 B2
`
`Before JENNIFER MEYER CHAGNON, CHRISTOPHER M. KAISER,
`and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`KAISER, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
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`Tel: 571-272-7822
`
`Paper 25
`Entered: October 5, 2016
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC. and APOTEX CORP.,
`Petitioner,
`
`v.
`
`ALCON RESEARCH, LTD.,
`Patent Owner.
`
`Case IPR2016-01640
`Patent 8,791,154 B2
`
`Before JENNIFER MEYER CHAGNON, CHRISTOPHER M. KAISER,
`and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`KAISER, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`IPR2016-01640
`Patent 8,791,154 B2
`
`INTRODUCTION
`
`A. Background
`Apotex Inc. and Apotex Corp. (“Petitioner”) filed a Petition (Paper 2,
`“Pet.”) requesting inter partes review of claims 1–4, 8, 12, 13, 21, and 22 of
`U.S. Patent No. 8,791,154 B2 (Ex. 1001, “the ’154 patent”). Alcon
`Research, Ltd. (“Patent Owner”) waived its opportunity to file a Preliminary
`Response. Paper 7, 2. Petitioner also moved for joinder with IPR2016-
`00544, an ongoing inter partes review that we instituted on July 18, 2016.
`Paper 3. Patent Owner does not oppose the motion for joinder. Paper 7, 2.
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). The standard for
`instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which
`provides that an inter partes review may not be instituted unless “there is a
`reasonable likelihood that the petitioner would prevail with respect to at least
`1 of the claims challenged in the petition.” Petitioner may be joined as a
`party to a previously instituted inter partes review if Petitioner “properly
`files a petition . . . that [we] . . . determine[] warrants the institution of an
`inter partes review.” 35 U.S.C. § 315(c); 37 C.F.R. § 42.4(a).
`After considering the Petition and the evidence currently of record, we
`determine that Petitioner has demonstrated that there is a reasonable
`likelihood that it would prevail with respect to at least one of the claims
`challenged in the Petition. Accordingly, we institute inter partes review.
`Because Petitioner has filed a Petition that warrants institution, we join
`Petitioner as a party to IPR2016-00544, and we terminate the present
`proceeding.
`
`2
`
`
`
`IPR2016-01640
`Patent 8,791,154 B2
`B. Related Matters
`The parties note that the ’154 patent is the subject of Alcon Research,
`Ltd. v. Watson Laboratories, Inc., Case No. 1-15-cv-01159-SLR (D. Del.),
`as well as Alcon Research, Ltd. v. Lupin Ltd., Case No. 1-16-cv-00195 (D.
`Del.). Pet. 1–2; Paper 6, 2.
`
`C. The Asserted Grounds of Unpatentability
`Petitioner contends that claims 1–4, 8, 12, 13, 21, and 22 of the ’154
`patent are unpatentable based on the following grounds (Pet. 18–59):1
`Statutory
`Basis
`Challenged Claims
`Ground
`§ 103
`
`1–4, 8, 12, 13, 21, and 22
`
`Bhowmick,2 Yanni,3 and
`Castillo4
`Schneider,5 Hayakawa,6
`Bhowmick, and Castillo
`
`§ 103
`
`
`
`1–4, 8, 12, 13, 21, and 22
`
`
`1 Petitioner also relies on declarations from Erning Xia, Ph.D. (Ex. 1002)
`and Leonard Bielory, M.D (Ex. 1003).
`2 Bhowmick et al., WO 2008/015695 A2, published Feb. 7, 2008 (Ex. 1004,
`“Bhowmick”).
`3 J.M. Yanni et al., The In Vitro and In Vivo Ocular Pharmacology of
`Olopatadine (AL-4943A), an Effective Anti-Allergic/Antihistaminic Agent,
`12 J. OCULAR PHARMACOLOGY & THERAPEUTICS 389, 389–400 (1996)
`(Ex. 1005, “Yanni”).
`4 Castillo et al., U.S. Patent No. 6,995,186 B2, issued Feb. 7, 2006
`(Ex. 1006, “Castillo”).
`5 Schneider et al., US 2011/0082145 A1, published Apr. 7, 2011 (Ex. 1007,
`“Schneider”).
`6 Hayakawa et al., U.S. Patent No. 5,641,805, issued June 24, 1997
`(Ex. 1008, “Hayakawa”).
`
`3
`
`
`
`IPR2016-01640
`Patent 8,791,154 B2
`
`These are identical to the grounds of unpatentability asserted in
`IPR2016-00544.
`
`D. The ’154 Patent
`The ’154 patent relates to “an ophthalmic composition containing a
`relatively high concentration of olopatadine.” Ex. 1001, at [57]. This
`“invention is directed to an ophthalmic composition for treatment of allergic
`conjunctivitis.” Id. at 2:41–42. The ’154 patent describes the claimed
`compositions as including “at least 0.67 w/v % olopatadine, preferably
`dissolved in solution.” Id. at 2:42–45. The claimed compositions also are
`described as “typically includ[ing] a cyclodextrin, and more particularly, a
`γ-cyclodextrin derivative and/or a β-cyclodextrin derivative to aid in
`solubilizing the olopatadine.” Id. at 2:45–48. In addition, the ’154 patent
`describes other ingredients to assist in solubilization of the olopatadine,
`including “a lactam polymer (e.g., polyvinylpyrrolidone (PVP))” and “a
`polyether (e.g., polyethylene glycol (PEG)).” Id. at 2:52–57. The claimed
`compositions also are described as including “a preservative” such as
`“benzalkonium chloride,” as well as “borate and/or polyol to aid in
`achieving desired preservation.” Id. at 2:60–67. In addition to the claimed
`compositions, the ’154 patent also describes “a method of treating ocular
`allergy symptoms” by “topically applying [the claimed compositions] to an
`eye of a human,” preferably by “dispensing an eyedrop from an
`eyedropper.” Id. at 3:1–6.
`
`E. Illustrative Claims
`Of the challenged claims in the ’154 patent, claims 1, 4, 8, and 21 are
`independent. Ex. 1001, 26:28–28:13. Independent claims 1 and 4 and
`dependent claim 12 are illustrative. They recite:
`
`4
`
`
`
`IPR2016-01640
`Patent 8,791,154 B2
`
`1. An aqueous ophthalmic solution for treatment of ocular allergic
`conjunctivitis, the solution comprising:
`at least 0.67 w/v % olopatadine dissolved in the solution;
`PEG having a molecular weight of 300 to 500;
`polyvinylpyrrolidone;
`hydroxypropyl-γ-cyclodextrin;
`benzalkonium chloride; and
`water.
`Ex. 1001, 26:28–35.
`
`4. An aqueous ophthalmic solution for treatment of ocular allergic
`conjunctivitis, the solution comprising:
`at least 0.67 w/v % but no greater than 1.0 w/v %
`olopatadine dissolved in the solution;
`2.0 w/v % to 6.0 w/v % PEG having a molecular weight
`of 300 to 500;
`2.0 w/v % to 6.0 w/v % polyvinylpyrrolidone;
`at least 0.5 w/v % but no greater than 2.0 w/v %
`cyclodextrin derivative selected from the group
`consisting of SAE-β-cyclodextrin, HP-γ-cyclodextrin,
`HP-β-cyclodextrin and combinations thereof; and
`water.
`Ex. 1001, 26:39–50.
`
`12. A method of treating at least one ocular allergy symptom in
`humans, the method comprising:
`topically applying to an eye of a human an amount of the
`solution of claim 4 sufficient to treat the at least one
`ocular allergy symptom.
`Ex. 1001, 27:7–11.
`
`5
`
`
`
`IPR2016-01640
`Patent 8,791,154 B2
`
`ANALYSIS
`Because the asserted grounds of unpatentability, the arguments, and
`the supporting evidence here are identical to those in IPR2016-00544, we
`adopt the analysis explained in our Decision to Institute in that case. See
`Argentum Pharm. LLC v. Alcon Research, Ltd., Case IPR2016-00544, slip
`op. at 5–27 (PTAB July 18, 2016) (Paper 8). Consistent with that analysis,
`we determine that Petitioner has shown a reasonable likelihood of prevailing
`in showing the obviousness of each of the challenged claims over the
`combinations of Bhowmick, Yanni, and Castillo and of Schneider,
`Hayakawa, Bhowmick, and Castillo. Accordingly, we institute inter partes
`review. See 35 U.S.C. § 314(a) (permitting institution of inter partes review
`if “there is a reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition”).
`In addition, Petitioner moves for joinder as a party to IPR2016-00544.
`Paper 3. Because Petitioner has filed a Petition that we have “determine[d]
`warrants the institution of an inter partes review,” the requirements of
`35 U.S.C. § 315(c) are met. Therefore, we must consider whether to
`exercise our discretion to join Apotex Inc. and Apotex Corp. as Petitioners
`to IPR2016-00544.
`Apotex Inc. and Apotex Corp., together with the parties to IPR2016-
`00544, filed a Joint Stipulation explaining the agreement between and
`among them regarding the prosecution of the consolidated proceedings
`should joinder be granted. Paper 7. Apotex Inc. and Apotex Corp. agree not
`to file any papers, objections, or discovery requests separately from those
`filed jointly with Argentum Pharmaceuticals, the current Petitioner in
`IPR2016-00544. Id. at 2. Apotex Inc., Apotex Corp., and Argentum
`
`6
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`IPR2016-01640
`Patent 8,791,154 B2
`
`Pharmaceuticals agree to identify a single questioning or defending attorney
`for each deposition, and Apotex Inc. and Apotex Corp. agree not to
`participate in any oral hearing in the consolidated proceedings. Id. at 2–3.
`Moreover, Apotex Inc. and Apotex Corp. agree to proceed on the evidence
`and arguments advanced by Argentum Pharmaceuticals and that the
`presence of Apotex Inc. and Apotex Corp. shall not be the basis for
`alteration of the schedule or page limits currently in place in IPR2016-
`00544. Id. at 3–4.
`Given these concessions by Apotex Inc. and Apotex Corp., we
`exercise our discretion and join Apotex Inc. and Apotex Corp. as Petitioners
`to IPR2016-00544. We also conclude that there is no need to maintain
`separate proceedings. Accordingly, we consolidate the present trial with
`IPR2016-00544, and we terminate the trial in the present case. See
`37 C.F.R. § 42.72 (permitting termination of trial following consolidation of
`trial with another proceeding).
`
`CONCLUSION
`Upon consideration of the Petition and the evidence before us, we
`determine that Petitioner has demonstrated a reasonable likelihood that it
`would prevail in showing that the claims it challenges are unpatentable on
`the following grounds:
`Claims 1–4, 8, 12, 13, 21, and 22 as obvious over the combination of
`Bhowmick, Yanni, and Castillo; and
`Claims 1–4, 8, 12, 13, 21, and 22 as obvious over the combination of
`Schneider, Hayakawa, Bhowmick, and Castillo.
`
`7
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`
`IPR2016-01640
`Patent 8,791,154 B2
`
`Accordingly, we institute inter partes review of these claims on these
`grounds. The Board has not made a final determination on the patentability
`of any challenged claim.
`We also join Petitioner as a party to IPR2016-00544, consolidate the
`present trial with IPR2016-00544, and terminate the present trial. The
`caption for IPR2016-00544 is modified to reflect the joinder of Apotex Inc.
`and Apotex Corp. as Petitioners in accordance with the example attached as
`the last page of the present Decision.
`
`
`ORDER
`
`It is hereby
`ORDERED that, pursuant to 35 U.S.C. § 314, an inter partes review
`is hereby instituted to determine:
`whether claims 1–4, 8, 12, 13, 21, and 22 are obvious over the
`combination of Bhowmick, Yanni, and Castillo; and
`whether claims 1–4, 8, 12, 13, 21, and 22 are obvious over the
`combination of Schneider, Hayakawa, Bhowmick, and Castillo;
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 314(c) and
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial
`commencing on the entry date of this decision;
`FURTHER ORDERED that Petitioner is joined as a party to
`IPR2016-00544;
`FURTHER ORDERED that the trial in this case is consolidated with
`IPR2016-00544;
`FURTHER ORDERED that, pursuant to 37 C.F.R. § 42.72, the trial in
`this case is terminated;
`
`8
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`IPR2016-01640
`Patent 8,791,154 B2
`
`FURTHER ORDERED that all further filings shall be made only in
`IPR2016-00544;
`FURTHER ORDERED that the asserted grounds of unpatentability on
`which trial was instituted in IPR2016-00544 are unchanged;
`FURTHER ORDERED that the current Scheduling Order for
`IPR2016-00544 shall continue to govern IPR2016-00544;
`FURTHER ORDERED that Apotex Inc. and Apotex Corp. shall abide
`by the Joint Stipulation with respect to consolidated filings, discovery, and
`objections;
`FURTHER ORDERED that all filings by Apotex Inc. and Apotex
`Corp. in IPR2016-00544 shall be consolidated with the filings of the other
`Petitioner, unless the filing involves an issue unique to Apotex Inc. and
`Apotex Corp. or states a point of disagreement related to the consolidated
`filing, and, in such circumstances, Apotex Inc. and Apotex Corp. shall seek
`authorization from the Board to file a separate paper;
`FURTHER ORDERED that all page limits set forth in 37 C.F.R.
`§ 42.24 will apply to all consolidated filings;
`FURTHER ORDERED that Apotex Inc. and Apotex Corp. shall be
`bound by any discovery agreements, including deposition arrangements,
`between the existing parties to IPR2016-00544;
`FURTHER ORDERED that Patent Owner shall not be required to
`provide any additional discovery or deposition time as a result of joinder;
`FURTHER ORDERED that Petitioners shall resolve any disputes
`between them and shall contact the Board only if such matters cannot be
`resolved;
`
`9
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`IPR2016-01640
`Patent 8,791,154 B2
`
`FURTHER ORDERED that the case caption in IPR2016-00544 shall
`be changed to reflect the joinder of Apotex Inc. and Apotex Corp. as
`Petitioners in accordance with the attached example; and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the file of IPR2016-00544.
`
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`10
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`IPR2016-01640
`Patent 8,791,154 B2
`
`PETITIONER:
`
`Michael R. Houston
`Joseph P. Meara
`FOLEY & LARDNER LLP
`jmeara-pgp@foley.com
`
`Teresa Stanek Rea
`Deborah H. Yellin
`Vincent J. Galluzzo
`CROWELL & MORING LLP
`trea@crowell.com
`dyellin@crowell.com
`vgalluzzo@crowell.com
`
`
`PATENT OWNER:
`
`David M. Krinsky
`Thomas S. Fletcher
`WILLIAMS & CONNOLLY LLP
`dkrinsky@wc.com
`tfletcher@wc.com
`pazeo-IPR@wc.com
`
`
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`11
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC,
`APOTEX INC., and APOTEX CORP.,
`Petitioners,
`
`v.
`
`ALCON RESEARCH, LTD.,
`Patent Owner.
`
`Case IPR2016-005441
`Patent 8,791,154 B2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 Petitioner Apotex Inc. and Apotex Corp. from IPR2016-01640 has been
`joined as a Petitioner to this proceeding.
`
`
`
`
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