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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMACEUTICAL
`INDUSTRIES, INC., AND SUN PHARMA GLOBAL FZE,
`Petitioners,
`v.
`NOVARTIS AG,
`Patent Owner.
`______________________
`Case IPR2017-008541
`U.S. Patent No. 9,187,405
`
`______________________
`
`REPLY IN SUPPORT OF CONTINGENT MOTION TO AMEND
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
`with this proceeding.
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`TABLE OF CONTENTS
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`Page
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`I.
`II.
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`PRELIMINARY STATEMENT ..................................................................... 1
`ARGUMENT ................................................................................................... 2
`A.
`Claim Construction ............................................................................... 2
`1.
`Preambles Limit Claims and Prevent Redundancy .................... 2
`2.
`“Consisting of” Narrows All of the Original Claims .................. 3
`3.
`“Dosing Regimen” Encompasses “Loading Dose
`Regimen” .................................................................................... 5
`“Daily Dosage” Is Properly Construed ....................................... 6
`4.
`Chavez Does Not Anticipate ................................................................. 7
`B.
`Proposed Amendments Respond to Grounds 1, 2 and 3 ..................... 10
`C.
`III. CONCLUSION .............................................................................................. 12
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
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`Aqua Products, Inc. v. Matal,
`872 F.3d 1290 (Fed. Cir. 2017)............................................................................................2, 10
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`Bettcher Indus., Inc. v. Bundle USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011)..................................................................................................10
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`Coalition for Affordable Drugs V LLC, v. Biogen MA Inc.,
`IPR2015-01136, Paper 23 (PTAB Sept. 2, 2015) ......................................................................8
`
`Ex Parte Davis & Tuukkanen,
`80 U.S.P.Q. 448 (Bd. App. 1948) ..............................................................................................4
`
`Janssen v. Rexall Sundown, Inc.,
`342 F.3d 1329 (Fed. Cir. 2003)..................................................................................................9
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`Karlin Tech. Inc. v. Surgical Dynamics, Inc.,
`177 F.3d 968 (Fed. Cir. 1999)....................................................................................................3
`
`Metabolite Labs., Inc. v. Lab. Corp. Of Am. Holdings,
`370 F.3d 1354 (Fed. Cir. 2004)................................................................................................10
`
`In re Montgomery,
`677 F.3d 1375 (Fed. Cir. 2012)..................................................................................................7
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`I.
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`PRELIMINARY STATEMENT
`The proposed amendments add the closed transitional phrase “consisting of”
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`to narrow all of the claims to a “dosing regimen consisting of a daily dosage amount
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`of 0.5 mg” of fingolimod. The negative limitation is deleted now as it is superfluous.
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`Petitioners oppose (Paper 62, “Opp.”) by misconstruing the term “dosing regimen”
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`in an attempt to show the claim amendments broaden the original claims. Instead of
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`evidence, Petitioners argue based on a hypothetical that easily falls apart under
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`scrutiny. The original claims excluded use of a loading dose, but encompassed an
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`up-titration. “Consisting of” commands nothing be added to the dosing regimen
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`recited in the claim, thereby resulting in a narrower scope than the original claims.
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`Petitioners urge that an April 2006 description of the upcoming Phase III trial
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`for fingolimod (Chavez, Ex. 2031; Press Release, Ex. 2072, collectively “Chavez”)
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`anticipates. Chavez however does not disclose the claim preambles—Chavez
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`describes the Phase III trial in one sentence and is silent as to whether 0.5 mg
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`fingolimod daily will have any effect at all—and Petitioners offer no evidence to
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`contradict the testimony from Drs. Lublin and Steinman refuting anticipation. A
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`person of skill would understand from Chavez that fingolimod was only to be tested,
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`not that it would be useful for treating RRMS.
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`The amended, narrowed claims address the hindsight-driven obviousness
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`challenges of Grounds 1 and 2 by reducing the scope of the claims such that the
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`1
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`broad disclosures of the art fail to make obvious the narrower claims. The
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`amendments render Ground 3 inapplicable. The burden of persuading the Board that
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`the amended claims are unpatentable rests with the Petitioner. Aqua Products, Inc.
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`v. Matal, 872 F.3d 1290, 1327 (Fed. Cir. 2017). Here, Petitioners suffer from a
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`failure of proof. They have no countervailing expert testimony and have not
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`disputed key facts that support patentability of the proposed amended claims.
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`II. ARGUMENT
`A. Claim Construction
`1.
`Preambles Limit Claims and Prevent Redundancy
`Petitioners say the preambles only inform the scope of “said subject” and do
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`not have an efficacy requirement. This is incorrect. All RRMS patients are in need
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`of each of the claimed methods. (Opp. at 4; Third Steinman Decl., Ex. 2096 ¶ 11.)
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`The presumption against claim redundancy thus requires the different preambles to
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`each have a different meaning beyond identifying the subject, as required by the
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`Board’s Institution Decision (Paper 11). Failing to accord meaning to the
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`differences in the preambles would eliminate any differences among the claims.
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`The Board found that the preambles are limiting and have their “ordinary and
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`customary meaning.” (Paper 11 at 12.) Dr. Steinman says a person of skill would
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`read the claims as having the purpose of achieving or actually achieving the specific
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`effects recited in each of the claims: “[A] person of skill in June 2006 would read
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`the claims to require that the dose be administered to achieve the effects of the
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`claimed benefits, or at least be intended to do so.” (Ex. 2096 ¶ 17.) Petitioners say
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`Novartis “conceded” this point (Opp. at 4), but that is incorrect as shown by, inter
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`alia, Paper No. 8 at 34-35; Paper No. 26 at 28, 50-52 and 57; Ex. 2003, ¶¶ 15-20;
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`and Ex. 2022, ¶¶ 57-60. The Board’s ruling is consistent with the specification and
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`the arguments relying on “efficacy” to support patentability of the original claims in
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`the file history. (Ex. 2096 ¶¶ 9-17.)
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`Petitioners offer no evidence on the “ordinary and customary meaning,”
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`instead relying entirely on attorney argument. The actual evidence here supports the
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`Board’s ruling that the preambles are limiting, and that the ordinary and customary
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`meaning of each preamble includes efficacy. Indeed, this meaning is the only aspect
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`of the claims that gives each claim a different scope in line with the presumption
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`against claim redundancy. There is presumed to be a difference in meaning and
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`scope when different words or phrases are used in separate claims. Karlin Tech. Inc.
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`v. Surgical Dynamics, Inc., 177 F.3d 968, 971-72 (Fed. Cir. 1999).
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`2.
`“Consisting of” Narrows All of the Original Claims
`Petitioners say removal of the negative limitation broadens the claims. But
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`they fail to acknowledge the addition of the closed phrase “consisting of,” which
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`excludes a loading dose just like the negative limitation did, and further excludes an
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`up-titration, something the original claims permitted. (First Steinman Decl., Ex.
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`2022 ¶ 188.) Thus, the original claims have been narrowed. The “consisting of”
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`language excludes everything from the fingolimod dosing regimen except 0.5 mg
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`daily. The negative limitation is superfluous once the phrase “consisting of” is part
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`of the claim. It was accordingly deleted, leaving narrower claims.
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`Petitioners say “consisting of” “does not prohibit the method from comprising
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`another dosing regimen.” (Opp. at 2.) They are incorrect if the dosing regimen is
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`for fingolimod. “Consisting of” is a closed phrase restricting the dosing regimen to
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`what is recited. The only other dosing regimens permitted would need to be for
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`other agents, not fingolimod. See Ex Parte Davis & Tuukkanen, 80 U.S.P.Q. 448
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`(Bd. App. 1948) (“consisting of” defined as “closing the claim to the inclusion of
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`materials other than those recited except for impurities ordinarily associated
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`therewith”).
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`Instead of evidence, Petitioners offer a hypothetical claim—it is a red herring.
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`Petitioners’ hypothetical is improper by being internally inconsistent while ignoring
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`the meaning of “consisting of.” Petitioners add into their claim a “loading dose
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`regimen” in violation of the posited claim’s use of “consisting of” that requires the
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`dosing regimen to be a daily dosage amount of 0.5 mg of fingolimod, no more and
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`no less. Adding in a loading dose is in conflict with the closed nature of “consisting
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`of.” The broadest reasonable interpretation here demands giving “consisting of” its
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`universally-accepted meaning, something Petitioners broaden with no evidentiary
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`basis or rationale. In Novartis’s amended claims, the phrase “consisting of” properly
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`limits the “dosing regimen” for fingolimod. This is evident from the claim language,
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`and the totality of the specification and file history of the ’405 patent. (Ex. 2096, ¶¶
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`9-17.)
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`3.
`“Dosing Regimen” Encompasses “Loading Dose Regimen”
`Petitioners’ attorney argument appears to hinge on a construction of “dosing
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`regimen” that excludes a “loading dose,” while simultaneously putting forth such a
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`“loading dose” as an additional potential “dosing regimen.” They offer no evidence
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`on this point, and they are wrong. “Dosing regimen” is an umbrella term that
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`encompasses a “loading dose regimen.” This is self-evident from the grammar: the
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`adjective “loading” modifies the term, narrowing it. A person of skill would know
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`that the term “dosing regimen” means “a schedule of doses of a therapeutic agent
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`per unit of time including the time between doses or the time when the doses are to
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`be given and the amount of the therapeutic agent to be given at each specific time.”
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`(Third Steinman Decl., Ex. 2096 ¶¶ 18-20; see also Ex. 2105 at, inter alia, page 1
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`and Figure 1-2 and Table 5-1.) The word “loading” refers to one type of dosing
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`regimen. There are others, such as, incremental dosing, up-titration, etc. (Ex. 2096
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`¶ 18.) In fact, Kovarik makes clear that a “loading dose” is a “specific dosage
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`regimen.” Kovarik states: “It has now surprisingly been found that a specific dosage
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`regimen, e.g. a loading dose, will provide further unexpected results.” (Ex. 1004 at
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`1 (emphasis added).) The hypothetical claim violates Section 112 as indefinite.
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`4.
`“Daily Dosage” Is Properly Construed
`Petitioners argue “daily dosage” is not given its broadest reasonable
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`construction. They say “daily dosage” should include “single or divided doses.” On
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`this point, Patent Owners agree so long as the “single or divided doses” result in a
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`0.5 mg total daily dosage being given day after day as required by the word “daily.”
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`(Ex. 1001 at 11:24-2; Ex. 2096 ¶ 24.) Petitioners also argue that “daily dosage”
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`encompasses a single, one-time dose. But this is unreasonable; it renders the term
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`“daily” in the phrase meaningless. The phrase “a dosage” is sufficient to indicate a
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`single, one-time dose. A “daily dosage” requires giving it day after day. (Third
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`Steinman Decl., Ex. 2096 ¶¶ 21-22.)
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`Petitioners’ citations to examples of the phrase “daily dosage” are unhelpful
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`because “daily dosage” is always modified by an adjective, making it narrower than
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`the actual claim phrase. For example, Petitioners cite phrases using the adjectives:
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`“incremental” and “varying” and “lower” and “standard” to narrow the meaning of
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`the broader term “daily dosage.” (Opp. at 8.) The meaning of the unmodified term
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`“daily dosage” is not informed directly by its use in modified form. In the proposed
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`amended claims, the term “daily dosage” does not include any of those
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`modifications. Petitioners also point to Kovarik’s “maintenance therapy” to support
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`their position (id.), but this is a different term and therefore irrelevant. Novartis
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`properly gives “daily dosage” its broadest reasonable construction and no evidence
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`is presented otherwise. Petitioners appear to believe the exclusion of a loading dose
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`comes from a too-narrow construction of “daily dosage,” but the amended claims
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`recitation of “consisting of” followed by “a daily dosage amount of 0.5 mg”
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`generates that exclusion, not the term “daily dosage” alone. (Ex. 2096, ¶¶ 21-23.)
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`Petitioners’ incorrect, unsupported arguments fail to carry their burden.
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`B. Chavez Does Not Anticipate
`Chavez does not expressly or inherently disclose: “treating RRMS” nor
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`“reducing or preventing or alleviating relapses in RRMS” nor “slowing progression
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`of RRMS” with 0.5 mg fingolimod daily. Petitioners cite inherency cases, but offer
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`no arguments or evidence on the theory. They fail to carry their burden, and those
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`cited cases should be disregarded. Petitioners also rely on In re Montgomery, 677
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`F.3d 1375 (Fed. Cir. 2012). It is inapposite because the challenged claims all related
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`to a single method with a single effect—“treatment or prevention of stroke.” The
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`Montgomery claims thus presented no redundancy issue, unlike the claims here.
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`Also, the Montgomery specification did not “describe any studies that show” stroke
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`treatment or prevention. Id. at 1380-1381. Here, of course, the specification
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`describes MS animal model studies that show each of the claimed effects, as Dr.
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`Steinman shows. (Ex. 2096 ¶¶ 13-15.) Petitioners also rely on Bristol-Myers Squibb
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`and other cases. But none of these cases have the issue here of claim redundancy,
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`nor do they have specifications with the experimental results that are present in this
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`case.
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`The facts here are different. Chavez relates to a press release focused on the
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`positive result of 1.25 mg in a Phase II trial (see title). A person of skill at that time
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`would have known that a 0.5 mg dose had never been given to a human MS patient
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`before, and was not part of the Phase II trial. The 0.5 mg dose had never been part
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`of a Phase II MS trial. Reading Chavez, he/she would understand the Phase III study
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`program was to confirm the positive results of the Phase II trial, i.e., only the 1.25
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`mg dose. (Fourth Lublin Decl., Ex. 2097 ¶¶ 8-11.)
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`Chavez never says the 0.5 mg dose was included to treat RRMS patients.
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`Chavez is silent about the reason the 0.5 mg dose is included, but in context, with
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`the laudatory statements about 1.25 mg, the silence has meaning. A person of skill
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`would understand the 0.5 mg dose was included to test for the lowest effective dose,
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`not that it would be useful. (Id.) At that time, another MS drug, Tysabri, had
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`recently caused patient deaths and persons of skill knew FDA was urging sponsors
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`to test much lower doses of candidate drugs to ensure safety. (Id. ¶ 7.) Thus, a
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`person of skill reading Chavez understood the new 0.5 mg dose was included for the
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`first time in the Phase III trial for evaluation, not confirmation. (Second Lublin
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`Decl., Ex. 2025 ¶¶ 41, 48-49; Doggrell 2007, Ex. 2036 at 385.) (Coalition for
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`Affordable Drugs V LLC, v. Biogen MA Inc., IPR2015-01136, Paper 23 at 10-11
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`(PTAB Sept. 2, 2015) (Petitioner “did not establish precise nature of the study and
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`whether researchers were determining a therapeutically effective amount…” and
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`thus the study “is not a description that DMF is useful for treating MS; rather, at best
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`it is a “hope” that DMF will turn out to be useful for treating MS. A hope may or
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`may not come true and does not establish that DMF is useful for treating MS.”))
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`An alternative legal basis supports the limiting preambles and the failure of
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`Chavez to anticipate. The Federal Circuit has held a preamble limiting for an
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`intended purpose. In Janssen v. Rexall Sundown, Inc., 342 F.3d 1329 (Fed. Cir.
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`2003), the Court held that a claim preamble was “a statement of the intentional
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`purpose for which the method must be performed.” Id. at 1333. So it is here.
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`Petitioners stated that the preambles “at most merely describe[s] the intended
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`purpose of the method.” (Paper 2 at 24.) Dr. Giesser also stated: “It is my opinion
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`that a person of skill in the art would understand the preambles of claims 1, 3, and 5
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`to express, at most, the purpose of the method.” (Ex. 1002 ¶¶ 44, 47.) Chavez
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`discloses 0.5 mg as an arm in a Phase III trial but with no recited purpose whatsoever.
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`A person of skill would have known that 0.5 mg was an unproven dose and nothing
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`in the prior developmental program said it would be effective. (Ex. 2097 ¶ 6, 12-
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`13.) A person of skill reading Chavez would have thought 0.5 mg was included to
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`be tested, not for the purpose of treating. Dr. Lublin said a person of skill reading
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`Chavez “would understand that a study was being done to test that dose.” (Ex. 1042
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`at 239:10-21.) “An invitation to investigate is not an inherent disclosure.”
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`Metabolite Labs., Inc. v. Lab. Corp. Of Am. Holdings, 370 F.3d 1354, 1367 (Fed.
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`Cir. 2004). Chavez does not anticipate and Petitioners offer no evidence failing to
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`carry their burden.
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`In the unpredictable art of finding treatments for MS, the never-before-tested
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`dose of 0.5 mg in Chavez does not meet the stringent inevitability requirement of
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`inherent anticipation. Bettcher Indus., Inc. v. Bundle USA, Inc., 661 F.3d 629, 639
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`(Fed. Cir. 2011) (“Inherency . . . may not be established by probabilities or
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`possibilities. The mere fact that a thing may result from a set of circumstances is
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`not sufficient.”). Dr. Lublin says it is not necessarily the case that the 0.5 mg arm of
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`the Phase III trial would have resulted in efficacy. (Ex. 2097 ¶ 8.) Chavez does not
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`expressly or inherently anticipate.
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`C.
`Proposed Amendments Respond to Grounds 1, 2 and 3
`Every original claim has been narrowed by the addition of the closed
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`transitional phrase “consisting of” and as such are “sufficiently narrower than the
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`challenged claim[s] to overcome the grounds of unpatentability upon which the IPR
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`was instituted.” Aqua Prod., Inc., 872 F.3d at 1290. Petitioners offer no evidence
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`in response to the amended claims, and rely only on attorney argument. Thus, Drs.
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`Steinman, Lublin, and Jusko’s opinions stand un-rebutted.
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`Ground 1 is overcome by this amendment. First, Petitioners do not dispute
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`the Board misread Kovarik in the Institution Decision (Paper 11). This clarification
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`in Kovarik’s disclosure should obviate Ground 1. The proposed amendments
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`address Ground 1 because without exception, every dosing regimen in Kovarik
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`includes a loading dose. Petitioners do not dispute this fact. The addition of
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`“consisting of” limits the “dosing regimen” to 0.5 mg fingolimod daily.
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`There is no specific disclosure in Kovarik of a 0.5 mg daily dose for treating
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`any specific disease, let alone multiple sclerosis or RRMS. The only disclosure in
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`Kovarik tied to “an autoimmune disease” is a dosing regimen including a loading
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`dose combined with a daily dose selected from a range of 0.1 to 0.5 mg. (Ex. 1004
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`at 17.) The amendment narrows the claims such that the Kovarik dosing regimen is
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`clearly outside the claimed subject matter. Therefore, a person of skill would not
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`have considered it obvious to use 0.5 mg fingolimod daily to treat RRMS.
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`Petitioners argue “efficacy of Kovarik’s maintenance therapy dose did not
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`depend on a loading dose regimen.” (Opp. at 17.) But this begs the question:
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`efficacy in what disease or condition? Kovarik generally discloses loading dose
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`regimens for a wide variety of diseases and conditions, but nothing specific. This is
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`not unusual in a methodological disclosure like Kovarik. “Consisting of” closes off
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`the breadth of the claims distinguishing them even further from the generalized
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`disclosure of Kovarik, thus addressing Ground 1 directly.
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`Ground 2 is similarly addressed by the amendments because the narrowed
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`amended claims make the hindsight driven arguments put forth by Petitioners even
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`less credible. Chiba discloses a huge range of possible doses (0.01-10 mg) and
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`diseases. (Ex. 1006. at 8:29-34). Budde discloses a wide range of fingolimod dose
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`amounts for a one-time, single administration to non-MS patients. (Ex. 1008 at
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`1073-74.) And Kappos 2005 reports on two much higher doses of fingolimod (5.0
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`mg and 1.25 mg) in line with the literature’s teaching away. (Ex. 1007 at II/41.)
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`The closed “consisting of” amendment distinguishes the claims away from this
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`combination of broader disclosures. The fingolimod “dosing regimen” is restricted
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`to something very specific, rendering these three far-reaching disclosures irrelevant
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`absent impermissible hindsight.
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`Ground 3 is predicated on the assumption that the original negative limitation
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`does not enjoy priority, an assumption Patent Owner disputes. However, in order to
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`reduce the issues the Board must consider, Patent Owner has narrowed the claims
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`here by deleting the negative limitation and in turn adding the closed transitional
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`phrase “consisting of.” This amendment disposes of Petitioner’s basis for Ground 3
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`and thus overcomes this ground directly.
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`III. CONCLUSION
`For the foregoing reasons, the Board should allow these amended claims to
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`issue.
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`Dated: March 23, 2018
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`Respectfully submitted,
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` /Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owner
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on March 23, 2018, true and
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`accurate copies of the foregoing REPLY SUPPORTING CONTINGENT MOTION
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`TO AMEND for IPR2017-00854 were served via electronic mail, on the following
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`counsel of record for Petitioners:
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`For Apotex:
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`For Argentum:
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`For Sun:
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`Steven W. Parmelee: sparmelee@wsgr.com
`Michael T. Rosato: mrosato@wsgr.com
`Jad A. Mills: jmills@wsgr.com
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`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`Telephone: 206-883-2542
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`
`Teresa Stanek Rea: trea@crowell.com
`Deborah H. Yellin: dyellin@crowell.com
`Shannon M. Lentz: slentz@crowell.com
`Tyler C. Liu: TLiu@agpharm.com
`
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`(202) 624-2620
`
`Samuel Park: SPark@winston.com
`Charles B. Klein: CKlein@winston.com
`Sharick Naqi: SNaqi@winston.com
`
`Winston & Strawn LLP
`
`i
`
`
`
`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`
`Amanda Hollis: amanda.hollis@kirkland.com
`Eugene Goryunov: egoryunov@kirkland.com
`Gregory Springsted: gregory.springsted@kirkland.com
`
`Kirkland & Ellis LLP
`300 North LaSalle
`Chicago, IL 60654
`Telephone: (312) 862-2000
`(202) 624-2620
`
`
`Respectfully submitted,
`
`
`For Teva:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: March 23, 2018
`
`
`
`
`
` /Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owner
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
`
`ii
`
`
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