Case 1:13-cv-05723-NLH-AMD Document 182 Filed 09/08/14 Page 1 of 15 PageID: 3796
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`CHIESI USA, INC.,
`CORNERSTONE BIOPHARMA, INC., and
`EKR THERAPEUTICS, LLC,
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`
`
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`SANDOZ INC., SANDOZ AG, and ACS
`DOBFAR INFO SA,
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`
`
`
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`Defendants.
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`Plaintiffs,
`
`
`v.
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`
`
`
`
`
`:
`:
`:
`:
`:
`: Civil Action No. 1:13-cv-05723-NLH-AMD
`:
`:
`:
`:
`:
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`JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT
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`Pursuant to L. Pat. R. 4.3 and the Court’s August 19, 2014 Scheduling Order (ECF No.
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`172), Plaintiffs Chiesi USA, Inc., Cornerstone BioPharma, Inc., and EKR Therapeutics, LLC
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`(collectively, “Chiesi” or “Plaintiffs”) and Defendant Sandoz Inc. hereby provide their Joint
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`Claim Construction and Prehearing Statement for U.S. Patent Nos. 7,612,102 (“the ’102 patent”),
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`7,659,291 (“the ’291 patent”), 8,455,524 (“the ’524 patent”), and 7,659,290 (“the ’290 patent”)
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`(collectively, the “patents in suit” or “asserted patents”).
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`Pursuant to the Court’s June 4, 2014 Order (ECF No. 103), Chiesi filed an Amended
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`Complaint adding Sandoz AG and ACS Dobfar Info SA as defendants in this case. Chiesi is
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`currently perfecting service of the Amended Complaint on these new defendants through the
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`Hague Convention on the Service Abroad of Judicial and Extrajudicial Documents in Civil or
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`Commercial Matters. As such, Chiesi and new defendants Sandoz AG and ACS Dobfar Info SA
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`have not commenced the disclosures required by the Federal Rules of Civil Procedure or by this
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`district’s Local Patent Rules, including: (1) Chiesi’s Disclosure of Asserted Claims pursuant to
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`L. Pat. R. 3.6(b); (2) Sandoz AG’s and ACS Dobfar Info SA’s Invalidity Contentions, Non-
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`1
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`Sandoz Exhibit 1008 Page 1
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`

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`Infringement Contentions, and production of documents pursuant to L. Pat. R. 3.6(c)-(f); (3)
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`Chiesi’s Disclosure of Infringement Contentions, Responses to Invalidity Contentions, and
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`production of documents pursuant to L. Pat. R. 3.6(g)-(i); (4) Exchange of Proposed Terms for
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`Construction pursuant to L. Pat. R. 4.1; (5) Exchange of Preliminary Claim Constructions and
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`Extrinsic Evidence pursuant to L. Pat. R. 4.2; (6) meet and confer regarding disputed terms and
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`constructions pursuant to L. Pat. R. 4.2(d); and (7) preparation and filing of the Joint Claim
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`Construction and Prehearing Statement pursuant to L. Pat. R. 4.3. Further to the August 18,
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`2014 Telephone Status Conference and the Amended Scheduling Order (ECF No. 172), Chiesi
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`and Sandoz Inc. are proceeding with claim construction activities. See also ECF No. 171.
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`I.
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`Background
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`In this Hatch-Waxman patent action, Chiesi is asserting infringement of the patents in
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`suit against defendants Sandoz Inc., Sandoz AG, and ACS Dobfar Info SA based on, inter alia,
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`ANDA 203978 seeking FDA approval for a generic version of Chiesi’s Cardene® I.V. Premixed
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`Injection.
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`The ’102 patent includes four independent claims and eleven dependent claims. The ’291
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`patent includes four independent claims and eight dependent claims. The ’524 patent includes
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`four independent claims and twenty-four dependent claims. The ’290 patent includes three
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`independent claims and eight dependent claims.
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`Independent claim 1 of the ’102 patent recites (disputed terms underlined):
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`A pharmaceutical composition for parenteral administration
`comprising a pre-mixed aqueous solution with a pH from about 3.6
`to about 4.7 comprising:
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`from about 0.1 to 0.4 mg/mL nicardipine hydrochloride;
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`a tonicity agent selected from (i) about 4.5% to about 5% dextrose
`or (ii) about 0.8% to about 0.9% sodium chloride; and
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`2
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`Sandoz Exhibit 1008 Page 2
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`

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`a buffer in an amount to maintain pH from about 3.6 to about 4.7;
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`the aqueous solution contained in a pharmaceutically acceptable
`container such that the solution does not come into contact with
`polar polymers;
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`the aqueous solution when stored in the container for at least one
`year at room temperature exhibiting (i) less than a 10% decrease in
`the concentration of nicardipine hydrochloride and (ii) a total
`impurity formation of less than about 3%.
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`Independent claim 1 of the ’291 patent recites (disputed terms underlined):
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`A method for treating acute elevations of blood pressure in a
`human subject in need thereof, said method comprising
`parenterally administering a composition comprising from about
`0.1 to 0.4 mg/mL nicardipine or a pharmaceutically acceptable salt
`thereof;
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`a tonicity agent;
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`and a buffer;
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`wherein the composition requires no dilution before administration
`and has a pH from about 3.6 to about 4.7,
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`the composition when stored in container for at least three months
`at room temperature exhibiting (i) less than a 10% decrease in the
`concentration of nicardipine or pharmaceutically acceptable salt
`thereof and (ii) a total impurity formation of less than about 3%.
`
`
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`Independent claim 1 of the ’524 patent recites (disputed terms underlined):
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`A method for treating acute elevations of blood pressure in a
`human subject in need thereof, said method comprising
`parenterally administering a pre-mixed aqueous solution
`comprising from about 0.1 to 0.4 mg/mL nicardipine or a
`pharmaceutically acceptable salt thereof;
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`a tonicity agent;
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`and a buffer;
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`wherein the aqueous solution requires no dilution before
`administration and has a pH from about 3.6 to about 4.7, the
`aqueous solution stored in a container such that the aqueous
`solution is in contact with non-polar polymers, the aqueous
`solution when stored in the container for at least three months at
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`3
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`Sandoz Exhibit 1008 Page 3
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`

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`room temperature exhibiting (i) less than a 10% decrease in the
`concentration of nicardipine or pharmaceutically acceptable salt
`thereof and (ii) a total impurity formation of less than about 3%.
`
`
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`Independent claim 1 of the ’290 patent recites (disputed terms underlined):
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`A method for making a pharmaceutical composition for
`intravenous administration comprising:
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`providing a solution comprising a tonicity agent, a buffer, and at
`least one active ingredient selected from the group consisting of
`nicardipine and/or pharmaceutically acceptable salts thereof;
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`adjusting the pH of the composition as necessary to achieve a pH
`within the range of from about 3.6 to 4.7;
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`further diluting the composition to a final active ingredient
`concentration from about 0.1 to 0.4 mg/mL; and
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`filling pharmaceutically acceptable containers with the pre-mixed
`composition;
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`the aqueous solution when stored in the container for at least one
`year at room temperature exhibiting (i) less than a 10% decrease in
`the concentration of nicardipine hydrochloride and (ii) a total
`impurity formation of less than about 3%.
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`Chiesi and Sandoz Inc. met and conferred pursuant to L. Pat. R. 4.2(d) and were able to
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`agree that the term “a pharmaceutically acceptable container comprising copolyester,
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`polyethylene or polyolefin” does not require the Court’s construction. There are currently 9
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`claim terms/phrases from the patents in suit requiring construction by the Court.
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`II.
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`Local Patent Rule 4.3
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`A.
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`Local Patent Rule 4.3(a)—Construction of Claim Terms on Which the
`Parties Agree
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`Chiesi and Sandoz Inc. met and conferred pursuant to L. Pat. R. 4.2(d) but were unable to
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`reach agreement on the construction of the disputed claim terms.
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`4
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`Sandoz Exhibit 1008 Page 4
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`B.
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`Local Patent Rule 4.3(b)—Proposed Constructions of Disputed Terms and
`Identification of Intrinsic and Extrinsic Evidence
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`In accordance with L. Pat. R. 4.3(b), Chiesi and Sandoz Inc. provide attached Exhibits A
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`and B.
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`Exhibit A is a table identifying: (1) Chiesi’s proposed construction of each disputed claim
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`term and the claim(s) of the patents in suit that include each disputed claim term; (2) an
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`identification of all references from the intrinsic evidence that support Chiesi’s proposed
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`constructions or oppose Sandoz Inc.’s proposed constructions; and (3) an identification of any
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`extrinsic evidence known to Chiesi on which it intends to rely either to support its proposed
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`constructions or to oppose Sandoz Inc.’s proposed constructions, including, but not limited to,
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`dictionary definitions, citations to learned treatises and prior art, and testimony of all witnesses
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`including experts. Chiesi may also rely on the intrinsic and extrinsic evidence identified by
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`Sandoz Inc. to support Chiesi’s proposed constructions or to oppose Sandoz Inc.’s proposed
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`constructions.
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`Exhibit B is a table identifying: (1) Sandoz Inc.’s proposed construction of each disputed
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`term, (2) an identification of all references from the intrinsic evidence that support Sandoz Inc.’s
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`construction, and (3) an identification of any extrinsic evidence known to Sandoz Inc. on which
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`it intends to rely either to support its proposed constructions or to oppose Chiesi’s proposed
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`constructions, including, but not limited to, dictionary definitions, citations to learned treatises
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`and prior art, and testimony of all witnesses including experts. Further, Sandoz Inc. may also
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`rely on the intrinsic and extrinsic evidence identified by Chiesi in Exhibit A.
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`5
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`Sandoz Exhibit 1008 Page 5
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`

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`C.
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`Local Patent Rule 4.3(c)—Identification of Most Significant Claim Terms
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`Local Patent Rule 4.3(c) requires Chiesi and Sandoz Inc. to identify whether any disputed
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`terms will be significant to the resolution of the case, case or claim dispositive, and/or
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`substantially conducive to promoting settlement.
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`1.
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`Plaintiffs’ Statement
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`In accordance with L. Pat. R. 4.3(c), Chiesi states that no disputed term will be significant
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`to the resolution of the case, case or claim dispositive, and/or substantially conducive to
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`promoting settlement. Chiesi disagrees with Sandoz Inc.’s statement in Section II.C.2. below
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`that the terms “does not come into contact with polar polymers” and “is in contact with non-polar
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`polymers” will be case or claim dispositive or substantially conducive to promoting settlement
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`because: (i) Sandoz Inc.’s ANDA products infringe these disputed claim limitations under either
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`parties’ proposed constructions; (ii) adoption of either parties’ proposed constructions will not
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`render the asserted claims invalid under 35 U.S.C. § 112; and (iii) the disputed term “does not
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`come into contact with polar polymers” is not recited in 46 of the 66 asserted claims and the
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`disputed term “is in contact with non-polar polymers” is not recited in 38 of the 66 asserted
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`claims.
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`2.
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`Sandoz Inc.’s Statement
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`In accordance with L. Pat. R. 4.3(c), Sandoz Inc. identifies the following terms whose
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`construction may be most significant to the resolution of the case:
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`• “does not come into contact with polar polymers”
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`• “is in contact with non-polar polymers”
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`• “container”
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`• “pharmaceutically acceptable container”
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`• “one year at room temperature”
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`6
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`Sandoz Exhibit 1008 Page 6
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`

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`Sandoz Inc. further identifies the following terms whose construction will be case or
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`claim dispositive or substantially conducive to promoting settlement, and the reasons therefor:
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`• “does not come into contact with polar polymers”
`o Should the Court construe this term as proposed by Sandoz Inc., Sandoz
`Inc. believes that the accused products would not infringe claims 1-4 and
`12 of the ’102 patent, claims 7-11 of the ’290 patent, and claims 3-12 of
`the ’291 patent.
`o Should the Court construe this term as proposed by Plaintiffs, Sandoz Inc.
`believes that claims 1-4 and 12 of the ’102 patent, claims 7-11 of the ’290
`patent, and claims 3-12 of the ’291 patent would be invalid as indefinite
`and/or for lack of written description or enablement under 35 U.S.C. §
`112.
`• “is in contact with non-polar polymers”
`o Sandoz Inc. believes claims 1-28 of the ’524 patent would be invalid
`under either parties’ proposed construction, but for different reasons.
`Therefore, Sandoz Inc. submits that it is important for the Court to
`construe this term in order to narrow and refine the issues in this case.
`Local Patent Rule 4.3(d)—Anticipated Length of Time Necessary for the
`Claim Construction Hearing
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`D.
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`In accordance with L. Pat. R. 4.3(d), Chiesi and Sandoz Inc. anticipate that the claim
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`construction hearing will require no more than one day.
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`E.
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`Local Patent Rule 4.3(e)—Anticipated Witnesses to be Called at Claim
`Construction Hearing
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`Local Patent Rule 4.3(e) requires Chiesi and Sandoz Inc. to identify each witness each
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`party proposes to call at the Claim Construction Hearing, and for each witness, provide a
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`summary of his or her testimony including, for any expert, each opinion to be offered related to
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`claim construction.
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`1.
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`Plaintiffs’ Statement
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`In accordance with L. Pat. R. 4.3(e), Chiesi identifies Prof. Alexander Klibanov, Ph.D.,
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`Prof. Benny Freeman, Ph.D., and Frank Peacock, M.D. as expert witnesses that Chiesi may call
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`at the Claim Construction Hearing to provide testimony to support its proposed constructions
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`7
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`Sandoz Exhibit 1008 Page 7
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`

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`and/or to oppose Sandoz Inc.’s proposed constructions, and/or to address the meaning of claim
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`terms as understood by a person of ordinary skill in the art.
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`Professor Klibanov may provide affirmative and/or rebuttal testimony, including as to the
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`meaning of the following claim terms to a person of ordinary skill in the art at the time of the
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`invention in the context of the patents in suit: “a pre-mixed aqueous solution;” “pre-mixed
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`composition;” “a pharmaceutically acceptable container;” “container;” “does not come into
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`contact with polar polymers;” “is in contact with non-polar polymers;” “one year at room
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`temperature;” “three months at room temperature;” and “a total impurity formation.”
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`Professor Freeman may provide affirmative and/or rebuttal testimony, including as to the
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`meaning of the following claim terms to a person of ordinary skill in the art at the time of the
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`invention in the context of the patents in suit: “container;” “does not come into contact with polar
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`polymers;” and “is in contact with non-polar polymers.”
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`Dr. Peacock may provide affirmative and/or rebuttal testimony, including as to the
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`meaning of the following claim terms to a person of ordinary skill in the art at the time of the
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`invention in the context of the patents in suit: “a pre-mixed aqueous solution;” “pre-mixed
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`composition;” “a pharmaceutically acceptable container;” and “container.”
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`Professors Klibanov and Freeman and Dr. Peacock may also opine that a person of
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`ordinary skill in the art is a person with at least a Bachelor of Science degree and a few years of
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`experience in Pharmaceutical Sciences or a related field (or a person of commensurate education
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`and experience).
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`Chiesi reserves the right to object to Sandoz Inc. advocating for any proposed
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`construction or relying on any intrinsic or extrinsic evidence, including expert testimony, not
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`timely disclosed by Sandoz Inc. in its L. Pat. R. 4.2 disclosures.
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`8
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`Sandoz Exhibit 1008 Page 8
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`

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`2.
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`Sandoz Inc.’s Statement
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`Sandoz Inc. expects to rely on the testimony of Dr. Michael Maurin regarding claim
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`construction as outlined below. However, as the Court is aware, Chiesi moved the Court to
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`disqualify Dr. Maurin based on his work over twenty years ago for a third-party, DuPont. Dkt.
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`No. 133. Sandoz Inc. opposes Plaintiffs’ motion and believes that there is no basis to disqualify
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`Dr. Maurin. Dkt. No. 145. However, should Dr. Maurin be disqualified, Sandoz Inc.
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`respectfully requests the Court grant Sandoz Inc. leave to identify another expert to testify
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`regarding claim construction as outlined below.
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`Sandoz Inc. expects to provide expert testimony regarding:
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`• background and state of the art relating to the asserted patents;
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`•
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`the person of ordinary skill and the level of skill in the art;
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`• FDA and industry practice as it related to parenteral drug compositions and their
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`containers;
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`• pharmacist and pharmacy practices relating to the compounding and admixing of
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`pre-mixed parenteral solutions for use in point-of-care administration by
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`healthcare providers; and
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`•
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`the plain and ordinary meaning of the terms “one year at room temperature,”
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`“three months at room temperature” and “a total impurity formation,” as known to
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`a person of ordinary skill in the art.
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`Further, Sandoz Inc. expects to provide expert testimony regarding the following
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`opinions in support of Sandoz Inc.’s claim construction:
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`•
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`the term “a pre-mixed aqueous solution” would be understood by a person of ordinary
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`skill in the art, in view of their own knowledge, the disclosure in the asserted patents
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`9
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`Sandoz Exhibit 1008 Page 9
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`

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`and file histories, and extrinsic evidence, to mean an aqueous solution that is mixed
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`and ready to use prior to its point-of-care administration;
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`•
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`the term “pre-mixed composition” would be understood by a person of ordinary skill
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`in the art, in view of their own knowledge, the disclosure in the asserted patents and
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`file histories, and extrinsic evidence, to mean a composition that is mixed and ready
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`to use prior to its point-of-care administration;
`
`•
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`the term “container” would be understood by a person of ordinary skill in the art to
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`have its plain and ordinary meaning in the art. However, should the Court require a
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`construction, the term “container” would be understood by a person of ordinary skill
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`in the art, in view of their own knowledge, the disclosure in the asserted patents and
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`file histories, and extrinsic evidence, to mean an object suitable for containing a
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`liquid;
`
`•
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`the term “a pharmaceutically acceptable container” would be understood by a person
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`of ordinary skill in the art, in view of their own knowledge, the disclosure in the
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`asserted patents and file histories, and extrinsic evidence, to mean a container
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`acceptable for pharmaceutical use;
`
`•
`
`the term “does not come into contact with polar polymers” would be understood by a
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`person of ordinary skill in the art, in view of their own knowledge, the disclosure in
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`the asserted patents and file histories, and extrinsic evidence, to mean “has no contact
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`with any polar polymers;”
`
`•
`
`the term “is in contact with non-polar polymers” would be understood by a person of
`
`ordinary skill in the art, in view of their own knowledge, the disclosure in the asserted
`
`10
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`Sandoz Exhibit 1008 Page 10
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`

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`patents and file histories, and extrinsic evidence, to mean “has contact with non-polar
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`polymers.”
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`In addition, Sandoz Inc. expects to provide expert testimony regarding the following
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`opinions in opposition to Chiesi’s claim construction:
`
`•
`
`the term “a pre-mixed aqueous solution” would not be understood by a person of
`
`ordinary skill in the art, in view of their own knowledge, the disclosure in the asserted
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`patents and file histories, and other intrinsic and extrinsic evidence, to be limited to “a
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`ready-to-use pharmaceutical composition that is an aqueous solution already mixed
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`from the point of manufacture and is stable, allows medical personnel to use prepared
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`containers containing an injectable formulation off the shelf without additional
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`preparation, avoids potential contamination problems, and eliminates dosage errors”
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`as proposed by Plaintiffs;
`
`•
`
`the term “pre-mixed composition” would not be understood by a person of ordinary
`
`skill in the art, in view of their own knowledge, the disclosure in the asserted patents
`
`and file histories, and other intrinsic and extrinsic evidence, to be limited to “a ready-
`
`to-use pharmaceutical composition that is an aqueous solution already mixed from the
`
`point of manufacture and is stable, allows medical personnel to use prepared
`
`containers containing an injectable formulation off the shelf without additional
`
`preparation, avoids potential contamination problems, and eliminates dosage errors”
`
`as proposed by Plaintiffs;
`
`•
`
`the term “container” would not be understood by a person of ordinary skill in the art,
`
`in view of their own knowledge, the disclosure in the asserted patents and file
`
`11
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`Sandoz Exhibit 1008 Page 11
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`

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`histories, and other intrinsic and extrinsic evidence, to be limited to “a container for
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`drug storage and direct administration to patients” as proposed by Plaintiffs;
`
`•
`
`the term “a pharmaceutically acceptable container” would not be understood by a
`
`person of ordinary skill in the art, in view of their own knowledge, the disclosure in
`
`the asserted patents and file histories, and other intrinsic and extrinsic evidence, to be
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`limited to “a container for drug storage and direct administration to patients” as
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`proposed by Plaintiffs;
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`• Plaintiffs’ proposed construction of the term “does not come into contact with polar
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`polymers” as “does not contact polar polymers sufficiently to cause significant drug
`
`adsorption” is not the plain and ordinary meaning of the term as understood by a
`
`person of ordinary skill in the art, and would not be understood by a person of
`
`ordinary skill in the art, in view of their own knowledge, the disclosure in the asserted
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`patents and file histories, and other intrinsic and extrinsic evidence, to be limited as
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`proposed by Plaintiffs;
`
`•
`
`the term “does not come into contact with polar polymers” as proposed by Plaintiffs
`
`to be “does not contact polar polymers sufficiently to cause significant drug
`
`adsorption” is indefinite, lacks written description, and is not enabled because the
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`specification provides no disclosure as to the amount of polar polymer that would be
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`sufficient to cause significant drug adsorption;
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`• Plaintiffs’ proposed construction of the term “is in contact with non-polar polymers”
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`as “is in contact with non-polar polymers to minimize drug adsorption” is not the
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`plain and ordinary meaning of the term as understood by a person of ordinary skill in
`
`the art, and would not be understood by a person of ordinary skill in the art, in view
`
`12
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`Sandoz Exhibit 1008 Page 12
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`of their own knowledge, the disclosure in the asserted patents and file histories, and
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`other intrinsic and extrinsic evidence, to be limited as proposed by Plaintiffs;
`
`•
`
`the term “is in contact with non-polar polymers” as proposed by Plaintiffs to be “is in
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`contact with non-polar polymers to minimize drug adsorption” is indefinite, lacks
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`written description, and is not enabled because the specification provides no
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`disclosure as to the amount of contact with non-polar polymers required to minimize
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`drug adsorption;
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`• a person of ordinary skill in the art, in view of their own knowledge, the disclosure in
`
`the asserted patents and file histories, and other intrinsic and extrinsic evidence,
`
`would understand “one year at room temperature” to include accelerated stability
`
`studies projecting at least one year stability at room temperature, and would not be
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`understood by a person of ordinary skill in the art to be limited to “one year full-term
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`at room temperature” as proposed by Plaintiffs;
`
`• a person of ordinary skill in the art, in view of their own knowledge, the disclosure in
`
`the asserted patents and file histories, and other intrinsic and extrinsic evidence,
`
`would understand “three months at room temperature” to include accelerated stability
`
`studies projecting at least three months stability at room temperature, and would not
`
`be understood by a person of ordinary skill in the art to be limited to “three months
`
`full-term at room temperature” as proposed by Plaintiffs;
`
`• Plaintiffs’ proposed construction of the term “total impurity formation” as “a total %
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`(w/w) of impurity formation” is not the plain and ordinary meaning of the term as
`
`understood by a person of ordinary skill in the art, nor is it the meaning one of skill in
`
`13
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`Sandoz Exhibit 1008 Page 13
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`the art would understand the term to have in light of their knowledge and the intrinsic
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`and extrinsic evidence;
`
`•
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`the term “total impurity formation” would not be understood by a person of ordinary
`
`skill in the art, in view of their own knowledge, the disclosure in the asserted patents
`
`and file histories, and other intrinsic and extrinsic evidence, to be limited to “a total %
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`(w/w) of impurity formation” as proposed by Plaintiffs, and a person of ordinary skill
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`in the art would not understand this construction to be the plain and ordinary meaning
`
`of the term, or the meaning of the term as read in light of the intrinsic and extrinsic
`
`evidence;
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`• a person of ordinary skill in the art would understand “total impurity formation” to
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`have its plain and ordinary meaning in the art, which includes the total percent of
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`impurities formed in a sample as determined, for example, using high performance
`
`liquid chromatography (HPLC) with ultraviolet (UV) detection to quantify the
`
`impurities based on height percent or area percent relative to the active ingredient.
`
`14
`
`Sandoz Exhibit 1008 Page 14
`
`

`

`Case 1:13-cv-05723-NLH-AMD Document 182 Filed 09/08/14 Page 15 of 15 PageID: 3810
`
`Dated: September 8, 2014
`
`
`By: /s/ Michael R. Griffinger
`Michael R. Griffinger
`Sheila F. McShane
`Gibbons P.C.
`One Gateway Center
`Newark, New Jersey 07102-5310
`Telephone No.: (973) 596-4500
`Facsimile No.: (973) 596-0545
`
`Of Counsel:
`Edgar H. Haug
`Angus Chen
`Nicholas F. Giove
`Leann M. Clymer
`Frommer Lawrence & Haug LLP
`745 Fifth Avenue
`New York, New York 10151
`Telephone No.: (212) 588-0800
`Facsimile No.: (212) 588-0500
`
`For Plaintiffs Chiesi USA, Inc.,
`Cornerstone BioPharma, Inc.,
`and EKR Therapeutics, LLC
`
`
`
`
`
`
`
`
`
`
`
`
`By: /s/ Christina Saveriano
`Eric I. Abraham
`Christina L. Saveriano
`HILL WALLACK LLP
`202 Carnegie Center
`Princeton, New Jersey 08540
`Telephone: (609) 924-0808
`Facsimile: (609) 452-1888
`
`Of Counsel:
`David C. Doyle
`MORRISON & FOERSTER LLP
`12531 High Bluff Drive, Suite 100
`San Diego, California 92130
`Telephone: (858) 720-5100
`Facsimile: (858) 720-5125
`
`Matthew M. D’Amore
`Hui Liu
`David J. Austin
`Sarah L. Prutzman
`MORRISON & FOERSTER LLP
`1290 Avenue of the Americas
`New York, New York 10104
`Telephone: (212) 468-8168
`Facsimile: (212) 468-7900
`
`For Defendant Sandoz Inc.
`
`
`
`
`
`
`
`
`
`
`
`Sandoz Exhibit 1008 Page 15
`
`

`

`Case 1:13-cv-05723-NLH-AMD Document 182-1 Filed 09/08/14 Page 1 of 24 PageID: 3811
`EXHIBIT A: Chiesi’s Proposed Constructions and Identification of Intrinsic and Extrinsic Evidence
`
`Disputed Claim Terms/
`Phrases
`
`“a pre-mixed aqueous
`solution”
`’102 patent1, claims 1,
`5–7, 8–11
`
`’290 patent, claims 7, 11
`
`’291 patent2, claims 3, 7,
`8, 12
`
`’524 patent3, claims 1–3,
`7, 8, 12, 19–22, 27, 28
`
`“pre-mixed
`composition” 4
`’290 patent, claim 1
`
`Chiesi’s Proposed Construction
`
`Intrinsic Evidence
`
`Extrinsic Evidence
`
`“a ready-to-use pharmaceutical
`composition that is an aqueous
`solution already mixed from the
`point of manufacture and is stable,
`allows medical personnel to use
`prepared containers containing an
`injectable formulation off the shelf
`without additional preparation,
`avoids potential contamination
`problems, and eliminates dosage
`errors”
`
`
`See, e.g.,’102 patent and file
`history generally, including at
`least: Title; Abstract; col.1, ll.51-
`57; col.1, ll.61-67; col.2, ll.4-9;
`col.2, ll.35-37; col.2, l.39–col.3,
`l.3; col.3, ll.7-53; col.8, ll.33-38;
`col.9, l.33–col.10, l.24; col.11,
`ll.12-40; col.14, 3-22; col.14,
`ll.39-54; col.14, l. 60-col.15, l.29;
`col.15, ll.36-59; col.15, l.66-
`col.16, l.37; col.16, l.43-col.17,
`l.13; col.17, l.15–col.27, l.55; Ex.
`1; Ex. 2; Ex. 3; Ex. 4; Ex. 5; Ex.
`6, Ex. 7; Ex. 8; Ex. 9; Ex. 10; Ex.
`11; Ex. 12; Figs. 1-5B; Claims 1,
`5, 6, and 7; July 6, 2009
`Amendment, e.g. at 8-12; Brittain
`Decl., e.g. at 2-5, 8; Reasons for
`Allowance, e.g. at 2;
`CRTXCAR0000092-145;
`CRTXCAR0000183-184;
`CRTXCAR0000367-376;
`CRTXCAR0000390-391;
`CRTXCAR0000396-401;
`
`American Heritage Dictionary
`(SAN_NIC_0005686-88);
`Oxford English Dictionary
`(SAN_NIC_0005681-82);
`Webster’s Third International
`Dictionary
`(SAN_NIC_0005683-85);
`Gard, Am J. Obs. Gyn., 2002
`(SAN_NIC_0005678-80);
`Ruble, Pharmacy Purchasing &
`Products, 2008
`(SAN_NIC_0005689-91);
`Summerfield, Pharmacy
`Purchasing & Products, 2008
`(SAN_NIC_0005702);
`Van Hassel, Pharmacy
`Purchasing & Products, 2009
`(SAN_NIC_0005703-05);
`Sanborn, Am. J. Health-Syst.
`Pharm., 2009
`
`
`1 Claims 8–11 of the ’102 patent recite “the aqueous solution.”
`2 Claims 7 and 12 of the ’291 patent recite “the pre-mixed aqueous solution.”
`3 Claims 19–22 of the ’524 patent recite “the aqueous solution.” Claims 7, 12, 27, and 28 recite “the pre-mixed aqueous solution.”
`4 Chiesi disagrees with Sandoz Inc.’s position that the disputed terms “a pre-mixed aqueous solution” and “pre-mixed composition”
`require separate constructions.
`
`1
`
`Sandoz Exhibit 1008 Page 16
`
`

`

`Case 1:13-cv-05723-NLH-AMD Document 182-1 Filed 09/08/14 Page 2 of 24 PageID: 3812
`EXHIBIT A: Chiesi’s Proposed Constructions and Identification of Intrinsic and Extrinsic Evidence
`
`Disputed Claim Terms/
`Phrases
`
`Chiesi’s Proposed Construction
`
`Intrinsic Evidence
`
`Extrinsic Evidence
`
`CRTXCAR0000489-495;
`CRTXCAR0000509-525;
`CRTXCAR0000595-598;
`CRTXCAR0000602-688;
`CRTXCAR0000690-696.
`
`See, e.g.,’290 patent and file
`history generally, including at
`least: Abstract; col.1, ll.53-59;
`col.1, ll.63-67–col.2, l.2; col.2,
`ll.6-11; col.2, ll.37-39; col.2,
`l.41–col.3, l.6; col.3, ll.10-55;
`col.9, l.58–col.10, l.24; col.11,
`ll.13-17; col.11, ll.12-40; col.14,
`3-22; col.17, l.15–col.27, l.25;
`Ex. 1; Ex. 2; Ex. 3; Ex. 4; Ex. 5;
`Ex. 6, Ex. 7; Ex. 8; Ex. 9; Ex. 10;
`Ex. 11; Ex. 12; Figs. 1-5B;
`Claims 7 and 11; October 16,
`2009 Amendment, e.g. at 5;
`Reasons for Allowance, e.g. at 3;
`CRTXCAR0000736-788;
`CRTXCAR0000797-803;
`CRTXCAR0000823-828;
`CRTXCAR0000830-836.
`See, e.g.,’291 patent and file
`history generally, including at
`least: Abstract; col.1, ll.53-59;
`col.1, ll.63-67; col.2, ll.1-2; col.2,
`ll.6-11; col.2, ll.37-39; col.2,
`
`(SAN_NIC_0005692-701);
`CAPS Compounding
`Pharmacy, 2014
`(SAN_NIC_0005677);
`Plaintiffs’ Response to Sandoz
`Inc.’s Invalidity Contentions at
`pgs. 356-358 and documents
`cited therein (e.g.,
`SAN_NIC_0001472;
`SAN_NIC_0001497;
`SAN_NIC_0001501;
`SAN_NIC_0001507;
`SAN_NIC_0001515;
`CRTXCAR0006037;
`CRTXCAR0006039;
`CRTXCAR0006041;
`CRTXCAR0006045;
`CRTXCAR0006052;
`CRTXCAR0006057;
`CRTXCAR0006063;
`CRTXCAR0006065;
`CRTXCAR0006067;
`CRTXCAR0006071; and
`CRTXCAR0006074).
`CRTXCAR0001663-2915,
`including:
`CRTXCAR0001663-1669;
`CRTXCAR0001672-1676;
`CRTXCAR0001678-1722;
`
`2
`
`Sandoz Exhibit 1008 Page 17
`
`

`

`Case 1:13-cv-05723-NLH-AMD Document 182-1 Filed 09/08/14 Page 3 of 24 PageID: 3813
`EXHIBIT A: Chiesi’s Proposed Constructions and Identification of Intrinsic and Extrinsic Evidence
`
`Disputed Claim Terms/
`Phrases
`
`Chiesi’s Proposed Construction
`
`Intrinsic Evidence
`
`Extrinsic Evidence
`
`l.41–col.3, l.6; col.3, ll.10-55;
`col.9, l.58–col.10, l.24; col.11,
`ll.13-17; col.11, ll.12-40; col.14,
`ll.3-22; col.17, l.15–col.27,