Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 1 of 61 PageID: 251
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`Christina L. Saveriano
`HILL WALLACK LLP
`21 Roszel Road
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`Princeton, New Jersey 08540
`Telephone: 609-924-0808
`Facsimile: 609-452-1888
`csaveriano@hillwallack.com
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`Lauren Martin
`MCDERMOTT WILL &
`EMERY LLP
`28 State Street
`Boston, MA 02109
`Telephone: 617-535-3889
`lnmartin@mwe.com
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`
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`
`
`Thomas P. Steindler
`Rebecca Harker Duttry
`David Mlaver
`MCDERMOTT WILL & EMERY LLP
`500 North Capitol Street, N.W.
`Washington, DC 20001
`Telephone: 202-756-8000
`Facsimile: 202-756-8087
`tsteindler@mwe.com
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`Attorneys for Defendant Sandoz Inc.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
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`
`
`
`)
`)
`)
`)
`)
`) Civil Action No.
`) 3:14-cv-5499 (PGS)(LHG)
`)
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`)
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`)
`)
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`
`
`DEFENDANT SANDOZ INC.’S
`OPENING CLAIM CONSTRUCTION BRIEF
`
`
`
`UNITED THERAPEUTICS
`CORPORATION,
`
`
`Plaintiff and Counterclaim-
`Defendant,
`
`
`v.
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`SANDOZ INC.,
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`Defendant and Counterclaim-
`Plaintiff.
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`

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`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 2 of 61 PageID: 252
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`TABLE OF CONTENTS
`
`
`Page
`
`
`I.
`
`INTRODUCTION .......................................................................................... 1
`
`II.
`
`BACKGROUND ............................................................................................ 1
`
`A.
`
`B.
`
`The Prior Art ........................................................................................ 1
`
`The ’393 Patent .................................................................................... 2
`
`III. LEGAL STANDARDS FOR CLAIM CONSTRUCTION ........................... 3
`
`IV. ARGUMENT .................................................................................................. 3
`
`A.
`
`B.
`
`Each Disputed Term Requires Construction ........................................ 3
`
`The Disputed Terms ............................................................................. 5
`
`1.
`
`Term 1 (claims 1 and 9): “product” ........................................... 5
`
`a.
`
`b.
`
`The Open-Ended Language Of The Claims
`Mandates Sandoz’s Proposed Construction .................... 5
`
`UTC’s Proposed Construction Ignores The Open-
`Ended Nature Of the Claims ............................................ 6
`
`2.
`
`Term 2 (claim 1) and term 12 (claim 9): “a product
`comprising a compound of formula I/IV or a
`pharmaceutically acceptable salt thereof” ................................. 8
`
`a.
`
`b.
`
`The Open-Ended Nature Of The Claimed Product
`Mandates Sandoz’s Proposed Construction .................. 10
`
`UTC’s Proposed Definition Seeks To Import An
`Unrecited Limitation Into The Claim ............................ 11
`
`3.
`
`Term 3 (claim 1) and term 13 (claim 9): “a process
`comprising” and “the process comprising” ............................. 12
`
`a.
`
`b.
`
`There Is A Genuine Dispute As To The Proper
`Construction Of “A Process Comprising” Such
`That Construction Is Warranted .................................... 13
`
`Sandoz’s Proposed Construction Gives Effect To
`The Patentee’s Definition Of “Comprising” ................. 14
`
`4.
`
`Term 4 (claim 1) and term 14 (claim 9): “an alkylating
`agent” ....................................................................................... 14
`
`i
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`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 3 of 61 PageID: 253
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`TABLE OF CONTENTS
`(continued)
`
`a.
`
`b.
`
`c.
`
`Sandoz’s Proposed Construction Defines “An
`Alkylating Agent” As The Term Is Used In The
`Context Of The Claim ................................................... 15
`
`Sandoz’s Proposed Construction Is Supported By
`The Specification ........................................................... 16
`
`UTC’s Proposed Construction Is Divorced From
`The Context Of The Claim In Which The Term
`Appears .......................................................................... 17
`
`5.
`
`Term 5 (claims 1 and 9): “a base B” ........................................ 18
`
`a.
`
`b.
`
`Sandoz’s Proposed Construction Is Consistent
`With The Plain Language Of The Claims, While
`UTC’s Proposed Construction Impermissibly
`Reads A Limitations Out Of The Claims. ..................... 19
`
`Sandoz’s Proposed Construction Is Consistent
`With The Specification .................................................. 20
`
`6.
`
`Term 6 (claim 1) and term 15 (claim 9): “a salt of
`formula IS” and “a salt of formula IVS” ................................... 21
`
`a.
`
`Sandoz’s Proposed Construction Explains And
`Clarifies The Disputed Term ......................................... 22
`
`7.
`
`Term 7 (claims 1 and 9): “HB+” ............................................. 23
`
`a.
`
`b.
`
`c.
`
`Sandoz’s Proposed Construction Gives Effect To
`The Claim Language ..................................................... 24
`
`Sandoz’s Proposed Construction Is Fully
`Supported By The Specification .................................... 26
`
`UTC’s Proposed Construction Reads Out The “H”
`and “B” Limitations Of “HB+” ..................................... 26
`
`8.
`
`Term 8 (claim 1) and term 16 (claim 9): “(c) contacting
`the product of step (b) with a base B to form a salt of
`formula [IS/IVS]” ...................................................................... 27
`
`a.
`
`During Prosecution, UTC Disclaimed Processes
`Which Involved Salt Formation Where
`Treprostinil Has Previously Been Isolated .................... 29
`
`ii
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`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 4 of 61 PageID: 254
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`
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`TABLE OF CONTENTS
`(continued)
`
`9.
`
`Term 9 (claim 2): “The product of claim 1, wherein the
`purity of the compound of formula I in said product is at
`least 99.5%” ............................................................................. 31
`
`a.
`
`b.
`
`The Law Requires Different Constructions Of The
`Claimed Product For Purposes Of Validity And
`Infringement .................................................................. 32
`
`Sandoz’s Proposed Constructions Further Clarify
`The Meaning Of “The Purity . . . Is At Least
`99.5%”, While UTC’s Proposed Construction
`Does Not ........................................................................ 34
`
`10. Term 10 (claims 2, 4 and 8) and term 17 (claim 16): “the
`product of claim 1” and “the product of claim 9”.................... 35
`
`11. Term 11 (claim 8) and term 18 (claim 16): “purifying the
`compound of formula III produced in step (a)” or
`“purifying the compound of formula VI produced in step
`(a)” ............................................................................................ 38
`
`a.
`
`Sandoz’s Construction Is Based On The Plain And
`Ordinary Meaning Of “Purifying” Read In Light
`Of The Specification. ..................................................... 39
`
`V.
`
`CONCLUSION ............................................................................................. 40
`
`
`APPENDIX I
`
`APPENDIX II
`
`iii
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`

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`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 5 of 61 PageID: 255
`
`TABLE OF AUTHORITIES
`
`
`
`
`Cases
`
` Page(s)
`
`Abbott Labs v. Sandoz Inc.,
`566 F.3d 1282 (Fed. Cir. 2009) (en banc) .......................................................... 33
`
`ACTV, Inc. v. Walt Disney Co.,
`346 F.3d 1082 (Fed. Cir. 2003) .......................................................................... 18
`
`Amgen Inc. v. F. Hoffman-La Roche, Ltd.,
`580 F.3d 1340 (Fed. Cir. 2009) .............................................................. 10, 32, 34
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`314 F.3d 1313 (Fed. Cir. 2003) .......................................................................... 32
`
`Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,
`489 U.S. 141 (1989) ............................................................................................ 32
`
`CIAS, Inc. v. Alliance Gaming Corp.,
`504 F.3d 1356 (Fed. Cir. 2007) ............................................................................ 5
`
`Cochrane v. Badische Anilin & Soda Farbrik,
`111 U.S. 293 (1884) ............................................................................................ 33
`
`Gen. Elec. Co. v. Wabash Appliance Corp.,
`304 U.S. 364 (1938) ............................................................................................ 33
`
`Genentech, Inc. v. Chiron Corp.,
`112 F.3d 495 (Fed. Cir. 1997) ........................................................................ 6, 10
`
`IGT v. Bally Gaming Int’l Inc.,
`659 F.3d 1109 (Fed. Cir. 2011) ................................................................... 18, 20
`
`Invitrogen Corp. v. Biocrest Mfg, L.P.,
`327 F.3d 1364 (Fed. Cir. 2003) .......................................................................... 14
`
`Kyocera Wireless Corp. v. Int’l Trade Comm’n,
`545 F.3d 1340 (Fed. Cir. 2008) .......................................................................... 18
`
`iv
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`

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`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 6 of 61 PageID: 256
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`TABLE OF AUTHORITIES
`(continued)
`
`
`Laitram Corp. v. NEC Corp.,
`163 F.3d 1342 (Fed. Cir. 1998) ......................................................................... 11
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`134 S. Ct. 2120 (2014) ........................................................................................ 39
`
`O2 Micro Int’l Ltd. v. Beyond Innov. Tech Co.,
`521 F.3d 1351 (Fed. Cir. 2008) ...................................................................... 4, 14
`
`Omega Eng’g, Inc. v. Raytek Corp.,
`334 F.3d 1314 (Fed. Cir. 2003) ......................................................................... 29
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ................................................................... 12, 18
`
`RF Delaware, Inc. v. Pac. Keystone Techs., Inc.,
`326 F.3d 1255 (Fed. Cir. 2003) .......................................................................... 11
`
`Shire Dev., LLC v. Watson Pharms., Inc.,
`Case No. 2013-1409, slip op. (Fed Cir. June 3, 2015) ................................. 29, 31
`
`Tate Access Floors, Inc. v. Interface Architectural Res., Inc.,
`279 F.3d 1357 (Fed. Cir. 2002) .......................................................................... 39
`
`In re Thorpe,
`777 F.2d 695 (Fed. Cir. 1985) ............................................................................ 33
`
`United Therapeutics Corp. v. Sandoz Inc.,
`Civil Action Nos. 12-cv-1617, 13-cv-316 (D.N.J.) .......................................... 1, 3
`
`Williamson v. Citrix Online, LLC,
`No. 2013-1130, slip op. (Fed. Cir. June 16, 2015) ....................................... 11, 12
`
`v
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`

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`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 7 of 61 PageID: 257
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`I.
`
`INTRODUCTION
`
`
`
`On September 2, 2014, United Therapeutics Corporation (“UTC”) filed the
`
`present patent infringement action under the Hatch-Waxman provisions of the
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`patent law, 35 U.S.C. § 271(e), asserting that Sandoz Inc.’s (“Sandoz’s”) filing of
`
`its Abbreviated New Drug Application (“ANDA”) for a generic treprostinil
`
`product infringes claims 1, 2, 4, 8, 9, and 16 (the “Asserted Claims”) of U.S. Patent
`
`No. 8,497,393 (“the ’393 patent”).
`
`Sandoz has identified the terms it believes require construction. UTC
`
`contends that no construction is necessary but has proposed alternative
`
`constructions. UTC has agreed to two of Sandoz’s proposed constructions; the rest
`
`remain in dispute.1
`
`II. BACKGROUND
`
`A. The Prior Art
`
`The history of the early development and commercialization of treprostinil
`
`has been addressed in prior litigation. United Therapeutics Corp. v. Sandoz Inc.,
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`Civil Action Nos. 12-cv-1617, 13-cv-316 (D.N.J.) (“Treprostinil I”). As explained
`
`in Treprostinil I, UTC hired Dr. Robert Moriarty to develop a new commercial
`
`manufacturing process for treprostinil. That process was disclosed in U.S. Patent
`
`No. 6,765,117 (“the ’117 patent”), addressed in Treprostinil I, as well as in other
`
`
`1 The parties’ agreed constructions are set out in Appendix I hereto. The disputed
`terms, and the parties’ proposed constructions, are set out in Appendix II.
`
`1
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`

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`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 8 of 61 PageID: 258
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`
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`publications such as Moriarty et al., “The Intramolecular Assymetric Pauson-
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`Khand Cyclization as a Novel and General Stereoselective Route to Benzindene
`
`Prostacyclins: Synthesis of UT-15 (Treprostinil),” 69 J. Org. Chem. 1890-1902
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`(2004) (“Moriarty 2004”). The ’393 patent addresses an alleged improvement to
`
`the Moriarty 2004 process.
`
`B.
`
`The ’393 Patent
`
`The ’393 patent, entitled “Process to Prepare Treprostinil, the Active
`
`Ingredient in Remodulin®,” issued on July 30, 2013. The patent is assigned to
`
`United Therapeutics Corporation. The patent is directed to “an improved process
`
`to convert benzindene triol to treprostinil via salts of treprostinil and to purify
`
`treprostinil.” (’393 patent (“Ex. A”)2, Abstract).
`
`The ’393 patent has a total of 22 claims. UTC asserts six claims in the
`
`present litigation: claims 1, 2, 4, 8, 9 and 16.
`
`Claim 1 is drawn to a product comprising a compound of a genus that
`
`includes the treprostinil compound, or a pharmaceutically acceptable salt thereof.
`
`Independent claim 9 is identical to claim 1 except that it is drawn to a product
`
`comprising the specific treprostinil compound, a species of the genus of claim 1.
`
`
`2 All Exhibits are attached to the Declaration of Lauren N. Martin filed
`concurrently herewith.
`
`
`
`2
`
`

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`
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`Each of the claims includes limitations that the claimed compound is made
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`by a process comprising three specified steps: (a) alkylating a benzindene triol to
`
`form a benzindene nitrile intermediate; (b) hydrolyzing the benzindene nitrile with
`
`a base to form treprostinil acid; and (c) contacting the treprostinil acid with a base
`
`to form treprostinil salt.3
`
`Asserted Claims 2, 4, and 8 each depend from claim 1. Claim 2 adds the
`
`limitation that the purity of treprostinil in the final product be at least 99.5%.
`
`Claim 4 adds the limitation that the base in step (b) must be KOH or NaOH. Claim
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`8 adds the limitation that the product of step (a) is not purified. Asserted Claim 16
`
`depends from claim 9 and adds the limitation that the process does not include
`
`purifying the product of step (a).
`
`III. LEGAL STANDARDS FOR CLAIM CONSTRUCTION
`
`The legal standards for claim construction are set out in this Court’s
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`Markman decision in Treprostinil I and are incorporated herein by reference.
`
`Memorandum Decision & Order at 4-6, Treprostinil I, Civil Action No. 12-cv-
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`1617 (D.N.J. June 25, 2013) (D.I. 95).
`
`IV. ARGUMENT
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`A. Each Disputed Term Requires Construction
`
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`3 The claims also contain an optional fourth step which is not at issue in this
`litigation as it was not addressed in either party’s invalidity or infringement
`contentions.
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`
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`3
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`

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`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 10 of 61 PageID: 260
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`
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`One of the salutary lessons of Treprostinil I is that the parties should identify
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`claim construction disputes as early as possible, so that the Court can fulfill its
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`obligation to resolve such disputes during the Markman phase and not be burdened
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`to address claim construction during trial. O2 Micro Int’l Ltd. v. Beyond Innov.
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`Tech Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008) (“When the parties present a
`
`fundamental dispute regarding the scope of a claim term, it is the court’s duty to
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`resolve it”).
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`Sandoz has identified a series of claim terms which require construction and
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`proposed constructions of these terms to UTC. UTC has agreed to Sandoz’s
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`proposed construction of two terms, but contends that none of the remaining terms
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`requires construction. UTC has, however, proposed alternative constructions for
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`each of the disputed terms.
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`The very fact that the parties have been unable to agree on the alternative
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`constructions of the remaining terms makes it abundantly clear that the parties
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`have a fundamental dispute as to the meaning of these terms. Accordingly, the
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`Court should construe each of the disputed terms at the Markman stage and reject
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`UTC’s invitation to kick the can down the road by simply stating the terms should
`
`be given their “plain and ordinary meaning.” O2 Micro, 521 F.3d at 1361
`
`(“reliance on a term’s ‘ordinary’ meaning [may] not resolve the parties’ dispute”).
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`4
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`

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`
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`B.
`
`The Disputed Terms
`
`1.
`
`Term 1 (claims 1 and 9): “product”
`
`“product”
`
`UTC’s Construction
`
`Sandoz’s Construction
`
`Plain and ordinary meaning.
`
`“A chemical composition.”
`
`To the extent the Court determines that
`this term requires construction, UTC
`proposes the following:
`
`“a substance resulting from a chemical
`reaction”
`
`
`
`a.
`
`The Open-Ended Language Of The Claims Mandates
`Sandoz’s Proposed Construction
`
`The open-ended language and structure of the claims mandates that
`
`“product” should be construed as a “chemical composition” rather than, as UTC
`
`proposes, “a substance resulting from a chemical reaction.” Both the product and
`
`the process are written as open-ended terms using the transition “comprising” (“a
`
`product comprising . . .” and “a process comprising . . .”). The ’393 patent
`
`specification expressly defines “comprising”:
`
`The expression “comprising” means “including but not limited to.”
`Thus, other non-mentioned substances, additives, carriers, or steps
`may be present.
`
`(Ex. A., col. 4:23-24). The specification’s definition is consistent with
`
`longstanding Federal Circuit jurisprudence defining “comprising” as “including
`
`but not limited to” in patent claims. See, e.g., CIAS, Inc. v. Alliance Gaming
`
`Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007) (“In the patent claim context the term
`
`
`
`5
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`

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`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 12 of 61 PageID: 262
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`
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`‘comprising’ is well understood to mean ‘including but not limited to.’”);
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`Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“comprising”
`
`allows the addition of other elements so long as the named elements, which are
`
`essential, are included); see generally Chisum on Patents § 8.06[1][b][ii][A].
`
`“Product” is therefore properly defined as “a chemical composition.” It is a
`
`composition because “product” is open-ended and includes the treprostinil
`
`compound along with other substances. A composition connotes more than one
`
`element or ingredient. It is a chemical composition because treprostinil is a
`
`chemical and a composition containing treprostinil is a chemical composition. For
`
`these reasons, “product” should be construed as “a chemical composition.”
`
`b.
`
`UTC’s Proposed Construction Ignores The Open-
`Ended Nature Of the Claims
`
`UTC’s proposed construction as “a substance resulting from a chemical
`
`reaction” should be rejected for several reasons. First, the claimed product is not
`
`limited to a substance resulting from a chemical reaction. The process for making
`
`treprostinil includes numerous chemical reactions, not just “a” chemical reaction.
`
`More importantly, the process includes steps that are not chemical reactions.
`
`These additional steps can include, for example, physical separation steps,
`
`filtration, drying, recrystallization, and the like, as well as any other process steps
`
`for making a treprostinil composition, such as formulating the active
`
`
`
`6
`
`

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`
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`pharmaceutical ingredient (“API”) into a finished drug product like Remodulin®.
`
`(Ex. B, Heathcock Declaration at ¶¶ 71-76).
`
`The examples in the ’393 patent specification illustrate this point. Example
`
`6 is described as a “Comparison of the Former Process and a Working Example of
`
`the Process According to the Present Invention.” (Ex. A, col. 15:2-5 (emphasis
`
`added)). Example 6 depicts 50 separate process steps to make treprostinil. (Id.at
`
`col. 15:1-17:25). Of these, the last chemical reaction in the process occurs at step
`
`35 (hydrolysis). (Ex. B at ¶ 72). All of the subsequent steps, Steps 36 through 50,
`
`are process steps designed to purify the final product. (Id.). These include, inter
`
`alia, extraction, a water wash, a brine wash, filtration, evaporation, crude drying,
`
`crystallization, an additional filtration step, washing, drying in a vacuum oven. It
`
`is only after all of these process steps are complete that the purity of the “product”
`
`is calculated. (Id. at 73). These additional steps, performed after the last chemical
`
`reaction, are part of the process of making the “product” of the claimed invention.4
`
`The fact that the claimed process can include steps that are not chemical
`
`reactions is also reflected in the claims themselves. Dependent claim 8, for
`
`example, depends on claim 1 and adds the limitation that “the process does not
`
`
`4 Example 5 also illustrates the same point. (Ex. A at col. 14:1-54). Example 5
`discloses physical separation steps, washing, brining, drying, filtration,
`concentration under vacuum, recrystallization of the crude treprostinil, further
`filtration, washing, drying and drying in a vacuum oven, all after the last chemical
`reaction. (Ex. B at ¶ 74).
`
`
`
`7
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`

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`
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`include purifying the compound of formula (III) produced in step (a).” (Ex. A at
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`col. 19:44-47). This confirms that purification can be part of the process of
`
`independent claim 1. And as the above-cited Examples reflect, there are many
`
`types of purification steps that do not involve chemical reactions.
`
`Therefore, it would be improper to construe the “product” of the claims to be
`
`“a substance resulting from a chemical reaction.” The “product” is not limited to a
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`substance that results from a chemical reaction. It can result from chemical
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`reactions along with any other type of process step, without limitation, whether it is
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`filtration, washing, evaporation, recrystallization, or the addition of additives or
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`carriers such as water, preservatives, sodium chloride, etc. to make a finished drug
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`product. The only limitation imposed by the claims is that the process must result
`
`in a product that includes some amount of treprostinil along with any other
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`substances.
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`2.
`
`Term 2 (claim 1) and term 12 (claim 9): “a product
`comprising a compound of formula I/IV or a
`
`pharmaceutically acceptable salt thereof” 5
`
`Term 2 (claim 1)
`“a product comprising a compound of formula I:
`
`
`5 Term 2 (claim 1) and Term 12 (claim 9) differ only in that Term 2 (claim 1)
`references a compound of “formula I,” which is a genus that includes treprostinil,
`while Term 12 (claim 9) refers to a compound of “formula IV,” which is the
`specific treprostinil compound. Apart from this difference, the language and
`analysis of Term 2 and Term 9 is the same.
`
`
`
`8
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`

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`
`
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` or a pharmaceutically acceptable salt thereof”
`
`UTC’s Construction
`
`Sandoz’s Construction
`
`Plain and ordinary meaning.
`
`To the extent the Court determines that
`this term requires construction, UTC
`proposes the following:
`
`“a substance resulting from a chemical
`reaction constituted primarily of formula
`I
`
`“A chemical composition that includes,
`but is not limited to, a compound of
`formula I, or a pharmaceutically
`acceptable salt thereof, and that may
`also include other non-mentioned
`substances (including impurities),
`additives, or carriers, without limitation
`as to the types or relative amounts
`thereof”
`
`
`
`or a pharmaceutically acceptable salt
`thereof”
`
`Term 12 (claim 9)
` “a product comprising a compound of formula IV
`
`
` or a pharmaceutically acceptable salt thereof”
`
`Plain and ordinary meaning.
`
`To the extent the Court determines that
`this term requires construction, UTC
`proposes the following:
`
`“a substance resulting from a chemical
`reaction constituted primarily of formula
`
`“A chemical composition that includes,
`but is not limited to, a compound of
`formula IV, or a pharmaceutically
`acceptable salt thereof, and that may
`also include other non-mentioned
`substances (including impurities),
`additives, or carriers, without limitation
`
`
`
`9
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 16 of 61 PageID: 266
`
`
`
`IV
`
`as to the types or relative amounts
`thereof”
`
`
`or a pharmaceutically acceptable salt
`thereof”
`
`
`
`
`
`a.
`
`The Open-Ended Nature Of The Claimed Product
`Mandates Sandoz’s Proposed Construction
`
`This term defines the product of claim 1 and is thus the focus of the validity
`
`analysis. Amgen Inc. v. F. Hoffman-La Roche, Ltd., 580 F.3d 1340, 1369-70 (Fed.
`
`Cir. 2009) (“[i]n determining validity of a product-by-process claim, the focus is
`
`on the product and not on the process of making it”). The term is written in open-
`
`ended form by reciting “a product comprising a compound of formula I . . .” As
`
`noted, the patentees expressly defined the term “comprising” in the ’393 patent
`
`specification to mean “including but not limited to” and added that “[t]hus, other
`
`non-mentioned substances, additives, [or] carriers . . . may be present.” (Ex. A,
`
`col. 4:23-25). See also Genentech, Inc., 112 F.3d at 501 (“comprising” allows the
`
`addition of other elements so long as the named elements, which are essential, are
`
`included).
`
`
`
`Sandoz’s proposed construction gives effect to the meaning of “comprising.”
`
`It repeats verbatim the patentees’ definition of “comprising” in the specification
`
`(Ex. A., col. 4:23-25), and clarifies that the composition can include other non-
`
`
`
`10
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 17 of 61 PageID: 267
`
`
`
`mentioned substances without limitation as to the types or relative amounts
`
`thereof. That is what it means to say that the composition comprises, or includes
`
`but is not limited to, the claimed compound. There are no recited limitations as to
`
`the types or amounts of impurities or other non-mentioned substances, and no
`
`unrecited limitation can be read into the claims. RF Delaware, Inc. v. Pac.
`
`Keystone Techs., Inc., 326 F.3d 1255, 1264 (Fed. Cir. 2003) (it is “[a] basic claim
`
`construction cannon . . . that one may not read a limitation into a claim from the
`
`written description”); Williamson v. Citrix Online, LLC, No. 2013-1130, slip op. at
`
`10 (Fed. Cir. June 16, 2015) (“[A] court may not import limitations from the
`
`written description into the claims”) (quoting Laitram Corp. v. NEC Corp., 163
`
`F.3d 1342, 1347 (Fed. Cir. 1998)).
`
`b.
`
`UTC’s Proposed Definition Seeks To Import An
`Unrecited Limitation Into The Claim
`
`
`
`UTC’s proposed construction has two parts: (1) “a substance resulting from
`
`a chemical reaction” and (2) “constituted primarily of formula I.” The first part is
`
`UTC’s proposed construction of “product” (Term 1) and should be rejected for the
`
`reasons discussed above regarding Term 1. The second part is a new, unrecited
`
`purity limitation requiring that the substance is “constituted primarily of formula I”
`
`that UTC is seeking to read into the claim. It should be rejected as well.
`
`There is no basis for reading this unrecited limitation into the claim. The
`
`Federal Circuit’s command is unequivocal: “A court may not import limitations
`
`
`
`11
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 18 of 61 PageID: 268
`
`
`
`from the written description into the claims.” Williamson, slip op. at 10; RF
`
`Delaware, Inc., 326 F.3d at 1264; Phillips v. AWH Corp., 415 F.3d 1303, 1323
`
`(Fed. Cir. 2005). This conclusion is underscored by the structure of the claims
`
`themselves. Claim 2 depends on claim 1 and adds the further limitation that “the
`
`purity of the compound of formula I in said product is at least 99.5%.” Under the
`
`doctrine of claim differentiation, adding a purity limitation in dependent claim 2
`
`creates a presumption that there is no purity limitation in independent claim 1.
`
`Phillips, 415 F.3d at 1315. UTC was fully capable of reciting a purity limitation in
`
`claim 1 as it did in dependent claim 2, but did not do so. UTC cannot now have
`
`the Court rewrite independent claim 1 to add an unrecited purity limitation.6
`
`3.
`
`Term 3 (claim 1) and term 13 (claim 9): “a process
`comprising” and “the process comprising”7
`
`Term 3 (claim 1)
`“a process comprising”
`
`UTC’s Construction
`
`Sandoz’s Construction
`
`
`6 It bears noting that UTC’s proposed construction would not cover Remodulin®,
`UTC’s commercial treprostinil product. Remodulin® is not “constituted primarily
`of formula I.” Rather, Remodulin® contains 0.1% of treprostinil, or less,
`depending on the dosage strength, along with sodium chloride, metacresol, sodium
`citrate, and water. (Ex. C, DTX 148; Ex. D, Treprostinil I Trial Tr. at 538:23-
`539:3). It is unclear why UTC would pursue its construction: under UTC’s
`construction, Sandoz’s ANDA product, a generic version of Remodulin®, would
`not infringe.
`7 Terms 3 and 13 differ only in their use of the articles “a” and “the,” respectively.
`They are otherwise identical, and the same analysis applies to both terms.
`
`
`
`12
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 19 of 61 PageID: 269
`
`
`
`Plain and ordinary meaning.
`
`
`
`“A process that includes, but is not
`limited to, the recited process steps, and
`may include, without limitation, any
`other non-recited steps.”
`
`Term 13 (claim 9)
`“the process comprising”
`
`Plain and ordinary meaning.
`
`
`
`“The process that includes, but is not
`limited to, the recited process steps, and
`may include, without limitation, any
`other non-recited steps.”
`
`a.
`
`There Is A Genuine Dispute As To The Proper
`Construction Of “A Process Comprising” Such That
`Construction Is Warranted
`
`UTC urges the Court not to construe “a process comprising” and instead
`
`adopt the term’s “plain and ordinary meaning.” UTC is wrong. The parties clearly
`
`dispute the scope of the claimed process, and this dispute can only be resolved
`
`through claim construction.
`
`The dispute is apparent in the parties’ competing proposed constructions of
`
`the term “product,” discussed above. UTC’s proposed construction suggests that
`
`the claimed process is limited to chemical reactions, while Sandoz’s proposed
`
`construction is not so limited. The dispute is also apparent in the parties’
`
`respective invalidity contentions, where UTC contends the claimed process
`
`produces a specific characteristic impurity profile while Sandoz contends the open-
`
`ended nature of the process means there is no characteristic impurity profile of the
`
`claimed process. This dispute would not be resolved by simply stating that the
`
`
`
`13
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41 Filed 07/07/15 Page 20 of 61 PageID: 270
`
`
`
`phrase should be given its plain and ordinary meaning, as UTC proposes. O2
`
`Micro, 521 F.3d at 1360-61 (“[a] determination that a claim term ‘needs no
`
`construction’ or has the ‘plain and ordinary meaning’ may be inadequate when . . .
`
`reliance on a term’s ‘ordinary’ meaning does not resolve the parties’ dispute”).
`
`This term should be construed and given Sandoz’s proposed construction; UTC
`
`offers none.
`
`b.
`
`Sandoz’s Proposed Construction Gives Effect To The
`Patentee’s Definition Of “Comprising”
`
`Sandoz’s proposed construction applies essentially verbatim the patentee’s
`
`definition of “comprising” as meaning “including but not limited to” and that
`
`“other non-mentioned . . . steps may be present.” (Ex. A, col. 4:23-25). See also
`
`Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003)
`
`(“The transition ‘comprising’ in a method claim indicates that the claim is open-
`
`ended and allows for additional steps”). The open-ended term “comprising”
`
`dictates that the while the claimed process must include the