Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 1 of 47 PageID: 535
`
`Stephen M. Orlofsky
`David C. Kistler
`New Jersey Resident Partners
`BLANK ROME LLP
`301 Carnegie Center, 3d Floor
`Princeton, NJ 08540
`Telephone: (609) 750-7700
`
`William C. Jackson
`BOIES, SCHILLER & FLEXNER LLP
`5301 Wisconsin Ave, NW
`Washington, DC 20015
`
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`Suite 200
`San Diego, CA 92130
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`Civil Action No. 3:14-cv-5499
`(PGS)(LHG)
`
`
`
`
`
`UNITED THERAPEUTICS
`CORPORATION,
`
`Plaintiff,
`
`
`
`
`v.
`
`
`
`SANDOZ, INC.,
`
`Defendant.
`
`
`PLAINTIFF’S OPENING CLAIM CONSTRUCTION BRIEF
`
`
`
`
`
`

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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 2 of 47 PageID: 536
`
`
`TABLE OF CONTENTS
`
`
`Page
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`Legal Standards ............................................................................................... 2
`
`III. Disputed Terms of the ’393 Patent .................................................................. 5
`
`A.
`
`Base Related Terms ............................................................................... 5
`
`1.
`
`2.
`
`“a base B” (claims 1 and 9) (Term 5) ......................................... 5
`
`“HB+” (claims 1 and 9) (Term 7) ............................................... 9
`
`B.
`
`Product Related Claim Terms ............................................................. 11
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
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`“Product” (claims 1 and 9) (Term 1) ........................................11
`
`“The product of claim 1” (claims 2, 4 and 8) (Term 10) ..........15
`
`“The product of claim 9” (claim 16) (Term 17) .......................16
`
`“The product of claim 1, wherein the purity of compound
`of formula I in said product is at least 99.5%” (claim 2)
`(Term 9) ....................................................................................20
`
`“A product comprising a compound of formula I...or a
`pharmaceutically acceptable salt thereof” (claim 1)
`(Term 2) ....................................................................................22
`
`“A product comprising a compound having formula
`IV...or a pharmaceutically acceptable salt thereof” (claim
`9) (Term 12) ..............................................................................22
`
`“(c) contacting the product of step (h) with a base B to
`form a salt of formula Is” (claim 1) (Term 8) ...........................24
`
`“(c) contacting the product of step (h) with a base B to
`form a salt of formula IVs” (claim 9) (Term 16) ......................25
`
`C.
`
`Process Related Terms ........................................................................ 28
`
`1.
`
`“a/the process comprising” (claims 1 and 9) (Terms 3 and
`13) .............................................................................................28
`
`2.
`
`“an alkylating agent” (claims 1 and 9) (Terms 4 and 14) .........30
`
`D.
`
`Salt Related Claim Terms ................................................................... 32
`
`1.
`
`“a salt of formula Is” (claim 1) (Term 6) ..................................32
`
`
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`-i-
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 3 of 47 PageID: 537
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`2.
`
`“a salt of formula IVs” (claim 9) (Term 15) .............................32
`
`E.
`
`Purification Related Claim Terms ....................................................... 35
`
`1.
`
`2.
`
`“purifying the compound of formula (III) produced in
`step (a)” (claim 8) (Term 11) ....................................................35
`
`“wherein the process does not include purifying the
`compound of formula (VI) produced in step (a)” (claim
`16) (Term 18) ............................................................................35
`
`IV. Conclusion ..................................................................................................... 40
`
`
`
`
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`-ii-
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 4 of 47 PageID: 538
`
`TABLE OF AUTHORITIES
`
`
`CASES
`
`ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc.,
`
`694 F.3d 1312 (Fed. Cir. 2012) ................................................................. 3, 25
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`
`239 F.3d 1343 (Fed. Cir. 2001) ..................................................................... 17
`
`Amgen Inc. v. F. Hoffman-La Roche Ltd,
`
`580 F.3d 1340 (Fed. Cir. 2009) ..................................................................... 17
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`
`314 F.3d 1313 (Fed. Cir. 2003) ..................................................................... 17
`
`Beachcombers, Int'l, Inc. v. WildeWood Creative Prods., Inc.,
`
`31 F.3d 1154 (Fed. Cir. 1994) ....................................................................... 17
`
`Biagro W. Sales, Inc. v. Grow-More, Inc.,
`
`423 F.3d 1296 (Fed. Cir. 2005) ....................................................................... 2
`
`C.R. Bard, Inc. v. M3 Sys., Inc.,
`
`157 F.3d 1340 (Fed. Cir. 1998) ..................................................................... 17
`
`CIAS, Inc. v. Alliance Gaming Corp.,
`
`504 F.3d 1356 (Fed. Cir. 2007) ..................................................................... 29
`
`DSW, Inc. v. Shoe Pavilion, Inc.,
`
`537 F.3d 1342 (Fed. Cir. 2008) ................................................................. 3, 28
`
`Elbex Video, Ltd. v. Sensormatic Elecs. Corp.,
`
`508 F.3d 1366 (Fed. Cir. 2007) ..................................................................... 27
`
`Epos Techs. Ltd. v. Pegasus Techs. Ltd.,
`
`766 F.3d 1338 (Fed. Cir. 2014) ....................................................................... 7
`
`Finjan, Inc. v. Secure Computing Corp.,
`
`626 F.3d 1197 (Fed. Cir. 2010) ................................................................. 3, 25
`
`Harris Corp. v. IXYS Corp.,
`
`114 F.3d 1149 (Fed. Cir. 1997) ....................................................................... 4
`
`Hastings v. United States,
`
`78 Fed. Cl. 729 (Fed. Cl. 2007) ................................................................. 4, 31
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc.,
`
`381 F.3d 1111 (Fed. Cir. 2004) ................................................................... 5, 6
`
`Input/Output, Inc. v. Sercel, Inc., No. 5:06-CV-236,
`
`2008 WL 5427982 (E.D. Tex. Apr. 28, 2008) .................................... 4, 29, 31
`
`
`
`-iii-
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`

`
`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 5 of 47 PageID: 539
`
`Jazz Pharms., Inc. v. Roxane Labs., Inc., No. 10-6108,
`
`2012 WL 4103880 (D.N.J. Sept. 14, 2010) ................................................... 19
`
`JVI, Inc. v. Truckform Inc., No. 11-6218,
`
`2012 WL 6708169 (D.N.J. Dec. 26, 2012) ................................................... 19
`
`The Medicines Co. v. Dr. Reddy’s Labs., Ltd., No. 11-2456,
`
`2013 WL 64913 (D.N.J. Jan. 3, 2013) ................................................. 6, 12, 20
`
`Nat’l Oilwell Varco, L.P. v. Auto-Drill, Inc., No. 5:09cv85,
`
`2011 WL 3648532 (E.D. Tex. Aug. 16, 2011) .............................................. 19
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`
`521 F.3d 1351 (Fed. Cir. 2008) ....................................................................... 3
`
`Phillips v. AWH Corp.,
`
`415 F.3d 1303 (Fed. Cir. 2005................................................................. 2, 3, 5
`
`Purdue Pharm. Products, L.P. v. Actavis Elizabeth, LLC, Nos. 12-5311,
`13-5003, 2014 WL 2624787 (D.N.J. June 11, 2014) .................................... 29
`
`Rosco, Inc. v. Velvac Inc., No. 11-117,
`
`2012 WL 6028239 (D. Del. Dec. 4, 2012) ............................................ 3, 4, 29
`
`Southwall Techs., Inc. v. Cardinal IG Co.,
`
`54 F.3d 1570 (Fed. Cir. 1995) ....................................................................... 17
`
`Teleflex, Inc. v. Ficosa N. Am. Corp.,
`
`299 F.3d 1313 (Fed. Cir. 2002) ....................................................................... 3
`
`Teva Pharm. USA, Inc. v. Sandoz, Inc.,
`
`135 S. Ct. 831 (2015) ....................................................................................... 5
`
`Toshiba Corp. v. Imation Corp.,
`
`681 F.3d 1358 (Fed. Cir. 2012) ....................................................................... 4
`
`United States Surgical Corp. v. Ethicon, Inc.,
`
`103 F.3d 1554 (Fed. Cir. 1997) ....................................................................... 4
`
`United Therapeutics Corp. v. Sandoz, Inc., Nos. 12-cv-1617, 13-cv-316,
`2014 WL 4259153 (D.N.J. Aug. 29, 2014) ................................................... 17
`
`-iv-
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 6 of 47 PageID: 540
`
`UTC
`
`Sandoz
`
`TABLE OF ABBREVIATIONS
`
`Plaintiff United Therapeutics Corporation
`
`Defendant Sandoz, Inc.
`
`’393 patent
`
`U.S. Patent No. 8,497,393
`
`ANDA
`
`__:__
`
`D.D.
`
`W.D.
`
`Ex.
`
`POSA
`
`Abbreviated New Drug Application
`
`The column and line numbers, respectively, of a U.S.
`patent
`
`The Declaration of Bobby Delafield In Support of United
`Therapeutics’ Opening Claim Construction Brief
`
`The Declaration of Robert M. Williams In Support of
`United Therapeutics’ Opening Claim Construction Brief
`
`
`
`
`
`
`
`
`
`Exhibit
`
`A person of ordinary skill in the art
`
`Formula I
`
`
`
`
`
`Formula Is
`
`
`
`
`
`
`
`
`
`Formula IV
`
`
`
`
`
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`
`
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`-v-
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 7 of 47 PageID: 541
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`Formula IVs
`
`
`
`
`
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`
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`-vi-
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 8 of 47 PageID: 542
`
`Introduction
`
`I.
`
`
`This case relates to Sandoz’s proposed marketing and sale of a generic copy
`
`of UTC’s REMODULIN® (Treprostinil Sodium) Injection product. UTC holds
`
`approved New Drug Application No. 21-272 for Treprostinil Sodium Injection,
`
`which UTC markets and sells as REMODULIN®. The ’393 patent, entitled
`
`“Process To Prepare Treprostinil, The Active Ingredient In Remodulin®,” appears
`
`in the FDA “Orange Book” for REMODULIN®. The patent contains twenty-two
`
`product-by-process claims, including two independent claims, directed to an
`
`improved treprostinil product.
`
`Sandoz asks the Court to construe eighteen terms, which encompass nearly
`
`every word in the claims. In effect, Sandoz invites the Court to rewrite the claims
`
`in an effort to create non-infringement and invalidity positions where none
`
`otherwise exist. The plain fact is that none of the terms Sandoz identifies require
`
`construction because they are readily understandable by a person of ordinary skill
`
`in the art (POSA). Sandoz’s proposed constructions are nothing more than attempts
`
`to change the scope of the claims from what a POSA would understand by either
`
`improperly broadening the claims so as to create an invalidity challenge, or
`
`erroneously narrowing the claims to manufacture its non-infringement position.
`
`Sandoz’s proposed constructions for the ’393 patent violate the most basic
`
`principles of claim construction by adding limitations not found in the claims, by
`
`
`
`

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`excluding preferred embodiments from the claims, and by rewriting claim terms
`
`with constructions that do not define or explain the term. Specifically, Sandoz’s
`
`proposed constructions exclude entirely from their scope the very methods that the
`
`’393 invention addresses: the efficient process for producing prostacyclin
`
`derivatives and novel intermediate compounds on a large scale suitable for
`
`commercial production.
`
`UTC respectfully requests that the Court reject Sandoz’s proposed
`
`constructions and instead construe the disputed terms as drafted according to their
`
`plain and ordinary meaning. If the Court is inclined to enter a specific claim
`
`construction for a given term, UTC has provided an alternative proposed
`
`construction consistent with the plain and ordinary meaning as well as the intrinsic
`
`and extrinsic evidence.
`
`II. Legal Standards
`
`
`“[C]laim construction begins with, and remains focused on, the language of
`
`the claims.” Biagro W. Sales, Inc. v. Grow-More, Inc., 423 F.3d 1296, 1302 (Fed.
`
`Cir. 2005) (internal citations omitted). “It is a bedrock principle of patent law that
`
`the claims of a patent define the invention to which the patentee is entitled the right
`
`to exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en
`
`banc) (internal quotations omitted). Claim terms are generally given their plain
`
`and ordinary meaning. Id. at 1312-13. “[T]he ordinary and customary meaning of
`
`
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`-2-
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`

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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 10 of 47 PageID: 544
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`a claim term is the meaning that the term would have to a [POSA] in question at
`
`the time of the invention, i.e., as of the effective filing date of the patent
`
`application.” Id. at 1313. Indeed, there is “a ‘heavy presumption’ that a claim
`
`term carries its ordinary and customary meaning.” Teleflex, Inc. v. Ficosa N. Am.
`
`Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002); DSW, Inc. v. Shoe Pavilion, Inc., 537
`
`F.3d 1342, 1347 (Fed. Cir. 2008) (“[A]bsent contravening evidence from the
`
`specification or prosecution history, plain and unambiguous claim language
`
`controls the construction analysis.”). “[D]istrict courts are not (and should not be)
`
`required to construe every limitation present in a patent’s asserted claims.” O2
`
`Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir.
`
`2008) (emphasis omitted).
`
`Courts often decline to construe claim terms for a variety of reasons. For
`
`example, courts permit claim terms to carry their plain and ordinary meanings
`
`where the opposing proposed construction erroneously reads limitations into the
`
`claims. Finjan, Inc. v. Secure Computing Corp., 626 F.3d 1197, 1207 (Fed. Cir.
`
`2010); ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1326
`
`(Fed. Cir. 2012). Courts also permit claim terms to carry their plain meanings
`
`where a party’s proposed construction accomplishes nothing helpful and is a mere
`
`attempt to rewrite the claim language or create confusion. Rosco, Inc. v. Velvac
`
`Inc., No. 11-117, 2012 WL 6028239, at *8 (D. Del. Dec. 4, 2012) (stating that
`
`
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`-3-
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 11 of 47 PageID: 545
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`“claim construction should not become an obligatory exercise in redundancy”
`
`(internal quotation omitted)); United States Surgical Corp. v. Ethicon, Inc., 103
`
`F.3d 1554, 1568 (Fed. Cir. 1997) (“The Markman decisions do not hold that the
`
`trial judge must repeat or restate every claim term . . . It is not an obligatory
`
`exercise in redundancy.”); Input/Output, Inc. v. Sercel, Inc., No. 5:06-CV-236,
`
`2008 WL 5427982, at *10 (E.D. Tex. Apr. 28, 2008) (declining to provide
`
`constructions “where it would cause further confusion by introducing synonymous
`
`words that would themselves require construction or where providing a
`
`construction would improperly limit the scope of the claim”).
`
`Finally, when courts find that terms are readily understood, the claim terms
`
`require no further interpretation. “The Federal Circuit has held that where the
`
`claim term’s meaning is apparent on its face, the court need not venture far from
`
`the claim language itself, long admonishing courts not to make constructions that
`
`‘contribute nothing but meaningless verbiage to the definition of the claimed
`
`invention.’” Hastings v. United States, 78 Fed. Cl. 729, 733 (Fed. Cl. 2007)
`
`(quoting Harris Corp. v. IXYS Corp., 114 F.3d 1149, 1152 (Fed. Cir. 1997)).
`
`Absent a disclaimer of subject matter (i.e., a clear or unmistakable surrender of
`
`subject matter in the patent specification or prosecution history) or lexicography
`
`explicitly defining a claim term, the plain meaning of the claim controls. Toshiba
`
`Corp. v. Imation Corp., 681 F.3d 1358, 1369 (Fed. Cir. 2012).
`
`
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`-4-
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 12 of 47 PageID: 546
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`If a claim term is construed, courts should construe claim terms in view of
`
`the intrinsic evidence, which includes the claim language, the specification, and the
`
`prosecution history. See Phillips, 415 F.3d at 1312-17. Courts are permitted to
`
`consider extrinsic evidence when testimony of scientific witnesses is indispensable
`
`to a correct understanding of a claim’s meaning. See, Teva Pharm. USA, Inc. v.
`
`Sandoz, Inc., 135 S. Ct. 831, 841 (2015) (“In some cases, however, the district
`
`court will need to look beyond the patent’s intrinsic evidence and to consult
`
`extrinsic evidence in order to understand, for example, the background science or
`
`the meaning of a term in the relevant art during the relevant time period.”)
`
`(citations omitted). A court’s claim construction analysis is centered on the claim
`
`language itself as it is the claims, not the specification, which defines the
`
`invention. See Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381
`
`F.3d 1111, 1115 (Fed. Cir. 2004).
`
`III. Disputed Terms of the ’393 Patent
`A. Base Related Terms
`“a base B” (claims 1 and 9) (Term 5)1
`1.
`
`
`UTC’s Proposed Plain and ordinary meaning. To the extent the Court
`
`
`1 UTC has ordered the terms to be construed by general subject matter – first, terms related to
`the meaning of the base involved; then terms related to the product involved; third, terms related
`to the process involved; fourth, related to the salt forms involved; and finally terms related to
`purification. UTC believes that placing the terms in this order will allow the Court and the
`parties to focus on each general topic in order, reducing confusion and inconsistency. UTC
`invited Sandoz to use a similar order, but Sandoz declined. For ease of reference, UTC has
`identified the term number for this claim term as listed in the Joint Claim Construction and Pre-
`Hearing Statement filed on June 3, 2015 [Dkt. No. 36].
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`-5-
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 13 of 47 PageID: 547
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`Construction
`
`determines that this term requires construction, UTC proposes
`the following:
`“a substance that produces hydroxide ions in aqueous solution,
`a proton acceptor”
`“A chemical species capable of receiving a proton (hydrogen
`ion, i.e., H ) from the product of step (b) to form the
`positively charged conjugate acid HB .”
`
`Sandoz’s
`Proposed
`Construction
`
`The term “a base B” is a prime example of Sandoz seeking to improperly
`
`narrow claim scope to generate a non-infringement argument where none exists.
`
`In chemistry, a POSA would understand that bases can exhibit their property of
`
`basicity through a number of mechanisms, including by producing hydroxide ions
`
`or by accepting protons. W.D. at ¶¶ 18-27. Sandoz, through improper claim
`
`construction, seeks to eliminate all but one of these mechanisms from the
`
`definition of the word “base.”
`
`The term “a base B” was used commonly and was readily understood by
`
`POSAs at the time of the invention to include chemicals that exhibit basic
`
`properties regardless of the mechanism. See W.D. at ¶¶ 26-28. As such, this term
`
`would have been clear and unambiguous to a POSA, and require no further
`
`construction. See The Medicines Co. v. Dr. Reddy’s Labs., Ltd., No. 11-2456,
`
`2013 WL 64913, at *2 (D.N.J. Jan. 3, 2013) (Sheridan, J.). Nothing in the patent
`
`claims or specification suggests any construction for the term “a base B” other than
`
`its plain and ordinary meaning.
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`
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 14 of 47 PageID: 548
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`In fact, Sandoz’s proposed construction excludes from the scope of “base B”
`
`substances explicitly taught in the ’393 patent as being suitable as “base B.” The
`
`claims and specification provide examples of substances that may act as base B in
`
`the claimed reaction, including “ammonia, N-methylglucamine, procaine,
`
`tromethanine, magnesium, L-lysine, L-arginine, triethanolamine, and
`
`diethanolamine.” See D.D. Ex. 1 at UTC_REM_II_000003365, patent claims 5,
`
`13, 17; UTC_REM_II_000003360, Col. 9:3-5. Each of these substances can
`
`produce hydroxide ions in aqueous solution, or can act as a proton acceptor, but
`
`not necessarily both. For example, ammonia is a proton acceptor, and magnesium
`
`is a substance capable of producing hydroxide ions in aqueous solution. W.D. at ¶
`
`27. Thus, under Sandoz’s construction, magnesium would not qualify as “a base
`
`B” despite the ’393 patent’s express statement to the contrary. Sandoz’s
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`construction cannot be correct. See, Epos Techs. Ltd. v. Pegasus Techs. Ltd., 766
`
`F.3d 1338, 1347 (Fed. Cir. 2014) (vacating the district court’s construction finding
`
`“[t]he district court’s construction is incorrect because it reads out preferred
`
`embodiments.”).
`
`The practical effect of Sandoz’s construction is to exclude an entire class of
`
`bases, including the sodium base Sandoz intends to use in its ANDA product.
`
`Specifically, Sandoz’s construction only allows for bases that are “a chemical
`
`species capable of receiving a proton (hydrogen ion, i.e., H+) from the product of
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 15 of 47 PageID: 549
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`step (b) to form the positively charged conjugate acid HB+” but not other
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`substances that a POSA would know to be a base by virtue of other properties, e.g.,
`
`producing hydroxide ions or otherwise not forming the complementary cation
`
`accepting the proton as part of that cationic structure. W.D. at ¶ 41. This is at odds
`
`with the express teachings of the ’393 patent, as discussed above. W.D. at ¶¶ 38-
`
`40. Sandoz’s construction is also inconsistent with the relevant extrinsic evidence
`
`as a POSA would understand that both proton acceptor bases and hydroxide ion
`
`producing bases are commonly used and would be considered “a base B” in the
`
`context of the ’393 patent. W.D. at ¶¶ 18-41. Accordingly, Sandoz’s proposed
`
`construction should be rejected.
`
`To the extent the Court determines that this term requires construction, UTC
`
`proposes a construction, above, sourced directly from a well-known chemistry
`
`textbook, and is consistent with the intrinsic evidence. See W.D. at ¶ 25; D.D. Ex.
`
`2. Indeed, “[a] POSA would understand this as a complete definition for a base as
`
`it encompasses bases that act as hydroxide ion producers or proton acceptors.”
`
`W.D. at ¶ 26. Additionally, the letter “B” is often used to denote a base, regardless
`
`of whether it is a hydroxide ion producer or proton acceptor. Id.at ¶ 26-28; D.D.
`
`Exs. 3-4. UTC’s construction is further supported by the extrinsic evidence. Many
`
`well-known chemistry references define “base” as a proton acceptor or hydroxide
`
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 16 of 47 PageID: 550
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`ion producer, consistent with UTC’s construction. W.D. at ¶ 39; see also D.D.
`
`Exs. 4-10.
`
`2.
`
` “HB+” (claims 1 and 9) (Term 7)
`
`
`UTC’s Proposed
`Construction
`
`Plain and ordinary meaning. To the extent the Court
`determines that this term requires construction, UTC proposes
`the following:
`“the cation formed in aqueous solution by base B subsequent to
`reacting base B with the product of step (b)”
`“The positively charged conjugate acid of base B formed when
`base B receives a proton (hydrogen ion, i.e., H ) from the
`product of step (b).”
`
`Sandoz’s
`Proposed
`Construction
`
`The term “HB+” is neither ambiguous nor overly technical and should also
`
`be given its plain and ordinary meaning. Nonetheless, Sandoz proposes an
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`improperly narrow construction that excludes preferred embodiments. Much like
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`Sandoz’s proposed construction for “base B,” Sandoz’s proposed construction for
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`“HB+” improperly excludes from the claims certain types of bases. Specifically,
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`Sandoz seeks to exclude any base that does not receive “a proton (hydrogen ion,
`
`i.e., H+) from the product of step (b) to form the positively charged conjugate acid
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`HB+.”. W.D. at ¶¶ 40-41. For example, magnesium is specifically identified in the
`
`specification as an example of “base B” and other metals such as sodium,
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`potassium, and calcium are similarly identified as bases to form base addition salts,
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`but each of these bases do not accept the “H+” as part of the complementary
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`cationic species. W.D. at ¶¶ 29-41. But a POSA would understand from the claim
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`itself and the specification that this term is directed to the resulting chemical
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 17 of 47 PageID: 551
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`species after “a base B” has been exposed to the product of step (b) as specified in
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`the claims. For all the same reasons that “a base B” should not be improperly
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`construed to exclude particular types of bases, the term “HB+” should similarly not
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`be read in Sandoz’s narrow fashion to exclude whole categories of bases.
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`To the extent the Court determines that this term requires construction, UTC
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`proposes a construction, above, that is supported by the intrinsic evidence, does not
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`exclude bases identified in the specification, and is consistent with the
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`understanding of a POSA. The claims and specification consistently depict the
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`species “HB+” as the aqueous cation formed after “a base B” is reacted with the
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`product of step (b), as specified by the ’393 patent. See D.D. Ex. 1 at
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`UTC_REM_II_000003357, Col. 3:4-15, Col. 3:66-4:15;
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`UTC_REM_II_000003358-59, Col. 6:66-7:10; UTC_REM_II_000003364-65,
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`claims 1, 9.
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`UTC’s proposed construction is also consistent with the use of the term “a
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`base B” in the ’393 patent, as discussed above, and with the patent’s examples of
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`substances that may act as base B. See id. at UTC_REM_II_000003365, patent
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`claims 5, 13, 17; UTC_REM_II_000003360, Col. 9:3-5. Each of these substances
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`can be reacted with the product of step (b) through the claimed process to produce
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`a cation in aqueous solution. UTC’s construction similarly comports with how a
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`POSA would understand the term “HB+” in the context of the ’393 patent. As
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 18 of 47 PageID: 552
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`previously noted, “B” is commonly used to refer to a base. W.D. at ¶¶ 26-28.
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`“Likewise, ‘BH+’ or ‘HB+’ is also often used to represent the cation (or positively
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`charged ion) formed in aqueous solution by base B,” regardless of whether the
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`‘H+’ is actually accepted as part of the complementary cationic species or not.
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`W.D. at ¶44. The ’393 patent definition for “base B” is consistent with this
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`understanding because magnesium is specifically listed as an example, but
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`magnesium-sourced bases do not accept the proton (H+) as part of the
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`complementary magnesium cationic species directly. W.D. at ¶¶ 38, 41, 43. Thus,
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`HB+ is a commonly-used descriptor for the conjugate acid of base B that would
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`have been easily understood by a POSA given the specific context. W.D. at ¶ 44-
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`45; see also D.D. Ex. 3.
`
`B.
`
`Product Related Claim Terms
`1.
`“Product” (claims 1 and 9) (Term 1)
`Plain and ordinary meaning. To the extent the Court
`UTC’s Proposed
`determines that this term requires construction, UTC
`Construction
`proposes the following:
`“a substance resulting from a chemical reaction”
`“A chemical composition.”
`
`Sandoz’s Proposed
`Construction
`
`
`Sandoz proposed that the term “product” be construed as “a chemical
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`composition.” Undoubtedly, Sandoz will use that definition to roll-out its
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`previously failed argument that any previously prepared treprostinil invalidates any
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`product-by-process claim that yields a single molecule of treprostinil. UTC,
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`however, submits that “product” requires no construction because a POSA would
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 19 of 47 PageID: 553
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`understand it to mean the real world product of a chemical reaction, particularly in
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`the context of these product-by-process claims. The meaning of “product” is
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`readily apparent to a POSA and, thus, no construction should be required. See The
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`Medicines Co., 2013 WL 64913, at *2.
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`To the extent the Court opts to construe the claim language, UTC’s proposes
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`that it means “a substance resulting from a chemical reaction,” which is consistent
`
`with the plain and ordinary meaning of the term as used in the context of the ’393
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`patent as well as the extrinsic evidence.
`
`The intrinsic evidence supports this definition. In particular, the claims and
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`specification of the ’393 patent consistently use the word “product” to refer to a
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`substance resulting from a chemical reaction. See D.D. Ex. 1 at
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`UTC_REM_II_000003358, Col.5:45-46 (“the product of the process according to
`
`the present invention”); UTC_REM_II_000003359, Col. 7:16-20 (“a compound of
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`formula XI, which is a cyclization product of a compound of formula X”);
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`UTC_REM_II_000003364, Col.17:37-40 (“This process provides better quality of
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`final product.”); UTC_REM_II_000003364-66, claims 1-22.
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`In the prosecution history, UT distinguished the “product” of the claimed
`
`invention from the prior art on the basis that both the chemical process steps
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`recited in the claims “and the products resulting from those steps are different than
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`the chemical process and product of” the prior art reference. D.D. Ex. 11 at
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`UTC_REM_II_000003490.2 Furthermore, Dr. David Walsh submitted a
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`declaration providing “evidence that the product of present claims is physically
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`differen[t] than treprostinil produced according to the process of [the prior art].”
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`Id. at UTC_REM_II_000003513. The file history’s clear use of the term “product”
`
`to refer to the real world substance that results from employing a specific chemical
`
`process, as differentiated from the substance obtained from employing a different
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`chemical process, is consistent with the plain and ordinary meaning of this term
`
`and with UTC’s proposed construction.
`
`UTC’s construction also comports with how a POSA would understand
`
`these terms in the context of the ’393 patent. Indeed, well-known chemistry
`
`textbooks specifically define “product” as “a substance resulting from a chemical
`
`reaction; it is shown to the right of the arrow in a chemical equation.” W.D. at ¶
`
`50; D.D. Ex. 12; see also Ex. 13. Several other references also similarly define or
`
`describe a “product” to indicate it is the result of a chemical reaction. W.D. at ¶ 51;
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`D.D. Exs. 14-15. In fact, Dr. Williams’ own publications as well as Sandoz’s
`
`expert Dr. Heathcock’s publications also describe the term “product” as the
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`resulting substance of a reaction. W.D. at ¶ 52; D.D. Exs. 16-22.
`
`Simply put, the “product” claimed in a product-by-process claim is
`
`necessarily a substance that results from the process specified in that claim. In the
`
`2 D.D. Ex. 11 is the certified copy of the ’393 patent file history which was also produced at
`UTC_REM_II_000001334-1501 and SDZ5499 0004761-4932.
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`Case 3:14-cv-05499-PGS-LHG Document 42 Filed 07/07/15 Page 21 of 47 PageID: 555
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`case of the ’393 patent, wherein the claims specify the process of a certain
`
`chemical reaction, the claimed “product” must be understood to be “a substance
`
`resulting from a chemical reaction.” UTC’s proffered definitions, for both the term
`
`“product” and for other related terms that contain this word, comport with this
`
`understanding.
`
`Sandoz’s construction of “product” is overbroad, ignores the very nature of
`
`the claims, and is inconsistent with how a POSA would understand the term in the
`
`context of the ’393 patent and with the intrinsic and extrinsic evidence.
`
`Furthermore, Sandoz’s definition of “product” erroneously removes from the term
`
`any reference to the process (i.e., a chemical reaction) by which the product is
`
`made. In doing so, Sandoz’s definition disregards both the intrinsic evidence and
`
`the nature of a product-by-process claim. Here, Sandoz attempts to improperly
`
`broaden the scope of the term “product” to encompass any “chemical composition”
`
`in an attempt to invalidate the p