Ex. 2003
`
`Pozen Inc. v. Par Pharm., Inc.,
`719 F.Supp.2d 718 (E.D. Tex. 2011)
`
`

`
`718
`
`719 FEDERAL SUPPLEMENT, 2d SERIES
`
`gram Administrator and the plaintiff has
`sued both Regions and Lot under the same
`contract—the 6697 Loan. Accordingly, the
`plaintiff’s actions have bound her to arbi-
`trate with Lot. See Grigson v. Creative
`Artists Agency, LLC, 210 F.3d at 528–29
`(estoppel binding non-signatory through
`claim on common instrument with signato-
`ry); Washington Mutual Finance Group,
`LLC v. Bailey, 364 F.3d 260, 266 (5th
`Cir.2004) (same); and Terminix Int’l, Inc.
`v. Rice, 904 So.2d 1051, 1058 (Miss.2004)
`(even though only the wife was the only
`signatory to the extermination contract at
`issue, because the husband’s claims related
`to the contract, he was also required to
`arbitrate even though he was a non-signa-
`tory).
`
`[7] Once the court finds that the par-
`ties agreed to arbitrate, it must then de-
`termine whether any legal constraints ex-
`ternal to the parties’ agreement foreclose
`the arbitration of the claims involved. The
`court can find no legal constraint which
`prevents this case from being submitted to
`arbitration. In fact, the plaintiff has stat-
`ed that she ‘‘does not claim that external
`legal constraints have foreclosed arbitra-
`tion in this case.’’ See Doc.[7] at 1–2.
`Once the court determines that a valid
`arbitration agreement exists and that the
`claims presented are arbitrable thereun-
`der, the court has to make a decision as to
`the course of the litigation before it. The
`FAA contemplates that parties that are
`aggrieved by another party’s failure to ar-
`bitrate under a written agreement, may
`file a motion to stay the trial of an action
`until such arbitration has been had in ac-
`cordance with the terms of the agreement.
`See, 9 U.S.C. § 3. After arbitration, the
`parties can then file a request with the
`court to enforce the results of the arbitra-
`tion. However, this court follows the prac-
`tice of dismissing the present litigation
`without prejudice subject to the refiling of
`
`an enforcement action at the conclusion of
`arbitration, if such is necessary.
`IT IS THEREFORE ORDERED AND
`ADJUDGED that the defendants’ Motion
`to Compel Arbitration [# 4] is Granted
`and the parties are ordered to submit the
`matter to binding arbitration as per the
`agreement between the parties.
`IT IS FURTHER ORDERED AND
`ADJUDGED that this matter is dismissed
`without prejudice subject to a refiling of a
`future separate action to enforce any arbi-
`tration award and that any other pending
`motions herein are denied as moot.
`
`,
`
`
`
`
`
`POZEN INC., Plaintiff,
`
`v.
`PAR PHARMACEUTICAL, INC., Al-
`phapharm Pty. Ltd., Teva Pharmaceu-
`ticals USA Inc., Dr. Reddy’s Laborato-
`ries, Inc., Defendants.
`
`Civil Action Nos. 6:08cv437–LED–
`JDL, 6:09cv003, 6:09cv182.
`
`United States District Court,
`E.D. Texas,
`Tyler Division.
`
`June 18, 2010.
`Background:
` Patentee brought action
`against competitors, alleging infringement
`of patents describing pharmaceutical for-
`mulation and corresponding methods for
`treating migraine headaches.
`Holdings: Following a Markman hearing,
`the District Court, John D. Love, United
`States Magistrate Judge, held that:
`(1) term ‘‘administering’’ meant to mete
`out, and
`
`

`
`POZEN INC. v. PAR PHARMACEUTICAL, INC.
`Cite as 719 F.Supp.2d 718 (E.D.Tex. 2010)
`
`719
`
`(2) term ‘‘multilayer pharmaceutical tab-
`let’’ meant a pharmaceutical tablet
`with at least two separate, distinct lay-
`ers.
`Ordered accordingly.
`
`1. Patents O165(2)
`The claims of a patent define the in-
`vention to which the patentee is entitled
`the right to exclude.
`2. Patents O314(5)
`Courts construe the scope and mean-
`ing of disputed patent claims as a matter
`of law.
`3. Patents O165(1), 167(1), 168(2.1)
`In patent claim construction, courts
`examine the patent’s intrinsic evidence to
`define the patented invention’s scope; in-
`trinsic evidence includes the claims them-
`selves, the specification, and the prosecu-
`tion history.
`4. Patents O157(1), 161
`Courts give patent claim terms their
`ordinary and accustomed meaning as un-
`derstood by one of ordinary skill in the art
`at the time of the invention in the context
`of the entire patent.
`5. Patents O162
`A patentee may define his own terms,
`give a claim term a different meaning than
`the term would otherwise possess, or dis-
`claim or disavow the claim scope.
`6. Patents O167(1)
`A specification may resolve ambiguous
`patent claim terms where the ordinary and
`accustomed meaning of the words used in
`the claims lack sufficient clarity to permit
`the scope of the claim to be ascertained
`from the words alone.
`7. Patents O167(1.1)
`Although a specification may aid the
`court in interpreting the meaning of dis-
`puted patent claim language, particular
`embodiments and examples appearing in
`
`the specification will not generally be read
`into the claims.
`8. Patents O101(2, 11)
`Term ‘‘administering’’ in patents de-
`scribing pharmaceutical formulation and
`corresponding methods for treating mi-
`graine headaches meant to mete out; term
`would be given its ordinary and customary
`meaning.
`9. Patents O101(2, 11)
`Term ‘‘concomitant administration’’ in
`patents describing pharmaceutical formu-
`lation and corresponding methods
`for
`treating migraine headaches meant simul-
`taneous administration or administration
`of second drug for migraine relief while
`first drug was present in a therapeutically
`effective amount.
`10. Patents O101(2, 11)
`Term ‘‘long-acting, nonsteroidal, anti-
`inflammatory drug’’ in patents describing
`pharmaceutical
`formulation and corre-
`sponding methods for treating migraine
`headaches meant an NSAID with a phar-
`macokinetic half-life of at least about 4-6
`hours and preferably about 8-14 hours and
`a duration of action equal to or exceeding
`about 6-8 hours.
`11. Patents O101(2, 11)
`Term ‘‘multilayer pharmaceutical tab-
`let’’ in patents describing pharmaceutical
`formulation and corresponding methods
`for treating migraine headaches meant a
`pharmaceutical tablet with at least two
`separate, distinct layers.
`Patents O328(2)
`6,060,499, 6,586,458, 7,332,183. Con-
`strued.
`
`Willem G. Schuurman, Erin A. Thom-
`son, Stephen M. Hash, Tracey B. Davies,
`Vinson & Elkins, Austin, TX, Collin Mi-
`
`

`
`720
`
`719 FEDERAL SUPPLEMENT, 2d SERIES
`
`chael Maloney, Otis W. Carroll, Jr, Ireland
`Carroll & Kelley, Tyler, TX, Daniel Lee
`Tobey, Vinson & Elkins, Dallas, TX, Petra
`Scamborova, Rebecca Cantor, Stephanie
`Lollo, Vinson & Elkins LLP, New York,
`NY, for Plaintiff.
`Allen Franklin Gardner, Michael E.
`Jones, Potter Minton PC, Deron R. Dacus,
`Ramey & Flock, Charles Ainsworth, Rob-
`ert Christopher Bunt, Parker Bunt &
`Ainsworth, Tyler, TX, Amy Schoenhard,
`Aziz Burgy, Janine A. Carlan, Joshua T.
`Morris, Richard J. Berman, Samuel C. Co-
`hen, Timothy W. Bucknell, Arent Fox,
`LLP, Washington, DC, Natalie Clayton,
`Thomas J. Parker, Alston & Bird LLP,
`New York, NY, Michael H. Teschner, Paul
`H. Kochanski, Stephen J. Brown, William
`L. Mentlik, Lerner David Littenberg
`Krumholz & Mentlik, Westfield, NJ,
`Claude Edward Welch, Law Office of
`Claude E. Welch, Lufkin, TX, Alexandra
`Olson, Jeffer Ali, Mark Schuman, Samuel
`T. Lockner, Carlson Caspers Vandenburgh
`& Lindquist, Minneapolis, MN, for Defen-
`dants.
`
`MEMORANDUM OPINION
`AND ORDER
`JOHN D. LOVE, United States
`Magistrate Judge.
`This Memorandum Opinion and Order
`sets forth the Court’s constructions for the
`disputed claim terms in the patents assert-
`ed by Plaintiff Pozen Inc. (‘‘Pozen’’). Po-
`zen asserts U.S. Patent Nos. 6,060,499
`(‘‘the 8499 patent’’), 6,586,458 (‘‘the 8458
`
`1. Defendant Teva Pharmaceuticals USA, Inc.
`originally joined in this briefing but later en-
`tered into a stipulation with Pozen on April
`14, 2010 to stay the case as to Teva based on
`a settlement reached by these two parties.
`
`2. The parties also provided the Court with a
`Joint Claim Construction Chart pursuant to
`P.R. 4–5(d).
`
`3. Sumatriptan is the preferred species in the
`‘‘triptan’’ family of drugs, also known as 5–
`
`patent’’), and 7,332,183 (‘‘the 8183 patent’’)
`and has filed an Opening Claim Construc-
`tion Brief (Doc. No. 164) (‘‘Opening’’), as
`well as a Reply in support of Pozen’s pro-
`posed constructions (Doc. No. 176) (‘‘Re-
`ply’’).
` Defendants Par Pharmaceutical,
`Inc., Alphapharm Pty Ltd., and Dr. Red-
`dy’s Laboratories, Inc. (collectively, ‘‘De-
`fendants’’) 1 have filed a Responsive Claim
`Construction Brief (Doc. No. 170) (‘‘Re-
`sponse’’). A Markman hearing was held
`on February 25, 2010 (Doc. No. 184),
`where thirteen disputed claim terms were
`submitted to the Court for construction.
`(Doc. No. 159–2) (‘‘Joint Claim Chart’’).2
`The Court entered a Provisional Claim
`Construction Order (Doc. No. 189) on
`March 26, 2010, 2010 WL 2231989. For
`the reasons stated herein, the Court
`adopts the constructions set forth below.
`
`BACKGROUND
`This case is a patent infringement suit
`arising out of the Hatch–Waxman Act, 21
`U.S.C. § 355.
` All three patents-in-suit
`cover a pharmaceutical formulation and
`corresponding methods for treating mi-
`graine headaches. The disclosed inven-
`tions relate to migraine treatment through
`the combination of two established drugs.
`The 8499 and 8458 patents disclose a treat-
`ment model that provides relief for mi-
`graine headaches through the simulta-
`neous administration of two therapeutic
`agents in a single tablet: (1) sumatriptan 3
`and (2) long-acting, non-steroidal anti-in-
`flammatory agent (‘‘LA–NSAID’’) naprox-
`en.4 The sumatriptan is targeted at reduc-
`
`HT agonists, which are a subtype of cell sur-
`face receptor proteins.
`
`4. Naproxen, or naproxen sodium, is the pre-
`ferred species of a class of non-steroidal anti-
`inflammatory drugs (‘‘NSAIDs’’), which binds
`in a highly selective way to 5–HT agonists
`(e.g. sumatriptan).
`
`

`
`POZEN INC. v. PAR PHARMACEUTICAL, INC.
`Cite as 719 F.Supp.2d 718 (E.D.Tex. 2010)
`
`721
`
`ing already-existing inflammation and the
`naproxen is targeted at reducing residual
`inflammation. OPENING at 4. The combina-
`tion of these drugs produces ‘‘longer last-
`ing efficacy’’ than the administration of
`either drug alone. 8458 patent at 2:18–22.
`This treatment model is currently sold
`in a single tablet as an FDA-approved
`pharmaceutical known as Treximetb. De-
`fendants have each submitted an Abbrevi-
`ated New Drug Application (‘‘ANDA’’) to
`the U.S. Food and Drug Administration
`(‘‘FDA’’) seeking approval to market a ge-
`neric bioequivalent of the Pozen product.
`These applications challenge the patents-
`in-suit by asserting that they are invalid or
`not
`infringed by Defendants’ proposed
`products. RESPONSE at 2. After Defen-
`dants filed ANDAs, Pozen filed three sepa-
`rate lawsuits,5 alleging infringement of the
`asserted claims. Claim 1 of the 8458 patent
`is set forth below as a representative
`claim, with disputed claim terms set forth
`in bold.
`1. A method of treating a patient for
`migraine headache, comprising:
`a) administering a 5–HT agonist to
`said patient, wherein said 5–HT
`agonist is a triptan; and
`b) administering a long-acting, non-
`steroidal, anti-inflammatory drug
`(LA–NSAID)
`to
`said
`patient,
`wherein said LA–NSAID has a
`pharmokinetic half-life of at least 4
`hours and a duration of action of at
`least 6 hours;
`wherein:
`i) said 5–HT agonist and said LA–
`NSAID are concomitantly admin-
`istered in unit dosage form; and
`(ii) the respective amounts of said
`5–HT agonist and said LA–NSAID
`administered to said patient are suf-
`
`ficient to produce longer lasting ef-
`ficacy compared to the administra-
`tion of said 5–HT agonist in the
`absence of said LANSAID or the
`administration of said LANSAID in
`the absence of said agonist.
`8458 patent at 12:6–25 (claim 1).
`The 8183 patent discloses a unique tablet
`architecture to orally administer the com-
`bination of therapeutic agents. In this
`delivery model, sumatriptan and naproxen
`are ‘‘segregated into separate layers’’ that
`dissolve in the stomach substantially inde-
`pendent of one another. 8183 patent at
`1:56–57. The specific oral dosage and the
`segregation of the therapeutic agents is
`intended to provide superior dissolution
`and absorption in the body. Id. at 1:60–62
`(‘‘The dosage forms of the invention have
`been found to have substantial advantages
`over others in terms of release properties,
`stability, and? pharmacokinetic profile.’’).
`The Treximetb product contains the tablet
`architecture claimed by the 8183 patent for
`the delivery of sumatriptan and naproxen.
`OPENING at 5. Claim 1 of the 8183 patent is
`set forth below as a representative claim
`with disputed claim terms set forth in bold.
`1. A multilayer pharmaceutical tab-
`let comprising naproxen and a triptan
`and, wherein
`a) substantially all of said triptan is
`in a first layer of said tablet and
`substantially all of said naproxen
`is in a second, separate layer; and
`b) said first layer and said second
`layer are in a side by side arrange-
`ment such that the dissolution of
`said naproxen occurs independently
`of said triptan.
`8183 patent at 18:30–37 (claim 1).
`The parties present thirteen disputed
`claim terms for construction. The fol-
`
`5. The separate lawsuits were consolidated
`into a single action in February 2009 (Doc.
`
`No. 30).
`
`

`
`722
`
`719 FEDERAL SUPPLEMENT, 2d SERIES
`
`lowing terms are presented from the
`8499 patent: 1) ‘‘by administering,’’ ‘‘ad-
`ministering,’’
`and
`‘‘administered’’;
` 2)
`‘‘concomitantly administering,’’ ‘‘concomi-
`tantly administered,’’ and
`‘‘concomitant
`administration’’; 3) ‘‘long-acting, nonster-
`oidal,
`anti-inflammatory
`drug
`(LA–
`NSAID);’’ 4) ‘‘said LA–NSAID is naprox-
`en.’’ The following terms are presented
`from the 8458 patent: 5) ‘‘a long-acting,
`nonsteroidal,
`anti-inflammatory
`drug
`(LA–NSAID)’’; 6) ‘‘concomitantly admin-
`istered’’; 7) ‘‘administering,’’ and ‘‘admin-
`istered’’; 8) ‘‘wherein said LA–NSAID is
`naproxen or a pharmaceutically accept-
`able salt thereof’’; 9) ‘‘said LA–NSAID
`is naproxen’’; 10) ‘‘wherein said naprox-
`en is in the form of a sodium salt.’’ The
`following terms are presented from the
`8183 patent: 11) ‘‘A multilayer pharma-
`ceutical tablet’’; 12) ‘‘substantially all of
`said triptan is in a first layer of said
`tablet and substantially all of said na-
`proxen is in a second, separate layer’’;
`and 13) ‘‘administering to said patient.’’ 6
`Due to the significant overlap of the
`terms as they are presented among the
`three patents, the Court will issue con-
`structions for the following ‘‘groups’’ of
`terms: 7 1) ‘‘administering’’ and its permu-
`tations; 2) ‘‘concomitant administration’’
`and its permutations; 3) ‘‘long-acting, non-
`steroidal, anti-inflammatory drug,’’ or
`‘‘LA–NSAID’’; 4) ‘‘said LA–NSAID is na-
`proxen’’; 5) ‘‘a multilayer pharmaceutical
`tablet’’; 6) ‘‘substantially all of said triptan
`is in a first layer of said tablet and sub-
`stantially all of said naproxen is in a sec-
`ond, separate layer.’’
`
`LEGAL STANDARD
`[1–4]
`‘‘It is a ‘bedrock principle’ of pat-
`ent law that ‘the claims of a patent define
`
`the invention to which the patentee is enti-
`tled the right to exclude.’ ’’ Phillips v.
`AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir.
`2005) (en banc) (hereinafter
`‘‘Phillips’’)
`(quoting Innova/Pure Water Inc. v. Safari
`Water Filtration Sys., Inc., 381 F.3d 1111,
`1115 (Fed.Cir.2004)). Under Markman v.
`Westview Instruments, Inc., the court con-
`strues the scope and meaning of disputed
`patent claims as a matter of law. 517 U.S.
`370, 373, 116 S.Ct. 1384, 134 L.Ed.2d 577
`(1996). In claim construction, courts ex-
`amine the patent’s intrinsic evidence to
`define the patented invention’s scope. See
`id.; C.R. Bard, Inc. v. U.S. Surgical Corp.,
`388 F.3d 858, 861 (Fed.Cir.2004); Bell Atl.
`Network Servs., Inc. v. Covad Commc’ns
`Group, Inc., 262 F.3d 1258, 1267 (Fed.Cir.
`2001). This intrinsic evidence includes the
`claims themselves, the specification, and
`the prosecution history. See Phillips, 415
`F.3d at 1314; C.R. Bard, Inc., 388 F.3d at
`861. Courts give claim terms their ordi-
`nary and accustomed meaning as under-
`stood by one of ordinary skill in the art at
`the time of the invention in the context of
`the entire patent. Phillips, 415 F.3d at
` Alloc, Inc. v. Int’l Trade
`1312–13;
`Comm’n, 342 F.3d 1361, 1368 (Fed.Cir.
`2003).
`The claims themselves provide substan-
`tial guidance in determining the meaning
`of particular claim terms. Phillips, 415
`F.3d at 1314. First, a term’s context in
`the asserted claim can be very instructive.
`Id. Other asserted or unasserted claims
`can also aid in determining the claim’s
`meaning because claim terms are typically
`used consistently throughout the patent.
`Id. Differences among the claim terms
`can also assist in understanding a term’s
`meaning. Id. For example, when a de-
`pendent claim adds a limitation to an in-
`
`6. The parties have also agreed to a number of
`constructions. See JOINT CHART (Doc. No. 159–
`1).
`
`7. Such groupings promote efficiency and
`track the manner in which they were argued
`at the claim construction hearing.
`
`

`
`POZEN INC. v. PAR PHARMACEUTICAL, INC.
`Cite as 719 F.Supp.2d 718 (E.D.Tex. 2010)
`
`723
`
`dependent claim, it is presumed that the
`independent claim does not include the
`limitation. Id. at 1314–15.
`[5–7]
`‘‘[C]laims ‘must be read in view
`of the specification, of which they are a
`part.’ ’’ Id. (quoting Markman v. West-
`view Instruments, Inc., 52 F.3d 967, 979
`(Fed.Cir.1995) (en banc)). ‘‘[T]he specifi-
`cation ‘is always highly relevant to the
`claim construction analysis. Usually, it is
`dispositive; it is the single best guide to
`the meaning of a disputed term.’ ’’ Id.
`(quoting Vitronics Corp. v. Conceptronic,
`Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996));
`Teleflex, Inc. v. Ficosa N. Am. Corp., 299
`F.3d 1313, 1325 (Fed.Cir.2002). This is
`true because a patentee may define his
`own terms, give a claim term a different
`meaning than the term would otherwise
`possess, or disclaim or disavow the claim
`scope. Phillips, 415 F.3d at 1316. In these
`situations, the inventor’s lexicography gov-
`erns. Id. Also, the specification may re-
`solve ambiguous claim terms ‘‘where the
`ordinary and accustomed meaning of the
`words used in the claims lack sufficient
`clarity to permit the scope of the claim to
`be ascertained from the words alone.’’ Te-
`leflex, 299 F.3d at 1325. Nonetheless,
`‘‘ ‘[a]lthough the specification may aid the
`court in interpreting the meaning of dis-
`puted claim language, particular embodi-
`ments and examples appearing in the spec-
`ification will not generally be read into the
`claims.’ ’’ Comark Commc’ns, Inc. v. Har-
`ris Corp., 156 F.3d 1182, 1187 (Fed.Cir.
`1998) (quoting Constant v. Advanced Mi-
`cro–Devices, Inc., 848 F.2d 1560, 1571
`(Fed.Cir.1988)); see also Phillips, 415 F.3d
`at 1323. The prosecution history is anoth-
`er tool to supply the proper context for
`claim construction because a patent appli-
`cant may also define a term in prosecuting
`the patent. Home Diagnostics, Inc. v.
`
`LifeScan, Inc., 381 F.3d 1352, 1356 (Fed.
`Cir.2004) (‘‘As in the case of the specifica-
`tion, a patent applicant may define a term
`in prosecuting a patent.’’).
`Although extrinsic evidence can be use-
`ful, it is ‘‘ ‘less significant than the intrinsic
`record in determining the legally operative
`meaning of claim language.’ ’’ Phillips,
`415 F.3d at 1317 (quoting C.R. Bard, Inc.,
`388 F.3d at 862). Technical dictionaries
`and treatises may help a court understand
`the underlying technology and the manner
`in which one skilled in the art might use
`claim terms, but technical dictionaries and
`treatises may provide definitions that are
`too broad or may not be indicative of how
`the term is used in the patent. Id. at
`1318. Similarly, expert testimony may aid
`a court in understanding the underlying
`technology and determining the particular
`meaning of a term in the pertinent field,
`but an expert’s conclusory, unsupported
`assertions as to a term’s definition is en-
`tirely unhelpful to a court. Id. Generally,
`extrinsic evidence is ‘‘less reliable than the
`patent and its prosecution history in deter-
`mining how to read claim terms.’’ Id.
`
`DISCUSSION
`
`I.
`
`‘‘administering’’ and its permuta-
`tions 8
`Plaintiff’s Proposed
`Construction
`Ordinary and customary
`meaning.
`
`Alternatively, ‘‘to mete
`out.’’
`
`Defendants’ Proposed
`Construction
`Putting into a patient
`
`[8] The patents-in-suit contain
`the
`terms ‘‘by administering,’’ ‘‘administering,’’
`‘‘administered,’’ and ‘‘administering to said
`patient.’’
` For ease of discussion, the
`Court will collectively discuss the repre-
`sentative term ‘‘administering’’ and permu-
`
`8. The term ‘‘administering’’ and its permuta-
`tions is contained in claims 1, 2, 3, 6, 7 and
`9–27 of the 8499 patent; claims 1, 2, 5, and 6–
`
`24 of the 8458 patent; and claims 13–18 and
`20 of the 8183 patent.
`
`

`
`724
`
`719 FEDERAL SUPPLEMENT, 2d SERIES
`
`tations of this term should be given the
`same construction in each patent. Omega
`Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314,
`1334 (Fed.Cir.2003) (‘‘we presume, unless
`otherwise compelled, that the same claim
`term in TTT related patents carries the
`same construed meaning’’).
`Pozen contends that the claim term
`should be given its ordinary and custom-
`ary meaning and no further construction is
`necessary because a person of ordinary
`skill in the art would readily understand
`the meaning of ‘‘administering’’ and its
`permutations. OPENING at 9–10. Pozen
`argues that if the Court is inclined to
`provide a construction,
`‘‘administering’’
`should mean ‘‘to mete out,’’ as it is set
`forth in Webster’s general purpose dictio-
`nary. Id. at 10.
`Defendants respond that the goal of
`the 8499 and 8458 patents is to treat mi-
`graines in patients, and this can only be
`accomplished when the drug is ‘‘put into
`a patient.’’
` RESPONSE at 6. Therefore,
`Defendants argue that the term must be
`construed more narrowly than its ordi-
`nary meaning to comport with the pat-
`ent’s description of the invention. Defen-
`dants cite to passages from the claim
`language and relevant specifications to
`argue that when the claims are read in
`the context of offering clinical treatment,
`‘‘administering’’ should mean putting the
`drug into a migraine patient. Id. at 6.
`As discussed at the hearing, it appears
`that Defendants are asking the Court to
`construe ‘‘administering’’ as it appears in
`non-asserted method claims only. This
`approach is unavailing at the current junc-
`ture because Pozen is not alleging in-
`fringement of the method claims underly-
`ing Defendants’ argument. For example,
`Defendants contend that claim 3 of the
`8499 patent and claim 5 of the 8458 patent
`teach that ‘‘administering’’ means ‘‘putting
`the drug in a migraine patient.’’ Defen-
`dants maintain that for these claims, this is
`
`the only definition that allows for the pat-
`ents’ claimed therapeutic effect. Evaluat-
`ing the patents as a whole, however, this
`context is not determinative where Pozen
`is not asserting these particular claims and
`the claim term can be understood without
`including Defendants’ proposed step that
`must occur ‘‘in a method for treating a
`migraine patient.’’ See, e.g., 8499 patent at
`13:39. The manner in which Defendants
`present the dispute frames a question as to
`when or how unasserted claims require a
`step—putting the drug into the patient—to
`perform the medical method.
`The Court declines to narrow the mean-
`ing of the claim term. Instead, the Court
`considers the intrinsic record for both the
`method and composition claims. Pozen
`has only asserted composition and thera-
`peutic package claims against Defendants,
`and the Court finds that ‘‘administering’’
`and all of its permutations (including those
`in unasserted method claims) have an ordi-
`nary and customary meaning. Abiding by
`the ‘‘heavy presumption’’ that a claim term
`carries its ordinary and customary mean-
`ing, CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359, 1366 (Fed.Cir.2002), one of
`ordinary skill in the art would understand
`‘‘administering’’ and its permutations as
`conveying its ordinary meaning in the con-
`text of the claim language. Brookhill–
`Wilk 1, LLC v. Intuitive Surgical, Inc.,
`334 F.3d 1294, 1298 (Fed.Cir.2003). De-
`fendants’ proposed construction, ‘‘putting
`into,’’ does not appear in the8499 patent
`and the Federal Circuit makes clear that
`additional limitations should not be read
`into the claim. Innova/Pure Water, 381
`F.3d at 1117–18. The claim terms are the
`primary source for the meaning of the
`claim, and ‘‘[a]bsent a clear disavowal or
`contrary definition in the specification or
`prosecution history, the patentee is enti-
`tled to the full scope of its claim language.’’
`Home Diagnostics, 381 F.3d at 1358; En-
`ercon GmbH v. Int’l Trade Comm’n, 151
`
`

`
`POZEN INC. v. PAR PHARMACEUTICAL, INC.
`Cite as 719 F.Supp.2d 718 (E.D.Tex. 2010)
`
`725
`
`F.3d 1376, 1384 (Fed.Cir.1998) (requiring
`that absent some special definition, claim
`terms are to be given their ordinary mean-
`ing). No such special definition or disa-
`vowal is found here.
`As discussed at the hearing, this readily-
`understandable term would include giving
`a patient a drug in any normal manner
`(i.e., providing a tablet to a patient under
`circumstances where it is reasonable to
`believe that a patient is going to take the
`tablet). Accordingly, the Court finds that
`the proper and most internally-consistent
`construction of the term ‘‘administering,’’
`and its relevant permutations, is its ordi-
`nary and customary meaning. For the sake
`of further clarity, the Court also deter-
`mines that the ordinary and customary
`meaning of ‘‘administering’’ is equivalent
`to the general purpose dictionary defini-
`tion of ‘‘administer.’’ Should the meaning
`of ‘‘administering’’ be called into question
`at trial, ‘‘to mete out’’ is an alternative
`reflection of the claim language.
`
`II.
`
`‘‘concomitant administration’’ and
`its permutations 9
`[9] The 8499 and 8458 patents both con-
`tain the claim terms ‘‘concomitantly admin-
`istering,’’
`‘‘concomitantly administered,’’
`and ‘‘concomitant administration.’’ In or-
`der to fully assess the context in which
`‘‘concomitant administration’’ and its per-
`mutations is presented, the Court assesses
`the term separately as it is used in each
`patent.
`
`A. The 8499 Patent
`Plaintiff’s Proposed
`Defendants’ Proposed
`Construction
`Construction
`
`Simultaneous administra-
`tion; or
`
`
`administration of a second
`drug for migraine relief
`while a first drug for mi-
`graine relief is present in a
`
`Putting into a patient two
`(or more) compositions (i.e.,
`drugs) such that:
`
`a) the drugs are put into a
`patient at the same time;
`or
`
`therapeutically effective
`amount; or
`
`administration of a 5–HT
`agonist and NSAID such
`that the effective plasma
`levels of the NSAID will
`be present in a subject
`from about one hour to
`about 12–24 hours after
`the onset of migraine
`or onset of precursor
`symptoms of a migraine.
`
`
`
`b) the second drug is put
`into a patient while the
`first drug is present in the
`patient in a therapeutically
`effective amount, or
`
`
`c) putting into a patient a
`5–HT agonist and NSAID
`such that effective plasma
`levels of the NSAID will be
`present in a subject from
`about one hour to about
`24 hours after the onset
`migraine or onset of
`precursor symptoms of a
`migraine.
`
`Pozen and Defendants present the same
`arguments discussed in the previous sec-
`tion as to disputed claim term ‘‘administer-
`ing’’ and its permutations. Having already
`provided a construction for this term in
`section I, supra, the Court incorporates
`the foregoing discussion and now turns to
`the meaning of ‘‘concomitantly.’’
`Pozen contends that the inventor acted
`as his own lexicographer in the 8499 patent
`specification and defined ‘‘concomitant ad-
`ministration’’ as ‘‘simultaneous administra-
`tion,’’ ‘‘co-timely administration,’’ or ‘‘coor-
`dinated administration.’’ OPENING at 12
`(citing 8499 patent at 7:37–8:5). Pozen also
`suggests that the language in the specifica-
`tion aligns with the ordinary and custom-
`ary meaning of the term, namely ‘‘simulta-
`neous administration.’’
`Defendants generally ‘‘agree with Pozen
`that the proposed construction for this
`term should be nothing more than the
`express definition of ‘concomitant adminis-
`tration’ from the 8499 patent specification,’’
`but Defendants dispute whether Plaintiff
`accurately characterizes the specification.
`RESPONSE at 11–12. Defendants maintain
`that to have a concomitant administration,
`
`9. The term ‘‘concomitant administration’’ and
`its permutations are contained in claims 1, 2,
`
`3, 5–8, and 9–27 of the 8499 patent and claims
`1, 2, 5, and 6–24 of the 8458 patent.
`
`

`
`726
`
`719 FEDERAL SUPPLEMENT, 2d SERIES
`
`there must be at least two drugs adminis-
`tered. After the Provisional Claim Con-
`struction Order was issued, Defendants
`moved the Court to clarify that ‘‘simulta-
`neous administration’’ should alternatively
`mean ‘‘administration of a second drug for
`migraine relief,’’ with the requested con-
`struction designating the combination of
`therapeutic agents and the time required
`to alleviate symptoms. (Doc. No. 204).
`As suggested by both parties, the 8499
`patent specification recites an express
`definition that describes the drug admin-
`istration:
` ‘‘For convenience, the term
`‘concomitant administration’ shall refer to
`‘simultaneous administration,’
`‘co-timely
`administration,’ or ‘coordinated adminis-
` See
`tration.’ ’’
`8499 patent at 8:1–5.
`Since this is an instance where the inven-
`tor has clearly defined his own terms, the
`inventor’s
`lexicography will govern the
`construction provided
`for
`‘‘concomitant
` Phillips, 415 F.3d at
`administration.’’
`1316. The 8499 patent prosecution histo-
`ry is also consistent as to the explicit
`definition. Accordingly, the Court finds
`that ‘‘concomitant administration’’ means
`‘‘simultaneous administration,’’ and fur-
`ther extrapolating ‘‘concomitantly’’ in the
`context of the
`8499 specification, the
`Court finds ‘‘concomitantly’’ to mean ‘‘si-
`multaneously.’’
`Alternatively, the Court adopts addition-
`al language 10 proposed first by Pozen at
`the Markman hearing, and then by Defen-
`dants in the Motion to Clarify the Provi-
`
`10. This additional language reads: ‘‘or ad-
`ministration of a second drug for migraine
`relief while a first drug for migraine relief is
`present in a therapeutically effective amount
`or administration of a 5–HT agonist and
`NSAID such that the effective plasma levels of
`the NSAID will be present in a subject from
`about one hour to about 12–24 hours after the
`onset of migraine or onset of precursor symp-
`toms of a migraine.’’ (Doc. No. 225 at 2, n.
`1).
`
`sional Claim Construction Order (Doc. No.
`204). The 8499 patent specifications sup-
`ports a broad understanding of ‘‘simulta-
`neously’’ that includes a ‘‘co-timely’’ or
` See 8499
`‘‘coordinated’’ administration.
`patent at 7:37–40, 46–51. It necessarily
`follows that a ‘‘simultaneous administra-
`tion’’ would include the limitations provid-
`ed for in ‘‘co-timely’’ 11 and ‘‘coordinated’’ 12
`administrations, such as the administration
`of a second drug. Therefore, the adminis-
`tration details disclosed in the 8499 patent
`specification are incorporated as an alter-
`native construction
`for
`‘‘simultaneous.’’
`The proper construction of the term ‘‘con-
`comitant administration’’ and its permuta-
`tions in the 8499 patent is ‘‘simultaneous
`administration,’’ or ‘‘administration of a
`second drug for migraine relief while a
`first drug for migraine relief is present in
`a therapeutically effective amount,’’ or ‘‘ad-
`ministration of a 5–HT agonist and
`NSAID such that the effective plasma lev-
`els of the NSAID will be present in a
`subject from about one hour to about 12–
`24 hours after the onset of migraine or
`onset of precursor symptoms of a mi-
`graine.’’
`
`B. The 8458 Patent
`Plaintiff’s Proposed
`Defendants’ Proposed
`Construction
`Construction
`Given in close enough tem-
`Putting into a patient two
`poral proximity to allow
`(or more) compositions (i.e.,
`their individual therapeutic
`drugs) such that they are
`effects to overlap.
`‘‘given in close enough tem-
`poral proximity to allow
`their individual therapeutic
`effects to overlap.’’
`
`‘‘Co-timely’’ is described in the8499 patent
`11.
`specification as: ‘‘administration of a second
`drug for migraine relief while a first drug for
`migraine relief is present in a therapeutically
`effective amount.’’ 8499 patent at 7:37–40.
`
`‘‘Coordinated’’ is described in the 8499 pat-
`12.
`ent specification as: ‘‘administration of an
`NSAID such that effective plasma levels of the
`NSAID will be present in a subject from about
`one hour to about 12–24 hours after the onset
`of migraine or onset of precursor symptoms
`of a migraine.’’ 8499 patent at 7:46–51.
`
`

`
`POZEN INC. v. PAR PHARMACEUTICAL, INC.
`Cite as 719 F.Supp.2d 718 (E.D.Tex. 2010)
`
`727
`
`The parties agree that claims using
`‘‘concomitantly’’ and its permutations in
`the 8458 patent are expressly defined, and
`they only dispute the meaning of ‘‘adminis-
`tration.’’ Incorporating the discussion of
`‘‘administering’’ as