IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`UCB INC UCB BIOPHARMA SPRL
`RESEARCH CORPORATION
`TECHNOLOGIES INC and HARRIS FRC
`CORPORATION
`
`Plaintiffs
`
`ACCORD HEALTHCARE INC et
`
`Defendants
`
`C.A No I3-l2O6.LPS
`CONSOLIDATED
`
`Blumenfeld Maryellen Noreika Paul Saindon Ethan
`Jack
`NICHOLS ARSHT
`TUNNELL LLP Wilmington DE
`Berman Jeffrey
`Andersen Michael
`Elikan Erica
`Pappas Paul
`George
`Nofal COVINGTON
`BURLING LLP Washington DC
`Christopher
`Hansen COVINGTON
`BURLING LLP San Francisco CA
`Alexa
`
`Townsend MORRIS
`
`Chajon
`
`Attorneys for Plaintiffs
`
`Kenneth
`
`John
`
`Dorsney MORRIS JAMES LLP Wilmington DE
`Shaw SHAW KELLER LLP Wilmington DE
`Tiradentes BAYARD P.A Wilmington
`Brauerman Vanessa
`Kirk Stephen
`
`Kraman YOUNG CONA WAY STARGATT
`
`TAYLOR LLP
`
`Richard
`DE
`Adam
`Poff Pilar
`Wilmington DE
`Gattuso PROCTOR HEYMAN LLP Wilmington DE
`Dominick
`Francis Murphy MURPHY
`LANDON Wilmington DE
`Haney PHILLIPS GOLDMAN
`Phillips Jr Megan
`John
`DE
`Nicole Stafford WILSON SONSINI GOODRICH
`
`SPENCE P.A Wilmington
`
`ROSATI Austin TX
`
`Attorneys for Defendants
`
`MEMORANDUM OPINION
`
`May 14 2015
`Wilmington DE
`
`MYLAN - EXHIBIT 1007
`
`

`
`STARK U.S District Judge
`
`Plaintiffs Research Corporation Technologies
`
`Inc Harris FRC Corporation and UCB
`
`BioPharma SPRL Plaintiffs filed patent infringement actions against multiple defendants
`
`Defendants for infringing U.S Reissued Patent No RE 38551 the 551 Patent after
`
`Defendants filed Abbreviated New Drug Applications with the U.S Food and Drug
`
`Administration
`
`The 551 Patent generally relates to an anticonvulsant drug marketed
`
`under the name Vimpat having lacosamide as its active ingredient Id
`
`Pending before the Court is the issue of claim construction for one term in the patent-in
`
`suit therapeutic composition as used in claim 10 The parties completed briefing on claim
`
`construction on November 24 2014 D.I 158 160 176 178 In addition to briefing the parties
`
`submitted multimedia technology tutonals
`
`167 168 The Court held
`
`claim consturction
`
`hearing on December 15 2014 See Transcript Tr
`
`LEGAL STANDARDS
`
`The ultimate question of the proper construction of patent is
`
`question of law See
`
`Teva Pharm USA Inc
`
`Sandoz Inc 135 Ct 831 837 2015 citing Markinan
`
`Westview
`
`Instruments Inc 517 U.S 370 388-91 1996 It is
`
`bedrock principle of patent law that the
`
`claims of patent define the invention to which the patentee is entitled the right to exclude
`
`Phillips
`
`WH Corp 415
`
`3d 1303 1312 Fed Cir 2005 internal quotation marks omitted
`
`is no magic formula or catechism for conducting claim construction Phillips 415
`
`F.3d at 1324 Instead the court is free to attach the appropriate weight
`
`to appropriate sources in
`
`light of the statutes and policies that inform patent law Id
`
`words of claim are generally given their ordinary and customary meaning
`
`

`
`is the meaning that the term would have to
`
`person of ordinary skill
`
`in the art in
`
`question at the time of the invention i.e as of the effective filing date of the patent application
`
`Id at 1312-13 internal citations and quotation marks omitted
`
`ordinary meaning of
`
`claim term is its meaning to the ordinary artisan after reading the entire patent
`
`Id at 1321
`
`internal quotation marks omitted The patent specification is always highly relevant
`
`to the
`
`claim construction analysis Usually it
`
`is dispositive it
`
`is the single best guide to the meaning of
`
`disputed term Vitronics Corp
`
`Conceptronic
`
`Inc 90 F.3d 1576 1582 Fed Cir 1996
`
`While the claims themselves provide substantial guidance as to the meaning of particular
`
`claim terms the context of the surrounding words of the claim also must be considered
`
`Phillips 415
`
`3d at 1314 Furthermore
`
`claims of the patent in question both asserted
`
`and unasserted can also be valuable sources of enlightenment..
`
`claim terms are
`
`normally used consistently throughout
`
`the patent
`
`Id internal citation omitted
`
`It
`
`is likewise true that
`
`among claims can also be
`
`useful guide... For
`
`example the presence of
`
`dependent claim that adds
`
`particular limitation gives rise to
`
`presumption that the limitation in question is not present in the independent claim Id at 1314-
`
`15 internal citation omitted This presumption is especially strong when the limitation in
`
`dispute is the only meaningful difference between an independent and dependent claim and one
`
`party is urging that the limitation in the dependent claim should be read into the independent
`
`claim SunRace Roots Enter Co Ltd
`
`SRAM Corp 336 F.3d 1298 1303 Fed Cir 2003
`
`It
`
`is also possible that the specification may reveal
`
`special definition given to
`
`claim
`
`term by the patentee that differs from the meaning it would otherwise possess
`
`In such cases the
`
`inventors lexicography governs Phillips 415 F.3d at 1316 It bears emphasis that
`
`

`
`when the specification describes only
`
`single embodiment the claims of the patent will not be
`
`read restnctively unless the patentee has demonstrated
`
`clear intention to limit
`
`the claim scope
`
`using words or expressions of mamfest exclusion or restnction Liebel-Flarsheim Co
`
`Medrad Inc 358 F.3d 898 906 Fed Cir 2004 internal quotation marks omitted affd 481
`
`F.3d 1371 Fed Cir 2007
`
`In addition to the specification
`
`court should also consider the patents prosecution
`
`history if it
`
`is in evidence Markman
`
`Westview Instruments Inc 52 F.3d 967 980 Fed Cir
`
`1995 affd 517
`
`370 1996 The prosecution history which is intrinsic evidence
`
`consists of the complete record of the proceedings before the PTO
`
`and Trademark
`
`Office and includes the prior art cited during the examination of the patent Phillips 415 F.3
`
`at 1317
`
`prosecution history can often inform the meamng of the claim language by
`
`demonstrating how the inventor understood the invention and whether the inventor
`
`limited the
`
`invention in the course of prosecution making the claim scope narrower than it would otherwise
`
`be Id
`
`In some cases the district court will need to look beyond the patents intrinsic evidence
`
`and to consult extrinsic evidence in order to understand for example the background science or
`
`the meaning of
`
`term in the relevant art during the relevant
`
`time period Teva 135 Ct at
`
`841 Extrinsic evidence consists of all evidence external to the patent and prosecution history
`
`including expert and inventor
`
`testimony dictionanes and learned treatises Markman 52
`
`3d
`
`at 980 For instance technical dictionanes can assist the court in determining the meamng of
`
`term to those of skill
`
`in the relevant art because such dictionaries endeavor to collect
`
`the
`
`accepted meanings of terms used in various fields of science and technology Phillips 415
`
`3d
`
`

`
`at 1318
`
`In addition expert testimony can be useful to ensure that the courts understanding of
`
`the technical aspects of the patent is consistent with that of person of ordinary skill
`
`in the art or
`
`to establish that particular term in the patent or the prior art has
`
`particular meamng in the
`
`pertinent field Id Nonetheless courts must not lose sight of the fact that expert reports and
`
`testimony
`
`generated at the time of and for the purpose of litigation and thus can suffer from
`
`bias that is not present in intnnsic evidence Id Overall while extrinsic evidence may be
`
`useful to the court it
`
`is less reliable than intnnsic evidence and its consideration is unlikely
`
`to result in reliable interpretation of patent claim scope unless considered in the context of the
`
`intrinsic evidence Id at 1318-19 Where the intrinsic record unambiguously describes the
`
`scope of the patented invention reliance on any extrinsic evidence is improper See Pitney
`
`Bowes Inc
`
`Hewlett-Packard Co 182 F.3d 1298 1308 Fed Cir 1999 citing Vitronics 90
`
`3d at 1583
`
`Finally
`
`construction that stays true to the claim language and most naturally aligns
`
`with the patents description of the invention will be in the end the correct construction
`
`RenishawPLCv Marposs Societa perAzioni 158
`
`3d 1243 1250 Fed Cir 1998 It
`
`follows
`
`that
`
`claim interpretation that would exclude the inventors device is rarely the correct
`
`interpretation Osram GmbHv mt lTrade Comm
`
`505
`
`3d 1351 1358 Fed Cir 2007
`
`

`
`II
`
`CONSTRUCTION OF THE DISPUTED TERM
`
`therapeutic composition
`
`Plaintiffs Proposal
`
`regimen over an
`treatment
`composition suitable for use as
`extended period of time chronic administration
`
`Defendants Proposal
`
`The preamble is not
`
`claim limitation needs no construction
`
`Or alternatively pharmaceutical composition
`
`Courts Construction
`
`regimen over an
`composition suitable for use as
`extended period of time chronic administration
`
`treatment
`
`The claims of the 551 Patent are directed to compounds compositions and methods of
`
`treating cental nervous system disorders The term therapeutic composition appears in the
`
`preamble to claim 10 of the 551 Patent
`
`The parties dispute whether the preamble is
`
`claim
`
`limitation and therefore whether therapeutic composition even needs to be construed and if
`
`so whether limiting the term to long-term or chronic use is appropriate
`
`preamble is limiting only under certain circumstances
`
`such as when it recites an
`
`essential structure or steps or is necessary to give life meaning and vitality to
`
`claim See
`
`Poly-Am L.P
`
`GSE Lining Tech Inc 383 F.3d 1303 1309 Fed Cir 2004 Whetherto
`
`treat
`
`preamble as
`
`claim limitation is determined on the facts of each case in light of the claim
`
`as whole and the invention described in the patent Bicon Inc
`
`Straumann Co 441 F.3d
`
`945 952 Fed Cir 2006
`
`court reviews the entirety of the patent to gain an understanding of
`
`what the inventors actually invented and intended to encompass by the claim to determine what
`
`effect
`
`the preamble language should be given See Corning Glass Works
`
`Sumitomo Elec
`
`While the parties have not agreed on the definition of person having ordinary skill
`in
`the art they agree that the Courts resolution of their claim construction dispute is not affected by
`this disagreement See Tr at 9-10 28
`
`

`
`USA Inc
`
`868
`
`2d 1251 1257 Fed Cir 1989
`
`Defendants assert that the term therapeutic composition as it appears in claim 10 is
`
`non-limiting preamble Defendants further argue that the preamble here only states
`
`purpose or
`
`intended use for the invention and therefore is not limiting D.I 160 at
`
`citing Catalina
`
`Mktg Intl
`
`Inc
`
`Coolsavings.com Inc 289 F.3d 801 808 Fed Cir 2002
`
`Claim 10 recites in its entirety
`
`therapeutic composition comprising an anticonvulsant effective
`amount of
`compound according to any one of claims 1-9 and
`pharmaceutical carrier therefor
`
`The specification in describing the treatment of epileptic and other disorders prior to the
`
`invention of the patent-in-suit states that
`
`may appear upon repeated dosing that are
`
`not apparent with acute administration Because many drugs which require chronic
`
`administration ultimately place an extra burden on the liver
`
`many anticonvulsants have
`
`associated therewith liver toxicity 551 Patent col
`
`67 col
`
`The specification goes
`
`on to identify four goals for an anticonvulsant drug including for the treatment of chronic
`
`conditions like epilepsy
`
`ideal anticonvulsant drug is one that satisfies the following
`four criteria
`has
`has
`high anticonvulsant activity
`minimal neurological
`has
`relative to its potency
`toxicity
`maximum protective index sometimes known as selectivity or
`margin of safety which measures the relationship between the
`doses of drug required to produce undesired and desired effects.
`and
`is relatively safe as measured by the median lethal dose
`LD50 relative to its potency and is non-toxic to the animal that is
`being treated e.g it exhibits minimal adverse effects on the
`remainder of the treated animal its organs blood its bodily
`functions etc even at high concentrations especially during long
`term chronic administration of the drug Thus for example it
`exhibits minimal i.e little or no liver toxicity
`
`

`
`Id at col
`
`11 13-32 emphasis added The patent specification then describes the compound
`
`of the invention as non-toxic to the liver See
`
`id at col 37 11 26-40 These compounds
`
`of the present invention exhibit advantages
`
`that have not heretofore been realized They
`
`therefore can be used in
`
`treatment regimen requiring administration thereof over extended
`
`periods of time chronic administration Id at col 37 11 47-50
`
`Relatedly the patent states that
`
`it
`
`is directed to epilepsy or related central nervous
`
`system disorders Id at col
`
`ill 28292 It
`
`is undisputed that epilepsy requires long-term
`
`often lifelong treatment See Tr at 14 31-32 The specification goes on to disclose that the
`
`compounds and compositions of the invention provide the desired little if any liver toxicity
`
`551 Patent col 24 11 50-5
`
`and hence have advantageous
`
`characteristics making the
`
`invention useful for long-term treatment of conditions such as epilepsy3 See id at col 24 11 31-
`
`2See also 551 Patent col
`11 17-2 Moreover the administration of an effective
`forms provides an
`amount of the present compounds in their pharmaceutically
`acceptable
`excellent regime for the treatment of epilepsy nervous anxiety psychosis insomnia and other
`related central nervous disorders id at col 2111 12-15 The compounds of the present
`for the treatment of central nervous disorders such as epilepsy nervous
`invention are useful
`anxiety psychosis insomnia and the like in animals
`
`11 56-60 However the present inventor has found such
`3See also 551 Patent col
`group of compounds that is generally potent exhibit minimal neurological
`toxicity has
`high
`protective index and is relatively non-toxic to the body organs including the liver upon multiple
`dosing id at col
`11 23-25 These anti-convulsants
`the present invention are utilized in
`treatment regime requiring acute dosing and especially chronic dosing thereof to the patient
`id at col 24 11 31-53 There is thus still another factor which must be taken into consideration
`relating to the toxicity of the drug when administered for extended periods to the animal
`Obviously even if the drug has excellent anti-convulsant activity and an excellent PT ratio the
`drug will not be useful
`Based upon the
`if the drug is toxic upon chronic dosing to the patient
`above data both the furyl derivative and the compounds of the present invention have an
`excellent drug profile and both could be used in acute administration However.
`the furyl
`On the other hand the compounds of the present
`compound is more toxic to the animal
`invention as shown hereinbelow are significantly less toxic than the furyl compound and in fact
`exhibit little if any toxicity to the animal Thus the compounds of the present invention are
`
`

`
`53
`
`In the Courts view these repeated extended discussions of use of the invented
`
`compounds for long-term potentially lifelong treatment of conditions including epilepsy mean
`
`that
`
`the therapeutic composition claimed in claim 10 must at least be capable of providing safe
`
`and effective chronic treatment From this conclusion it
`
`follows that the term therapeutic
`
`composition is
`
`claim limitation as it states
`
`fundamental characteristic of the invention of
`
`claim 10
`
`In this case construing the term is necessary to give life vitality and meamng to claim
`
`10
`
`Having determined that therapeutic composition requires construction the Court
`
`further concludes
`
`that Plaintiffs proposed construction of the term tracks the pertinent
`
`language
`
`recited in the specification See id at col 37 11 48-50 Accordingly the Court adopts
`
`Plaintiffs proposed construction
`
`In adopting Plaintiffs construction the Court is not holding that claim 10 is limited only
`
`to methods of treating epilepsy
`
`concern Defendants have raised See e.g Tr at 26-27 The
`
`Court is instead only holding that to fall within the scope of claim 10
`
`therapeutic composition
`
`must at least be safe and effective for the long-term treatment of epilepsy Compositions within
`
`the scope of claim 10 may also be safe and effective for treatment of other conditions including
`
`those called out in the specification
`
`central nervous system disorders insonmia anxiety
`
`for an extended period see generally id at col
`useful for administration to the treated animal
`11 32-41 Although not as critical
`in short term or acute administration of an anticonvulsant
`the fourth criteria outlined above is extremely important for an anti-convulsant which is to be
`long period of time chronic administration or in high dosage It may be the most
`taken over
`important factor in determining which anti-convulsant
`to administer to
`patient especially if
`chronic dosing is required
`
`

`
`None of Defendants arguments persuade the Court to endorse Defendants positions
`
`either that
`
`the preamble is not limiting or that therapeutic composition should be construed as
`
`pharmaceutical composition For the reasons already explained in concluding that the
`
`preamble is
`
`limitation requiring construction the Court does not agree with Defendants that in
`
`adopting Plaintiffs construction the Court is improperly limiting the claim to
`
`preferred
`
`embodiment Nor does the Court find in the patent what Defendants contend is
`
`rigid and
`
`consistent distinction between compounds and therapeutic compositions Defendants
`
`premise much of their claim construction position on the view that it
`
`is only the compounds
`
`claimed by the patentee that have the advantageous
`
`characteristics described in the portions of
`
`the specification Plaintiffs cite and on which the Court relies Defendants suggest
`
`further that
`
`the disclosures in the specification have no impact on what the patentee meant when he claimed
`
`therapeutic compositions in claim 10 However claim 10 explicitly references both
`
`compounds and therapeutic composition and expressly and undisputedly requires as
`
`limitation that the therapeutic composition include one of the compounds of claims 1-9
`
`Therefore Defendants rigid distinction between compounds and therapeutic compositions
`
`fails and with it much of the force of Defendants claim construction argument See also Id at
`
`62-63
`
`At the heanng substantial attention was devoted to the issue of whether claim 10 covers
`
`composition that is only suitable for short-termlacute administration Plaintiffs admit that under
`
`their construction which is now the Courts construction
`
`composition that is suitable only to
`
`short-term use e.g hypothetical
`
`injection that may only be used once and never again is not
`
`within the scope of the claim See id at 62-63 Given all of the references to suitability for safe
`
`

`
`and effective chronic even lifelong administration and given the Courts conclusion that the
`
`preamble is
`
`limitation requiring construction the Court agrees with Plaintiffs that the patentee
`
`did not claim such
`
`short-term embodiment which anyway may not exist
`
`The Court is not
`
`persuaded by Defendants argument
`
`that this conclusion undermines support for Plaintiffs
`
`construction
`
`conclusion based on Defendants premise that the specification
`
`particularly in
`
`discussing acute treatments including injectable compounds see e.g id at 33-34 54-55
`
`discloses preferred embodiments that are only acceptable for short-term use Contrary to
`
`Defendants reading of the specification the Court is unable to find from the evidence before it
`
`intrinsic and extrinsic that injectable compounds containing lacosamide that are suitable for
`
`acute treatment of epilepsy cannot also be used as part of
`
`therapeutic composition that is safe
`
`and effective for the long-term treatment of chronic epilepsy Among other things as Plaintiffs
`
`explained at the hearing and as appears to be undisputed chronic treatment may begin with
`
`acute treatment See id at 15
`
`use applies to the treatment
`
`for particular seizure and
`
`long-term use starts with acute administration...
`
`other words if you are going to be treated
`
`for epilepsy with Vimpat you will be treated acutely and then over
`
`long period of time.4
`
`Additionally the Court does not agree with Defendants that therapeutic and
`
`pharmaceutical
`
`are consistently used interchangeably in the patent See
`
`id at 46 Claim
`
`10 itself short as it is uses both therapeutic and pharmaceutical and there is no persuasive
`
`basis to overcome the presumption that the patentees use of different adjectives in such
`
`Thus compounds that are suitable for acute treatment are within the scope of claim 10
`compounds exhibit
`as long as such compounds are also suitable for chronic treatment
`can thus be administered for short term
`excellent anti-convulsant activity and of course
`treatment Moreover the compounds of the present invention have the added advantage of being
`in drug regimes for long-term treatment 551 Patent col 2111 17-21
`useful
`
`10
`
`

`
`proximity to one another indicates that the patentee intended the different words to have different
`
`meaning See generally Innova/Pure Water Inc
`
`Sqfari Water Filtration Sys Inc 381 F.3d
`
`1111 1119 Fed Cir 2004
`
`Finally the Court finds that Defendants have not presented clear and convincing evidence
`
`showing that claim 10 is indefinite Defendants base this contention on their uncertainty as to
`
`exactly how long period is required to constitute chronic administration and further suggest
`
`there is an absence of data to demonstrate that lifelong treatment with lacosamide actually is safe
`
`See Tr at 34-35 56-58 The record does not contain clear and convincing evidence that
`
`person of ordinary skill
`
`in the art at the time of the invention would lack reasonable certainty as
`
`to what the patent means by chronic administration See Nautilus Inc
`
`Biosig Instruments
`
`Inc 134 Ct 2120 2124 2014 see also Tr at 60 Nor is the Court convinced that the
`
`novelty of the chronic administration of the patented therapeutic compositions containing
`
`lacosamide which have received FDA approval
`
`and the unavoidable lack of incontrovertible
`
`evidence that lifetime treatment will prove to be safe and effective
`
`somehow renders the
`
`patents claim indefinite
`
`III
`
`CONCLUSION
`
`An appropnate Order follows
`
`11