Free Claim Construction Answering Brief - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE RELIANT PHARMACEUTICALS, INC., Plaintiff, v. PAR PHARMACEUTICAL, INC., Defendant. ) ) ) ) ) ) ) ) )

Civil Action No. 06-774-JJF

PLAINTIFF RELIANT PHARMACEUTICALS, INC.'S ANSWERING CLAIM CONSTRUCTION BRIEF

OF COUNSEL: John Desmarais Gerald J. Flattmann, Jr. Christine Willgoos KIRKLAND & ELLIS, LLP Citigroup Center 153 E. 53rd Street New York, NY 10022 (212) 446-4800 March 19, 2008

MORRIS, NICHOLS, ARSHT & TUNNELL LLP Jack B. Blumenfeld (#1014) Maryellen Noreika (#3208) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 [email protected] [email protected] Attorneys for Plaintiff

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TABLE OF CONTENTS Page TABLE OF AUTHORITIES .......................................................................................................... ii INTRODUCTION ...........................................................................................................................1 ARGUMENT...................................................................................................................................1 I. II. PAR'S PROPOSED CONSTRUCTIONS VITIATE WELL-RECOGNIZED PRINCIPLES OF CLAIM CONSTRUCTION ...................................................................1 RELIANT'S PROPOSED CONSTRUCTIONS ARE CONSISTENT WITH THE INTRINSIC AND EXTRINSIC EVIDENCE .....................................................................4 A. B. C. D. E. F. G. H. I. J. K. L. "Delayed Release Microtablet"................................................................................4 "Cylindrical" ............................................................................................................8 "A Convex Or Flat Upper Side And Lower Side".................................................11 "The Tablet Contains No Release-Delaying Ancillary Substance".......................13 "Lubricant" ............................................................................................................17 "Other Conventional Ancillary Substances" .........................................................18 "Release Rate Is Virtually Independent Of The Pressure When Compressing The Tablets".....................................................................................20 "Active Ingredient Density" ..................................................................................21 "A Pronounced Plasma Level Plateau With A PTF<75%" ...................................22 "Bioavailability Does Not Depend On The Intake Of Food" ................................23 "Cylindrical Mold" ................................................................................................25 The Term "The Active Ingredient Content Is In The Range From 81 To 99.9% Of The Weight Of The Microtablet" Does Not Need Construction...........26

CONCLUSION..............................................................................................................................27

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TABLE OF AUTHORITIES Page(s) Cases Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003)........................................................................................... 7 Brown v. Huger, 21 How. 305 (1859) ............................................................................................................ 2 Burke, Inc. v. Bruno Indep. Living Aids, 183 F.3d 1334 (Fed. Cir. 1999)........................................................................................... 3 C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858 (Fed. Cir. 2004)............................................................................................. 2 Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693 (Fed. Cir. 1983)..................................................................................... 3, 6, 7 Gummow v. Splined Tools Corp., No. 3-03-CV-1428-L, 2004 WL 893436 (N.D. Tex. Apr. 26, 2004) ................................. 9 Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111 (Fed. Cir. 2004)........................................................................................... 4 John Mezzalingua Assocs., Inc. v. Arris Int'l, Inc., No. 03-C-353-C, 2003 WL 23282752 (W.D. Wis. Nov. 14, 2003) ................................... 9 Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996)............................................................................................................ 2 NeoMagic Corp. v. Trident Microsystems, Inc., 287 F.3d 1062 (Fed. Cir. 2002)........................................................................................... 8 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005)................................................................................. 2, 3, 12 SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107 (Fed. Cir. 1985)....................................................................................... 7, 8 SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870 (Fed. Cir. 2004)............................................................................................. 7 Synthes (USA) v. Smith & Nephew, Inc., No. 03-CV-0084, 2008 WL 343114 (E.D. Pa. Feb. 4, 2008) ..................................................................................................................... 27

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U.S. Phillips Corp. v. Iwasaki Elec. Co., Ltd., 505 F.3d 1371 (Fed. Cir. 2007)......................................................................................... 26 U.S. Surgical v. Ethicon, Inc., 103 F.3d 1554 (Fed. Cir. 1997)......................................................................................... 27 Xerox Corp. v. 3Com Corp., 267 F.3d 1361 (Fed. Cir. 2001)........................................................................................... 7

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INTRODUCTION The terms of a patent claim are properly construed according to their ordinary and customary meaning ­ the meaning that one of skill in the art at the time of the invention would ascribe to them. Par, however, rather than relying on the plain meaning of the claims and supportive intrinsic evidence, attempts to import limitations from the specification of the patent into the claims, read in limitations from extrinsic evidence, and even goes so far as to propose limitations that have no support in either the intrinsic or extrinsic evidence. More importantly, Par's proposed construction simultaneously reads such limitations into the claims, and at the same time reads out of the claims not only the preferred embodiments of the invention, but also every example in the specification. Accordingly, Par's proposed constructions cannot be correct. In contrast, each of Reliant's proposed claim constructions is supported by the plain meaning of the terms in the context of the claims, the specification, and the prosecution history of the `588 patent. In addition, two experts skilled in the art of the invention confirm that Reliant's proposed constructions reflect the understanding of one of ordinary skill in the art at the time of the invention. ARGUMENT I. PAR'S PROPOSED CONSTRUCTIONS VITIATE PRINCIPLES OF CLAIM CONSTRUCTION WELL-RECOGNIZED

Par's proposed claim constructions set forth in its opening Markman brief ignore well-settled principles of claim construction and turn Federal Circuit precedent on its head. Rather than rely on the intrinsic evidence ­ the patent claims, the specification (including the examples of the invention), and the file history of the patent ­ Par instead relies on extrinsic evidence having no bearing on the patent claims, including documents from its own

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manufacturing and supply chain. See, e.g., Def. Br. at 24.1 But well-established Supreme Court and Federal Circuit case law make clear that intrinsic evidence establishes the meaning of claim terms used in a patent. Markman v. Westview Instruments, Inc., 517 U.S. 370, 383 n.8 (1996) ("[T]he patent itself must be taken as evidence of its meaning") (quoting Brown v. Huger, 21 How. 305, 318 (1858))); Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005) (en banc) ("[W]hile extrinsic evidence `can shed useful light on the relevant art,' we have explained that it is `less significant than the intrinsic record in determining `the legally operative meaning of claim language.'" (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004))). Par also purports to define terms of art ­ words and phrases that would be readily understood by those skilled in the art of pharmaceutical formulation ­ by their "plain meaning," using no fewer than six separate dictionaries. In doing so, Par ignores the clear meaning of the terms to one of skill in the art, and introduces ambiguity into otherwise clear terms. But the Federal Circuit has warned against using dictionary definitions when the claim terms are clear from the specification and known in the art. See, e.g., Phillips, 415 F.3d at 1321 ("The main problem with elevating the dictionary to such prominence is that it focuses the inquiry on the abstract meaning of words rather than on the meaning of claim terms within the context of the patent."). Par's proposed constructions abstract the claim terms to meanings not found in, and contradicted by, the intrinsic evidence. Even more troubling, Par urges the Court to construe several claim terms in a manner that would effectively read out of the claims the preferred embodiments explicitly set
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"Def. Br." as used herein refers to Defendant Par Pharmaceutical, Inc.'s Opening Claim Construction Brief. See D.I. 197.

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forth in the specification. See infra Section II.D ("The Tablet Contains No Release-Delaying Ancillary Substances"), Section II.E ("Lubricant"), Section II.F ("Other Conventional Ancillary Substance"), and Section II.H ("Active Ingredient Density"). Such constructions are

impermissible under Federal Circuit law. See, e.g., Burke, Inc. v. Bruno Indep. Living Aids, 183 F.3d 1334, 1341 (Fed. Cir. 1999) ("The district court's claim interpretation ... would exclude the preferred embodiment described in the specification and, thus, cannot be sustained."). In addition, Par proposes reading into the independent composition claim a single (and non-limiting) embodiment disclosed in the specification and claimed in a dependent claim of the patent. See infra Section II.A ("Delayed Release Microtablet"). Yet again, Par's proposed construction ignores Federal Circuit law to the contrary. See, e.g., Burke, 183 F.3d at 1340 ("[W]e have often held that limitations cannot be read into the claims from the specification or the prosecution history."); see Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 699 (Fed. Cir. 1983) ("It is improper for courts to read into an independent claim a limitation explicitly set forth in another claim."). Thus, far from "adher[ing] to the well-established principles of claim construction" (Def. Br. at 2), Par's proposed claim constructions turn those well-established principles upside down. In contrast, Reliant's proposed constructions are supported by and consistent with the patent claims, specification, and file history, and comport with the plain and ordinary meaning that would be ascribed to the terms by one of ordinary skill in the art. Phillips, 415 F.3d at 1313 ("The inquiry into how a person of ordinary skill in the art understands a claim term provides an objective baseline from which to begin claim interpretation." (citing

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Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004))). II. RELIANT'S PROPOSED CONSTRUCTIONS ARE CONSISTENT WITH THE INTRINSIC AND EXTRINSIC EVIDENCE A. "Delayed Release Microtablet" Reliant requests that the court construe the term "delayed release microtablet" to mean "a small unit of solid medicament prepared by compaction in which the release of active ingredient after 3 hours is not more than 80% and after 24 hours is not less than 80%." Par proposes that the term be construed as two separate terms, "delayed release" and "microtablet." See Def. Br. at 16, 18. As set forth in Reliant's opening brief, these terms are not properly separable. The patent does not disclose or claim any "microtablet" other than a "delayed release microtablet." See Pl. Br. at 9, n. 4.2 Therefore, the Court should construe "delayed release microtablet" as a single term. Par goes to great lengths, using two dictionaries and three foreign patents, to set forth a definition of the term "delayed release" that serves only to add uncertainty to a term clearly defined within the first claim of the `588 patent. Par's proposed construction ­

"prolonged diffusion of an active ingredient" ­ merely substitutes the words "prolonged" and "diffusion" for "delayed" and "release," without giving any real meaning to the term. See Def. Br. at 16-18. In contrast, the relevant portion of Reliant's construction contains a clear set of parameters: "the release of active ingredient after 3 hours is not more than 80% and after

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"Pl. Br." as used herein refers to Plaintiff Reliant Pharmaceuticals, Inc.'s Opening Claim Construction Brief. See D.I. 194.

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24 hours is not less than 80%." These same parameters are set forth within Claim 1 of the patent: "the release of active ingredient in the USP paddle method at 50 rpm is 80% as a maximum after 3 hours and as a minimum after 24 hours" (Ex. 3 at Claim 1); within the specification: "the release of active ingredient after 3, preferably 5, hours is not more than 80[%] and after 24, preferably 15, hour is not less than 80%" (Ex. 3 at Col. 2:5557); and several times within the file history: "the present microtablets provide no more than 80% release after 3 hours and no less than 80% release after 24 hours" (Ex. 5 at 3); "the present invention ... is drawn to a delayed release microtablet which is required by the claim to have no more than 80% release of the active ingredient after 3 hours and no less than 80% after 24 hours" (Ex. 5 at 4); and "the claims . . . require that the release of active ingredient be delayed to meet the requirements of part (d) of claim 1" (Ex. 5 at 4). Thus, it is unnecessary to resort to any extrinsic evidence to define the term "delayed release." Par's proposed construction of the term "microtablet" similarly looks beyond the `588 patent claims, specification, and file history ­ and even beyond the extrinsic references Par uses to support its construction ­ to improperly narrow the claim term. Par proposes that the Court construe the word "microtablet" within the claim term "delayed release microtablet" to mean "a small compressed solid dosage form of precise shape and dimensions." Def. Br. at 18. Yet nowhere in the intrinsic or extrinsic evidence does the phrase "of precise shape and dimensions" appear. Par's blatant attempt to impermissibly narrow the claim term is plain from even a cursory review of its argument. Par first sets forth the basic definition of the components of the word, i.e., "micro" and "tablet." These basic definitions as set forth by Par ­ "micro" means

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"small" and "tablet" means "a solid pharmaceutical dosage form containing drug substance with or without suitable diluents and prepared by either compression or molding methods" ­ comport with the intrinsic evidence, the understanding of one skilled in the art of the invention, and Reliant's proposed construction, i.e., "a small unit of solid medicament prepared by compaction..." See Pl. Br. at 10; Rhodes Decl.3 at ¶ 44; Hubbell Decl.4 at ¶ 25; Def. Br. at 18. Had Par's definition stopped here, there might have been no need for the Court to construe the term, as the parties would likely have come to agreement over the small semantic differences in what is substantively the same definition. Par, however, adds the phrase "of precise shape and dimensions" to its proposed construction. This phrase does not appear anywhere in the intrinsic or extrinsic evidence. Par purports to divine this phrase from the patent specification, pointing to several embodiments described in the specification: one embodiment describes a punch, another a mold. Par then unilaterally concludes that these embodiments have "precise shape and dimensions" and attempts to read this limitation into its proposed construction to narrow the invention. But Par's made-up limitation ­ even if it were supported by the specification ­ cannot form the definition of the claim term "microtablet" because it is improper to read an embodiment, even a preferred embodiment, into the claims.5
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See Envtl. Designs, 713 F.2d at 699 ("The claim, not the

"Rhodes Decl." as used herein refers to the Declaration of Dr. Christopher T. Rhodes In Support of Reliant Pharmaceutical, Inc.'s Opening Claim Construction Brief. See D.I. 195. "Hubbell Decl." as used herein refers to the Declaration of Dr. Jeffrey A. Hubbell In Support of Reliant Pharmaceutical, Inc.'s Opening Claim Construction Brief. See D.I. 196. In addition, Par's alleged support for its improper limitation, that Claim 6 of the patent comprises a "mold," (Def. Br. at 18), cuts against adding Par's proposed limitation to the term "microtablet." Basic principles of claim differentiation hold that a dependent claim is presumed to be narrower than the claim from which it depends. See Xerox Corp. v. 3Com (Continued...)

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specification, measures the invention.... [Defendant's] argument that claim 1 must include a limitation found in the specification is thus legally unsound.") (internal citations omitted). See also Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1325 (Fed. Cir. 2003) ("Because the claims are best understood in light of the specification of which they are a part, however, courts must take extreme care when ascertaining the proper scope of the claims, lest they simultaneously import into the claims limitations that were unintended by the patentee.") Par's attempt to narrow the definition of "microtablet" is also evident from its self-serving statement that the patent does not cover "ground or milled granules of compressed solid material...."6 Def. Br. at 19. But no such exclusion appears anywhere in the patent claims, specification or file history, and the specification need not disclose every embodiment of the claimed invention. See SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 880 (Fed. Cir. 2004) ("The law `does not require that an applicant describe in his specification every conceivable and possible future embodiment of his invention.'" (quoting SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (en banc))). Indeed, Par confuses a question of infringement, i.e., whether "ground or milled granules of compressed solid material" are encompassed by the term "microtablet" as that term is described in the patent and understood in the art, with a question of claim construction, i.e., what the claim term "microtablet" means. Corp., 267 F.3d 1361, 1366 (Fed. Cir. 2001); see also AK Steel Corp. v. Sollac and Ugine, 344 F.3d 1234, 1242 (Fed. Cir. 2003) ("Under the doctrine of claim differentiation, dependent claims are presumed to be of narrower scope than the independent claims from which they depend." (internal citations omitted)). Par's use of the embodiment comprising a "mold" to support its narrow definition of "microtablet" as having "precise shape and dimensions" is improper because it attempts to read a dependent limitation into an independent claim. See Envtl. Designs, Ltd., 713 F.2d at 699 ("It is improper for courts to read into an independent claim a limitation explicitly set forth in another claim.").
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Not surprisingly, this is exactly what Par purports that its formulation comprises.

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See NeoMagic Corp. v. Trident Microsystems, Inc., 287 F.3d 1062, 1074 (Fed. Cir. 2002) ("[C]laims are not construed `to cover' or `not to cover' the accused device.... It is only after the claims have been construed without reference to the accused device that the claims, as so construed, are applied to the accused device to determine infringement." (quoting SRI, 775 F.2d at 1118)). Moreover, the claims of the `588 patent themselves contain sufficient disclosure of the physical characteristics necessary for a person skilled in the art to understand what is meant by the term "delayed release microtablet." For example, Claim 1 discloses an acceptable range of shapes ("cylindrical ... with a convex or flat upper side and lower side"); sizes ("the height and diameter are ... 1-3 mm"); densities ("greater than 1"); and compositions ("no release-delaying ancillary substance but 0.1-5% by weight of a lubricant and 0-18.9% by weight of other conventional ancillary substances") of the claimed delayed release microtablet. See Ex. 3 at Claim 1. Notably, nowhere in the claims is the invention limited to a "precise shape" or "precise dimensions." Par's proposed constructions of the claim term "delayed release" and "microtablet" contradict both established Federal Circuit law and the plain language of the patent claims. Accordingly, the Court should construe the term "delayed release microtablet" to mean "a small unit of solid medicament prepared by compaction in which the release of active ingredient after 3 hours is not more than 80% and after 24 hours is not less than 80%." B. "Cylindrical" Reliant proposes that the claim term "cylindrical" be construed to mean "a threedimensional shape which includes a flat or convex surface in which the height and diameter are, independently of one another, 1-3 mm." Par, in contrast, seeks a very narrow construction of "cylindrical" as "having the form of a cylinder, i.e., the solid figure traced out when a rectangle 8

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rotates around one of its sides as the axis of rotation, with two parallel circles of equal size at the ends." Def. Br. at 15. Unlike Reliant's construction, Par's proposed construction is not consistent with the use of the term "cylindrical" in the claims of the `588 patent and finds no support in either the specification or the file history of the `588 patent. Instead, Par relies solely on the dictionary definitions of the terms "cylindrical" and "cylinder."7 Par's proposed construction, however, encompasses only one type of cylinder, a right circular cylinder.8 But there is nothing in the `588 patent that limits the "cylindrical" shape of the invention to a cylinder with right angles or a cylinder which is defined by a rectangle. Thus, Par narrows the term "cylindrical" far beyond any reasonable interpretation that can be made in the context of the `588 patent and its claims.9 A person of ordinary skill in the art need only look at Claim 1 of the `588 patent to understand that the term "cylindrical" cannot have Par's narrow meaning within the context of the invention. Claim 1 recites a "cylindrical delayed release microtablet with a convex or flat upper side and lower side." A person of ordinary skill in the art would readily understand that

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Par uses three different dictionaries to define a one-word term, "cylindrical," changing references whenever a definition suits its purpose. See Ex. 6 (attached hereto) ("Right circular cylinder, Geom., a cylinder generated by the revolution of a rectangle about one of its sides."). Other courts have rejected Par's narrow definition of similar claim terms. See, e.g., Gummow v. Splined Tools Corp., No. 3-03-CV-1428-L, 2004 WL 893436, at *4 (N.D. Tex. Apr. 26, 2004) ("Although this definition [of `cylinder'] references a circular cylinder by way of example, it does not necessarily limit a cylinder to such a shape. To the contrary, at least two geometry treatises make clear that such a limitation is not inherent in the definition of a cylinder."); John Mezzalingua Assocs., Inc. v. Arris Int'l, Inc., No. 03-C-353-C, 2003 WL 23282752, at *9 (W.D. Wis. Nov. 14, 2003) ("Even if the ordinary meaning of `cylindrical' required a perfect cylinder, it is clear that the patentee did not intend this definition to apply in the context of the `194 patent.").

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the claimed invention includes, as one embodiment, a delayed release microtablet having at least one convex upper side or lower side. See Rhodes Decl. at ¶ 64; Hubbell Decl. at ¶ 34. Par's definition, however ­ a "figure traced out when a rectangle rotates around one of its sides as the axis of rotation" ­ necessarily has both a flat upper side and a flat lower side. Par's proposed construction of the claim term "cylindrical," therefore, reads out any embodiment that has a convex upper side or a convex lower side. Those embodiments, however, are explicitly set forth in the claims. Thus, Par's construction cannot be correct. Par's proposed construction also reads out other preferred embodiments of the claimed cylindrical delayed release microtablet. The patent specification states that "[t]he

microtablets according to the invention are cylindrical with a flat or convex upper side and lower side and with a diameter and height which are preferably approximately equal...." See Ex. 3 at Col. 2:42-45. Accordingly, one embodiment with the preferred height and diameter is a delayed release microtablet in the shape of a sphere ­ a sphere is a cylindrical shape of the invention with a convex upper side and a convex lower side in which the height and diameter are equal. A spherical delayed release microtablet is within the scope of the patent claims and is, indeed, one of the preferred embodiments described in the specification of the patent. Id. Yet, a sphere is not "a solid figure traced out when a rectangle rotates around one if its sides as the axis of rotation, with two parallel circles of equal size at the ends." Reliant's definition, however, would include an embodiment of the delayed release microtablet with a convex upper side and a convex lower side in which the height and diameter are approximately equal. Par's construction of the term "cylindrical" is also inconsistent with both the specification and the file history of the `588 patent. As set forth in Reliant's opening brief, the specification discloses that "[t]he microtablets according to the invention are cylindrical with a

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flat or convex upper side and lower side" and that "[t]he resulting microtablets have a cylindrical shape with flat or convex surface [sic]." See Ex. 3 at Col. 2:42-46, 4:19-22. For example, during prosecution of the `588 patent, the applicants stated, consistent with the patent claims and specification, that "[t]he present invention relates to a cylindrical delayed release microtablet having a convex or flat upper side and lower side" See Ex. 5 at 1, 2. These statements contradict Par's proposed construction of the term "cylindrical" as having a cross-section of a rectangle, i.e., a flat upper side and a flat lower side. Further, as explained by Dr. Rhodes in his declaration in support of Reliant's opening brief, a person skilled in the art at the time of the invention would know that cylindrical tablets do not necessarily have circular upper or lower sides. For instance, widely used solid dosage drugs Lipitor® and Tylenol® have elliptical and rounded rectangular cross-sections, respectively. See Rhodes Decl. at ¶ 57. Therefore, in the context of the `588 patent, any closed surface would satisfy the definition of a cylinder, not only the right circular cylinder that Par defines. Id. Thus, the Court should adopt Reliant's proposed construction of the term "cylindrical" as "a three-dimensional shape which includes a flat or convex surface in which the height and diameter are, independently of one another, 1-3 mm." C. "A Convex Or Flat Upper Side And Lower Side" Reliant proposes that the Court construe the term "a convex or flat upper side and lower side" to mean that "each of the upper side and lower side has a surface that is without marked projections or depressions (`flat') or is curved or rounded outward (`convex')." Par argues that this term means "the two ends of the cylindrical microtablet are both curved or rounded outward, like the exterior of a sphere, or both have a continuous horizontal surface

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without peaks or depressions." See Def. Br. at 19 (emphasis added). Par's proposed definition finds no support in the claims of the patent, the specification, or the file history. Par's definition unreasonably narrows the scope of the claims to a meaning that would not logically occur to a person of ordinary skill of the art, or to anyone else, reading the patent claims. Par does not, and cannot, cite to even a single sentence in the claims,

specification, or file history ­ or any other document produced in this case ­ in support of its proposed construction. There is simply nothing in the intrinsic evidence that states that the invention is limited to a delayed release microtablet wherein both the upper side and lower side are convex or both are flat. Nor has Par cited to any scientific literature or other prior art in support of its proposed construction. Indeed, without support in either the claims or the specification for its proposed definition, Par instead purports to rely on the rules of English grammar in support of its argument. See Def. Br. at 20. But even under its own test, Par fails. Par's proposed

construction is based in the illogical supposition that the phrase "a convex or flat upper side and lower side" is somehow plural. But Par's interpretation is unsupported by anything other than its own purported grammar lesson. Par's grammar, however, includes re-writing the claim term to change its meaning. The Federal Circuit has warned against such attempts to "focus[] the inquiry on the abstract meaning of words rather than on the meaning of claim terms within the context of the patent." See Phillips, 415 F.3d at 1321. Reliant's construction focuses on the plain meaning of the claim terms in light of the specification. Moreover, Reliant has provided two expert declarations that demonstrate that one of skill in the art would understand the claim term to mean that each of the upper side and

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lower side of the claimed delayed release microtablet has a surface that is convex or flat. See Rhodes Decl. at ¶ 64; Hubbell Decl. at ¶ 34. Thus, Reliant's proposed construction of the term "a convex or flat upper side and lower side" to mean "each of the upper side and lower side has a surface that is without marked projections or depressions (`flat') or is curved or rounded outward (`convex')" is not only consistent with the language of the `588 patent and its file history, but also reflects the understanding of the plain meaning of this term by one skilled in the art. D. "The Tablet Contains No Release-Delaying Ancillary Substance" Reliant requests that the Court construe the term "the tablet contains no releasedelaying ancillary substance" to mean "the tablet contains no excipient that forms a releasedelaying coating or matrix." Par, in contrast, proposes that the term be construed to mean "the claimed microtablet includes no amount of any chemical element or compound other than the active ingredient that prolongs the diffusion of the active ingredient to any degree." See Def. Br. at 25-26. Par's proposed construction, however, simultaneously reads into the claims a

limitation that is not found in the intrinsic or extrinsic evidence and reads out of the claims preferred embodiments in the patent. In support of its proposed construction, Par separately parses the meanings of no less than six of the seven words in the claim phrase and then adds another phrase ­ "to any degree" ­ that does not appear anywhere in the intrinsic evidence, the several extrinsic dictionaries that Par cites, or the definitions of any word that Par sets forth. See Def. Br. at 26. Instead, Par coins its own term and adds that phrase to its construction in an attempt to narrow the claims. But Par's proposed construction is directly contradicted by the intrinsic evidence, the knowledge of one of skill in the art, and the prior art.

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The `588 patent claims a delayed release microtablet with certain characteristics and compositions. Specifically, the claimed delayed-release microtablet comprises an active ingredient of specific formulas and 0.1-5% by weight of a lubricant, and may also comprise 018.9% by weight of other conventional ancillary substances. See Ex. 3 at Claim 1. Further, the specification teaches that "[i]t is possible to employ all conventional binders or adhesives..." as the "other conventional ancillary substances." See Ex. 3 at Col. 3:66-67. It was well known in the art at the time of invention that lubricants and other excipients, including binders, acted to delay or prolong release of the active ingredient from a tablet. See Rhodes Decl. at ¶¶ 70-71. For example, it was well known that lubricants often delayed release of an active ingredient from a tablet. See Rhodes Decl. at ¶ 70. Similarly, it was well known in the art that binders, whose primary function is to hold together the tablet, may also impact the release rate of the tablet and slow dissolution of the active ingredient. See Rhodes Decl. at ¶ 71. Significantly, Par's definition narrows the claims such that it reads out not only the preferred embodiments, but each and every example of the invention set forth in the specification. For example, not only is magnesium stearate set forth as the preferred lubricant in the specification, see Ex. 3 at Col. 4:7-13, but it is the lubricant used in every example in the patent. Yet, magnesium stearate, at the time of the invention, was a lubricant known to delay release of an active drug. See Rhodes Decl. at ¶ 70 (citing the Handbook of Pharmaceutical Excipients) ("Magnesium stearate is hydrophobic and may retard the dissolution of drug from a solid dosage form."). Par's proposed construction of the term "the tablet does not contain a release-delaying ancillary substance," however, would read out the use of magnesium stearate as a lubricant in the claimed microtablets because magnesium stearate will act in some degree to prolong diffusion of the active ingredient. See Rhodes Decl. at ¶ 70.

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Similarly,

the

patent

specification

and

examples

include

the

binder

hydropropylmethylcellulose ("HPMC") as a preferred embodiment of the invention that contains "other ancillary substances" such as binders. See Ex. 3 at Cols. 3:66-4:3. HPMC is used as a binder in six of the eight examples in the patent. Ex. 3 at Examples 1-4, 6, 7. In its function as a binder, however, it is inevitable that HPMC will slow dissolution of the active ingredient to some extent. See Rhodes Decl. at ¶ 71. This was well known to the skilled artisan at the time of the invention. See Rhodes Decl. at ¶ 71. Par's proposed construction of the term "the tablet does not contain a release-delaying ancillary substance," however, would read out HPMC as a binding agent because HPMC will act in some degree to prolong dissolution. See Rhodes Decl. at ¶ 71. Accordingly, Par's proposed construction of "the tablet contains no releasedelaying agent" to mean "the claimed microtablet includes no amount of any chemical element or compound other than the active ingredient that prolongs the diffusion of the active ingredient to any degree" cannot be correct. Par's construction does not allow for the preferred

embodiments and examples of the invention to fall within the scope of the claims because it excludes any substance, such as the preferred lubricant magnesium stearate and the preferred binder HPMC, "that prolongs the diffusion of the active ingredient to any degree." Par's construction, moreover, excludes not only the preferred embodiment, but also excludes every example of the invention included in the `588 patent. In contrast, Reliant's proposed construction comports with the understanding of one of skill in the art and is supported by the specification and file history of the patent. As set forth in Reliant's opening brief, the intrinsic evidence demonstrates that "the tablet contains no release-delaying ancillary substance" means that "the tablet contains no excipient that forms a release-delaying coating or matrix." See Pl. Br. at 13-16.

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Indeed, the patent specification specifically and repeatedly distinguishes the invention from the prior art release-delaying tablets that contained release-delaying matrices and release-delaying coatings. See, e.g., Ex. 3 at Col. 1:20-24 ("In the prior art the release of active ingredient from tablets is delayed either by a release-delaying matrix in which the active ingredient is embedded, or by a release-delaying coating through which the digestive fluid diffuses in and the active ingredient diffuses out") (emphasis added); id. at 8:11-16 (Comparing film-coated delayed release bolus tablets and the microtablets of the invention and reporting that "the in vivo release is entirely different and, in fact, better according to the invention, cf. drug levels shown in FIG. 11") (emphasis added); id. at Col. 3:13-19 ("The microtablets accordingly increase therapeutic safety ... and the bioavailability of this form is unaffected by food intake, in contrast to the bolus delayed release [coated] form") (emphasis added). The prosecution history similarly distinguishes the invention from the prior art release-delaying forms. See Ex. 5 at 3 (claimed delayed release microtablets have "surprisingly improved delayed release characteristics compared to other delayed release formats."). Moreover, at the time of invention, the two primary and well known release delaying excipients were release-delaying matrices and release-delaying coatings. See Rhodes Decl. at ¶ 68; Hubbell Decl. at ¶ 42. Accordingly, one of skill in the art at the time of invention would have understood in the context of the invention that a "release-delaying ancillary substance" was a release-delaying coating or a release-delaying matrix. See Rhodes Decl. at ¶ 76; Hubbell Decl. at ¶¶ 38, 45. For all of these reasons, the Court should construe the claim term "the tablet contains no release-delaying ancillary substance" to mean "the tablet contains no excipient that forms a release-delaying coating or matrix."

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E.

"Lubricant" Reliant requests that the Court construe the claim term "lubricant" to mean "a

pharmaceutical ingredient that reduces friction and prevents tablet adhesion, e.g., talc or magnesium stearate." Par initially sets forth this well-accepted definition, but then adds its own made-up limitation that the lubricant "does not prolong the diffusion of the active ingredient to any degree." Def. Br. at 28. Par's limitation is not found in any of the intrinsic or extrinsic evidence it cites. Accordingly, the Court should reject Par's proposed construction of

"lubricant" as "a chemical element or compound that lessens or prevents friction and that does not prolong the diffusion of the active ingredient to any degree" in favor of Reliant's clear construction that comports with the plain meaning of the term to one of skill in the art. As set forth above in Section II.D, at the time of invention, it was well known to one of skill in the art that lubricants delayed release of an active ingredient from a solid dosage form. See Rhodes Decl. at ¶ 70. Yet the claims of the patent recite delayed release microtablets that include a lubricant. Indeed, the preferred lubricant taught in the `588 patent is magnesium stearate. See Ex. 3 at Col. 4:19-13, Examples 1-8. Magnesium stearate is a hydrophobic (low-watersolubility) material and will tend, to some extent, to retard dissolution of the active ingredient from the claimed delayed release microtablets. See Rhodes Decl. at ¶ 70. Magnesium stearate is used as a lubricant in every example in the patent. Accordingly, Par's proposed construction reads out the preferred embodiment of the claims and every example of the patent. If Par's construction was adopted, the claims would allow only lubricants that "do[] not prolong the diffusion of the active ingredient to any degree." Def. Br. at 28. That construction cannot be correct.

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Thus, the Court should adopt the plain meaning of the term "lubricant" as "a pharmaceutical ingredient that reduces friction and prevents tablet adhesion, e.g., talc or magnesium stearate." F. "Other Conventional Ancillary Substances" Reliant requests that the Court construe the term "other conventional ancillary substances" to mean "commonly used pharmaceutical ingredients other than an active pharmaceutical ingredient, a lubricant, or a `release-delaying ancillary substance' as defined above, e.g., binders, adhesives, colorants, stabilizers, fillers, wetting agents, and flow regulators." Consistent with its pattern of reading into the claims limitations that it has coined itself, Par proposes a construction that unduly narrows the claim term and contradicts the plain meaning of the term to one of skill in the art. Par's proposed construction of "other conventional ancillary substances" to mean a "chemical element or compound, other than a lubricant or the active ingredient, that does not prolong the diffusion of the active ingredient to any degree" (Def. Br. at 28) should be rejected because it reads out of the claims a preferred embodiment of the invention set forth in the specification and examples of the patent. Both Par and Reliant set forth the meaning of the term "other conventional ancillary substances" to one of skill in the art in the context of the patent claims, i.e., a commonly used compound other than a lubricant, an active ingredient, or a release-delaying agent. Par, however, urges that the Court further read the phrase "does not prolong the diffusion of the active ingredient to any degree" into the common definition known to one of skill in the art. As in the case of the claim terms "the tablet contains no release-delaying ancillary

substance" and "lubricant," Par is effectively asking the Court to adopt a construction that reads into the claim a limitation that is found nowhere in the specification or prosecution history and that is contrary to the teachings of the `588 specification. 18

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As set forth above in Section II.D, as of the time of the invention, one of ordinary skill in the art would have known that conventional pharmaceutical excipients such as binders act, to some extent, to delay the release of active ingredient from a solid dosage form. See Rhodes Decl. at ¶ 75. Indeed, the binder HPMC was known to delay release when acting as a binder. See Rhodes Decl. at ¶ 71. The claims of the patent, however, explicitly allow for the addition of between 0-18.9% of "other conventional ancillary substances." The specification states that such substances include binders. Ex. 3 at Col. 3:66-67. Moreover, the delayed release microtablets set forth in six of the eight Examples in the `588 patent use HPMC as the "other conventional ancillary substance." Ex. 3 at Examples 1-4, 6, 7. Accordingly, Par's construction of the claim term "other conventional ancillary substances" to include the phrase "does not prolong the diffusion of the active ingredient to any degree" cannot be correct because it reads out of the claims the patent's preferred "other conventional ancillary substance," HPMC. As set forth in Reliant's opening brief, the plain ordinary meaning of the term "other conventional ancillary substances" in the context of the patent is "commonly used pharmaceutical ingredients other than an active pharmaceutical ingredient, a lubricant, or a `release-delaying ancillary substance' as defined above, e.g., binders, adhesives, colorants, stabilizers, fillers, wetting agents, and flow regulators." As stated above, "release-delaying ancillary substance" in the context of the patent means a release-delaying coating or a releasedelaying matrix. Reliant's proposed construction comports with the understanding of one of skill in the art. See Rhodes Decl. at ¶ 86; Hubbell Decl. at ¶ 51.

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G.

"Release Rate Is Virtually Independent Of The Pressure When Compressing The Tablets" Reliant proposes that the claim term "release rate is virtually independent of the

pressure when compressing the tablets" be construed to mean "within the ordinary range of compression used in the formulation of pharmaceutical tablets, the effect of the pressure when compressing the tablets on the release rate of the active ingredient can be neglected for practical purposes." Par proposes that the Court construe this term to mean "the effect of differences in force per area exerted to form the claimed microtablet on the percent diffusion of the active ingredient from the microtablet over time can be neglected for practical purposes." Def. Br. at 24. Par's proposed construction is unnecessarily complex and adds confusion to an otherwise clear term. construction. Par, by defining terms such as "pressure" and "release rate" obfuscates the clear meaning of the claim term that is set forth in the patent claims and specification using words that are readily understood by one in the art. A person of ordinary skill in the art, having experience in formulation and evaluation of pharmaceutics, is able to understand these terms without the aid of a dictionary. See Rhodes Decl. at ¶ 88; Hubbell Decl. at ¶ 57. Therefore, the Court should adopt Reliant's more straightforward construction, reflecting the plain and ordinary meaning of the term "release rate is virtually independent of the pressure when compressing the tablets." Accordingly, the term should be construed to mean "within the ordinary range of compression used in the formulation of pharmaceutical tablets, the effect of the pressure when compressing the tablets on the release rate of the active ingredient can be neglected for practical purposes." Accordingly, the Court should adopt Reliant's straightforward, plain-meaning

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H.

"Active Ingredient Density" Reliant requests that the Court construe "active ingredient density" to refer to the

"density of the active ingredient in the delayed release microtablet." Par, in contrast, contends that the claim term refers to the density of the active ingredient "used to make the claimed microtablet." Def. Br. at 23. Notably, only Reliant cites intrinsic evidence in support of its proposed construction. As set forth in Reliant's opening brief, the context of the patent claims, specification and prosecution history make clear that "active ingredient density" refers to an attribute or characteristic of the microtablet. For example, Claim 1 recites "A cylindrical delayed release microtablet ... wherein ... (c) the active ingredient density is greater than 1." Ex. 3 at Claim 1. Thus, "the active ingredient density" refers to a characteristic of the

microtablet. See Rhodes Decl. at ¶ 95; Hubbell Decl. at ¶ 62. Consistent with the claims, the specification and file history make clear that the density refers to the density of the microtablet. See, e.g., Ex. 3 at Col. 1:9-12 ("The present invention relates to cylindrical microtablets of -phenylpropiophenone derivatives with a high content and density of active ingredient") (emphasis added); Ex. 5 at 2 ("The cylindrical delayed release microtablet of the present invention is required to ... have an active ingredient density that is greater than 1") (emphasis added); id. at 2-3 ("Applicants have found that by preparing a microtablet having the required ... active ingredient density, containing the phenylpropiophenone derivative of formula I as its active ingredient, it is possible to provide a microtablet that has surprisingly improved delayed release characteristics compared to other delayed release formats.") (emphasis added). See also Rhodes Decl. at ¶ 97; Hubbell Decl. at ¶ 64.

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Par ignores the plain language of the claims, the specification and the file history, instead citing to its own supply chain of generic propafenone, in a misguided attempt to construe the term to mean the bulk density used to make the microtablet. See Def. Br. at 24. But Par's proposition is illogical. The delayed release microtablets of the invention are made by

compression of the active ingredient. This compression "squeezes out most of the air" from the bulk mixture. Rhodes Decl. at ¶ 19. Since density is a measure of mass per unit volume, the compression of the bulk dosage form necessarily increases the density by compressing the same mass into a smaller volume. The `588 patent claims a delayed release microtablet wherein the active ingredient density is greater than 1; it does not claim a bulk mixture wherein the active ingredient density is greater than 1. Thus, pursuant to the patent claims themselves, the density must be measured by reference to the microtablet. Accordingly, the Court should construe the claim term "active ingredient density" to mean "the density of the active ingredient in the delayed release microtablet." I. "A Pronounced Plasma Level Plateau With A PTF<75%" Reliant requests that the Court construe "a pronounced plasma level plateau with a PTF<75%" to mean "a plasma level plateau with a peak to trough fluctuation (PTF) of less
C max - C min

than 75%, where peak to trough fluctuation is defined as PTF (%) =

AUC t

× 100 ." Par

agrees that PTF is specifically defined in the specification by the above formula but introduces ambiguity into the otherwise clear claim term by adding two extraneous phrases that require that the plateau be "markedly level" during an undefined "relevant time interval." See Def. Br. at 29. Par's proposed construction should be rejected.

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As set forth in Reliant's opening brief, the specification expressly provides that a pronounced blood level plateau was evidenced by the PTF and exemplified in Figure 11 of the patent: Despite the short half-life, a pronounced blood level plateau develops (FIG. 11). The fluctuations in the blood level are considerably less with the microtablets. This is evident from the t75% (period in the dosage interval during which the plasma levels are at least 75% of the maximum level), which is 8 to 9 hours with the microtablets according to the invention compared with 5 to 6 hours with the bolus delayed release form, and from the PTF ... C max - C min
PTF (%) = AUC t × 100

for the AUC ... which has a value for the microtablets which is only about half that for the bolus forms, in particular less than 75[%], preferably less than 60%. Ex. 3 at Col. 2:60-3:13 (citations omitted), Fig. 11. See also Rhodes Decl. at ¶ 101; Hubbell Decl. at ¶ 69. One of skill in the art need only read the specification to have an understanding of a term that is defined by a clear mathematical formula. Accordingly, the Court should construe "a pronounced plasma level plateau with a PTF<75%" to mean a plasma level plateau with a peak to trough fluctuation of less than 75%, where PTF is defined by the formula set forth in the specification. Rhodes Decl. at ¶ 102; Hubbell Decl. at ¶ 67. J. "Bioavailability Does Not Depend On The Intake Of Food" Reliant requests that the Court construe the claim term "bioavailability does not depend on the intake of food" to mean "bioavailability of the active pharmaceutical ingredient is unaffected by food intake for practical purposes." As set forth in Reliant's opening brief, this construction is consistent with the patent claims and specification.

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Par's proposed definition, "the ingestion of food has no effect on the rate and amount of the active ingredient in the claimed microtablet that reaches the blood" (Def. Br. at 31) obfuscates the meaning of the term. For example, "bioavailability" is a term of art that needs no definition to a skilled artisan. Par's definition adds uncertainty by defining the term without describing how or when the "rate and amount" of drug "that reaches the blood" should be measured, or if it intends its definition to be different from the term as used in the art. See Def. Br. at 31. Similarly, Par's addition of the phrase "no effect" is a masked attempt to improperly limit the claim term. Par seeks to impose a negative limitation where one does not exist in the claims. Moreover, Par's limitation is unclear: does it mean "no effect" in the absolute sense; "no effect" that can be measured on standard equipment; "no effect" that can be determined to be statistically significant; "no effect" clinically; "no effect" upon single administration or repeated administration? Any of these are possible interpretations of Par's proposed construction that make an otherwise clear phrase equivocal. In contrast, Reliant's proposed construction comports with the patent claims and specification. Specifically, the specification states that "the bioavailability of this form [i.e., the delayed release microtablet of the invention] is unaffected by food intake, in contrast to the bolus delayed release form. The AUC found for the bolus delayed release form is 50% higher when fasting." See Ex. 3 at Col. 3:17-21. See also Hubbell Decl. at ¶ 72. The specification describes studies on volunteers that demonstrate that upon repeated administration of the claimed delayed release microtablets, the bioavailability of the active ingredient was similar in the fasting and non-fasting states. See Ex. 3 at Table 1; Rhodes Decl. at ¶ 104. One of skill in the art would understand this claim term to mean that the bioavailability of the active pharmaceutical

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ingredient is unaffected by food intake for practical purposes. Rhodes Decl. at ¶ 105; Hubbell Decl. at ¶ 71. Accordingly, the Court should construe the claim term "bioavailability does not depend on the intake of food" to mean "bioavailability of the active pharmaceutical ingredient is unaffected by food intake for practical purposes." K. "Cylindrical Mold" Reliant proposes that the Court construe the term "cylindrical mold" to mean "die and punch in which a formulation is formed into a `cylindrical' shape (as defined above)." Par's proposed construction of this term is "a cavity for forming a substance into the shape of a cylinder, a solid figure traced out when a rectangle rotates around one of its sides as the axis of rotation, with two parallel circles of equal size at the ends." Def. Br. at 32. The Court should adopt the construction of the term "cylindrical mold" proposed by Reliant. Par's proposed construction is contradicted by the claims of the `588 patent, the specification, and the file history. For all of the reasons set forth above regarding the claim term "cylindrical," Par's definition of "cylindrical mold" should be rejected. See supra Section II.B. Instead of looking to the field of the invention, Par relies only on a dictionary to define the term "mold." See Def. Br. at 33. Reliant's construction of this term as die and punch in which a formulation is formed is preferable because it comports with the plain meaning of the term "mold" as understood by a person of ordinary skill in the art at the time of the invention. See Hubbell Decl. at ¶ 76; Rhodes Decl. at ¶ 109. In addition, Reliant's proposed construction is consistent with the `588 patent specification, which discloses a non-limiting example of tooling that comprises "a suitable tabletting machine equipped with multiple microtablet punches." Ex. 3 at Col. 4:19-20.

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Accordingly, the Court should construe the term "cylindrical mold" to mean "a die and punch in which a formulation is formed into a `cylindrical' shape." L. The Term "The Active Ingredient Content Is In The Range From 81 To 99.9% Of The Weight Of The Microtablet" Does Not Need Construction There is no need to construe the claim language "the active ingredient content is in the range from 81 to 99.9% of the weight of the microtablet" because the meaning of the phrase is clear on its face. Neither party disputes, for example, what the "active ingredient" is, what "content" means and that a range is recited in the claims. However, to the extent that the Court believes a construction is necessary, the Court should reject Par's urging that the "applicants intended 81% and 99.9% to be precise end points for the claimed range." See Def. Br. at 22. Indeed, by inserting the word "precise" into the claim construction analysis, as with the case of many of its other proposed constructions, Par actually makes the claim less clear. For example, the claim phrase recites "the active ingredient content is in the range from 81 to 99.9% of the weight of the microtablet." Par does not ­ and cannot ­ explain why the language of the phrase is not clear on its face. Instead, Par proposes that the claim be defined as a "precise" lower limit of 81 and a "precise" upper limit of 99.9%. Yet, Par does not explain what it means by the term "precise," and indeed, numbers by their nature are only as precise as their significant figures allow. See U.S. Philips Corp. v. Iwasaki Elec. Co., Ltd., 505 F.3d 1371, 1377 (Fed. Cir. 2007) ("We emphasize that the claim construction we affirm today should not be read to state the endpoints of the claimed range with greater precision than the claim language warrants. In some scientific contexts, `1' represents a less precise quantity than `1.0,' and `1' may encompass values such as 1.1 that `1.0' may not"). Thus, Par's proposal to cloud the meaning of the claim should be rejected. See Synthes (USA) v. Smith & Nephew, Inc., No. 03-CV-0084, 2008 WL 343114, at *18 (E.D. Pa.

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Feb. 4, 2008) ("Neither party has explained how its proffered definition would be any clearer for a juror than the plain language of term in the claim itself . . . in fact, the ambiguity of `generally' may actually make its meaning less clear" (emphasis in original)). See also U.S. Surgical v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997). In any event, Par's citation of the `588 patent specification as supporting its proposed construction is a red herring. Neither party disputes that the terms "about" or

"approximately" do not appear in the claim phrase. Moreover, far from reciting precise figures, each and every Example in the `588 patent employs rounding. See, e.g., Ex. 3 at Example 1 (propafenone content, calculated by dividing 6.25 by 6.50 is listed as 96%); id. at Example 5 (propafenone content is listed as 86%). Accordingly, the claim language "the active ingredient content is in the range from 81 to 99.9% of the weight of the microtablet" does not need to be construed at all, let alone construed pursuant to Par's proposed "precise upper and lower limit." Should the Court decide to construe the claim term, it should be defined to mean "the active ingredient content is in the range from 81 to 99.9% of the weight of the microtablet." CONCLUSION For all of the foregoing reasons, Reliant requests that the claim terms of the `588 patent be construed as follows: (1) Delayed release microtablet: a small unit of solid medicament prepared

by compaction in which the release of active ingredient after 3 hours is not more than 80% and after 24 hours is not less than 80%; (2) Cylindrical: a three-dimensional shape which includes a flat or convex

surface in which the height and diameter are, independently of one another, 1-3 mm;

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(3)

Convex or flat upper side and lower side: each of the upper side and

lower side has a surface that is without marked projections or depressions ("flat") or is curved or rounded outward ("convex"); (4) The tablet contains no release-delaying ancillary substance: the tablet

contains no excipient that forms a release-delaying coating or matrix; (5) Lubricant: a pharmaceutical ingredient that reduces friction and prevents

tablet adhesion, e.g., talc or magnesium stearate; (6) Other conventional ancillary substances: commonly used pharmaceutical

ingredients other than an active pharmaceutical ingredient, a lubricant, or a "release-delaying ancillary substance" as defined above, e.g., binders, adhesives, colorants, stabilizers, fillers, wetting agents, and flow regulators; (7) Release rate is virtually independent of the pressure when compressing the

tablets: within the ordinary range of compression used in the formulation of pharmaceutical tablets, the effect of the pressure when compressing the tablets on the release rate of the active pharmaceutical ingredient can be neglected for practical purposes; (8) Active ingredient density: the density of the active ingredient in the

delayed release microtablet; (9) A pronounced plasma level plateau with a PTF<75%: a plasma level

plateau with a peak to trough fluctuation of less than 75%, where peak to trough fluctuation is
C max - C min

defined as PTF (%) =

AUC t

× 100 ;

(10)

Bioavailability does not depend on the intake of food: bioavailability of

the active pharmaceutical ingredient is unaffected by food intake for practical purposes;

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(11)

Cylindrical mold: die and punch in which a formulation is formed into a

"cylindrical" shape (as defined above); and (12) The active ingredient content is in the range from 81 to 99.9% of the

weight of the microtablet: the active ingredient content is in the range from 81 to 99.9% of the weight of the microtablet.

MORRIS, NICHOLS, ARSHT & TUNNELL LLP

/s/ Jack B. Blumenfeld
Jack B. Blumenfeld (#1014) Maryellen Noreika (#3208) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 [email protected] [email protected] Attorneys for Plaintiff

OF COUNSEL: John M. Desmarais Gerald J. Flattmann, Jr. Christine Willgoos KIRKLAND & ELLIS LLP Citigroup Center 153 E. 53rd Street New York, NY 10022 (212) 446-4800 March 19, 2008
2163015

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CERTIFICATE OF SERVICE I hereby certify that on March 19, 2008 I electronically filed the foregoing with the Clerk of the Court using CM/ECF, which will send notification of such filing to: Josy W. Ingersoll, Esquire YOUNG, CONAWAY, STARGATT & TAYLOR I further certify that I caused to be served copies of the foregoing document on March 19, 2008 upon the following in the manner indicated: Josy W. Ingersoll, Esquire YOUNG, CONAWAY, STARGATT & TAYLOR The Brandywine Building 1000 West Street, 17th Floor Wilmington, DE 19801 John G. Taylor, Esquire James K. Stronski, Esquire FROMMER LAWRENCE & HAUG LLP 745 Fifth Avenue New York, NY 10151 VIA ELECTRONIC MAIL and HAND DELIVERY

VIA ELECTRONIC MAIL

/s/ Jack B. Blumenfeld
Jack B. Blumenfeld (#1014)

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