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Astellas Pharma Inc. v. Actavis Elizabeth LLC

United States District Court, D. Delaware

June 18, 2018

ASTELLAS PHARMA INC., et al, Plaintiffs,
v.
ACTAVIS ELIZABETH LLC, et al, Defendants.

          REPORT AND RECOMMENDATION

          CHRISTOPHER J. BURKE UNITED STATES MAGISTRATE JUDGE

         In these consolidated Hatch-Waxman actions filed by Plaintiffs Astellas Pharma Inc., Astellas Ireland Co., Ltd. ("AICL") and Astellas Pharma Global Development, Inc. ("APGD" and collectively with other Plaintiffs, "Astellas" or "Plaintiffs") against Actavis Elizabeth LLC, Lupin Ltd. and Lupin Pharmaceuticals, Inc., Zydus Pharmaceuticals (USA), Inc. and Cadila Healthcare Ltd., Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc. and Aurolife Pharma LLC (collectively, "Aurobindo"), Prinston Pharmaceutical Inc., Sandoz Inc., Sawai Pharmaceutical Co., Ltd. and Sawai USA, Inc. (collectively, "Sawai" and together with Aurobindo, "SA Defendants"), and Apotex Inc. and Apotex Corp., Plaintiffs allege infringement by all Defendants ("Defendants") of, inter alia, U.S. Patent Nos. 7, 342, 117 (the "'117 patent") and 7, 982, 049 (the "'049 patent"). Presently before the Court is the matter of claim construction. The Court recommends that the District Court adopt the constructions as set forth below.

         I. BACKGROUND

         A. The Parties

         Astellas Pharma Inc. is the record owner and assignee of the '117 patent and the '049 patent, and AICL is the exclusive licensee of the patents. (D.I. 1 at ¶¶ 42-43) APGD has contracted with Astellas Pharma US, Inc., a subsidiary of Astellas Pharma Inc., to market and sell the drug mirabegron under the trade name Myrbetriq®. (Id. at ¶¶ 39, 44) Myrbetriq tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. (Id. at ¶ 41)

         Defendants are in the business of developing, manufacturing and distributing generic versions of branded drug products throughout the United States. (See, e.g., Id. at ¶ 4)

         B. The'117 and'049 Patents[1]

         The '117 patent and the '049 patent are both entitled "α-Form or β-form crystal of Acetanilide Derivative." (D.I. 1, exs. B, C (hereinafter, the '"117 patent" and the '"049 patent")) The '049 patent is a continuation of the U.S. patent application that led to the '117 patent, and the patents therefore share a specification. (See '049 patent; D.I. 77 at 2) Both patents claim priority to PTC Application No. PCT/JP02/11217, filed on October 29, 2002, and to Japanese Patent No. JP2001-332914, filed on October 30, 2001. ('117 patent; '049 patent; D.I. 77 at 2) The '117 patent issued on March 11, 2008, ('117 patent), and the '049 patent issued on July 19, 2011, ('049 patent). The '117 patent claims crystal forms of mirabegron, and the '049 patent claims pharmaceutical compositions comprising crystal forms of mirabegron and a pharmaceutically acceptable carrier, as well as methods of treating diabetes utilizing the claimed pharmaceutical compositions. ('117 patent, col. 12:18-30; '049 patent, cols. 11:5-12:33; D.I. 1 at ¶¶ 27, 30)

         C. Technical Overview

         Solids can exist in crystalline form, meaning the atoms (or molecules) are arranged in a repeating and ordered pattern that extends in three dimensions to form the crystal. (D.I. 78 at ¶ 29; D.I. 97 at ¶ 25)[2] Many compounds have the ability to crystallize into more than one distinct crystal form, with the atoms packed differently in the crystal's structure from form to form; these different crystalline forms of the same substance are referred to as polymorphs. (D.I. 78 at ¶ 30; D.I. 97 at ¶ 26) For example, the molecules of an active pharmaceutical ingredient ("API") may exist in more than one crystalline form. (D.I. 78 at ¶ 30) Polymorphs of an API may have differing properties, such as solubility, hygroscopicity, [3] dissolution rate and chemical and thermal stability. (Id.) Each new crystal form is generally given a formal name using sequential Roman numerals, Arabic numerals, or Greek or Latin letters. (Id. at ¶ 39; D.I. 97 at ¶ 28) Each "Form X" name for a different polymorph refers to a unique, specific crystalline form having its own characteristics. (D.I. 78 at ¶¶ 30, 39; D.I. 97 at ¶ 28)

         Powder x-ray diffraction (known as "XRPD") is a common method that has been used for many years in the pharmaceutical industry to help characterize and distinguish different crystalline forms. (D.I. 78 at ¶ 31; D.I. 97 at ¶ 30) This method tests a small amount of crystalline powder (instead of a single crystal) by exposing the sample to x-rays. (D.I. 78 at ¶ 31) X-ray diffraction results when x-rays of particular wavelengths are directed at a sample; the diffraction angles are measured, and an observable pattern of peaks is created that serves as a fingerprint for each unique crystal structure. (Id. at ¶¶ 31-32; D.I. 97 at ¶¶ 30-31, 35) These patterns of peaks can be placed on a chart, known as an "x-ray diffraction diagram" or "x-ray diffractogram," so that all of these peaks (including those peaks that stand out as being the most intense) can be viewed at one time. (See, e.g., '049 patent at FIGS. 1, 3-4; D.I. 97 at ¶ 32)

         Another well-established analytical technique that can be used to characterize crystal forms is differential scanning calorimetry ("DSC"). (D.I. 78 at ¶ 40; D.I. 97 at ¶ 40) One property of a polymorph is its melting point and associated endotherm, which measures the temperature at which the compound turns from solid to liquid as well as the heat absorbed during the process. (D.I. 97 at ¶ 40) DSC measures the melting point of a sample by analyzing the difference in the amount of heat flowing between two pans sitting on top of two separate heaters-a sample pan and a reference pan left empty. (D.I. 78 at ¶ 41; D.I. 97 at ¶ 40) When a sample melts, energy is required, and this event is reflected by a peak in the DSC profile representing the energy required to melt the crystal. (D.I. 78 at ¶ 42; D.I. 97 at ¶ 40)

         D. Procedural History

         This litigation arises from each of Defendants' submissions of Abbreviated New Drug Applications ("ANDAs") to the United States Food and Drug Administration ("FDA"), which seek approval to market generic versions of Myrbetriq. (See, e.g., D.I. 1 at ¶ 45; D.I. 77 at 1) APGD is the holder of New Drug Application No. 202611, which covers Myrbetriq. (D.I. 1 at ¶ 39) Plaintiffs filed the instant cases in October 2016, alleging, inter alia, that Defendants' AND A products and the use thereof would infringe at least claim 1 of the '117 patent and certain claims of the '049 patent pursuant to 35 U.S.C. § 271(a), and that Defendants' submission of their AND As constituted acts of infringement of certain claims of the '049 patent pursuant to 35 U.S.C. § 271(e)(2). (See, e.g., D.I. 1 at ¶¶ 57, 60-61)[4]

         On August 10, 2017, Judge Joseph F. Bataillon referred "all dispositive and nondispositive matters on all issues, including claim construction, except for summary judgments, Daubert motions and pretrial motions in limine[]" to the Court. (D.I. 67) The parties completed lengthy briefing on claim construction on March 21, 2018. (D.I. 77, 93, 95, 112, 146, 148, 155, 156) The Court held a Markman hearing on March 23, 2018. (D.I. 163 (hereinafter, "Tr.")) The Scheduling Order states that the Court "shall issue its decision on claim construction on or before June 20, 2018." (D.I. 25 at 9 (emphasis omitted))

         II. STANDARD OF REVIEW[5]

         A. Claim Construction

         It is well-understood that "[a] claim in a patent provides the metes and bounds of the right which the patent confers on the patentee to exclude others from making, using, or selling the protected invention." Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989). Claim construction is a generally a question of law, although subsidiary fact finding is sometimes necessary. Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837-38 (2015).

         The Court should typically assign claim terms their '"ordinary and customary meaning[, ]'" which is "the meaning that the term[s] would have to a person of ordinary skill in the art ['POSA'] in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips v. AWHCorp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (citations omitted). However, when determining the ordinary meaning of claim terms, the Court should not extract and isolate those terms from the context of the patent, but rather should endeavor to reflect their "meaning to the ordinary artisan after reading the entire patent." Id. at 1321; see also Eon Corp. IP Holdings LLC v. Silver Spring Networks, Inc., 815 F.3d 1314, 1320 (Fed. Cir. 2016).

         In proceeding with claim construction, the Court should look first and foremost to the language of the claims themselves, because "[i]t is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude." Phillips, 415 F.3d at 1312 (internal quotation marks and citations omitted). For example, the context in which a term is used in a claim may be "highly instructive." Id. at 1314. In addition, "[o]ther claims of the patent in question, both asserted and unasserted, can ... be valuable" in discerning the meaning of a particular claim term. Id. This is "[b]ecause claim terms are normally used consistently throughout the patent, [and so] the usage of a term in one claim can often illuminate the meaning of the same term in other claims." Id. Moreover, "[differences among claims can also be a useful guide [, ]" as when "the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Id. at 1314-15.

         In addition to the words of the claims, the Court should look to other intrinsic evidence. For example, the Court should analyze the patent specification, which "may reveal a special definition given to a claim term . .. that differs from the meaning [that term] would otherwise possess" or may reveal an intentional disclaimer of claim scope. Id. at 1316. Even if the specification does not contain such revelations, it "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. at 1315 (internal quotation marks and citation omitted). That said, however, the specification "is not a substitute for, nor can it be used to rewrite, the chosen claim language." SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). And a court should also consider the patent's prosecution history, if it is in evidence, because it "can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution[.]" Phillips, 415 F.3d at 1317.

         Extrinsic evidence, "including expert and inventor testimony, dictionaries, and learned treatises [, ]" can also "shed useful light on the relevant art[.]" Id. (internal quotation marks and citations omitted). Overall, while extrinsic evidence may be useful, it is "less significant than the intrinsic record in determining the legally operative meaning of claim language." Id. (internal quotation marks and citations omitted); accord Markman v. Westview Instruments, Inc., 52 F.3d 967, 981 (Fed. Cir. 1995).

         In utilizing these resources during claim construction, courts should keep in mind that "[t]he construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction." Renishaw PLC v. Marposs Societa'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).

         B. Definiteness

         35 U.S.C. § 112 ("Section 112") requires that a patent claim "particularly point[] out and distinctly claim[] the subject matter which the applicant regards as his invention." 35 U.S.C. § 112, ¶ 2.[6] If it does not, the claim is indefinite and therefore invalid. Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2125 (2014) ("Nautilus"). In Nautilus, the Supreme Court of the United States set out the test to be applied in the definiteness inquiry: "a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention." Id. at 2124. Definiteness is to be evaluated from the perspective of a POSA at the time the patent was filed. Id. at 2128.

         Like claim construction, definiteness is a question of law for the court. H-WTech, L.C. v. Overstock.com, Inc., 758 F.3d 1329, 1332 (Fed. Cir. 2014); Pi-NetInt'l Inc. v. JPMorgan Chase & Co., 42 F.Supp.3d 579, 586 (D. Del. 2014). The United States Court of Appeals for the Federal Circuit has stated that "[a]ny fact critical to a holding on indefiniteness ... must be proven by the challenger by clear and convincing evidence." Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366 (Fed. Cir. 2003); see also Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1338 (Fed. Cir. 2008).[7]

         The primary purpose of the definiteness requirement is to ensure that patent claims are written in such a way that they give notice to the public of what is claimed, thus enabling interested members of the public (e.g., competitors of the patent owner) to determine whether they infringe. All Dental Prodx, LLC v. Advantage Dental Prods., Inc., 309 F.3d 774, 779-80 (Fed. Cir. 2002). Put another way, "[a] patent holder should know what he owns, and the public should know what he does not." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 731 (2002). Even so, the Supreme Court has recognized that "absolute precision is unattainable" and not required. Nautilus, 134 S.Ct. at 2129.

         III. DISCUSSION

         The Court takes up the three sets of disputed terms in the order in which the parties addressed them at the Markman hearing.[8]

         A. "α-form crystal" and "β-form crystal"

         The claim term "α-form crystal" appears in claim 1 of the '049 patent, and the claim term "β-form crystal" appears in claim 3 of that patent. Claims 1 and 3 are reproduced below:

1. A solid pharmaceutical composition comprising the α-form crystal of (R)-2-(2-aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino] ethyl] acetanilide and a pharmaceutically acceptable carrier.

('049 patent, col. 11:5-8 (emphasis added))

3. A solid pharmaceutical composition comprising the β-form crystal of (R)-2-(2-aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetanilide and a pharmaceutically acceptable carrier.

(Id., col. 11:14-17 (emphasis added))

         Plaintiffs explain that the terms "α-form crystal" and "β-form crystal" are "the names of the two novel crystal forms of mirabegron that are described in the specification" of the '049 patent. (D.I. 77 at 10) Defendants agree on this point, characterizing the terms as "arbitrary identifiers given to polymorphs of a given compound." (D.I. 93 at 12) With respect to the proper constructions of these claim terms, Plaintiffs propose that "α-form crystal" be construed to mean "α-form crystal which is a term of reference for a polymorphic crystal form of (R) 2-(2-aminothiazol-4-yl)-4'-[2-[(2 hydroxy-2-phenylethyl)amino]ethyl]acetanilide that can be distinguished from other forms." (D.I. 77 at 10) Likewise, as to "β-form crystal," Plaintiffs propose that the term be construed to mean "β-form crystal which is a term of reference for a polymorphic crystal form of (R) 2-(2-aminothiazol-4-yl)-4'-[2-[(2 hydroxy-2-phenylethyl)amino] ethyl] acetanilide that can be distinguished from other forms." (Id.)

         For their part, Defendants assert that the terms are indefinite. (D.I. 93 at 12) Defendants contend that since these terms do not have ordinary or customary meanings, the specification of the '049 patent must provide sufficient data that would allow the POSA to actually identify each form. (Id. at 12-13) According to Defendants, the specification fails to do so. (Id.) Instead, Defendants contend that the "minimal descriptions" of each form of crystal in the specification "are often inconsistent and contradictory" and thus cannot be used to determine whether a sample falls within the scope of the α-form or β-form crystal. (Mat 13; see also D.I. 146 at 4; Defendants' Claim Construction Arguments Presentation, Slides A9-A10) As for Plaintiffs' proposed constructions, Defendants point out that Plaintiffs' proposals fail to actually identify any further characteristics of the α-form and β-form crystals, and therefore just "[c]onfirm [that] the [t]erms [a]re [i]ndefmite[.]" (D.I. 93 at 15; Tr. at 30 (Defendants' counsel explaining that Plaintiffs' proposed construction for "α-form crystal[, ]" for example, essentially states that the "alpha form means alpha form"))

         Below, the Court addresses the key issues raised by the parties' respective positions.

         1. Why Plaintiffs' Proposed Constructions Are Not Acceptable

         The Court finds that Plaintiffs' proposed constructions for the terms "α-form crystal" and "β-form crystal" are problematic. This is because, as Defendants point out, the constructions do not provide any further clarification as to how the two terms can be distinguished from each other. (D.I. 93 at 15)[9]

         Plaintiffs argue that their proposed constructions are sufficient because: (1) once a new crystalline form has been identified and described, it will have a "chemical structure and a host of physical characteristics that can be used to identify it"; but (2) a POSA would find it unnecessary to recite all of these characteristics in order to identify the forms, since the POSA could make that identification simply by hearing the name for the form. (D.I. 77 at 13; Tr. at 61 (Plaintiffs' counsel contending that, if the claims used the word "mirabegron," for instance, that is just a name, but the name "tells you exactly what the thing is, because from the patent or from other sources, there's lots of identifying information that tells you what mirabegron is")) The problem with Plaintiffs position, however, is that we have a fundamental dispute here about the terms-i.e., whether there is sufficient guidance in the intrinsic record to allow the POSA to distinguish the α-form crystal and β-form crystal from each other (and if so, what is that guidance)? Were the Court to simply adopt Plaintiffs' proposed constructions, this would not resolve the dispute.[10] See, e.g., Celgene Corp. v. Natco Pharma Ltd., Civil Action No. 10-5197 (SDW), 2014 WL 2196941, at *4 (D.N.J. May 27, 2014) (rejecting plaintiffs proposal to construe "Form A" to mean "a polymorphic form of 3-(4-amino-l-oxo-1, 3 dihydro-insoindol-2-yl)piperidine-2, 6-dione that can be distinguished from other forms" because such a construction would "give no meaning to the term 'Form A'" and would "ignore the specific attributes of Form A as defined in the specification"). If the intrinsic record does in fact provide such guidance, then the constructions for these terms should at least make reference to that guidance. If the record provides no such guidance, that would indicate that the terms are indefinite.[11]

         2. Is There Sufficient Evidence in the Intrinsic Record that Can Be Used to Distinguish These Two Crystal Forms from Each Other, so as to Avoid Indefiniteness Concerns (and if so, What Is It)?

         Having concluded that Plaintiffs' proposed constructions will not be helpful here, the Court next examines whether the intrinsic record contains sufficient evidence that can be used to teach a POSA, with reasonable certainty, how to distinguish these two different crystal forms from each other?[12] In Plaintiffs' view, "the common specification of the [asserted patents] discloses to a POSA how to identify and distinguish the a-form and ]3-form crystals of mirabegron." (D.I. 112 at 3; see also D.I. 155 at 9 (explaining that Plaintiffs "do not argue that the term 'α-form crystal' or '(β-form crystal' have a meaning independent of and apart from the '117 and '049 Patent specifications"))

         The '049 patent's specification does expressly discuss observed properties of the α-form crystal and (3-form crystal. Plaintiffs point to the following supporting data described in the ...


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