Free Brief in Opposition to Motion - District Court of Colorado - Colorado

Case 1:03-cv-01973-PSF-MJW

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Filed 09/26/2005

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EXHIBIT E

EXHIBIT E

Case 1:03-cv-01973-PSF-MJW

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Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2002 WL 32348145 (E.D.Pa.) (Cite as: 2002 WL 32348145 (E.D.Pa.))

Only the Westlaw citation is currently available. United States District Court, E.D. Pennsylvania. ASTRAZENECA AB, et al. Plaintiffs, v. MUTUAL PHARMACEUTICAL COMPANY, INC. Defendant. No. Civ.A.00-4731. Oct. 3, 2002. Amr O. Aly, Errol B. Taylor, Lisa B. Baeurle, Fitzpatrick Cella Harper & Scinto, New York, NY, Eric Kraeutler, John V. Gorman, Morgan Lewis & Bockius LLP, Philadelphia, PA, for Plaintiffs. Christopher T. Griffith, Robert F. Green, Leydig Voit and Mayer Limited, Chicago, IL, John J. Higson, Thomas S. Biemer, Dilworth Paxson LLP, Philadelphia, PA, for Defendant. MEMORANDUM REED, J. *1 Now before this Court is the motion of defendant Mutual Pharmaceutical Company, Inc. ("Mutual" or "defendant") (Doc. No. 77) for reconsideration of this Court's Order of August 19, 2002, setting forth its conclusions of law regarding the patent claim construction, the response of plaintiffs (Doc. No. 80) and the reply thereto. For the reasons set forth below, the motion for reconsideration will be denied. Background Plaintiffs, Aktiebologet Hassle, KBI-E Inc., KBI Inc., AstraZeneca AB, and AstraZeneca LB, (collectively referred to as "Astra" or "plaintiffs") filed this patent infringement suit against defendant Mutual, alleging that under 35 U.S.C. § 271(e)(2), Mutual is infringing United States Patent No. 4,803,081 ("the '081 patent"), by filing its Abbreviated New Drug Application ("ANDA") seeking approval from the Federal Drug Administration ("FDA") to manufacture, use and sell Mutual's proposed Felodipine 10 mg, 5mg, and 2.5mg tablets products as generic versions of

plaintiffs' products. The '081 patent is entitled "New Pharmaceutical Preparations With Extended Release," and deals with pharmaceutical extended release preparations of active compounds with very low solubility. In total, the following six claims of the '081 patent are at issue in this lawsuit: 8, 12, 14, 15 and 17. A Markman hearing was held on April 30, 2002, in which the parties presented oral argument as to the proper construction of the disputed claim language in the claims at issue. The parties also submitted a series of briefs, deposition transcripts and proposed claim constructions to the Court, all of which were considered by this Court when construing the claims in the Order dated August 19, 2002 ("August 19th Opinion"). On each claim term to be construed, the parties submitted many arguments and pointed to many portions of the intrinsic and extrinsic record in their briefs, proposed claim constructions, and oral presentations. The Court considered all of the arguments and citations of the parties, although they may not have been reiterated in full in the Court's conclusions. Although six claim terms were presented to the Court for construction, Mutual has moved for reconsideration of this Court's conclusion regarding only the claim construction of the term "nonionic solubilizer" (Claims 1, 8, 12, 14, 15 and 17). In the August 19th Opinion, the Court construed "nonionic solubilizer" as meaning a nonionic compound that increases the solubility of a substance in a particular solvent (August 19th Opinion at 19). Legal Standard Although Mutual has moved for reconsideration pursuant to Federal Rule of Civil Procedure 59(e), this rule applies only to final judgments and orders, and not to interlocutory decisions. See Jairett v. First Montauk Securities Corp., 153 F.Supp.2d 562, 579 (E.D.Pa.2001). Nevertheless, "a federal district court has the inherent power to reconsider interlocutory orders 'when it is consonant with justice to do so.' " Id. (quoting United States v. Jerry, 487 F.2d 600, 605 (3d Cir.1973)). The purpose of a motion for reconsideration is "to correct manifest errors of law or fact or to present newly discovered evidence." Harsco Corp. v. Zlotnicki, 779 F.2d 906, 909 (3d Cir.1985). Motions for reconsideration

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Case 1:03-cv-01973-PSF-MJW

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Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2002 WL 32348145 (E.D.Pa.) (Cite as: 2002 WL 32348145 (E.D.Pa.))

will be granted only upon one of the following grounds: (1) an intervening change in controlling law; (2) the emergence of new evidence not previously available; or (3) the need to correct a clear error of law or to prevent a manifest injustice. See General Instrument Corp. v. Nu-Tek Elecs. & Mfg., 3 F.Supp.2d 602, 606 (E.D.Pa.1998), aff'd, 197 F.3d 83 (3d Cir.1999). In light of the "interest in finality ... courts should grant motions for reconsideration sparingly." Jairett, 153 F.Supp.2d at 580 (citation omitted). Analysis 1. August 19th Opinion *2 In the August 19th Opinion, I had determined that the key issue in construing the term "solubilizer" was whether the '081 patent claims all groups of solubilizers--including surface active agents ("surfactants"), co-solvents, and complexation agents--or whether the patent covers only surfactants. Mutual argued in its initial briefing that the intrinsic record of the '081 patent mandated the limitation of the term solubilizer to cover only surfactants. Upon a review of the specification of the '081 patent, I could find no clear expression of an intent by the inventor to redefine "solubilizer," and therefore concluded that the specification did not limit the claim term to surfactants. I then reviewed the prosecution history, encompassing the entire record of all proceedings before the United States Patent and Trademark Office, with particular regard to Astra's distinction of the '081 patent from the Kawata patent (United States Patent No. 4,673,564, Pls.' Ex. 4, Def.'s Ex. B, (hereinafter "the Kawata patent")). In their briefs presented to the Court prior to the August 19th Opinion, Mutual contended that the sole difference between Kawata and the '081 patent was the use of surfactants in the latter. Specifically, Mutual argued that because the Kawata Example 2 (Col. 5, ln. 64--Col. 6, ln. 9 of the Kawata patent) uses polyethylene glycol 400 ("PEG 400"), the co-solvent proposed as a solubilizer in Mutual's ANDA, Astra had surrendered its use. In contrast, Astra argued that the '081 patent was distinguished as an entirely different system from the Kawata patent. Astra maintained that Kawata, unlike the '081 patent, did not disclose the possibility of a controlled-release preparation based upon a

solution or dispersion of a drug in a nonionic solubilizer, and in fact taught against solubilizers. I found that Mutual failed to support its conclusory arguments against Astra's assertions that Kawata was distinguished as teaching the use of an amorphous drug. The Court further observed that Mutual never expressly denied that the two patents use completely different processes, and that Kawata does not use PEG 400 in Example 2 as a solubilizer. The Court noted that Mutual's argument was most weakened by the uncontested fact that the Kawata patent explicitly provides that the second optional component can be PEG 400 as well as a surfactant. I thus concurred with Astra's position that it would have been impossible for Astra to distinguish the ' 081 patent on the ground that the '081 patent invention used a surfactant, when the Kawata patent expressly teaches that a surfactant can be used as a possible optional second element. Ultimately, the Court rejected Mutual's argument and agreed with plaintiff that the prosecution history indicated that Astra did not distinguish its patent from Kawata (1) on the ground of a particular solubilizer because not only does Kawata use an entirely different process, but also because the specification teaches against solubilizers; and (2) the claims do not require surfactant type solubilizers because Kawata discloses both surfactants and co-solvents as possibilities for the optional second component. I further noted that Astra never defined nonionic solubilizer as excluding PEG 400 in the prosecution history. I therefore concluded that the prosecution history did not limit the claim term nonionic solubilizer beyond its ordinary meaning. 2. Mutual's Arguments for Reconsideration *3 In its reply memorandum in support of the motion for reconsideration, Mutual specifies that the basis for the instant motion is its contention that the claim construction of the term "nonionic solubilizer" was a clear error of law and fact. Mutual thus does not rely upon, nor has it pointed to, any new evidence or intervening change in the controlling law. In support of its argument that the Court committed clear factual and legal error, Mutual presses its previous

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Case 1:03-cv-01973-PSF-MJW

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Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2002 WL 32348145 (E.D.Pa.) (Cite as: 2002 WL 32348145 (E.D.Pa.))

contention that Astra did not distinguish the '081 patent from Kawata on the basis of a different process, but that in fact Astra limited its definition of the term "solubilizer" to include only surfactants. Specifically, defendant argues the following: (1) that the '081 patent claims at issue do not contain a process limitation, and that Astra has not met its burden in proving that PEG 400 does not act as a solubilizer in Example 2 of Kawata; (2) that the '081 patent claims at issue do not contain language that distinguish between amorphous drugs, as taught by the Kawata patent, and non-amorphous drugs; (3) that the first of the two Kawata embodiments, relied upon by Mutual, does not teach against the use of solubilizers, and therefore Astra's reliance upon the second Kawata embodiment, which does teach against the use of solubilizers, is irrelevant; and (4) that Astra distinguished the '081 patent from the Kawata patent by including the limitation "wherein the amount by weight of the solubilizer is at least equal to the amount by weight of the active" in combination with limiting the term "solubilizer" to include only surfactants. In its reply memorandum, Mutual further argues the following: (1) that PEG 400 must act as a solubilizer in the Kawata patent because its properties as a solubilizer is inherent in its chemical composition; (2) the '081 patent claims as widely construed by the Court would be invalid over the Kawata patent because the components are identical; (3) Astra could not have distinguished the '081 patent based upon the amorphous form of the active ingredient in Kawata; and (4) there was no factual or legal basis to support a distinction between the Kawata and '081 patents based upon a "purported co-precipitation property." The Court has already considered and rejected Mutual's arguments that Astra distinguished the '081 patent from the Kawata patent based on the limitation of the term "solubilizer" to include only surfactants. Unless otherwise compelled, a court should give full effect to the ordinary meaning of claim terms, even if the terms are broad. See Johnson Worldwide Assoc., Inc. v. Zebco Corporation, 175 F.3d 985, 989 (Fed.Cir.1999). "Although the prosecution history can and should be used to understand the language used in the claims, it [ ] cannot 'enlarge, diminish or vary' the limitations in the claims." Markman v. Westview

Instruments, Inc., 52 F.3d 967, 980 (Fed.Cir.1995) (quoting Goodyear Dental Vulcanite Co. v. Davis, 102 U.S. 222, 227, 26 L.Ed. 149 (1880)). "Unless altering claim language to escape an examiner['s] rejection, a patent applicant only limits claims during prosecution by clearly disavowing claim coverage," that is, by making a statement that concedes or disclaims coverage of the claims at issue based on a piece of prior art. York Products, Inc. v. Central Tractor Farm & Family Ctr., 99 F.3d 1568, 1575 (Fed.Cir.1996). I had previously determined after a thorough review of the prosecution history that Astra had not clearly disavowed claim coverage of all solubilizers, including PEG 400. I find no reason to change that conclusion. *4 In the instant motion, Mutual presents arguments that dance around but do not directly challenge this Court's conclusion that Astra did not distinguish its patent from Kawata based on a particular solubilizer. Mutual persistently contends that there is no legal or factual basis to distinguish the patents on the grounds that they utilized different systems, but again fails to expressly state that Kawata does not use a co-precipitation formula or PEG 400 in Example 2 as a solubilizer. The fact that the PEG 400 used in Example 2 of the Kawata patent has the properties of a solubilizer, without any further illustration, does not indicate that it is functioning as a solubilizer. Mutual's belated argument of patent invalidity based on the identical components of the '081 and Kawata patents is of no avail. The Court found in its August 19th Opinion that the '081 patent was accepted by the USPTO based on its distinct preparation process, a solution or dispersion of a drug in a nonionic solubilizer, unlike the Kawata patent which taught against solubilizers and required the use of an amorphous drug. Mutual has not persuaded me otherwise, and the record supports my conclusions. Finally, Mutual fails to counter effectively the fatal finding that Astra could not have distinguished the '081 patent based on its use of a surfactant because the Kawata patent expressly teaches that a surfactant can be used as a possible optional second element. Mutual presents no new arguments nor any grounds to show clear error by the Court in its claim construction of the

© 2005 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:03-cv-01973-PSF-MJW

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Filed 09/26/2005

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Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2002 WL 32348145 (E.D.Pa.) (Cite as: 2002 WL 32348145 (E.D.Pa.))

August 19th Order, nor any evidence that manifest injustice would result if the motion were denied. As numerous district courts in this circuit have commented, "[d]issatisfaction with the Court's ruling is not a proper basis for reconsideration." Evans v. United States, 173 F.Supp.2d 334, 335 (E.D.Pa.2001); Burger King Corp. v. New Eng. Hood & Duct Cleaning Co., Civ. No. 98-3610, 2000 U.S. Dist. LEXIS 1022, *5 (E.D.Pa. Feb. 4, 2000); Central Reserve Life Ins. Co. v. Marello, Civ. No. 00-3344, 2001 U.S. Dist. LEXIS 281, *5 (E.D.Pa. Jan. 17, 2001). "A motion for reconsideration is not properly grounded on a request that a court reconsider repetitive arguments that have been fully examined by the court or a request to raise arguments that could have previously been asserted." Tobin v. General Elec. Co., Civ. No. 95-4003, 1998 U.S. Dist. LEXIS 693, *7 (E.D.Pa. Jan. 27, 1998). "It is improper on a motion for reconsideration to ask the Court to rethink what it had already thought through--rightly or wrongly." Glendon Energy Co. v. Borough of Glendon, 836 F.Supp. 1109, 1122 (E.D.Pa.1993) (citation, internal quotation marks and brackets omitted). I find that Mutual has not met its burden under these standards for a motion for reconsideration. Consequently, there is no need to revisit the merits of the arguments presented. Conclusion For the foregoing reasons, Mutual's motion for reconsideration of this Court's claim construction for the term "non-ionic solubilizer" will be denied. *5 An appropriate Order follows. ORDER AND NOW, this 3rd day of October, 2002, upon consideration of the motion of defendant Mutual Pharmaceutical Company, Inc. (Doc. No. 77) for reconsideration of this Court's Order of August 19, 2002, setting forth its conclusions of law regarding the patent claim construction, the response of plaintiffs (Doc. No. 80) and the reply thereto, and for the reasons set forth in the foregoing Memorandum, it is hereby ORDERED that the motion for reconsideration is DENIED. Not Reported in F.Supp.2d, 2002 WL 32348145 (E.D.Pa.)

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