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IN RE AVENTIS PHARMACEUTICALS

September 17, 2004.

AVENTIS Pharmaceuticals, Inc., MERRELL Pharmaceuticals, Inc., and CARDERM CAPITAL L.P., Plaintiffs, BARR LABORATORIES, INC., Defendant. IMPAX LABORATORIES, INC., Defendant. TEVA PHARMACEUTICALS, USA, INC., Defendant. MYLAN PHARMACEUTICALS, INC., Defendant. DR. REDDY'S LABORATORIES, LTD. and DR. REDDY'S LABORATORIES, INC., Defendants.


The opinion of the court was delivered by: JOSEPH GREENAWAY, District Judge

AMENDED OPINION

This matter comes before the Court on the motion of Barr Laboratories, Inc. ("Barr"), Impax Laboratories, Inc. ("Impax"), Teva Pharmaceuticals USA, Inc. ("Teva"), Mylan Pharmaceuticals, Inc. ("Mylan"), Dr. Reddy's Laboratories, Ltd., and Dr. Reddy's Laboratories, Inc. ("Reddy"), (collectively "Defendants"), seeking summary judgment on their claim that U.S. Patent No. 5,738,872 ("the '872 patent") is invalid as anticipated, and that the '872 patent, as well as U.S. Patent Nos. 6,113,942 ("the '942 patent"), 5,855,912 ("the '912 patent"), 5,932,247 ("the '247 patent"), and 6,039,974 ("the '974 patent") are not infringed.*fn1 For the reasons set forth below, the summary judgment motion of non-infringement of the '912, '942, and '247 patents is granted. The motion as to the '974 patent is denied. A ruling on the '872 patent is reserved pending a Markman hearing to assist this Court in construing the patent's product-by-process claims. The scope of the Markman hearing shall be set forth below.

  BACKGROUND

  This dispute concerns patents owned by Aventis Pharmaceuticals, Inc., Merrell Pharmaceuticals Inc., and Carderm Capital L.P. (collectively "Plaintiffs" or "Aventis") disclosing solid dosage fexofenadine formulations sold in the United States by Aventis under the tradenames ALLEGRA® and ALLEGRA-D® These antihistamine allergy medication products have achieved substantial commercial success in the United States. Between May 2001 and November 2002, Defendants each filed Abbreviated New Drug Applications ("ANDA") seeking the Federal Drug Administration's ("FDA") approval to market generic drug products containing the same active ingredients (fexofenadine hydrochloride ("fexofenadine") and pseudoephedrine hydrochloride) as Aventis' ALLEGRA® and ALLEGRA-D® products.*fn2 In connection with their ANDA submissions, Defendants filed so-called "Paragraph IV Certifications" asserting that the Aventis patents*fn3 were invalid, unenforceable, or would not be infringed by the commercial manufacture, use, or sale of their drug products.*fn4 In response to notice of Defendants' Paragraph IV Certifications, and acting pursuant to statutorily prescribed procedures,*fn5 Plaintiffs commenced these, now consolidated, patent infringement actions.

  Defendants have filed the instant motions for summary judgment arguing that their accused products do not literally infringe the '942, '912, '274, and '974 patents, and further, that there can be no finding of infringement under the doctrine of equivalents. Defendants contend that Plaintiffs are barred from asserting the doctrine of equivalents by prosecution history estoppel, and in the alternative, are precluded from relying on the doctrine of equivalents because Plaintiffs' patents have dedicated inert ingredients or excipients used by Defendants in their accused products to the public. With respect to the '872 patent, Defendants argue that their accused products do not infringe, and that the '872 patent is invalid, as anticipated by the prior art.

  This Court will address infringement issues initially with respect to the '942, '912, '274, and '974 patents, followed by a focus on the inquiry into the validity of the '872 patent.

  APPLICABLE LEGAL STANDARDS

  I. FED. R.Civ. P. 56(c)

  Summary judgment is appropriate under FED. R.CIV.P.56(c) when the moving party demonstrates that there is no genuine issue of material fact and the evidence establishes the moving party's entitlement to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986); Orson, Inc. v. Miramax Film Corp., 79 F.3d 1358, 1366 (3d Cir. 1996). In making this determination, the Court must draw all reasonable inferences in favor of the non-movant. Hullett v. Towers, Perrin, Forster & Crosby, Inc., 38 F.3d 107, 111 (3d Cir. 1994); Nat'l State Bank v. Fed. Reserve Bank of N.Y., 979 F.2d 1579, 1581 (3d Cir. 1992).

  Once the moving party has satisfied its initial burden, the party opposing the motion must establish that a genuine issue as to a material fact exists. Jersey Cent. Power & Light Co. v. Lacey Township, 772 F.2d 1103, 1109 (3d Cir. 1985). The party opposing the motion for summary judgment cannot rest on mere allegations and instead must present actual evidence that creates a genuine issue as to a material fact for trial. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); Siegel Transfer, Inc. v. Carrier Express, Inc., 54 F.3d 1125, 1130-31 (3d Cir. 1995). "[U]nsupported allegations . . . and pleadings are insufficient to repel summary judgment." Schoch v. First Fid. Bancorporation, 912 F.2d 654, 657 (3d Cir. 1990); see also FED. R.Civ.P. 56(e) (requiring nonmoving party to "set forth specific facts showing that there is a genuine issue for trial").

  If the nonmoving party has failed "to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial, . . . there can be `no genuine issue of material fact,' since a complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts immaterial." Katz v. Aetna Cas. & Sur. Co., 972 F.2d 53, 55 (3d Cir. 1992) (quoting Celotex, 477 U.S. at 322-23). In determining whether there are any issues of material fact, the Court must resolve all doubts as to the existence of a material fact against the moving party and draw all reasonable inferences — including on issues of credibility — in favor of the non-moving party. Watts v. Univ. of Del., 622 F.2d 47, 50 (3d Cir. 1980).

  II. Infringement

  The test for patent infringement requires a two step analysis: "First, the claim must be properly construed to determine its scope and meaning. Second, the claim as properly construed must be compared to the accused device or process." Carroll Touch, Inc. v. Electro Mech. Sys., Inc., 15 F.3d 1573, 1576 (Fed. Cir. 1993). "In order for a court to find infringement, the plaintiff must show the presence of every limitation or its substantial equivalent in the accused device." KX Industries v. PUR Water Purification Products, 2001 WL 902507 *3 (Fed. Cir. 2001) (citing Wolverine World Wide, Inc. v. Nike, Inc., 38 F.3d 1192, 1199 (Fed. Cir. 1994)). Although claim construction is an issue of law, the determination of infringement is a question of fact. Id.

  "A district court should approach a motion for summary judgment on the fact issue of infringement with great care." Cole v. Kimberly-Clark Corp., 102 F.3d 524, 528 (Fed. Cir. 1996). Nonetheless, summary judgment of infringement may be granted when a rational jury could only conclude that infringement has occurred. See Karlin Tech. Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 974-75 (Fed. Cir. 1999).

  INFRINGEMENT UNDER THE DOCTRINE OF EQUIVALENTS

  A product may infringe a patent either literally or equivalently. Cybor Corp. v. FAS Techs., 138 F.3d 1448, 1459 (Fed. Cir. 1998). Plaintiffs cannot argue that each limitation of the claims at issue in patents '942, '912, '274, and '974, are satisfied exactly by the accused products, as required to prove literal infringement. Instead, they rely on the doctrine of equivalents which "prevents an accused infringer from avoiding liability for infringement by changing only minor or insubstantial details of a claimed invention while retaining the invention's essential identity." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F. 3d 558, 564 (Fed. Cir. 2000) ("Festo VI"). Infringement under the doctrine of equivalents is found "only when a patentee shows by a preponderance of the evidence that the accused product or process contain[s] elements identical or equivalent to each claimed element of the patented invention." Warner-Jenkinson Co. v. Hilton Davies Chem. Co., 520 U.S. 17, 40 (1997).

  Application of the doctrine of equivalents requires a fact intensive analysis to determine whether or not differences between a claim limitation of the patent, and the corresponding element of the accused device, are merely insubstantial or unimportant substitutions. In certain cases, however, the law restricts application of the doctrine of equivalents without further fact finding. This occurs when a patentee is found to have dedicated equivalent subject matter to the public, or where prosecution history estoppel bars application of the doctrine of equivalents.

  The '912, '942, '974, and '247 patents generally claim fexofenadine formulations with certain combinations of excipients, including pregelatinized starch, croscarmellose sodium, and microcrystalline cellulose. These excipients are not present in Defendants' accused product formulations.*fn6 For the purposes of this motion, it is assumed that defendants Barr, Impax, Teva, and Mylan's accused tablets substitute povidone, and Reddy substitutes mannitol as an equivalent for pregelatinized starch as a binder; Barr and Mylan substitute crospovidone, and Impax substitutes sodium starch glycolate for croscarmellose sodium as a disintegrant; and Barr and Reddy substitute powdered cellulose for microcrystalline cellulose as a diluent.

  PROSECUTION HISTORY ESTOPPEL

  I. Standard for the Bar of Prosecution History Estoppel to Availability of the Doctrine of Equivalents in an Infringement Action

  Prosecution history estoppel may bar a patentee from asserting infringement under the doctrine of equivalents:
[T]here are limits to the application of the doctrine of equivalents aside from the question of insubstantiality of the differences . . . [P]rosecution history estoppel can prevent a patentee from relying on the doctrine of equivalents when the patentee relinquishes subject matter during the prosecution of the patent, either by amendment or argument.
Eagle Comtronics, Inc. v. Arrow Commun. Labs., Inc., 305 F.3d 1303, 1315 (Fed. Cir. 2002). There are thus two different kinds of prosecution history estoppel: that based on amendment, and that based on argument.

  A. Amendment-Based Estoppel

  The Supreme Court established the standard for amendment-based estoppel in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002) ("Festo VIII"). The basic principle is: "[a] narrowing amendment made to satisfy any requirement of the Patent Act may give rise to an estoppel." Id. at 736. A patentee making such an amendment is presumed to have surrendered the territory for purposes of the doctrine of equivalents, and bears the burden of rebutting this presumption.

 
[W]e hold here that the patentee should bear the burden of showing that the amendment does not surrender the particular equivalent in question. The patentee, as the author of the claim language, may be expected to draft claims encompassing readily known equivalents. A patentee's decision to narrow his claims through amendment may be presumed to be a general disclaimer of the territory between the original claim and the amended claim.
Id. at 740. The Court held that there are three ways in which a patentee may rebut this presumption:
The equivalent may have been unforeseeable at the time of the application; the rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question; or there may be some other reason suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question.
Id. Even if estoppel applies, however, the patentee may demonstrate that the narrowing amendment did not surrender the particular equivalents at issue. Id. at 741. "The standard for determining whether particular subject matter was relinquished is an objective one that depends on what a competitor reasonably would conclude from the patent's prosecution history." Mark 1 Marketing, Corp. v. R.R. Donnelley & Sons Co., 66 F.3d 285, 291 (Fed. Cir. 1995).

  The issue of whether prosecution history estoppel bars the availability of the doctrine of equivalents in an infringement action is a matter of law. "We have stated on numerous occasions that whether prosecution history estoppel applies, and hence whether the doctrine of equivalents may be available for a particular claim limitation, presents a question of law." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1367 (Fed. Cir. 2003) ("Festo IX"). Any resolution of factual issues underlying these questions of law may be decided by the court, not the jury. Id. at 1369.

  B. Argument-Based Estoppel

  The Federal Circuit has extended the principles of prosecution history estoppel to arguments made by an applicant during patent prosecution, producing a second category of estoppel: argument-based estoppel. "Clear assertions made during prosecution in support of patentability, whether or not actually required to secure allowance of the claim, may also create an estoppel." Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1583 (Fed. Cir. 1995). "To invoke argument-based estoppel, the prosecution history must evince a clear and unmistakable surrender of subject matter." Eagle Comtronics, 305 F.3d at 1316. Thus, the legal standards for amendment-based estoppel and argument-based estoppel differ greatly.

  II. Prosecution History Estoppel Does Not Bar Availability of the Doctrine of Equivalents in Plaintiffs' Action for Infringement of the '974 Patent

  The '974 patent is for a two-layer tablet, with one layer of antihistamine (from the genus of which fexofenadine is one species) and another layer of decongestant. Defendants make only one argument relating to the examiner's statements in the office action allowing the claims: "[h]aving failed to contest the P.T.O.'s stated reasons for allowance, Plaintiffs have disallowed any broader constructions." (Impax Br. at 20). That single sentence contains Defendants' entire argument on this matter.*fn7 Defendants propose no legal theory to explain why Plaintiffs have disallowed any broader constructions. They cite no case law, and their reply brief does not even discuss the '974 patent. Non-response to a statement in an office action does not qualify for consideration as either amendment-based estoppel or argument-based estoppel. Defendants have failed to show a basis for their claim.

  III. Prosecution History Estoppel Bars Availability of the Doctrine of Equivalents in Plaintiffs' Actions for Infringement of the '942 and '912 Patents

  Both Plaintiffs and Defendants agree that the written descriptions of the '942 and '912 patents are virtually identical, and do not differ materially for the purposes of this summary judgment motion. Plaintiffs and Defendants have argued the two patents together, and they are considered together in this opinion.

  A. Prosecution History of the '942 and '912 Patents

  The '942 and '912 patents descended from three related applications: 1) application 08/395,952 was filed on February 28, 1995, and abandoned, but continued in part by 2) application 08/552,287, filed on December 12, 1995, and abandoned, but continued in part by 3) application 08/943,460 for the present patents, filed October 3, 1997. The '912 patent was granted directly from the last-mentioned application, and the '942 patent is a divisional offspring of that application. The claims in the first application, 08/395,952, are all pharmaceutical composition claims for a combination of an active ingredient and one or more inert ingredients. The record shows that the P.T.O. response to the first application, the first office action, was directed to the generic nature of the claims, finding that they encompassed a plurality of species, and seeking restriction or election of species. (Gresalfi Decl. at A270-272.) Applicants responded by electing the species of fexofenadine, with a group of specific inert ingredients (croscarmellose sodium, microcrystalline cellulose, lactose, pregelatinized starch, gelatin and magnesium stearate), for a group of the claims. (Gresalfi Decl. at A274.) The P.T.O. then responded by reiterating the restriction requirement for the claims that did not involve the elected formulation, and it rejected the claims involving the elected formulation as anticipated and/or obvious. (Gresalfi Decl. at A278-281).

  The applicants then filed the second application, 08/552,287, as a continuation-in-part of the first. The claims in the second application were of two types: most were pharmaceutical composition claims which varied from very broad and generic formulations to very specific formulations, while some were product-by-process claims. The P.T.O. responded by again seeking restriction/election for some claims and rejecting others under 35 U.S.C. §§ 102(b) and 103 (Gresalfi Decl. at A385-A390). The examiner's comments in this first office action are nearly identical to the comments in the first office action for the first application. Applicants then cancelled all claims except for the product-by-process claims, and added new composition claims for fexofenadine formulations with specific inert ingredients (croscarmellose sodium, microcrystalline cellulose, lactose, pregelatinized starch, and gelatin; some formulations also included magnesium stearate). (Gresalfi Decl. at A392-A394.) At this point, a significant change occurred in the specification of inert ingredients. As originally filed, claims in the second application referred specifically to the inert ingredients croscarmellose sodium, lactose, microcrystalline cellulose, pregelatinized starch, gelatin, calcium carbonate, magnesium stearate, and sodium starch glycolate. (Gresalfi Decl. at A355-A366.) The applicant cancelled all claims which specified the inert ingredients calcium carbonate and sodium starch glycolate, and added claims not specifying those two inert ingredients. Those two inert ingredients did not appear in the third application (08/943,460), nor are they specified in the claims in either the '942 or '912 patents. This is a crucial point in the prosecution history for this dispute, and the discussion below will focus on those events.

  The P.T.O. next reexamined this group of old and new claims and rejected all of them as obvious over prior art, focusing on the particular inert ingredients croscarmellose sodium, microcrystalline cellulose, lactose, pregelatinized starch, and gelatin. (Gresalfi Decl. at A404.) Applicants filed a reply to this rejection, arguing, in brief, that the combinations of fexofenadine with the particular inert ingredients were not obvious from the prior art. (Gresalfi Decl. at A407-410.) The P.T.O. responded by reversing its rejection and allowing the previously rejected claims. Nonetheless, the applicants abandoned the application.

  The applicants then filed the third application as a continuation of the second, adding some new claims, but essentially restricting the patent to the specific formulations claimed in the amended second application. These claims were allowed. The '912 patent was granted directly from the third application, and the '942 patent is a divisional offspring of that application. B. Narrowing Amendments Were Made for Reasons of Patentability of the '942 and '912 Patents

  The parties do not dispute that the applicant made narrowing amendments during the prosecution history of the '942 and '912 patents. The applicant had previously eliminated most claims with generic formulations when, in response to the first office action to the second application, the applicant cancelled the claims with the remaining generic references to inert ingredients. From this point on, the application contained only claims with combinations of specific inert ingredients. At this point, then, the claim amendments narrowed their scope.

  The focus of the parties' dispute here is the actual reason for the narrowing amendments. Plaintiffs argue that the applicants made narrowing amendments not for reasons of patentability, but to comply with the examiner's election/restriction requirements. Defendants argue that the narrowing amendments were made for reasons of patentability.

  Plaintiffs argue that they cancelled the claims in response to the election/restriction requirements, not in response to the rejections for patentability. This argument must fail for several reasons, but the simplest is that it does not match the facts. In the first office action to the second application, the examiner rejected claims 1-10, 14-17, 22-24, 29, and 31-35 under 35 U.S.C. §§ 102(b) and 103; the examiner determined that claims 11-13, 18-21, 25-28, 30, and 36-43 were subject to restriction/election requirements. (Gresalfi Decl. at A385.) Claims 1 and 3 were the broadest claims. The examiner rejected Claims 1 and 3 and the applicant then cancelled the claims. Plaintiffs cannot maintain that they cancelled these broad claims in response to a restriction requirement. The prosecution history clearly shows that they were cancelled due to a rejection, and thus necessarily for reasons of patentability. This analysis alone defeats Plaintiffs' argument.

  In addition, the Federal Circuit has held that a series of narrowing applications may form the basis for a finding of surrender of claim coverage. In Mark I Mktg. Corp. v. R.R. Donnelley & Sons Co., 66 F.3d 285, 292 (Fed. Cir. 1995), cert. denied, 516 U.S. 1115 (1996), the patentee "chose to file continuing applications with successively narrower claims in lieu of otherwise responding to the P.T.O.'s rejections," and the Court held that the patentee had surrendered claim coverage. To argue here that the patentees filed a series of narrowing claims, in the context of repeated rejections for reasons of patentability, but that the narrowing claims were not filed for reasons of patentability, is far-fetched.

  Moreover, even if one were to assume, arguendo, that the changes were made only because of the restriction/election requirements, Plaintiffs assert incorrectly that such an action would preclude the application of prosecution history estoppel. Plaintiffs argue, in effect, for a per se rule that restriction requirements and requests for election of species cannot invoke prosecution history estoppel. Yet the Federal Circuit has not established a per se rule; rather, it has held that whether restriction requirements invoke prosecution ...


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