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Teva Pharmaceutical Industries Ltd. v. Astrazeneca Pharmaceuticals LP

October 20, 2010

TEVA PHARMACEUTICAL INDUSTRIES LTD., PLAINTIFF
v.
ASTRAZENECA PHARMACEUTICALS LP, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Yohn, J.

MEMORANDUM

Plaintiff, Teva Pharmaceutical Industries Ltd. ("Teva"), sues AstraZeneca Pharmaceuticals LP and IPR Pharmaceuticals, Inc. (collectively "AstraZeneca"), for patent infringement, alleging that AstraZeneca's CRESTOR® prescription drug products infringe one or more claims of Teva's U.S. Patent No. RE39,502 ("the '502 patent").*fn1 According to Teva, the '502 patent, entitled "Stable Pharmaceutical Compositions Containing 7--Substituted--3,5-- Dihydroxyheptanoic Acids or 7--Substituted--3,5--Dihydroxyheptenoic Acids," claims "stabilized pharmaceutical compositions comprising statins for the treatment of dyslipidemia." (Compl. ¶ 12.) In particular, the '502 patent discloses "stabilized pharmaceutical compositions comprising statins formulated with certain excipients[,] [namely, amido-group containing polymeric compounds,] that prevent degradation of the statins over time." (Id.)

AstraZeneca has filed a motion for summary judgment of patent invalidity due to prior invention pursuant to 35 U.S.C. § 102(g)(2). Although AstraZeneca in fact disputes that its CRESTOR® products infringe the asserted claims of Teva's '502 patent, AstraZeneca concedes-for purposes of the instant motion only-that the accused CRESTOR® product formulations fall within the scope of those claims.*fn2 AstraZeneca argues that if the accused products infringe, as Teva alleges, then the asserted '502 patent claims are invalid because AstraZeneca "made," i.e., conceived of and reduced to practice, the drug formulations that are now sold as CRESTOR® before Teva invented the subject matter of the '502 patent, and because AstraZeneca has not abandoned, suppressed, or concealed those formulations. Teva opposes the motion, arguing that even if AstraZeneca made the infringing products first, AstraZeneca has not shown prior invention of the subject matter of the '502 patent because there is no evidence that AstraZeneca has ever appreciated that crospovidone, the amido-group containing polymeric compound included in CRESTOR®, contributes to the stability of the formulation, a critical appreciation in Teva's view.

As set forth herein, the court concludes that AstraZeneca was not required to have such a particularized appreciation in order to prove prior conception and reduction to practice of the invention claimed by Teva. Accordingly, because it is undisputed that (1) AstraZeneca made the accused product formulations before Teva invented the subject matter of the asserted claims, (2) appreciated that the formulations were stable, and (3) did not abandon, suppress, or conceal the formulations, the court will grant AstraZeneca's motion for summary judgment.

I. Facts and Procedural History*fn3

A. AstraZeneca's Development of CRESTOR®

CRESTOR® is a prescription medication belonging to a group of drugs called statins that are used to treat high cholesterol. (Compl. ¶ 14; AstraZeneca Ans. ¶ 14*fn4 ; AstraZeneca Statement ¶ 3; Teva Resp. ¶ 3.) The active pharmaceutical ingredient in CRESTOR® is rosuvastatin calcium. (Astrazeneca Statement ¶ 4; Teva Resp. ¶ 4.)

Sales of CRESTOR® products began after the FDA approved the New Drug Application ("NDA") for CRESTOR® in August 2003. (AstraZeneca Statement ¶ 23; Teva Resp. ¶ 23.) The CRESTOR® NDA lists the ingredients and the amount of each ingredient for all dosage strengths of CRESTOR® tablets that AstraZeneca sells commercially today. (See AstraZeneca Statement ¶ 24; Teva Resp. ¶ 24; Declaration of J. Richard Creekmore, Ph.D. ["Creekmore Decl."] ¶¶ 8-9 & Ex. A at AZ-EDPA-0019433; Decl. of Alan E. Sloan ["Sloan Decl."] ¶¶ 7-9.)*fn5

AstraZeneca researchers in Wilmington, Delaware, arrived at the formulations for all dosage strengths of the CRESTOR® tablet cores in 1999. (See AstraZeneca Statement ¶¶ 26, 42-45; Teva Resp. ¶¶ 26, 42-45.) The researchers had used different formulations for earlier Phase III clinical studies, but they wanted to improve on these earlier formulations for the final commercial product. (AstraZeneca Statement ¶ 27; Teva Resp. ¶ 27.) In particular, because the researchers already knew from the Phase III studies that rosuvastatin calcium would be safe and effective, they focused on product stability and manufacturability issues when developing the improved commercial formulations. (AstraZeneca Statement ¶ 28; Teva Resp. ¶ 28.)

Led by Richard Creekmore, the researchers began development of the planned commercial CRESTOR® products, referred to internally as the rosuvastatin "sales formulations," in early 1999.*fn6 (AstraZeneca Statement ¶¶ 29, 32; Teva Resp. ¶¶ 29, 32.) Shortly thereafter, AstraZeneca developed an uncoated tablet formulation containing all ingredients of the tablets cores of commercial CRESTOR® products: rosuvastatin calcium, lactose monohydrate, microcrystalline cellulose (trade name "Avicel"), tribasic calcium phosphate, crospovidone, and magnesium stearate. (AstraZeneca Statement ¶ 33; Teva Resp. ¶ 33.) Creekmore testified that at some point between the late summer of 1998 and early 1999, he had settled on tribasic calcium phosphate as a stabilizer for the product. (Declaration of Jonathan K. Waldrop ["Waldrop Decl."], Ex. 5 ["Creekmore Dep."] 206:20-24; see also Creekmore Decl., Ex. A at AZ-EDPA-0019432 (CRESTOR® NDA excerpt characterizing the function of tribasic calcium phosphate as "Stabilizer").) Although the formulation also included crospovidone, an amido-group containing polymeric compound, crospovidone "was included in the CRESTOR® formulations for its properties as a disintegrant." (AstraZeneca Reply 2; see also Creekmore Dep. 251:13-20, 252:7-13; Creekmore Decl., Ex. A at AZ-EDPA-0019432 (CRESTOR® NDA excerpt characterizing the function of crospovidone as "Disintegrant").)

In mid 1999, AstraZeneca planned to make 10,000-unit batches of uncoated 2.5 mg rosuvastatin sales formulation tablets. (AstraZeneca Statement ¶ 34; Teva Resp. ¶ 34.) A week later, AstraZeneca manufactured a 10,000-unit batch of 2.5 mg rosuvastatin sales formulation tablets containing the same ingredients, in the same amounts, as the commercial 2.5 mg CRESTOR® tablet cores. (AstraZeneca Statement ¶¶ 35-36; Teva Resp. ¶¶ 35-36.) Approximately two months later, AstraZeneca manufactured a 20,000-unit batch of 5 mg rosuvastatin calcium tablets. (AstraZeneca Statement ¶ 38-39; Teva Resp. ¶ 38.) These tablets contained the same ingredients, in substantially identical amounts, as the commercial 5 mg CRESTOR® tablet cores. (AstraZeneca Statement ¶ 39.)*fn7

In the late summer of 1999, Dr. Creekmore gave a presentation regarding AstraZeneca's rosuvastatin sales formulations, in which he described the proposed commercial formulations for "ZD4522" (i.e., rosuvastatin) tablet cores for each of the 2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg dosage strengths. (Creekmore Decl. ¶ 18 & Ex. E at AZ-EDPA-0041448; see also AstraZeneca Statement ¶¶ 41-43; Teva Resp. ¶¶ 41-43.) The ingredients and amounts in Dr. Creekmore's presentation are the same as those found in commercial CRESTOR® products. (AstraZeneca Statement ¶ 45; Teva Resp. ¶ 45.) Creekmore's presentation also noted that "[c]oncurrent stability studies show product will have an acceptable shelf life." (Creekmore Decl., Ex. E at AZ-EDPA-0041447; see also AstraZeneca Statement ¶ 46; Teva Resp. ¶ 46.)

In the fall of 1999, AstraZeneca made a 160,000-unit batch of coated 2.5 mg rosuvastatin tablets. (AstraZeneca Statement ¶ 47; Teva Resp. ¶ 47.) These tablets contained the same ingredients as commercial 2.5 mg CRESTOR® tablets in substantially identical amounts.*fn8 (See AstraZeneca Statement ¶ 47.) AstraZeneca later submitted these batch records to the FDA in connection with its Investigational New Drug Application for CRESTOR®. (AstraZeneca Statement ¶ 49; Teva Resp. ¶ 49.)

On January 26, 2000, Dr. Creekmore and Norman Wiggins filed a patent application in Great Britain on behalf of AstraZeneca AB covering their rosuvastatin formulation work. (Creekmore Decl. ¶ 22; Declaration of Rama G. Elluru ["Elluru Decl."], Ex. 6 (GB application no. 0001621.2).) According to Dr. Creekmore, Example 3 of that application contains a full description of the 2.5 mg rosuvastatin sales formulation tablets. (Creekmore Decl. ¶ 22.) Example 3 discloses the same ingredients and, apart from decimal point differences as to two ingredients, the same ingredient amounts as the 2.5 mg rosuvastatin sales formulation tablet cores that AstraZeneca made in May and October 1999, and as the 2.5 mg commercial CRESTOR® product tablet cores.*fn9 (Compare Elluru Decl., Ex. 6 at 6 (Example 3 of GB application no. 0001621.2), with Creekmore Decl, Ex. C at AZ-EDPA-0001351 (weigh sheet for mid 1999 batch), id., Ex. F at AZ-EDPA-0026414 (master formula for fall 1999 batch), and id., Ex. A at AZ-EDPA-0019433 (NDA).)

AstraZeneca thereafter filed a patent application in the United States on August 4, 2000, which issued as U.S. Patent No. 6,316,460 ("the '460 patent") on November 13, 2001.*fn10

(Creekmore Decl. ¶ 23; Elluru Decl., Ex. 2 ('460 patent).) Example 3 of the '460 patent is identical to Example 3 of the Great Britain patent application. (Compare Elluru Decl., Ex. 2 at col.5 ll.14-23, with id., Ex. 6 at 6.) Thus, apart from the rounding differences described in n.8 supra, Example 3 of the '460 patent discloses the same ingredients, in the same amounts, as the 2.5 mg rosuvastatin sales formulation tablets that AstraZeneca made in mid 1999 and fall 1999, and as the 2.5 mg commercial CRESTOR® products. (Compare Elluru Decl., Ex. 2 at col.5 ll.14-23, with Creekmore Decl., Ex. C at AZ-EDPA-0001351 (weigh sheet for mid 1999 batch), id., Ex. F at AZ-EDPA-0026414 (master formula for fall 1999 batch), and id., Ex. A at AZEDPA-0019433 (NDA).) In January 2001, while the United States patent application was pending, the Great Britain patent application was terminated. (Declaration of Darcy L. Jones ["Jones Decl."] ¶ 6 & Ex. I.)

According to Teva's expert, Harold B. Hopfenberg, Ph.D., the use of amido-group containing polymeric compounds to stabilize statin-containing pharmaceutical formulations is not disclosed in the patent application that AstraZeneca filed in Great Britain, the '460 patent, or the CRESTOR® NDA. (Decl. of Harold B. Hopfenberg ["Hopfenberg Decl."] ¶¶ 11, 14.) Although these documents do disclose certain amido-group containing polymeric compounds-including crospovidone-as excipients that can be used in the claimed formulations, such compounds are disclosed for use for purposes other than stabilization. (See id. ¶¶ 15, 17.) All three documents disclose ...


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