Astra Aktiebolag v. Andrx Pharmaceuticals, Inc.
| Decision Date | 16 October 2002 |
| Docket Number | No. 99 Civ. 8926 (BSJ), 99 Civ. 9887 (BSJ), 99 Civ. 8927 (BSJ), 00 Civ. 4467 (BSJ), 98 Civ. 3657 (BSJ), 98 Civ. 8094 (BSJ), 99 Civ. 8928 (BSJ), 99 Civ. 9888 (BSJ).,99 Civ. 8926 (BSJ), 99 Civ. 9887 (BSJ), 99 Civ. 8927 (BSJ), 00 Civ. 4467 (BSJ), 98 Civ. 3657 (BSJ), 98 Civ. 8094 (BSJ), 99 Civ. 8928 (BSJ), 99 Civ. 9888 (BSJ). |
| Parties | ASTRA AKTIEBOLAG, et al., Plaintiffs, v. ANDRX PHARMACEUTICALS, INC., Defendant. Astra Aktiebolag, et al., Plaintiffs, v. Cheminor Drugs, Ltd., et al., Defendants. Astra Aktiebolag, et al., Plaintiffs, v. Genpharm Inc., Defendant. Astra Aktiebolag, et al., Plaintiffs, v. Kremers Urban Development Co., et al., Defendants. In re Omeprazole Patent Litigation. |
| Court | U.S. District Court — Southern District of New York |
Andrew J. Miller, Brian Moriarty, David Novack, Bruce Radin, Frank D. Rodriguez, Budd Larner Gross Rosenbaum Greenberg & Sade, P.C., Short Hills, NJ, for Cheminor Drugs, et al.
Edgar H. Haug, Jeffrey A. Hovden, Charles J. Raubicheck, Christian M. Smolizza, Frommer Lawrence & Haug LLP, New York City, for Genpharm, Inc. Brian M. Poissant, F. Dominick Cerrito, Ronald M. Daignault, Leo Merken, Pennie & Edmonds LLP, New York City, for Kremers Urban Development Co., et al.
Pursuant to 28 U.S.C. § 1407, the Judicial Panel on Multidistrict Litigation consolidated for pre-trial purposes before this court the patent infringement suits filed by Astra Aktiebolag, Aktiebolaget Hässle, Astra Merck Enterprises Inc., Astra Merck Inc., KBI-E Inc., KBI Inc., Astra Pharmaceuticals L.P., and AstraZeneca L.P. in response to various pharmaceutical companies' requests for permission from the Food and Drug Administration ("FDA") to market generic versions of Prilosec®, Astra's highly profitable gastric acid inhibiting drug. At various points in this litigation, Plaintiffs have asserted as many as eight different patents against Defendants. At the time of trial, five of those patents remained in the suit. This consolidated trial resolves claims raising issues of infringement and validity asserted in eight different lawsuits involving four groups of Defendants.2 The case was tried to the court sitting without a jury for fifty-two trial days between December 6, 2001, and June 13, 2002. The court has considered over six thousand pages of trial testimony, volumes of deposition testimony, thousands of exhibits, and pre-trial and post-trial briefing submitted by all parties. The court has made determinations as to the relevance and materiality of the evidence and assessed the credibility of each witness. Upon the record before the court, pursuant to Federal Rule of Civil Procedure 52(a), the court finds the following facts to have been proven by the appropriate standard of proof and sets forth its conclusions of law.
For the reasons stated below, the court finds the following: Defendant Genpharm literally infringes claims 1, 5, 6, 8, 9, 10, 12, and 14 of the '505 patent and claims 1, 6, 7, 10, 11, 12, and 13 of the '230 patent. Defendant Genpharm does not infringe claim 11 of the '505 patent or claim 15 of the '230 patent. Defendants Cheminor literally infringe claims 1, 5, 10, and 14 of the '505 patent and claims 1, 6, 12, and 13 of the '230 patent. Defendants Cheminor do not infringe claim 9 of the '505 patent or claim 11 of the '230 patent. Defendant Andrx literally infringes claims 1, 5, 6, 8, and 10 of the '505 patent and claims 1, 6, 7, 10, and 13 of the '230 patent. Defendant Andrx does not infringe claims 3 or 11 of the '505 patent or claim 15 of the '230 patent. Defendants KUDCo do not infringe the asserted claims of the '505 and '230 patents. The asserted claims of the '505 and '230 patents are valid. Claim 1 of the '342 patent is invalid as anticipated.
Plaintiff Astra Aktiebolag is a company organized and existing under the laws of Sweden, having its principal place of business at Södertälje, Sweden. Plaintiff Aktiebolaget Hässle ("Hässle") is a company organized and existing under the laws of Sweden, having its principal place of business at MöIndal, Sweden. Plaintiff Astra Merck Enterprises, Inc. is a Delaware corporation, having its principal place of business at Wilmington, Delaware. Plaintiff Astra Merck, Inc. is a Delaware corporation, having its principal place of business at Wayne, Pennsylvania. Plaintiff KBI-E, Inc. is a Delaware corporation, having its principal place of business at Wilmington, Delaware. Plaintiff KBI, Inc. is a Delaware corporation having its principal place of business at Whitehouse Station, New Jersey. Plaintiff Astra Pharmaceuticals, L.P. is a limited partnership organized under the laws of Delaware having its principal place of business at Wayne, Pennsylvania. Plaintiff AstraZeneca, L.P. is a limited partnership organized under the laws of Delaware having its principal place of business at Wayne, Pennsylvania. Plaintiffs are referred to collectively as "Astra."
Defendant Andrx Pharmaceuticals, Inc. ("Andrx") is a Florida corporation, having its principal place of business at Davie, Florida. Defendant Cheminor Drugs, Ltd. is a public, limited-liability company incorporated and existing under the laws of India and having a principal place of business in Hyderabad, India. Defendant Reddy-Cheminor, Inc. is a New Jersey corporation, having its principal place of business at Ridgewood, New Jersey. Defendant Schein Pharmaceutical, Inc. is a Delaware corporation, having its principal place of business at Florham Park, New Jersey. These three Defendants are referred to collectively as "Cheminor." Defendant Genpharm Inc. ("Genpharm") is a Canadian corporation, having its principal place of business in Ontario, Canada. Defendant Kremers Urban Development Co., a wholly-owned subsidiary of Schwarz Pharma, Inc. ("Schwarz"), is a Wisconsin corporation, having its principal place of business in Mequon, Wisconsin. Defendant Schwarz is a Delaware corporation, having its principal place of business at Mequon, Wisconsin. These last two Defendants are referred to collectively as "KUDCo."
Omeprazole was the first of a class of medicines called "proton pump inhibitors." (Carlsson Tr. 157:14-19.)3 Omeprazole is used in formulations to treat many acidrelated diseases, including peptic ulcer disease, reflux disease, and Zollinger-Ellison syndrome. (Carlsson Tr. 159:13-19.) Astra's Prilosec® formulation is the result of more than twenty years of research by scientists at Astra's predecessor company, Haässle, in Sweden. (Carlsson Tr. at 219:9-13.) The research that resulted in Prilosec® began in 1967 with the start of Project 826. The goal of Project 826 was to develop a drug that could inhibit gastric acid secretion. (Carlsson Tr. at 161:9-13; P656.) In January of 1979, twelve years after the start of Project 826, Astra scientists first made the compound omeprazole. (Carlsson Tr. at 160:11-12, 161:9-13, 171:1-2.) Omeprazole inhibits the production of gastric acid through a unique mechanism. It is taken up and concentrated within the acid-producing parietal cells that line the stomach. In the parietal cell, omeprazole is transformed to its active species, which binds to the proton pump, the enzyme that produces acid, thereby inhibiting acid production. (Carlsson Tr. at 167:16-168:19.)
Even once the compound itself had been developed, the task of turning the compound omeprazole into a viable medicine proved to be formidable. (Carlsson Tr. at 170:10-171:20.) Before omeprazole could be used as a medicine, Astra had to establish the compound's safety and efficacy in animals and in human beings. In addition, Astra's scientists needed to develop a formulation or dosage form that would deliver the compound to the proper site of action in the body and remain stable both in the body and on the shelf. (Carlsson Tr. 171:8-20.) A group of Astra scientists set out to develop an oral dosage form for omeprazole and its related compounds, (Pilbrant Tr. 1587:2-5), and their work ultimately culminated in the patents at issue in this case. Drs. Ake Pilbrant4 and Kurt Lövgren5 were a part of that team, and they are two of the named inventors on Astra's '505 and '230 patents. (Lövgren Tr. 1741:8-18; Pilbrant Tr. 1317:12-14, 1318:21-22; P1, P2A.) Omeprazole proved to be a particularly difficult and challenging molecule to formulate. Omeprazole is an exceptionally acid labile compound, which means that it degrades quickly in acidic environments like the stomach. (Langer Tr. 295:1-23; Pilbrant Tr. 1587:6-15.)6 Omeprazole is also sensitive to heat, moisture, organic solvents, and, to some degree, light. (Carlsson Tr. 172:19-22, 179:14-21; Pilbrant Tr. 1323:25-1324:9, 1641:11-15; Lövgren Tr. 1747:4-11; P916 at 114.) Overcoming omeprazole's multiple sensitivities proved to be a substantial challenge, and Astra considered a number of different approaches to make an oral formulation. (Pilbrant Tr. 1328:12-20.)
First, Astra's formulation scientists tried dissolving omeprazole in oil to protect the omeprazole from gastric juice, but this approach did not work because omeprazole is unstable in oil. (Pilbrant Tr. 1328:21-1329:11.) A very rapidly dissolving dosage form was investigated on the theory that the rate of absorption of omeprazole into the body would be faster than the rate of...
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