In re Omeprazole Patent Litigation

• Decision Date: 06 July 2001
• Docket Number: MDL Docket No. 1291.
• Citation: 258 F.Supp.2d 221
• Parties: In re OMEPRAZOLE PATENT LITIGATION.
• Court: U.S. District Court — Southern District of New York

258 F.Supp.2d 221

In re OMEPRAZOLE PATENT LITIGATION.

MDL Docket No. 1291.

United States District Court, S.D. New York.

July 6, 2001.

COPYRIGHT MATERIAL OMITTED

ORDER

JONES, District Judge.

Pending before the Court is the motion of defendant Genpharm, Inc. ("Genpharm") pursuant to Fed.R.Civ.P. 56 for summary judgment of invalidity and non-infringement of U.S. Patent Nos. 5,599,794 ("the '794 patent"), 5,629,305 ("the '305 patent") and 5,093,342 ("the '342 patent").

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 Hassle, KBI-E, Inc., KBI, Inc. and Astrazeneca, L.P. (collectively "Astra") 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.

The infringement actions arise out of Abbreviated New Drug Applications ("ADAs") filed by the defendants. The Drug Price Competition and Patent Term Restoration Act, Pub.L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at 21 U.S.C. § 355 and 35 U.S.C. § 271(e) (1994)), also known as the Hatch-Waxman Act, amended the Federal Food, Drug, and Cosmetic Act ("FDCA"), Pub.L. No. 52-675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-397 (1994)), to permit filing of an ANDA to expedite FDA approval of a generic version of a drug previously approved by the FDA. See Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1244 (Fed.Cir.2000). Under the Hateh-Waxman Act, an applicant may seek FDA approval to market a generic drug without undergoing the same expensive and time-consuming FDA approval process undergone by the maker of the branded version of the drug, often called the pioneer drug, by 1) demonstrating that the generic drug is the bioequivalent of the branded drug and 2) certifying that manufacturing, marketing and selling the drug will not infringe the patent rights held by the patentee of the pioneer drug.

The holder of the New Drug Application for the pioneer drug lists all of its patents that claim the drug or a use of the drug in the book "New Drug Products With Therapeutic Equivalence Evaluations" (referred to as "the Orange Book") published by the FDA. In its ANDA, the generic applicant must certify one of the following four statements with respect to the patents listed under the pioneer drug in the Orange Book: no patent information has been filed (paragraph I certification), the patent has expired (paragraph II certification), the patent soon will expire on a specified date (paragraph III certification), or the patent "is invalid or will not be infringed by the manufacture, use, or sale of the new drug" covered by the ANDA (paragraph IV certification). See 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV).

The term of Astra's basic omeprazole patent covering the chemical formula for omeprazole and its administration for gastric acid inhibition, U.S. Patent No. 4,255,431 ("the '431 patent"), will expire on October 5, 2001.¹ The '431 patent is not, however, the only patent Astra has listed for omeprazole in the Orange Book. The patents at issue on this motion were also listed, and have been referred to by the parties as the "method of treatment" patents. The '342 patent, which will expire in 2010, claims the use of omeprazole as an antimicrobial agent against H. Pylori bacteria. The '794 and '305 patents, which will expire in 2014, claim the use of omeprazole in combination with an antibiotic to treat H. Pylori infections.

Although no actual infringement has taken place because the defendants' omeprazole product has not been released in the market, 35 U.S.C. § 271(e)(2)(A) "definet[s] a new (and somewhat artificial) act of infringement for a very limited and technical purpose that relates only to certain drug applications." Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990). Section 271(e)(2)(A) provides a patentee with a cause of action for patent infringement based solely upon the filing of an ANDA containing a paragraph IV certification implicating the plaintiffs patent rights. The artificial infringement arising by operation of law is an integral part of a statutory scheme designed to allow pharmaceutical manufacturers to market, and the public to purchase, generic drugs as soon as possible after the expiration of patents covering the pioneer drug. The infringement suit under § 271(e)(2) permits the patentee, in this case Astra, "to challenge the certification— i.e. to assert inter alia that the commercial manufacture, use or sale of the new drug would infringe its patent." Glaxo, Inc. v. Boehringer Ingelheim Corp., 954 F.Supp. 469, 473 (D.Conn.1996) (emphasis added). The patentee's challenge to the certification provides the Court with a justiciable controversy, permitting it to efficiently resolve patent issues in advance of the generic drug's release.

Genpharm certified in its ANDA for generic omeprazole that the method of treatment patents are "invalid or will not be infringed by the manufacture, use, or sale" of its generic omeprazole. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV). Based on Genpharm's ANDA filing, Astra filed a patent infringement suit pursuant to 35 U.S.C. § 271(e)(2)(A), alleging that the generic omeprazole for which Genpharm seeks approval would induce infringement of the method of treatment patents because it would be used by doctors and patients, both alone or in combination with an antibiotic, to treat infections of H. Pylori bacteria. At the close of consolidated discovery Genpharm filed the instant motion for summary judgment.

I.

Summary judgment may not be granted unless "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Gallo v. Prudential Residential Servs., Ltd. Partnership, 22 F.3d 1219, 1223 (2d Cir.1994). In determining whether summary judgment is appropriate, a court must resolve all ambiguities and draw all reasonable inferences against the moving party. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) (citing United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 8 L.Ed.2d 176 (1962)). Summary judgment is improper if there is any evidence in the record from any source from which a reasonable inference could be drawn in favor of the nonmoving party. See Chambers v. TRM Copy Ctrs. Corp., 43 F.3d 29, 37 (2d Cir.1994). Because each claim of a patent is presumed valid, in considering a motion for summary judgment of invalidity the Court must consider the facts in view of the clear and convincing evidentiary burden placed on the moving party to demonstrate invalidity. See Monarch Knitting Machinery Corp. v. Sulzer Morat Gmbh, 139 F.3d 877, 880 (Fed.Cir.1998).

II.

Astra was granted U.S. Patent No. 4,255,431 in 1981. The patent claims a chemical compound called omeprazole and its administration for inhibiting gastric acid secretion. Astra's scientists had found that when a human ingested omeprazole, the enzyme responsible for gastric acid secretion in the stomach, H⁺K⁺ AT-Pase, was inhibited and gastric acid was reduced. Japanese scientists working with Astra in a joint research and development venture later discovered that omeprazole had not only antisecretory properties useful in reducing gastric acid, but also antimicrobial properties useful in suppressing H. Pylori, the bacteria associated with the development of most cases of gastritis and peptic ulcer. Astra sought and received patent protection for this claimed discovery in the form of the '342 patent.

Building on the '342 patent, Astra scientists in Sweden found that combining omeprazole with an acid-degradable antibiotic such as clarithromycin or erythromycin increased the bioavailability² of those antibiotics, thereby increasing their effectiveness in suppressing H. Pylori. Astra sought and received patent protection in the form of the '794 and '305 patents for these combination therapies for treating H. Pylori. The '794 patent claims a combination of clarithromycin and omeprazole for the treatment of gastritis and pepticular. The '305 patent's 19 claims cover more broadly the combination of a class of proton pump inhibitors, which includes but is not limited to omeprazole, and a class of acid-degradable antibacterial compounds, which includes but is not limited to clarithromycin. Although the '305 patent's claims are broader, the '305 and '794 patents share the same patent specification.

Genpharm seeks summary judgment declaring the '342, '794 and '305 patents invalid under 35 U.S.C. § 102(b) as anticipated by prior art. The anticipation analysis comprises two steps. In the first step, the Court construes the content and scope of the claims of the patent at issue. In the second step, the Court compares the properly construed claims to the allegedly anticipating prior art. See Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1346 (Fed.Cir.2000). When a single prior art publication, published more than one year before the date a patent application was filed, discloses each and every element of the patent claim, either expressly or inherently, the claim is invalid. See In re Schreiber, 128 F.3d 1473, 1477 (Fed.Cir. 1997); Verdegaal Bros. Inc. v. Union Oil Co., 814 F.2d 628, 631 (Fed.Cir.1987).

A. Claim Construction and Validity of the '342 Patent

The Court construes the claims of the patent according to the hierarchy of evidence articulated in Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed.Cir. 1995), aff'd ...