Glaxo Group Ltd. v. Apotex, Inc.
| Decision Date | 26 June 2003 |
| Docket Number | No. 00 C 5791.,00 C 5791. |
| Citation | 268 F.Supp.2d 1013 |
| Parties | GLAXO GROUP LIMITED and SmithKline Beecham Corp., Plaintiffs, v. APOTEX, INC., Defendant. |
| Court | U.S. District Court — Northern District of Illinois |
Christopher S. Pennisi, Michael F. Hurley, Morgan, Lewis & Bockius, New York City, Dean Scott Rauchwerger, James F. Smith, Joshua Avinoam Aldort, Clausen Miller P.C., Chicago, IL, Stephen B. Judlowe, Dennis J. Mondolino, Janet B. Linn, Jason A. Lief, Morgan, Lewis & Bockius, LLP, New York City, for plaintiffs.
Hugh L. Moore, Scott B. Feder, Keith D. Parr, Paul J. Molino, William Andrew Rakoczy, Hugh Scott Balsam, Lord, Bissell & Brook, Chicago, IL, for defendant.
AMENDED FINDINGS OF FACT AND CONCLUSIONS OF LAW
This court has conducted a bench trial on plaintiff GlaxoSmithKline Beecham Corp.'s claims against defendant Apotex, Inc. for a declaration of infringement of patent nos. 4562181 and 4,820,833, and on Apotex's counterclaims of invalidity. In accordance with Fed.R.Civ.P. 52(a), the court enters the following findings of fact and conclusions of law.1
1. This is an action for patent infringement. The Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a), 2201 and 2202. The Court has personal jurisdiction over the parties. Venue in this judicial district is proper under 28 U.S.C. § 1391.
2. Plaintiff Glaxo Group Ltd. is a British corporation having a principal place of business in Brentford, United Kingdom. Plaintiff SmithKline Beecham Corp. is a Pennsylvania corporation having a place of business in Research Triangle Park, North Carolina. (Plaintiffs Glaxo Group Ltd. and SmithKline Beecham Corp. are collectively referred to as "GlaxoSmithKline"). GlaxoSmithKline is an innovator pharmaceutical company engaged in the research, development, clinical testing and regulatory approval of new drug substances and drug formulations for use in medicines.
3. Defendant Apotex Inc. ("Apotex") is a Canadian corporation having its principal place of business in Weston, Ontario. Apotex sells generic drug products which emulate pharmaceuticals developed and marketed by innovator companies. Apotex markets and sells generic drug products throughout the United States.
4. GlaxoSmithKline is the owner by assignment of U.S. Patent No. 4,562,181 ("the '181 patent"), entitled "Amorphous Form of Cefuroxime Ester", which issued on December 31, 1985 and claims highly pure, substantially amorphous cefuroxime axetil. The '181 patent expires on July 29, 2003.
5. GlaxoSmithKline is the owner by assignment of U.S. Patent No. 4,820,833, ("the '833 patent"), entitled "Preparation of a Highly Pure, Substantially Amorphous Form of Cefuroxime Axetil", which issued on April 11, 1989, and is directed to preparing highly pure substantially amorphous cefuroxime axetil by spray drying. The '833 patent also expires on July 29, 2003.
6. GlaxoSmithKline filed this suit for infringement of the 181 patent under 35 U.S.C. § 271(e) et seq. and the Declaratory Judgment Act on September 20, 2000. On June 25, 2001, GlaxoSmithKline filed an amended complaint adding a claim for declaratory judgment of infringement of the '833 patent.
7. On March 7, 2001 and July 20, 2001, Apotex filed its Answer and Counterclaims and Amended Answer and Counterclaims. Apotex denied infringement and asserted counterclaims for noninfringement and invalidity of both the '181 and '833 patents.
8. On June 5, 2002, the Court held a hearing on GlaxoSmithKline's motion for preliminary injunction and, on June 10, 2002, issued an order finding in GlaxoSmithKline's favor on all of the mandatory preliminary injunction factors and granting a preliminary injunction. Apotex's appeal of the preliminary injunction order has been rejected by the U.S. Court of Appeals for the Federal Circuit in an unpublished order dated April 22, 2003.
9. GlaxoSmithKline is the holder of a New Drug Application ("NDA") approved by the Food and Drug Administration ("FDA") for tablets containing, as the active ingredient or drug substance, highly pure, substantially amorphous cefuroxime axetil for use as a broad spectrum antibiotic. GlaxoSmithKline markets and sells its tablets under the tradename Ceftin®.
10. GlaxoSmithKline filed its Ceftin® NDA on July 30, 1985.
11. GlaxoSmithKline received approval for its Ceftin® NDA in December 1988. GlaxoSmithKline Ceftin® tablets were launched immediately after receiving FDA approval.
12. Antibiotics are substances which either kill or inhibit the growth of bacteria. There are many classes of antibiotics; the most well known are the penicillins.
13. The antibacterial properties of penicillins are conferred by the β-lactam ring in the structure of the molecule that allows it to bind to proteins in the cell wall of the bacterium. This binding by the antibiotic prevents the cell wall from budding effectively, thereby inhibiting bacterial replication.
14. Although penicillins are broad spectrum antibiotics, they are not effective against all bacteria. Also, as a result of wide use, penicillin-resistant strains of bacteria have developed. These resistant bacteria develop during infections when mutant bacteria produce β-lactamases that can open the β-lactam ring of the penicillin molecule—destroying its effectiveness. This β-lactamase penicillin-resistance is then transmitted by the bacteria from one population to another.
15. Closely related structurally to penicillins are the cephalosporins. Like penicillins, the cephalosporins have a β-lactam ring and both classes are generally referred to as β-lactam antibiotics.
16. The cephalosporin molecule differs from that of the penicillin molecule in that the ring adjacent to the &beta-lactam ring is a six-membered ring as opposed to the five-membered ring of penicillin. This six-membered ring adds rigidity to the β-lactam ring and protects it from bacterial J-lactamase attack.
17. In the 1970s, GlaxoSmithKline's scientists synthesized a new drug substance, cefuroxime, a broad spectrum cephalosporin antibiotic. Cefuroxime was disclosed and claimed in the patent no. 3974153.
18. Cefuroxime (the carboxylic acid) is not readily absorbed into the bloodstream from the small intestine, and cannot be administered orally because it is poorly absorbed into the bloodstream from the gastrointestinal tract and does not provide the systemic effect required for effective treatment. As a result, cefuroxime is only administered by injection.
19. Because orally administered medicines are preferred for ease of use, cost efficiency and patient compliance, GlaxoSmithKline invested in a development effort to synthesize an orally absorbable form of cefuroxime, that is, one which could pass through the wall of the small intestine into the bloodstream on oral administration. The goal was to synthesize a prodrug of cefuroxime, that is, a compound that could cross the intestinal wall to allow the cefuroxime, the portion of the molecule that imparts antibacterial activity, to be cleaved off the prodrug and enter the circulation.
20. GlaxoSmithKline synthesized many cefuroxime derivatives, including different cefuroxime esters. Among these was a class of cefuroxime esters that showed promise as orally absorbable compounds, including cefuroxime axetil in which an axetil group is attached to the cefuroxime molecule.
21. Cefuroxime axetil is absorbed through the intestinal wall, the axetil portion of the molecule is cleaved off by enzymes and cefuroxime is released to provide its antibiotic activity.
22. The discovery of the new class of cephalosporins, the cefuroxime esters, became the subject matter of U.S. Patent No. 4,267,320 (), which issued to GlaxoSmithKlihe on May 12, 1981. The '320 patent, entitled "Cephalosporin Antibiotics," generally discloses many different cefuroxime esters, including the preferred ester, cefuroxime axetil. Further development was needed to achieve the necessary high bioavailability and stability in orally administrable form. The '320 patent has now expired. Glaxo's Dr. Gordon Gribble testified that the '320 patent generally discloses at least 15-20 different cefuroxime esters, including the preferred ester, cefuroxime axetil.
23. Apotex filed an Abbreviated New Drug Application ("ANDA") No. 65-069 on April 5, 2000, seeking approval to market a generic cefuroxime axetil drug product containing a co-precipitate cefuroxime axetil, sorbitol and zinc chloride.
24. 35 U.S.C. § 271(e)(2) states "[I]t shall be an act of infringement to submit—
(A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent".
25. Apotex submitted its ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act.
26. Unlike an NDA submitted by an innovator pharmaceutical company, an ANDA submission by a generic company like Apotex does not require any independent efficacy or safety testing. The ANDA applicant must only demonstrate that its generic version is bioequivalent to the innovator medicine and otherwise relies on the data provided by the innovator.
27. The products that Apotex intends to market are 250 mg and 500 mg cefuroxime axetil tablets, which are bioequivalent to GlaxoSmithKline's Ceftin® tablets and impart the same medical benefit as Ceftin® tablets.
28. The antibacterial component of Apotex's co-precipitate is cefuroxime axetil.
29. Apotex's ANDA states that zinc chloride acts as a stabilizer and sorbitol acts as a solubilizer.
30. The Executive Summary of Apotex's ANDA states that the sorbitol and zinc chloride components of the co-precipitate are excipients.
31. Apotex's ANDA describes the manufacturing process for its tablets. Apotex's manufacturing process starts with pure crystalline cefuroxime axetil...
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