Research v. Apotex Inc.
| Decision Date | 23 May 2011 |
| Docket Number | No. 1:06–cv–1642–RLY–TAB.,1:06–cv–1642–RLY–TAB. |
| Citation | 790 F.Supp.2d 868 |
| Parties | ALCON RESEARCH, LTD. (f/k/a Alcon Manufacturing, Ltd.), Alcon Laboratories, Inc., and Kyowa Hakko Kirin Co., Ltd., Plaintiffs,v.APOTEX INC. and Apotex Corp., Defendants. |
| Court | U.S. District Court — Southern District of Indiana |
OPINION TEXT STARTS HERE
Adam L. Perlman, Bruce Roger Genderson, Christopher J. Mandernach, Daniel P. Shanahan, Jessamyn S. Berniker, Shelley J. Webb, Thomas H.L. Selby, Williams & Connolly LLP, Washington, DC, Deborah Pollack–Milgate, Donald E. Knebel, Paul B. Hunt, Todd G. Vare, Barnes & Thornburg LLP, Indianapolis, IN, for Plaintiffs.Abram B. Gregory, Gayle A. Reindl, Taft Stettinius & Hollister LLP, Indianapolis, IN, Brian J. Sodikoff, Craig M. Kuchii, Martin S. Masar, III, Robert B. Breisblatt, Thomas J. Maas, Katten Muchin Rosenman LLP, Chicago, IL, for Defendants.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
Plaintiffs, Alcon Research, Ltd. (f/k/a Alcon Manufacturing, Ltd.), Alcon Laboratories, Inc. (collectively “Alcon”), and Kyowa Hakko Kirin Co. Ltd. (f/k/a Kyowa Hakko Kogyo Co. Ltd.) (“Kyowa”) (collectively “Plaintiffs”), filed suit against the Defendants, Apotex, Inc. and Apotex Corp. (collectively “Apotex” or “Defendants”), for infringement of United States Patent No. 5,641,805 (“the '805 patent”). The parties tried this case before the court from April 26, 2010, through May 7, 2010. Following the trial, the parties filed proposed findings of fact and conclusions of law. The parties presented their final arguments to the court on August 3, 2010.
Being duly advised, the court finds that Plaintiffs have proven, by a preponderance of the evidence, that the Defendants' generic equivalent of Plaintiffs' patented allergy topical ocular medication, Patanol®, infringed claims 1–8 of the '805 patent. The court finds that Defendants have failed to prove by clear and convincing evidence that claims 1–8 of the '805 patent are invalid as obvious under 35 U.S.C. § 103, as anticipated under 35 U.S.C. § 102, and for lack of written description under 35 U.S.C. § 112. The court further finds that Defendants have failed to prove by clear and convincing evidence that the '805 patent is unenforceable due to inequitable conduct.
The court now issues its findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a):
FINDINGS OF FACT 1
1. Alcon Research, Ltd. (f/k/a Alcon Manufacturing, Ltd.) is a corporation organized and existing under the laws of the State of Delaware, having its corporate offices and principal place of business at 6201 South Freeway, Fort Worth, Texas 76134. (Docket # 173, Stipulation ¶ 1).
2. Alcon Laboratories, Inc. is a corporation organized and existing under the laws of the State of Delaware, having its corporate offices and principal place of business at 6201 South Freeway, Fort Worth, Texas 76134. (Docket # 173, Stipulation ¶ 2).
3. Kyowa Hakko Kirin Co., Ltd. (f/k/a Kyowa Hakko Kogyo Co., Ltd.) is a corporation organized and existing under the laws of Japan, having its principal place of business at 1–6–1 Ohtemachi, Chiyoda-ku, Tokyo 100–8185, Japan. (Docket # 173, Stipulation ¶ 3).
4. Apotex, Inc. is a corporation organized and existing under the laws of Canada, having its principal place of business at 150 Signet Dr., Weston, Ontario M9L 1T9. (Docket # 173, Stipulation ¶ 4).
5. Apotex Corp. is a corporation organized and existing under the laws of the State of Delaware, having its principal place of business at 2400 North Commerce Parkway, Suite 400, Weston, Florida 33326. (Docket # 173, Stipulation ¶ 5).
6. Alcon Laboratories, Inc. holds the approved New Drug Application (“ANDA”), # 20–688, for Patanol® ophthalmic solution. The NDA was approved on December 18, 1996. (Docket # 173, Stipulation ¶ 6).
7. On June 6, 1995, Alcon Laboratories, Inc. and Kyowa Hakko Kogyo Co. filed United States Patent Application # 08/469,729 (the “'729 application”), naming John Yanni, Stella Robertson, Eiji Hayakawa, and Masashi Nakakura as inventors. (Docket # 173, Stipulation ¶ 7).
8. The '729 application issued on June 24, 1997, as the '805 patent, entitled “Topical Ophthalmic Formulations for Treating Allergic Eye Diseases.” Alcon Laboratories, Inc. and Kyowa Hakko Kogyo Co. Ltd., were the original assignees of the '805 patent. (Docket # 173, Stipulation ¶ 7).
9. Alcon Laboratories, Inc.'s interest in the '805 patent has been subsequently assigned to Alcon Research, Ltd. Alcon Laboratories, Inc. sells drug products covered by the '805 patent under the trademark Patanol® pursuant to an ANDA held by Alcon Laboratories, Inc. and approved by the Food and Drug Administration (“FDA”). (Docket # 173, Stipulation ¶ 8).
10. Kyowa Hakko Kogyo Co., Ltd.'s interest in the '805 patent has been subsequently assigned to Kyowa Hakko Kirin Co., Ltd. (Docket # 173, Stipulation ¶ 9).
11. Patanol® is approved for the treatment of the signs and symptoms of allergic conjunctivitis. TX 131 at NDA000008; NDA000029 (). The active ingredient of Patanol® is olopatadine hydrochloride. The concentration of Patanol® is 1 mg/mL, or 0.1% w/v. (Docket # 173, Stipulation ¶ 10).
12. Apotex is the owner of ANDA # 78–350, which was submitted to the FDA under section 505(j) of the Federal Food, Drug and Cosmetic Act (“FDCA”), and seeks approval to engage in the commercial manufacture, use, and sale of a generic olopatadine hydrochloride product (“Apotex's product”) prior to the expiration of the '805 patent. (Docket # 173, Stipulation ¶ 13).
13. By letter dated October 2, 2006 (the “Notice Letter”), Apotex notified Plaintiffs that Apotex had submitted ANDA # 78–350 to the FDA. (Answer ¶ 16). In the Notice Letter, Apotex notified Plaintiffs that, as part of its ANDA, it had filed a certification of the type described in section 505(j)(2)(A)(vii)(IV) of the FDCA (“Paragraph IV” certification). (Answer ¶ 18); TX 131 at ANDA000043 (Paragraph IV certification statement).
14. On November 15, 2006, Plaintiffs brought suit against Apotex, asserting infringement of the '805 patent, arising out of Apotex's filing of ANDA # 78–350. (Docket # 1, Complaint).
15. Jurisdiction and venue are proper in this district pursuant to 28 U.S.C. §§ 1331, 1338(a), 1391, and 1400(b). (Docket # 21, Answer ¶ 8; Docket # 35, Entry on Defendants' Motion to Transfer at 3 ()).
II. The Science of Allergy and the Invention of Patanol®A. The Human Eye, the Conjunctiva, and Mast Cells
16. Mast cells are specialized cells that exist in many places throughout the body, including the eye, and are the primary cells involved in allergic reactions. (Kaliner Tr. 466:8–469:2, 476:3–24, 484:15–485:3; Bielory Tr. 1033:1–8, 1051:8–16; 1053:8–16).
17. The mast cells in the eye are located in the conjunctiva, which is the mucous membrane that lines the inner surface of the eyelids and the sclera on the front of the eyeball. (Yanni Tr. 113:24–114:20; AA–026.02; AA–027; Kaliner Tr. 459:25–460:3). The conjunctiva does not cover the tissues responsible for sight, including the cornea, lens, and retina. (Yanni Tr. 114:21–115:3; Kaliner Tr. 460:12–18; AA–027).
18. Like all mucous membranes, the conjunctiva is designed to keep things that are meant to be in the body in, and to prevent foreign matter from entering the body. The secretion of mucous on the surface of the membrane removes and flushes foreign objects from the surface of the membrane and protects the surface. (Kaliner Tr. 461:10–463:16; AA–33; AA–71).
19. The mast cells do not reside on the very surface of the eye. Within the conjunctiva, the epithelial goblet cells are located closest to the surface. (Kaliner Tr. 462:20–463:16, 464:15–466:7; AA–071; AA–033). Below the epithelial layer is a basement membrane. (Kaliner Tr. 464:15–466:7; AA–033; AA–071). Below the basement membrane is an area referred to as either the substantia or lamina propria. (Kaliner Tr. 464:15–466:7; AA–033; AA–071). The mast cells in the eye are located below the basement membrane in the substantia propria. (Kaliner Tr. 465:2–13; AA–071).
20. Mast cells contain granules, each of which contain pre-formed mediators. (Kaliner Tr. 467:10–468:15; AA–30; AA–32). Mediators are chemicals that, if released from the mast cells, have some effect on receptors located in the surrounding tissue. (Kaliner Tr. 467:10–468:15; AA–093). Each granule contains up to 25 different types of chemical mediators. (Kaliner Tr. 467:10–468:15; AA–093).
21. Adjacent to the conjunctiva is the conjunctival sac, which contains an extremely small amount of fluid that keeps the tissues moist. (Kaliner Tr. 460:19–461:6; AA–027).
B. The Allergic Cascade
22. The allergic response is a mechanism that the human body uses to attempt to expel something it recognizes as a foreign invading substance. (Yanni Tr. 119:16–120:4).
23. In the eye, the most common type of allergic disease is called allergic conjunctivitis. (Kaliner Tr. 507:2–13).
24. In general, an allergic reaction can occur in the sensitized human being upon exposure to an antigen. An antigen is a substance that has the ability to trigger an immunologic reaction, such as the production of antibodies. (Yanni Tr. 116:18–118:14; Kaliner Tr. 470:2–22).
25. Common antigens include substances such as cat dander, pollen, and ragweed. (Yanni Tr. 117:10–118:6; Kaliner Tr. 470:2–22).
26. Exposure occurs when an antigen, like pollen, comes into contact with the outer epithelial layer of the conjunctiva. Small proteins break off from the pollen grain and move through the epithelium, through the basement membrane, and into the substantia or lamina propria where the mast cells are located. (Kaliner Tr. 465:2–13).
27. In the portion of the human population that is genetically predisposed to do so, exposure over a period of time to certain...
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Alcon Research, Ltd. v. Apotex Inc.
...patent was enforceable and not invalid, and that Apotex's generic product infringed the asserted claims. Alcon Research, Ltd. v. Apotex Inc., 790 F.Supp.2d 868, 944–45 (S.D.Ind.2011). On the issue of validity, the district court held that Apotex failed to establish that the claims would hav......