In re Brimonidine Patent Litigation, MDL Docket No. 07-md-1866 GMS.
| Citation | 666 F.Supp.2d 429 |
| Decision Date | 23 October 2009 |
| Docket Number | MDL Docket No. 07-md-1866 GMS. |
| Parties | In re BRIMONIDINE PATENT LITIGATION. |
| Court | U.S. District Court — District of Delaware |
In this consolidated patent infringement action, the plaintiff alleges that the defendants' proposed generic pharmaceutical products infringe the asserted claims of the patents-in-suit.1 (D.I. 1.) The court held an eight-day bench trial in this matter on March 9 through March 18, 2009. (D.I. 227-34.) Presently before the court are the parties' post-trial proposed findings of fact and conclusions of law, and post-trial motions for judgment pursuant to Fed. R.Civ.P. 52(c) (the "Rule 52(c) motions").
Pursuant to Fed.R.Civ.P. 52(a), and after having considered the entire record in this case and the applicable law, the court concludes that: (A) the defendants' proposed generic products infringe the asserted claims of the patents-in-suit; (B) the patents-in-suit are not invalid; (C) the patents-in-suit are not unenforceable; and that (D) an award for attorneys' fees and costs is not warranted in this case.2 The court also grants the plaintiffs Rule 52(c) motion and denies Exela's Rule 52(c) motion. These findings of fact and conclusions of law are set forth in further detail below.
1. Plaintiff Allergan, Inc. is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business at 2525 DuPont Drive, Irvine, California 92612. (D.I. 190, Tab 1 at ¶ 1.)
2. Defendant Apotex, Inc. is a corporation organized and existing under the laws of Canada, with its principal place of business at 150 Signet Drive, Toronto, Ontario, Canada M9L 1T9. (Id. at ¶ 22.)
3. Defendant Apotex Corp. is a corporation organized and existing under the laws of the State of Delaware, with a place of business at 2400 North Commerce Parkway, Suite 400, Weston, Florida 33326. (Id. at ¶ 23.)
4. Defendant Exela PharmSci, Inc. is an entity organized under the laws of the State of Virginia, and is headquartered at 11710 Plaza America Dr., Suite 2000, Reston, Virginia 20190. (Id. at ¶ 27.)
5. Defendant Exela PharmSci Pvt., Ltd. is an entity organized under the laws of the country of India with headquarters in Hyderabad, India. Exela PharmSci Pvt., Ltd. is jointly owned by Exela PharmSci, Inc. and Exela Holdings, Inc. (D.I. 190, Tab 1 at ¶ 28.)
6. Defendant Paddock Laboratories, Inc. ("Paddock") is a corporation organized and existing under the laws of the State of Minnesota, with its headquarters and principal place of business at 3940 Quebec Avenue North, Minneapolis, MN 55427. (Id. at ¶ 29.)
7. Defendant PharmaForce, Inc. ("PharmaForce") is a corporation organized and existing under the laws of the State of Delaware, with its headquarters and principal place of business at 960 Crupper Avenue, Columbus, Ohio 43229. (Id. at ¶ 30.)
8. Allergan, Paddock, and Pharma-Force entered into a settlement agreement and submitted a consent judgment to the court on January 20, 2009. (D.I. 168.) The court entered an order granting consent judgment on February 25, 2009. (D.I. 221.)
9. Brimonidine tartrate (5-bromo-6-(2-imidozolin-2-ylamino) quinoxaline tartrate) ("brimonidine tartrate" or "brimonidine") is an alpha-2-adrenergic agonist drug compound that is used in ophthalmic solutions for the treatment of glaucoma. (D.I. 190, Tab 1 at ¶ 3.)
10. Allergan markets its brimonidine tartrate products under the ALPHAGAN P® brand name for use in the treatment of glaucoma. (Id. at ¶¶ 3, 5.) Specifically, Allergan's ALPHAGAN P® 0.1% and 0.15% brimonidine ophthalmic solution products are indicated for the lowering of intraocular pressure in patients with openangle glaucoma or ocular pressure. (Id.)
11. The "patents-in-suit" collectively consist of the following: U.S. Patent Nos. 6,627,210 (the "'210 patent"), 6,641,834 (the "'834 patent"), 6,673,337 (the "'337 patent") 6,562,873 (the "'873 patent"), and 5,424,078 (the "'078 patent"). Allergan owns all five patents-in-suit. (D.I. 190, Tab 1 at 2-3.)
12. Orest Olejnik, Ph.D. ("Dr. Olejnik") and Edward D.S. Kerslake, Ph.D. ("Dr. Kerslake") are the named inventors on the '210, '834, '337, and '873 patents. (Id. at 2.)
13. The '210 patent is entitled "Compositions Containing Alpha-2-Adrenergic Agonist Components." (D.I. 190, Tab 1 at 2.) The '210 patent issued on September 30, 2003. (Id.) The '210 patent generally covers therapeutically effective compositions containing brimonidine and a polyanionic solubility component ("SEC"), such as carboxymethylcellulose ("CMC"). (Id.)
14. The '834 patent is entitled "Compositions Containing Alpha-2-Adrenergic Agonist Components." (D.I. 190, Tab 1 at 2.) The '834 patent issued on November 4, 2003. (Id.) The '834 patent generally covers therapeutically effective ophthalmic compositions comprising up to about 0.15% brimonidine with a pH of about 7.0 or greater, where the brimonidine is soluble in the composition at room temperature. (D.I. 190, Tab 7.1 at 14.)
15. The '337 patent is entitled "Compositions Containing Alpha-2-Adrenergic Agonist Components." (D.I. 190, Tab 1 at 3.) The '337 patent issued on January 6, 2004. (Id.) The '337 patent generally covers therapeutically effective ophthalmic compositions containing alpha-2-adrenergic agonists and an anionic SEC other than cyclodextrin. (D.I. 190, Tab 7.1 at 15.)
16. The '210, '834, and '337 patents all share a common specification. (D.I. 190, Tab 1 at 3.)
17. The '873 patent is entitled "Compositions Containing Therapeutically Active Components Having Enhanced Solubility." (D.I. 190, Tab 1 at 2.) The '873 patent issued on May 13, 2003. (Id.) The '873 patent generally covers therapeutically effective compositions containing alpha-2-adrenergic agonists, CMC as an SEC, and an oxy-chloro preservative component. (D.I. 190, Tab 7.1 at 14.)
18. The '078 patent is entitled "Aqueous Ophthalmic Formulations and Methods for Preserving Same." (D.I. 190, Tab 1 at 3.) The '078 patent issued on June 13, 1995. (Id.) The named inventors on the '078 patent are Anthony J. Dziabo ("Dziabo") and Paul S. Ripley ("Ripley"). (Id.) The '078 patent generally covers aqueous ophthalmic formulations preserved by stabilized chlorine dioxide, buffered to a pH of about 6.8 to about 8 with tonicity components to maintain an osmolality of at least about 200 mOsmol/kg. (D.I. 190, Tab 7.1 at 106.)
19. One or more of the claims of each of the patents-in-suit covers each of the ALPHAGAN P® products. Specifically, ALPHAGAN P® 0.15% is encompassed within the scope of at least the following claims of the patents-in-suit: claims 1-5, 7-9, 12-23, 25-27, 29-31, and 33-34 of the '210 patent; claims 1-7, 10-16, 20, and 22 of the '834 patent; claims 5 and 8 of the '337 patent; claims 12, 25, 26, 31, 33, and 45 of the '873 patent; and claims 1-12 and 14-18 of the '078 patent. ALPHAGAN P® 0.1% is encompassed within the scope of at least the following claims of the patents-in-suit: claims 1-5, 7-9, 12-23, 25-27, 29-31, and 33-34 of the '210 patent; claims 1-2, 5-7, 10-11, 14-16, 20, and 22 of the '834 patent; claims 5 and 8 of the '337 patent; claims 12, 25, 26, 31, 33, and 45 of the '873 patent; and claims 1-12 and 14-18 of the '078 patent.3 (D.I. 190, Tab 1 at 3-4.) Refresh Tears® is an artificial tear product made by Allergan that lubricates and moisturizes dry eyes. (D.I. 190, Tab 7.1 at 33.) Refresh Tears® contains PURITE® as a preservative. (Id.) PURITE® is a stabilized chlorine dioxide compound that is predominantly composed of chlorite ion.4 (Id.) Since at least 1998, Refresh Tears® has, been formulated with a pH of 7.7. (Id.)
20. The effective filing date of the '210, '834, '337, and '873 patents is July 14, 2000. (D.I. 190, Tab 7.1 at 13-15.) The effective filing date of the '078 patent is November 29, 1988. (Id.)
21. On February 12, 2007, Allergan received a paragraph IV letter dated February 8, 2007, indicating that Exela had submitted ANDA No. 78-590 with the FDA under section 505(j)(2)(B) of the Federal Food, Drug and Cosmetic Act seeking approval to engage in the commercial manufacture, use, importation, offer for sale, or sale of a 0.15% brimonidine tartrate ophthalmic solution prior to the expiration of the patents-in-suit. (D.I. 190, Tab 1 at 6.) Exela's paragraph IV letter states that the product in ANDA No. 78-590 would not infringe certain claims of the patents-in-suit, and that all of the claims of the patents-in-suit are invalid. (Id.) The paragraph IV letter further states that the pH of the proposed product in ANDA No. 78-590 is "between 6.5 and 6.7." (PTX-026 at XLA000372.)
22. ANDA No. 78-590 seeks approval to market a generic product for the lowering of intraocular pressure ("IOP") in patients with open-angle glaucoma or ocular hypertension. (D.I. 190, Tab 1 at 7.) The proposed product in ANDA No. 78-590 is formulated as a topically administrable aqueous solution. (Id. at 6.) The active ingredient in the proposed product in ANDA No. 78-590 is brimonidine tartrate. (Id.) The proposed product in ANDA No. 78-590 has the same dosage form, route of administration, dosing regimen, and indication as ALPHAGAN P®. (Id. at 6-7.)
23. In its original submission to the FDA, Exela indicated that the proposed product in ANDA No. 78-590 had a manufacturing pH range of 6.5 to 6.7 and a release specification range of 6.2 to 6.5. (PTX-030 at XLA000400-01.) Exela's proposed labeling for the product, however, stated a pH range of 5.5 to 6.7. (PTX-026 at XLA000372.) In a June 20, 2007 bioequivalence deficiency letter, the FDA rejected Exela's request for a bioequivalency waiver based on a proposed product with a pH range of 5.5 to 6.7. (PTX-029 at XLA000395.) In the deficiency letter, the FDA noted that Exela had not shown...
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