Allergan, Inc. v. Apotex, Inc.
| Decision Date | 24 January 2013 |
| Docket Number | 1:10-CV-681,1:11-CV-298,1:11-CV-650 |
| Parties | ALLERGAN, INC. and DUKE UNIVERSITY, Plaintiffs, v. APOTEX, INC. and APOTEX CORP., Defendants. ALLERGAN, INC. and DUKE UNIVERSITY, Plaintiffs, v. SANDOZ, INC., Defendant. ALLERGAN, INC. and DUKE UNIVERSITY, Plaintiffs, v. HI-TECH PHARMACAL CO., INC., Defendant. |
| Court | U.S. District Court — Middle District of North Carolina |
These consolidated Hatch-Waxman1 cases concern two patents covering Latisse®, a drug for treating hypotrichosis of the eyelashes. Latisse® is protected by U.S. Patent No. 7,388,029("the '029 Patent"), which is owned by Duke University ("Duke") and licensed to plaintiff Allergan, Inc. ("Allergan") (collectively "Plaintiffs"), and U.S. Patent No. 7,351,404 ("the '404 Patent"), which is owned by Allergan. Allergan holds the New Drug Application ("NDA") for Latisse®, which has been approved by the Food and Drug Administration ("FDA"). The defendants, Apotex, Inc., Apotex Corp., Sandoz, Inc., and Hi-Tech Pharmacal Co., Inc. (collectively "Defendants") sought to make and sell generic versions of Latisse® without going through the clinical trial process by filing Abbreviated New Drug Applications ("ANDAs") with the FDA, as allowed by the Hatch-Waxman Act, 21 U.S.C. § 355(j).
After receiving notice of Defendants' Paragraph IV certifications,2 Plaintiffs initiated this lawsuit pursuant to 35 U.S.C. § 271(e)(2)(A), alleging that Defendants infringed their patents. (Doc. 1 at 13; No. 1:11-cv-298 Doc. 1 at 1; No. 1:11-cv-650 Doc. 1 at 1.) Defendants countersued, seeking declaratory judgments that their products do not infringe on Plaintiffs' patents, and that if they do, the patents are invalid due to anticipation, obviousness, inadequate description, and lack of enablement. (Doc. 24 at 15-18; No. 1:11-cv-298 Doc. 22 at 24-26; No. 1:11-cv-650 Doc. 25 at 14-16.) The cases were consolidated. (Doc. 41, 61.)
A bench trial was held in November 2012. Having considered the documentary evidence and testimony, the Court finds that the Plaintiffs have proven infringement and that the Defendants have not proven their defenses. The Court makes the following findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a).
Scientists have been researching hair growth agents for decades with little success, and the field of hair growth biology is unpredictable. (Tr. 11/19/12 at 91:10-14.) Latisse® is the only product ever approved by the FDA to stimulate natural eyelash growth. (Tr. 11/19/12 at 83:16-24.) Before Latisse®, the FDA had approved only two hair growth agents; each was for the growth of scalp hair, not eyelashes. (Id.)
The effective ingredient in Latisse® is bimatoprost ophthalmic solution. Bimatoprost is a synthetic prostaglandin F ("PGF2a") analog and has been termed a "prostamide" by Allergan scientists. (Tr. 11/5/12 at 132:1-6; Tr. 11/6/12 at 149:11-15; Tr. 11/20/12 at 6:20-7:5; see also DTX 695 at -028.) Prostaglandins are naturally occurring molecules that play an important signaling role in human biology by binding to cell receptors. (Tr. 11/5/12 at 143:12-146:13.) A receptor is a target protein for a drug molecule that creates a signal to the cell to change its properties and functions. (Id. at 143:17-144:14; Tr. 11/6/12 at 175:25-177:15.) Studying receptors is central to pharmacology—the science of drug therapeutics—because knowing what receptors are associated with a biological effect aids in designing a drug to target those receptors and produce or inhibit that effect. (Tr. 11/5/12 at 144:15-18.) Prostaglandins bind with several receptors in the human body; for example, the naturally-occurring PGF2a binds to the prostaglandin F receptor (also called the FP receptor). (Id. at 152:18-153:9.) Compounds that bind with more than one receptor are "nonselective"; selective compounds are generally preferable for reducing side effects. (Tr. 11/6/12 at 174:18-25, 175:10-13, 176:20-177:15.)
Bimatoprost was identified in the early 1990s by Dr. Mitchell deLong, a scientist at Proctor & Gamble, during extensive research on prostaglandins in connection with efforts to develop drugs to treat osteoporosis. (Id. at 170:13-20, 201:23-202:14.) It was one of many FP-selective prostaglandins observed to cause hair growth in mice after injections. (Id. at 192:4-193:10.) As a result of their research, Dr. deLong and other scientists applied for the '029 Patent on March 31, 2000, and the patent issued on June 17, 2008. (PTX 2 at -130, -136.) At issue in the '029 Patent are claims 1, 8, 14, 18, and 20, which, in short, claim a method of treating hair loss by repeatedly administering to a mammal certain compounds systemically or topically. (See PTX 2 at 60:39-61:48, 61:62-64, 62:47-49, 63:4-64:14, 64:19-66:15.)
Scientists at Allergan were also studying bimatoprost in the 1990s, but for the purpose of developing a new glaucoma treatment. (Tr. 11/5/12 at 151:4-13, 201:23-25.) Prostaglandins had been known to treat glaucoma by lowering intraocular pressure ("IOP") since the mid-1980s. (Id. at 151:14-152:4.) The FDA approved latanoprost, another PGF2a analog, to treat glaucoma in 1996. (Id. at 132:7-10; 191:5-13.) In 2001, the FDA approved bimatoprost for the treatment of glaucoma, (Id. at 190:23-191:13; Doc. 155 at ¶ 27); Allergan sells it under the name Lumigan®. (Id. at 190:23-191:13.)
Allergan's work on prostaglandins was overseen by Dr. David Woodward. (Tr. 11/5/12 at 151:4-8.) During the clinical trials studying bimatoprost in eyedrop form as a treatment for glaucoma, Dr. Woodward and Dr. Amanda VanDenburgh, who planned and oversaw the clinical trials at Allergan, observed a significant number of reports of the adverse effect of eyelash growth. (PTX 171; PTX 184A; PTX 185A; Tr. 11/5/12 at 210:15-24, 212:5-213:10; Tr. 11/6/12 at 117:23-121:25.) Drs. Woodward and VanDenburgh applied for the '404 Patent on February 4, 2002, and the patent issued on April 1, 2008. (PTX 5 at -631-32.) At issue in the '404 Patent is claim 14, which essentially claims a method of stimulating eyelash growth by applying an effective amount of bimatoprost. (See PTX 5 at 13:66-14:45, 18:6-9.)
In a Hatch-Waxman case, the filing of an ANDA "for a drug claimed in a patent or the use of which is claimed in a patent" is an act of infringement "if the purpose of such submission is to obtain approval . . . to engage in the commercial manufacture, use, or sale of [the] drug . . . before the expiration of such patent." 35 U.S.C. § 271(e)(2). The infringement analysis in a Hatch-Waxman case is the same as in any other infringement suit, except that it looks to the future. Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997). The patentee seeking relief under § 271(e)(2) thus has the burden to prove by a preponderance of the evidence that the product to be sold following FDA approval will infringe. Id. at 1568. Because the purpose of the submission of an ANDA is to obtain approval to market and sell a well-defined compound, "the ultimate question of infringement is usually straightforward" when the generic manufacturer seeks approval to sell the product for the same use as that which is patented. Id. at 1569.
Plaintiffs contend that the sale of Defendants' proposed products will indirectly infringe their patents under the doctrines of induced and contributory infringement. See Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1331 (Fed. Cir. 2003) (). The Court finds by a preponderance of the evidence that the sale and marketing of Defendants' generic versions of Latisse® will constitute induced and contributory infringement.
To show induced infringement, Plaintiffs must prove that Defendants: a) will knowingly induce infringement, and b) possess specific intent to encourage another's infringement. AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1056 (Fed. Cir. 2010); see 35 U.S.C. § 271(b).Circumstantial evidence, such as including "instructions in [a] proposed label that will cause at least some users to infringe the asserted method claims," can prove specific intent. Id. at 1060.
The '029 Patent claims a method of treating hair loss by administering to a mammal a compound, the formula for which includes bimatoprost. (PTX 2 at 60:40-41, 63:4-5, 64:18-19; Tr. 11/7/12 at 172-73.) Defendants concede that their products consist of .03% bimatoprost. (PTX 39 at -118; PTX 46 at -482; PTX 59 at -106; PTX 74 at -689; Tr. 11/7/12 at 140:2-9; Tr. 11/8/12 at 17:1-23.) This Court previously construed "treating hair loss" as "arresting hair loss, reversing hair loss, or both, and promoting hair growth," meaning that the invention may arrest hair loss, reverse hair loss, or promote hair growth in the alternative. (Doc. 88 at 3-4.) Defendants' proposed labels instruct patients to apply their products in order to promote hair growth by increasing lash length, thickness, and darkness. (PTX 35A at -045; PTX 39 at -118; PTX 63 at -385; PTX 72 at -499; Tr. 11/7/12 at 157:18-158:7.)
Defendants contend the '029 Patent claims require the compound to promote growth of hair lost as a result of a disease. Such a requirement is not in the language of the patent, nor did Defendants raise this contention during the claim construction proceedings. Moreover, the evidence does not support Defendants' contentions. While Dr. Rosic testified that "reversing hair loss" and "arresting hair loss" mean stopping disease-induced hair loss and making the hair grow back, (Tr. 11/8/12 at 114: 23-115:8, 122:15-123:2), she also testified that she did not use those terms in her dermatology practice. (Id. at 114:25-115:1; 122:18-19.) Moreover, Dr. Rosic did not testify that any of the products at issue failed to promote hair growth. (See id. at 152:6-10, 155:4-9; Doc. 88 at 3-4.) Defend...
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