Allergan, Inc. v. Alcon Laboratories, Inc.

Citation200 F.Supp.2d 1219
Decision Date08 May 2002
Docket NumberNo. SA CV 02-40 DOC.,SA CV 02-40 DOC.
CourtUnited States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
PartiesALLERGAN, INC.; Allergan Sales, Inc., Plaintiffs, v. ALCON LABORATORIES, INC.; Alcon Research, Ltd.; Alcon Universal, Ltd.; Bausch & Lomb, Inc., Defendants.

Daniel J. Thomasch and Veronica Mullally of Orrick Herrington & Sutcliffe, New York, NY; William W. Oxley of Orrick Herrington & Sutcliffe, Los Angeles, CA; Lisa Marie Schull of Orrick Herrington & Sutcliffe, San Francisco, CA., for Alcon Laboratories, Inc.; Alcon Research, Ltd.; and Alcon Universal, Ltd.

John B. Hurlbut, Jr. of Rutan & Tucker, Costa Mesa, CA; Robert L Baechtold, Scott K Reed, Bruce M Wexler, and F. Christopher Mizzo of Fitzpatrick Cella Harper & Scinto, New York, NY; Michael K O'Neill of Fitzpatrick Cella Harper & Scinto, Costa Mesa, CA; Denis A Polyn, Rochester, N.Y. for Bausch & Lomb, Inc. (not a party to the motion).

ORDER GRANTING ALCON DEFENDANTS' MOTION FOR SUMMARY JUDGMENT

CARTER, District Judge.

Before the Court is Defendants' Alcon Laboratories, Inc., Alcon Research, Ltd., and Alcon Universal, Ltd.'s (collectively Alcon) motion for summary judgment on Plaintiffs' Allergan, Inc. and Allergan Sales, Inc.'s (collectively Allergan) complaint for patent infringement. After reviewing the moving, opposing, and replying papers, after oral argument on April 29, 2002, and for the reasons set forth below, the Court GRANTS Alcon's motion.

I. BACKGROUND
A. Glaucoma

Open-angle glaucoma, the most common form of glaucoma, is a disease of the eye that leads to a gradual loss of vision. Glaucoma is caused by damage to optical cells. As those cells are damaged, vision becomes impaired. Generally, individuals that suffer from glaucoma lose their peripheral vision and subsequently develop blind spots at the sides. If not arrested, it may lead to blindness. Risk factors for glaucoma have traditionally included people with diabetes, high blood pressure, near sightedness, a family history of glaucoma, and black and elderly people. Treatment at the early stages of glaucoma is important because damaged cells cannot be repaired.

The human eye works when light enters through the cornea, passes through the pupil, and then travels through the lens and the vitreous body to the retina and the optic nerve. The optic nerve then carries the images to the brain for interpretation. The eye produces a watery fluid called aqueous humor that nourishes the eye's internal structures. Aqueous humor is continuously produced and drained between the lens and the vitreous body. When the drainage does not keep up with the production, the fluid backs up causing increased pressure in the eye, called intraocular pressure (IOP). For decades, the traditional view of the medical profession was that glaucoma was caused by an abnormally high IOP, which pushed against the optic nerve causing it to be damaged. Treatment for glaucoma thus consisted of reducing IOP.

Research has shown that the drug brimonidine, sold by Allergan under the trade name Alphagan®, reduces IOP. Alphagan® therefore became a leading drug to treat glaucoma.

In recent years, however, the medical science view of glaucoma has changed. Scientists discovered that patients with lower IOP's were still contracting glaucoma. Some evidence has since shown that the disease may originate from the optic nerve itself. Scientists are now increasingly thinking of glaucoma as a neurode-generative disease.

In the early 1990's, Allergan scientists discovered that brimonidine had neuroprotective properties such that applying it to nerve cells make them less susceptible to injury and degeneration than those not treated with brimonidine. Thus, Alphagan® may be a potent treatment for glaucoma as a neuroprotective agent under this new view of the disease.

B. New Drug and Generic Drug Application Procedures

The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, was adopted by Congress to address the need to bring generic drugs to the market quickly and changed the way in which the Food and Drug Administration (FDA) approved the manufacture and use of new and generic drugs. See Glaxo, Inc. v. Novopharm Ltd., 110 F.3d 1562, 1568 (Fed.Cir.1997). One of the most important aspects of the Hatch-Waxman Act was to "make available more low cost generic drugs." Id. (quoting H.R.Rep. No. 98-857(I), at 14-15 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647-48).

In order to market a new drug, the maker of the drug must obtain approval from the FDA. 21 U.S.C. § 355(a). In order to obtain FDA approval, the maker must submit a New Drug Application (NDA) which includes extensive information and testing of the new drug to insure its safety. See 21 U.S.C. § 355(b). Once the NDA is approved, the holder of an approved NDA is automatically granted a five-year period of exclusivity in marketing its drug. 21 U.S.C. § 355(c)(3)(D)(ii). That period of exclusivity is extended by an additional six months if the maker conducts certain tests to insure its safety and efficacy in children. 21 U.S.C. § 355a(a)(1)(i). During this period of exclusivity, the FDA may not grant any other drug maker a license to manufacture and sell the same drug or its bioequivalent. This period of exclusivity is intended to recognize the efforts and costs that the drug maker undertook in the first place to test and insure the safety and efficacy of a new, or pioneer, drug.

Near the end of that period of exclusivity, a drug maker may file an Abbreviated New Drug Application (ANDA). See 21 U.S.C. § 355(j). A party submitting an ANDA need only show that the proposed new drug is the same, or the bioequivalent, of the pioneer drug.

During the ANDA process, a generic drug maker must certify that the pioneer drug is either: (i) not patented (Paragraph I Certification); (ii) protected by a patent that has expired (Paragraph II Certification); (iii) patented, but setting forth the date the patent will expire (Paragraph III Certification); or (iv) that the pioneer drug's patent is either expired or will not be infringed by the generic drug (Paragraph IV Certification). See 21 U.S.C. § 355(j)(2)(A)(vii). An ANDA with either Paragraph I or II certification may be quickly approved and marketed as soon as all regulatory requirements are met. An ANDA with Paragraph III Certification may not be approved until the relevant patents have expired.

Paragraph IV Certification, however, creates a different set of procedures. Under Section 202 of the Hatch-Waxman Act, Congress has specifically exempted a party that uses a patent in order to prepare an application for commercial marketing of a drug from liability for infringement. 35 U.S.C. § 271(e)(1). However, the submission of an ANDA is an act of infringement. 35 U.S.C. § 271(e)(2)(A). This infringement is "highly artificial." See Eli Lilly and Co. v. Medtronic, Inc., 496 U.S. 661, 676, 110 S.Ct. 2683, 2691, 110 L.Ed.2d 605 (1990). Congress enacted this statutory scheme in order to allow generic drugs to come to the market as quickly as possible. See id. By allowing a generic drug maker to use the patent as it prepares to obtain FDA approval, the drug maker can bring the generic drug to market as soon as the patent expires, rather than waiting for the patent to expire before undertaking years of regulatory hurdles. By the same token, allowing the filing of the ANDA to amount to an act of infringement, the validity of a patent can be challenged before the drug comes to market. A party submitting an ANDA with a Paragraph IV Certification must inform the drug and patent owner of the application. See 21 U.S.C. § 355(j)(2)(B)(i). The patent owner then has 45 days in which to file an action for infringement, the basis of which is the "artificial" act of infringement of filing an ANDA. If the patent-holder does not sue for infringement, the ANDA may be quickly approved and marketed as soon as all regulatory requirements are met. If the patent-holder does file suit, the ANDA may not be approved until either the date that the Court determines either invalidity or non-infringement, the date the patent expires, or 30 months (subject to modification by the Court) after the ANDA patent holder receives notice of the Paragraph IV Certification.

C. Allergan's NDA for Alphagan® (Brimonidine)

On September 6, 1996, Allergan obtained FDA approval of its NDA, granting approval for the manufacture and sale of Alphagan® for reducing IOP, in accordance with a specific set of labeling instructions. Allergan was entitled to a five year period of exclusivity under 21 U.S.C. § 355(c)(3)(D)(ii) and an additional six month period under 21 U.S.C. § 355a(a)(1)(i). Brimonidine, however, was not protected by a patent, and thus Allergan's period of exclusivity was originally set to expire March 6, 2002.

Before that time elapsed, however, Allergan scientists discovered the neuroprotective properties of brimonidine. Accordingly, in 1999 and 2000, Allergan applied for patents covering this new use of brimonidine. In 2001, Allergan was granted U.S. Patents Nos. 6,194,415 (the '415 Patent) and 6,248,741 (the '741 Patent), both of which are continuations in part of U.S. Patent No. 5,856,329 (the '329 Patent).

The '415 and the '741 Patents (the patents at issue in this case) both claim a method of using brimonidine for treating ocular neural injury. During the prosecution of the patents at issue, Allergan initially attempted to claim the use of brimonidine to reduce IOP. The patent examiner rejected those claims as being obvious. Allergan then limited its claims to a method of using brimonidine as a neuroprotective agent to treat glaucoma. Allergan then listed the...

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