Drug Litigation Newsroom

Permits A Patent Holder To Bring An Infringement Action

In The Supreme Court of the United States

Question Presented:
Whether 35 U.S.C. § 271(e)(2) permits a patent holder to bring an infringement action upon the filing of an Abbreviated New Drug Application ("ANDA") "for a drug the use of which is claimed in a patent," as the plain language of the statute states, or whether such an action can be brought only upon the filing of an ANDA "for a drug the use of which is claimed in a patent and is listed in the ANDA," as the Federal Circuit ruled below.

Statement Of Case:
WLF hereby adopts by reference the Statement of the Case set forth in the Petition. In brief, this case involves a dispute between a pioneer drug manufacturer (Allergan) and two generic drug manufacturers (Alcon and Bausch & Lomb) regarding Alcon' s and Bausch & Lomb' s proposed sale of brimonidine, a drug used to treat open-angle glaucoma, a
disease of the eye. In September 1996, Allergan obtained Food and Drug Administration (FDA) approval for the manufacture and sale of brimonidine for the purpose of  lowering intraocular pressure ("IOP") in patients with openangle
glaucoma.

At the time that FDA approved Allergan' s New Drug Application ("NDA"), it was generally thought within the medical profession that glaucoma was caused by abnormally high IOP, which pushed against and thereby damaged  the optic nerve. Pet. App. 46a. Allergan marketed its product under the trade name Alphagan; the product soon became a leading drug to treat glaucoma.

The Food, Drug, and Cosmetics Act (FDCA) grants the holder of an approved NDA a five-year period of exclusivity
in marketing its drug. 21 U.S.C. § 355(c)(3)(D)(ii). Allergan' s exclusivity period for brimonidine was extended for six months pursuant to 21 U.S.C. § 355a(a)(1)(i) (which permits extensions based on manufacturer testing of a product' s safety and efficacy in children); thus, its exclusivity period expired in March 2002.

The issue that divided the two Federal Circuit panels whether 35 U. S.C. § 271(e)(2) creates a cause of action for
infringing or inducing infringement of patents covering offlabel uses of FDA-approved products -- is a recurring one, as is evidenced by the nearly simultaneous consideration of the issue in two separate Federal Circuit cases. Because the arner-Lambert panel happened to issue its decision more quickly, its decision has created the controlling precedent in the Federal Circuit. Because that decision is so clearly at odds with the statutory language and is likely to have significant impact on the delivery of health care in this country, review by this Court is warranted.

Conclusion:
Amicus curiae Washington Legal Foundation respectfully requests that the Court grant the petition for a writ of
certiorari.

On Petition for Writ of Certiorari to the United States Court of Appeals for the Federal Circuit.
October 24, 2003