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ANDA Filing for Unpatented Use of Unapproved Drug Is Not Cognizable Act of Induced Infringement

March 28, 2003

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Last Month at the Federal Circuit - April 2003

Judges: Clevenger, Schall, and Linn (per curiam)

In Allergan, Inc. v. Alcon Laboratories, Inc., No. 02-1449 (Fed. Cir. Mar. 28, 2003), the Federal Circuit affirmed the district court’s grant of SJ in favor of Defendants, Alcon Laboratories, Inc. (“Alcon”) and Bausch & Lomb, Inc. (“B&L”). While the Federal Circuit relied on different reasoning than the district court, it agreed that there was not sufficient basis for inducing infringement under 35 U.S.C. § 271(e)(2) due to the filing of Defendants’ ANDAs, which did not recite the patented methods of use.

Allergan, Inc. (“Allergan”) sells a compound, brimonidine, as a drug for treatment of open-angle glaucoma, a condition that causes damage to optical cells, presumably by increased intraocular pressure. Brimonidine is not a patented compound, though its use to reduce the intraocular pressure associated with glaucoma is approved by the FDA. After further research, Allergan discovered that brimonidine is also effective in treating patients with neurodegeneration of the optic nerve, even if they do not have increased intraocular pressure. Allergan obtained two patents on the use of brimonidine to treat neurodegeneration. Subsequently, Alcon and B&L filed ANDAs in the FDA to market generic versions of brimonidine for reducing intraocular pressure, but not for the methods claimed in Allergan’s patents.

Allergan proceeded with this suit under a theory of induced infringement under 35 U.S.C. § 271(e)(2), contending that if Alcon and B&L obtained approval for their ANDA for use of brimonidine to reduce intraocular pressure, they would then encourage doctors to also use brimonidine to reduce neurodegeneration. Alcon and B&L countered that there would be no infringement because their ANDAs were filed for a use that was not patented.

The district court granted SJ, finding that the filing of an ANDA is not sufficient for a claim of induced infringement under 35 U.S.C. § 271(e)(2), because claims under that statute can only be claims that are excluded under the exemptions of 35 U.S.C. § 271(e)(1). In addition, the district court found a lack of controversy in the induced infringement cause of action because no third party had directly infringed Allergan’s patents yet.

On appeal, the Federal Circuit found that the issue was decided in Warner Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003), where the Court ruled that it was not an act of infringement to submit an ANDA for the use of a drug when neither the intended use is claimed in the patent-insuit, nor the patented use is approved by the FDA. In reaching its decision, the Court explained that infringement under 35 U.S.C. § 271(e)(2) is not merely jurisdictional, but reflects Congress’s intent that filing of an ANDA is an act of infringement, which is then subject to the other determinations of infringement found elsewhere in the statute. The Court concluded that while a § 271(e)(2) induced infringement claim may be speculative, it is not sufficiently so to contravene the case or controversy requirement. Although no third party may have directly infringed the patents, the Court found that Congress’s intent to extend infringement to acts by the ANDA filer before the generic drug was even marketed surmounted any constitutional hurdle for a lack of case or controversy.

Nevertheless, the Federal Circuit affirmed the SJ of noninfringement because the patents-in-suit protected only methods of use that were not approved by the FDA and, therefore, not a part of Alcon’s and B&L’s ANDAs, given the Warner Lambert precedent.

Judge Schall, joined by Judge Clevenger, wrote a concurring opinion because of the Court’s precedent in Warner-Lambert, but disputed the holding of that case. These judges commented that Congress’s intent in drafting 35 U.S.C. § 271(e)(2) was to allow for an infringement suit for the filing of an ANDA when there was sufficient evidence that the filer would encourage any use of an approved drug that is claimed in a patent, not just the FDA-approved uses. Writing separately, Judge Linn concurred because of the holding of Warner-Lambert, but stated that the Warner-Lambert Court had overstepped its bounds in interpreting Congress’s intent by making policy decisions that were not apparent in the plain language of the statute.