Pfizer Inc. filed suit against Apotex, Inc. (formerly known as TorPharm, Inc.) in the United States District Court for the Northern District of Illinois on July 30, 2003, alleging that, pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), Apotex’s filing with the United States Food and Drug Administration (“FDA”) of its Abbreviated New Drug Application (“ANDA”) No. 76-719 seeking approval to commercially sell amlodipine besylate tablets (2.5 mg, 5 mg, and 10 mg strengths) before the expiration of the term of U.S. Patent No. 4,879,303 (“the ’303 patent”) to Pfizer, infringed claims 1-3 of the ’303 patent. The ANDA product sought to be approved by Apotex is a generic version of Pfizer’s amlodipine besylate drug product, which is commercially sold in tablet form in the United States under the trademark Norvasc®. Norvasc® is approved by the FDA for treating hypertension and chronic stable and vasospastic angina. The ’303 patent, entitled “Pharmaceutically Acceptable Salts,” is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) with respect to the Norvasc® drug product in accordance with 21 U.S.C. § 355(b)(1). Apotex certified in ANDA No. 76-719 that it believed the ’303 patent was invalid and unenforceable, and sought approval to market and sell its amlodipine besylate tablets before September 25, 2007 (i.e., the expiration date of the ’303 patent plus an additional six months of pediatric exclusivity) pursuant to 21 C.F.R. § 314.94(a)(12)(i)(A)(4).
In its answer to Pfizer’s complaint, Apotex denied infringement and counterclaimed for declaratory judgments that the claims of the ’303 patent are invalid for anticipation and obviousness, and that the ’303 patent is unenforceable due to Pfizer’s alleged inequitable conduct before the United States Patent and Trademark Office (“USPTO”). Prior to trial, however, Apotex stipulated that its ANDA product contains each limitation of claims 1-3 of the ’303 patent, and that if the ’303 patent were upheld as valid and enforceable, its ANDA product would literally infringe those claims.
Following a bench trial, the district court entered a final judgment on January 29, 2006 for Pfizer and against Apotex on Apotex’s request for declaratory judgments that the claims of the ’303 patent are invalid or unenforceable. Based on the stipulation, the trial court found infringement. The district court then ordered that the effective date of any approval of Apotex’s ANDA No. 76-719 shall not be earlier than September 25, 2007, and enjoined Apotex from making, using, offering to sell, selling, or importing into the United States any product comprising amlodipine besylate covered by (or the use of which is covered by) the claims of the ’303 patent until September 25, 2007. Pfizer Inc. v. Apotex, Inc., No. 03C 5289 (N.D. Ill. Jan. 29, 2006).
Pfizer dismissed its claim of willful infringement against Apotex by a Stipulation and Order dated January 23, 2006. Apotex now appeals from the district court’s final judgment, challenging the rulings as to validity and enforceability. Because the district court erred in holding that the subject matter of claims 1-3 of the ’303 patent would not have been obvious, we reverse. We therefore do not address Apotex’s assertion that it had proven that Pfizer engaged in inequitable conduct before the USPTO during prosecution of the ’303 patent.
