Astrazeneca Pharmaceuticals Lp. v. Apotex Corp.
669 F.3d 1370
| Fed. Cir. | 2012Background
- AstraZeneca owns rosuvastatin patents ('314 composition; '618 HeFH; '152 CRP) and obtained FDA approval for rosuvastatin calcium in 2003 under CRESTOR®.
- Appellees filed ANDAs seeking approval for HoFH and hypertriglyceridemia uses only, carving out patented HeFH and high-CRP indications; they filed Section viii statements for the asserted method patents.
- AstraZeneca sued under § 271(e)(2) alleging that Appellees’ ANDAs would infringe the method patents if approved, and that labeling would include patented indications.
- The district court dismissed for lack of subject-matter jurisdiction (based on the view that there was no §271(e)(2) claim tied to the ANDAs) and for lack of ripeness concerning potential future labeling amendments.
- The court acknowledged jurisdiction under 28 U.S.C. § 1338(a) but agreed AstraZeneca failed to state a viable §271(e)(2) claim because the ANDAs did not seek patented uses; labeling-amendment claims were deemed not ripe.
- The Federal Circuit affirms the dismissal, applying Warner-Lambert to hold that carving out patented indications via ANDA and Section VIII statements defeats §271(e)(2) claims based on existing filings, and that future-labeling claims are unripe.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether §271(e)(2) provides district-court jurisdiction over AstraZeneca’s claims given the ANDAs with Section VIII statements | AstraZeneca asserts §271(e)(2) claims arise from Appellees’ ANDA filings regardless of carved-out uses | Appellees contend no §271(e)(2) claim unless ANDA seeks patented use | Jurisdiction exists under §1338(a) |
| Whether AstraZeneca states a viable §271(e)(2) claim based on Appellees’ existing ANDAs | AstraZeneca argues filed ANDAs infringe the patented use when approved | Warner-Lambert allows carved-out patented indications; no infringement unless ANDA seeks patented use | No viable §271(e)(2) claim based on existing ANDAs |
| Whether AstraZeneca’s claims based on potential future labeling amendments are ripe | Future labeling will require inclusion of patented indications causing infringement | Claims are contingent; may not occur; not ripe | Claims based on future labeling amendments are unripe |
Key Cases Cited
- Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322 (Fed. Cir. 2003) ( §271(e)(2) jurisdiction when ANDA filed for patented use)
- Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) (ANDA carve-out of patented indications permitted; use is limited to claimed indications)
- Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997) (statutory interpretation of §271(e)(2) and pre-ANDA infringement)
- Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (Supreme Court 1990) (§271(e)(2) creates a highly artificial act of infringement)
- Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) (defined “the use” in §271(e)(2) as use listed in the ANDA; carving out patented uses possible)
- Samish Indian Nation v. United States, 419 F.3d 1355 (Fed. Cir. 2005) (court may affirm on any proper basis in the record)
- Susquehanna Valley Alliance v. Three Mile Island Nuclear Reactor, 619 F.2d 231 (3d Cir. 1980) (deference unwind; not ripe for adjudication)