BAYER SCHERING PHARMA AG v. Lupin, Ltd.
676 F.3d 1316
| Fed. Cir. | 2012Background
- Bayer owns Yasmin and its method-of-use patent for triple effects (gestagenic, antiandrogenic, anti-aldosterone) in premenopausal/menopausal women needing all three.
- Defendants Watson, Sandoz, and Lupin filed ANDAs to market generic Yasmin for oral contraception only, with §271(e)(2)(A) certifications.
- Bayer sued for infringement, alleging the FDA-approved label covers the three simultaneous effects claimed in the '652 patent.
- The district court granted Rule 12(c) motions, ruling no infringement because FDA had not approved the triple-use method.
- The Federal Circuit consolidated the appeals and affirmed dismissal, holding no FDA-approved triple-use and thus no infringement liability at this Hatch-Waxman stage.
- The dissent argues Bayer should have a full infringement adjudication on pleadings because the ANDAs align with the FDA-approved label and physicians prescribe for the triple-use.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA approval encompasses the three effects of the '652 patent | Bayer contends FDA label approves all three effects | Watson/Sandoz/Lupin rely on label not showing triple-use approval | No; FDA label does not approve the triple-use method. |
| Whether 271(e)(2)(A) infringement can be found when ANDA uses the drug for an FDA-approved use that does not expressly cover the patent's triple-use | Bayer argues induced infringement via label supporting triple-use | Defendants market only contraception; no approved triple-use | No; triple-use not FDA-approved, so no §271(e)(2)(A) infringement. |
| Whether the district court erred in dismissing on pleadings | Bayer alleges well-pleaded facts show potential infringement | Complaint failed to show FDA-approved triple-use | Affirmed; court did not err in dismissal. |
| Whether cited regulatory and labeling evidence can establish FDA approval of anti-mineralocorticoid/antiandrogenic effects | Label proves FDA recognized these effects; approval implied | Label only describes potential pharmacology, not approved uses | No; labeling does not show FDA approval for inducing those effects. |
Key Cases Cited
- Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) (INA: ANDA for approved use not infringing where use not approved by FDA)
- Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322 (Fed. Cir. 2003) (Gives framework: FDA-approved use governs §271(e)(2) infringement for method-of-use patents)
- AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370 (Fed. Cir. 2012) (Addresses implied indications and FDA-approved labeling scope)
- Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 601 F.3d 1359 (Fed. Cir. 2010) (Discusses paragraph IV certifications and infringement scope)
- Eli Lilly & Co. v. Teva Pharm. USA, Inc., 557 F.3d 1346 (Fed. Cir. 2009) (ANDA framework and infringement considerations under Hatch-Waxman)