Apotex, Inc. v. Daiichi Sankyo, Inc.
781 F.3d 1356
Fed. Cir.2015Background
- Apotex seeks a declaratory judgment that its generic olmesartan medoxomil would not infringe the disclaimed ’703 patent, enabling earlier FDA approval and market entry.
- Daiichi marketed Benicar with two listed patents: the ’599 active ingredient patent and the ’703 method-of-use patent; the ’599 patent expires in 2016, with adjustments, and the ’703 patent expires in 2021.
- Daiichi disclaimed the ’703 patent in 2006, but did not remove it from the Orange Book; Apotex challenges the continuing impact of that listing on exclusivity and entry timing.
- Mylan, the first ANDA filer, held 180-day exclusivity tied to the ’703 patent; MMA of 2003 added forfeiture provisions that could transfer exclusivity if a second filer pursues timely competition.
- Apotex filed an ANDA in 2012 with two certifications (Paragraph III and Paragraph IV), alleging non-infringement of the disclaimed patent and potential entry benefits, while Daiichi and Mylan argued no live controversy until tentative FDA approval.
- The district court dismissed for lack of case or controversy; the Federal Circuit reverses, preserving Mylan’s intervenor rights and recognizing a live conflict over market-entry economics.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Do Apotex and Mylan have a live case or controversy to justify declaratory relief? | Apotex claims concrete stake via potential earlier entry and lost revenue to Daiichi/Mylan. | Daiichi/Mylan contend no controversy because non-infringement is certain and entry depends on tentative approval. | Yes; a live controversy exists with concrete market-entry impacts. |
| May forfeiture provisions create an actual forfeiture of Mylan’s exclusivity based on Apotex’s action? | If Apotex wins non-infringement and tentative FDA approval occurs timely, Mylan may forfeit exclusivity. | The forfeiture trigger is uncertain and may require tentative approval before action. | Yes; the court can determine forfeiture potential and thus maintain controversy. |
| Is tentative FDA approval a prerequisite to the case or controversy? | Tentative approval not required to adjudicate the non-infringement issue because the relief is concrete and timing actionable. | Tentative approval may be necessary to foreclose or delay entry and forfeit timing calculations. | No; tentative approval is not a precondition for this dispute. |
| How should the MMA forfeiture provisions (bb)(AA) and related timing be interpreted for this case? | The non-infringement judgment together with tentative approval triggers forfeiture 75 days after non-infringement finality, enabling Apotex entry. | Second filer must have tentative approval before filing or that forfeiture depends on a different timing. | The court adopts a reading that forfeiture is triggered when Apotex obtains non-infringement finality and tentative approval, enabling timely entry. |
Key Cases Cited
- MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (U.S. 2007) (standing for declaratory judgments can arise from concrete, imminent harm)
- Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278 (Fed. Cir. 2008) (ANDA filing creates immediate controversy over infringement)
- Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353 (Fed. Cir. 2008) (pre-MMA exclusivity framework for second filers)
- Teva Pharm. USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010) (forfeiture analysis under MMA; interplay with FDA actions)
- Arlington Heights v. Metropolitan Housing Development Corp., 429 U.S. 252 (U.S. 1977) (standing when removal of barrier to beneficial action is likely)