19 F.4th 1325
Fed. Cir.2021Background
- AstraZeneca sued Mylan over three Orange-Book-listed patents claiming a pMDI suspension of formoterol fumarate dihydrate and budesonide with excipients including PVP K25 at “0.001% w/w.”
- Mylan filed an ANDA for a generic Symbicort® pMDI; after the district court construed “0.001%” as the ordinary one-significant-digit value (0.0005%–0.0014%), Mylan stipulated to infringement and the court entered judgment.
- The district court later held a bench trial on validity and found Mylan failed to prove obviousness by clear-and-convincing evidence, crediting that prior art (Rogueda) taught away from the claimed formulations.
- On appeal the Federal Circuit reviewed claim construction de novo and intrinsic evidence for meaning in context, and reviewed factual findings for clear error.
- The Federal Circuit reversed the district court’s construction of “0.001%,” construing it narrowly as 0.00095%–0.00104% (precise 0.001% with only minor variation), vacated the stipulated infringement judgment and remanded; it affirmed the no-invalidity judgment because Rogueda taught away.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Construction of “0.001% w/w” PVP | Ordinary meaning / no special construction; one significant digit → 0.0005%–0.0014% | 0.001% is intended as a precise critical value with only minor variations (practically 0.00095%–0.00104% or 0.0010%) | Court adopts a narrow construction: 0.001% ± minor variation (0.00095%–0.00104%); vacates infringement judgment and remands for reconsideration under this construction. |
| Obviousness (Rogueda) — did prior art render claims obvious? | Claims are nonobvious; specification data show criticality of 0.001% PVP | Rogueda’s control formulations anticipate or render obvious the claimed composition | Court affirms district court factual finding that Rogueda taught away (controls performed poorly; a skilled artisan would be discouraged), so nonobviousness affirmed. |
Key Cases Cited
- Teva Pharms. USA, Inc. v. Sandoz, Inc., 574 U.S. 318 (2015) (claim construction review principles; de novo review of intrinsic-evidence constructions)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claims construed in view of specification and prosecution history)
- Takeda Pharm. Co. Ltd. v. Zydus Pharms. USA, Inc., 743 F.3d 1359 (Fed. Cir. 2014) (claim meaning must align with patent description)
- Meiresonne v. Google, Inc., 849 F.3d 1379 (Fed. Cir. 2017) (teaching-away standard explained)
- In re Mouttet, 686 F.3d 1322 (Fed. Cir. 2012) (a reference that teaches away can preclude obviousness)
- Viskase Corp. v. American Nat'l Can Co., 261 F.3d 1316 (Fed. Cir. 2001) (recognizing significant-figure conventions in claim interpretation)