Alcon Research, Ltd. v. Apotex Inc.
687 F.3d 1362
| Fed. Cir. | 2012Background
- Apotex sought FDA approval to market a generic Patanol®; Alcon sued for patent infringement under 35 U.S.C. § 271(e)(2)(A).
- The asserted ’805 patent covers a method of treating allergic eye disease by stabilizing conjunctival mast cells with olopatadine eye drops at defined concentrations.
- The district court held the claims not obvious as to claims 1-3, 5-7, but not invalidating claims 4 and 8; it also found the patent valid and enforceable.
- Kamei taught olopatadine eye drops with overlapping concentrations but not mast cell stabilization in humans, and led to a finding of teaching away from stabilization.
- The court deemed Kamei combined with ordinary skill and other references could render claims 1-3, 5-7 obvious, while 0.1% formulation of claims 4 and 8 remained nonobvious.
- On appeal, the Federal Circuit reversed-in-part: claims 1-3 and 5-7 were deemed obvious over Kamei; claims 4 and 8 were affirmed as nonobvious.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Obviousness of claims 1-3 and 5-7 | Apotex: Kamei teaches overlapping concentrations; skilled artisan would adapt for humans | Alcon: district court properly found lack of motivation/expectation and noninherency | Obviousness found for claims 1-3 and 5-7 |
| Obviousness of claims 4 and 8 | Apotex: routine experiments and Lever support 0.1% formulation | Alcon: Kamei/Lever insufficient to teach/enable 0.1% composition; concerns about biphasic response | Not obvious; claims 4 and 8 affirmed nonobvious |
| Motivation to adapt Kamei for humans | Apotex: animal data and antihistaminic efficacy provide motivation | Alcon: no motivation to focus olopatadine as mast cell stabilizer from art | There is motivation to adapt for human use; Kamei overlaps with claimed ranges and provides a prima facie case of obviousness |
| Inherency and stabilization as inherent property | Apotex: stabilization is inherent at claimed concentrations | Alcon: stabilization not inherent for all concentrations | Inherency supports claim construction; stabilizing mast cells is inherent at claimed concentrations |
| Effect of claim construction on validity | Apotex: dependent claims constrain independent claim; need to include therapeutic range | Alcon: range includes nonenabled portions | Dependent-claim scope must be read as part of independent claim; range overlaps with prior art leading to obviousness finding |
Key Cases Cited
- KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (Supreme Court 2007) (reasonableness in combining prior art; motivation can be from sources other than patentee’s problem)
- In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (inherency may render a limitation inherent to the claimed invention)
- In re Kao, 639 F.3d 1057 (Fed. Cir. 2011) (objective evidence must be tied to the claimed invention; commercial success not always nexus)
- Microsoft Corp. v. i4i Ltd. Partnership, 131 S. Ct. 2238 (Supreme Court 2011) (clear and convincing evidence standard for invalidity)