501 F. App'x 965
Fed. Cir.2013Background
- Allergan markets Lumigan and owns the ’819 patent directed to bimatoprost and its use for ocular hypertension/glaucoma.
- Barr and Sandoz filed ANDAs for generic Lumigan with Paragraph IV certifications, alleging the patent was invalid or noninfringing.
- District Court held asserted claim 10 of the ’819 patent and related claims not invalid and infringed, following bench trial on validity and infringement.
- The only contested term was –N(R4)2 in claim 5; the district court found Allergan had acted as its own lexicographer to permit nonidentical R4 elements.
- Barr and Sandoz argued the plain meaning required identical R4 substituents; Allergan contended the term covers nonidentical substituents.
- On appeal, the Federal Circuit affirmed the district court’s claim construction and its nonobviousness ruling, concluding the asserted claim was not obvious.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does –N(R4)2 include nonidentical R4 elements? | Allergan's lexicography allows nonidentical R4 substituents | Barr/Sandoz contend plain meaning requires identical R4 substituents | Yes; nonidentical R4 elements are encompassed |
| Was the asserted claim 10 obvious over Stjernschantz and related art? | Obviousness shown by combining Stjernschantz with other references | No valid motivation or reasonable expectation; credibility issues | Not proven by clear and convincing evidence |
| Did the court err in requiring expert testimony to prove invalidity given the complexity of the art? | Expert testimony should not be indispensable | Complex technology requires expert input | No error; expert testimony was necessary to support obviousness |
Key Cases Cited
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (contextual claim construction; ordinary meaning in light of specification)
- Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (claim construction reviewed de novo)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (S. Ct. 2007) (obviousness requires motivation and reasonable expectation of success)
- Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008) (expert testimony may be critical in technical validity questions)
- Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010) (expert testimony may be necessary in complex technology cases)
- Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir. 2008) (to determine when ordinary knowledge suffices vs. expert testimony)