Duramed Pharmaceuticals, Inc. v. Watson Laboratories, Inc.
413 F. App'x 289
Fed. Cir.2011Background
- Duramed owns the ’969 patent covering an extended-cycle COC regimen (Seasonique) with 84 days of 30 μg EE and 150 μg LNG, followed by 7 days of 10 μg EE; Duramed accuses Watson of infringement under 35 U.S.C. § 271(e)(2) and asserts the patent’s validity under § 103.
- Watson admitted infringement but challenged validity as obvious; its challenge relied on Kovacs (84 days of 30 μg EE /150 μg LNG), the ’749 patent (7 days of 10 μg EE after extended regimens), and Sulak articles regarding headaches and possible use of unopposed estrogen.
- The district court granted summary judgment of nonobviousness, analyzed three references in isolation, and excluded Dr. Thomas’s testimony on prior use as uncorroborated.
- Watson’s expert testified to a motivation to combine Kovacs with unopposed estrogen and that the claimed regimen had been prescribed prior to 2001; Duramed sought exclusion and the court limited consideration of certain arguments.
- We reverse in part, affirm in part, and remand for reconsideration consistent with this opinion, including re-evaluating obviousness with a holistic view of the prior art and skill level, and reconsidering excluded testimony.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the district court properly analyzed obviousness. | Watson argues the district court erred by treating references in isolation and applying an incorrect standard. | Duramed contends the court correctly used a traditional obviousness framework focusing on the art as a whole. | No; the district court erred in isolating references and misapplying the standard. |
| What is the appropriate level of ordinary skill in the art for this case? | Watson contends a skilled clinician (medical doctor) or higher level; Thomas should be admissible. | Duramed asserts a lower level of skill (nurse practitioner acceptable); the court erred in excluding Thomas. | Reversed; district court failed to determine the level of skill, which could affect obviousness. |
| Whether the district court abused its discretion in excluding prior-use testimony. | Watson argues such testimony can contribute to obviousness even if not sole evidence. | Duramed contends corroboration is required and the district court correctly excluded it. | Affirmed exclusion; the district court did not abuse its discretion. |
| Whether the content and scope of the prior art supports a motivation to combine Kovacs with unopposed estrogen. | Watson asserts Kovacs, ’749, and Sulak collectively teach a motivation to combine. | Duramed maintains no single or combined teaching establishes a motivation to combine with reasonable expectation of success. | Reversed; the court should consider the prior art as a whole and the reasonable likelihood of success. |
Key Cases Cited
- Graham v. John Deere Co., 383 U.S. 1 (1966) (establishes framework for obviousness including factual inquiries and secondary considerations)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (requires a reason to combine and allows common sense in diagnosing obviousness)
- Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed. Cir. 2001) (establishes clear and convincing standard for invalidity on summary judgment)
- Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH, 139 F.3d 877 (Fed. Cir. 1998) (discusses weighing disputed facts in obviousness)
- Freedman Seating Co. v. Am. Seating Co., 420 F.3d 1350 (Fed. Cir. 2005) (clarifies summary judgment evidentiary standards for obviousness)
- In re Rouffet, 149 F.3d 1350 (Fed. Cir. 1998) (addresses skill level and testimony scope in obviousness analysis)