Merck Sharp & Dohme B v. v. Warner Chilcott Company, LLC
711 F. App'x 633
| Fed. Cir. | 2017Background
- The ’581 patent (NuvaRing®) claims a single-compartment thermoplastic vaginal ring that releases both etonogestrel (ETO, progestin) and ethinyl estradiol (EE, estrogen), with claims at issue requiring ETO be supersaturated (2–5× saturation in claim 4) and specific wt% ranges for ETO and EE in claim 11.
- Warner Chilcott sought to market a generic that would infringe the ’581 patent if claims were valid; it argued the claims were obvious in view of PCT ’015.
- PCT ’015 discloses a two-compartment vaginal ring: one compartment with ETO only and a second compartment with ETO+EE; it criticizes one-compartment designs as unable to independently control release rates. PCT ’015 discloses broad ranges for compartment size and drug concentrations.
- The district court found claims 4 and 11 obvious, reasoning a person of ordinary skill would optimize PCT ’015’s second compartment to deliver physiologically required amounts of both drugs (rendering the first compartment unnecessary) and could derive the claimed concentrations from PCT ’015’s target release rates.
- The Federal Circuit reviewed obviousness de novo (factual findings for clear error) and reversed, holding the record did not show a motivation to modify PCT ’015 to a one-compartment design or to select the specific combinations of compartment size and concentrations claimed without impermissible hindsight.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether claims 4 and 11 of the ’581 patent are obvious in light of PCT ’015 | PCT ’015 teaches ETO and EE release and target doses; a POSITA would optimize the second compartment to deliver both drugs and derive claimed concentrations from target release rates | The asserted single-compartment concentrations and supersaturation technique are not taught; PCT ’015 criticizes one-compartment designs and gives broad ranges, so selecting the specific values is hindsight | Reversed: not obvious — no motivation to collapse PCT ’015’s two-compartment design into the claimed single compartment or to pick the precise parameter combination without hindsight |
| Whether PCT ’015’s broad ranges disclose the specific 97% compartment size and concentration combination relied on by the district court | PCT ’015 discloses ranges that encompass many combinations and includes the necessary parameters | The particular combination relied upon requires selecting extremes from independent ranges; nothing in PCT ’015 points to those selections | Held that PCT ’015 does not disclose or motivate the specific combination; selecting it would be hindsight |
| Whether target release rates in PCT ’015 make the claimed single-compartment concentrations predictable | Target release rates show desired dosing and could be converted into concentrations by a POSITA | Target rates apply to a two-compartment system; converting them to a single compartment contradicts PCT ’015’s teaching that single compartments are suboptimal | Held that applying two-compartment release targets to a single compartment is not an obvious, predictable modification |
| Whether district court improperly relied on hindsight reasoning | Plaintiff relied on the ’581 patent as a roadmap to select values from PCT ’015’s ranges | Defendant argued the combination was nonobvious and PCT ’015 discouraged the one-compartment approach | Held district court relied on impermissible hindsight; reversed |
Key Cases Cited
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (framework for obviousness; caution against hindsight and requirement of a reasoned motivation to combine)
- Graham v. John Deere Co., 383 U.S. 1 (1966) (sets the Graham factual inquiries for obviousness)
- Honeywell Int’l v. United States, 609 F.3d 1292 (Fed. Cir. 2010) (standard of review: obviousness is legal, underlying facts reviewed for clear error)
- Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012) (warning against using the inventor’s path as hindsight)
- InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327 (Fed. Cir. 2014) (requiring explanation of why a POSITA would combine references rather than treating them as separate puzzle pieces)