Novartis Pharmaceuticals Corp. v. Par Pharmaceutical, Inc.
48 F. Supp. 3d 733
D. Del.2014Background
- Novartis sues Watson and Par for infringement of Rivastigmine patents '031 and '023, covering compositions, transdermal devices, and stabilization methods.
- Patents share same specification and claim rivastigmine with an antioxidant in a transdermal system.
- Novartis markets Exelon patch; Watson seeks FDA approval via ANDA for a rivastigmine patch with antioxidant.
- Court held four-day bench trial in Aug 2013; Novartis proved infringement by preponderance; obviousness defense failed.
- Claims at issue include presence claims (claims 3,7 of '031; claims 2,7 of '023) and function claims (claims 13,16,18 of '031).
- Final judgment was ordered with final judgment form to be submitted within two weeks.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Infringement of presence claims requires what? | Novartis: presence claims require Compound A, antioxidant, carrier; no need for functional interaction. | Watson: antioxidant must function to stabilize rivastigmine; presence claims negate without function. | Presence claims do not require antioxidant function; infringement proven. |
| Infringement of function claims requires what evidence? | Novartis: BHT stabilizes rivastigmine in oxidative environment; tests show protection over time. | Watson: no proof antioxidant acted to stabilize rivastigmine in patch. | Function claims infringed; evidence shows antioxidant activity over time. |
| Was the asserted subject matter obvious? | Novartis: prior art did not render rivastigmine degradation obvious; antioxidant addition not obvious. | Watson: GB '040, '807, Elmalem suggest antioxidant in rivastigmine patches. | Obviousness not proven by clear and convincing evidence. |
Key Cases Cited
- Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed.Cir.1997) (infringement analysis; premarket applicability of §271(e)(2)A)
- Kustom Signals, Inc. v. Applied Concepts, Inc., 264 F.3d 1326 (Fed.Cir.2001) (fact-specific infringement; element-by-element comparison)
- Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363 (Fed.Cir.2009) (circumstantial evidence may prove infringement)
- Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340 (Fed.Cir.2012) (obviousness framework; objective considerations)
- Allegro, Inc. v. Sandoz Inc., 726 F.3d 1286 (Fed.Cir.2013) (reasonable expectation of success; motivation to combine)