Teva Pharmaceutical Industries Ltd. v. Astrazeneca Pharmaceuticals LP
661 F.3d 1378
Fed. Cir.2011Background
- Teva appeals district court’s invalidity ruling on Teva’s ‘502 patent based on AstraZeneca’s prior invention.
- AstraZeneca’s rosuvastatin drug uses crospovidone as a disintegrant and a non-AGCP stabilizer; Teva asserts formula stabilized exclusively by AGCP or amino-group polymers.
- AstraZeneca conceived and reduced to practice the drug before Teva’s first conception and batches were made in 1999 with the same ingredients and amounts as the commercial drug.
- AstraZeneca conceded infringement for summary judgment purposes, but did not understand crospovidone’s stabilizing effect prior to Teva’s conception.
- District court granted summary judgment under 35 U.S.C. §102(g)(2), holding AstraZeneca’s earlier development satisfies prior invention.
- This court reviews the §102(g)(2) priority question de novo for legal conclusions with underlying factual context.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether 102(g)(2) requires appreciation of stabilization | Teva argues AstraZeneca must appreciate stabilizer effect. | AstraZeneca contends appreciation not required; must know what it made. | Not required; appreciation of the invention suffices. |
| Whether prior invention can be established without same claim language | Teva claims broad claim construction immunizes AstraZeneca from proving appreciation. | AstraZeneca argues protection via scope of asserted claims, not language match. | No error; invention defined by subject matter, not exact claim language. |
| Whether inherency or suppression theories alter priority | Teva argues inherency and concealment should matter. | AstraZeneca argues inherency not needed; suppression not required if appreciation not required. | Inherency and suppression do not affect this §102(g)(2) priority outcome. |
| Whether AstraZeneca’s prior invention satisfies §102(g)(2) as a matter of law | Teva maintains genuine factual dispute on appreciation. | AstraZeneca contends undisputed facts show priority. | AstraZeneca’s prior invention satisfies 102(g)(2) as a matter of law. |
Key Cases Cited
- Mycogen Plant Sci. v. Monsanto Co., 243 F.3d 1316 (Fed. Cir. 2001) (conception and reduction-to-practice require not exact language, but the same subject matter)
- Dow Chemical Co. v. Astro-Valcour, Inc., 267 F.3d 1334 (Fed. Cir. 2001) (invention not necessarily recognized in same terms; subject matter defined by invention)
- Silvestri v. Grant, 496 F.2d 593 (CCPA 1974) (language of the count not required to define the invention)
- In re Kao, 639 F.3d 1057 (Fed. Cir. 2011) (claims focus on subject matter, not exact measurement language)
- Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052 (Fed. Cir. 2005) (conception includes structure and method of making; recognition of invention may be unrecognized at time of creation)
- Dow Chemical Co. v. Astro-Valcour, Inc., 267 F.3d 1334 (Fed. Cir. 2001) (previously cited; see above)