Astrazeneca Lp v. Breath Limited
603 F. App'x 999
Fed. Cir.2015Background
- AstraZeneca sued multiple generic manufacturers (Breath, Apotex, Sandoz, Watson) under Hatch‑Waxman, asserting U.S. Patent No. 7,524,834 (’834) covering sterile micronized budesonide compositions (powder and aqueous suspension, e.g., Pulmicort Respules®).
- This Court previously reversed district court noninfringement based on erroneous claim construction and remanded for further proceedings.
- After a 13‑day bench trial on remand, the district court found the asserted claims infringed but invalid for obviousness under 35 U.S.C. § 103; AstraZeneca appealed the obviousness ruling.
- The district court concluded a person of ordinary skill, motivated to make sterile budesonide, would have had a reasonable expectation of success using four of five known sterilization techniques (sterile filtration/aseptic crystallization, moist heat, ethylene oxide, irradiation), making the claimed sterile compositions obvious.
- The district court rejected AstraZeneca’s objective‑indicia evidence (commercial success, long‑felt need, industry skepticism, failures) as insufficiently connected to the claimed sterile feature; this Court found no clear error and affirmed.
- The Court also dissolved the injunction that had been entered pending appeal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the asserted ’834 claims are obvious in light of prior art sterilization methods | AstraZeneca: prior art did not show "actual success" making sterile, pure micronized budesonide; references don’t disclose processes yielding pharmaceutically acceptable sterile budesonide | Defendants: prior art disclosed nonsterile budesonide and known sterilization techniques; skilled artisan would be motivated and have reasonable expectation of success | Court: Claims obvious — only a reasonable expectation, not guaranteed success, is required; four of five methods gave reasonable expectation of success |
| Whether objective indicia (commercial success, long‑felt need) rebut obviousness | AstraZeneca: Pulmicort Respules® met an unmet U.S. need (FDA required sterility), sales and success tied to sterility → supports nonobviousness | Defendants: Success driven by drug efficacy, safety, and nebulized delivery, not by sterility per se; regulatory compliance ≠ nexus | Court: District court correctly found lack of nexus between claimed sterility and commercial success or unmet need; objective indicia do not overcome obviousness |
| Whether industry skepticism and failures support nonobviousness | AstraZeneca: evidence of skepticism and various failures (including AstraZeneca’s) shows invention was not obvious | Defendants: Proffered evidence insufficient in nature/extent to show skepticism or meaningful failures | Court: District court did not err in discounting this evidence; it fails to show nonobviousness |
Key Cases Cited
- Amgen Inc. v. F. Hoffman‑La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009) (reasonable expectation of success is the relevant standard for obviousness)
- Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (obviousness requires only a reasonable expectation, not certainty)
- Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346 (Fed. Cir. 2013) (standard of review: legal obviousness de novo; factual findings for clear error)
- PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186 (Fed. Cir. 2014) (reasonable expectation of success does not require absolute certainty)