Classen Immunotherapies, Inc. v. Biogen Idec
659 F.3d 1057
| Fed. Cir. | 2011Background
- Classen Immunotherapies appeals district court grants on §101, §102, §112, and §271(e)(1) regarding three related vaccines patents.
- Patents: '139, '739 claim methods to optimize infant immunization schedules; '283 claims surveying literature to determine if schedule affects disease incidence.
- District court held all claims ineligible under §101 as abstract ideas; Merck's prior-use defense and §271(e)(1) safe harbor defenses were unresolved.
- Federal Circuit on remand after Supreme Court in Bilski v. Kappos; majority concludes '139/'739 are §101 eligible while '283 is not, and Merck non-infringement affirmed with safe harbor issues reconsidered.
- Court vacates §271(e)(1) safe-harbor dismissal as to Biogen and GlaxoSmithKline and remands for further proceedings; Merck non-infringement affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether '139/'739 claims pass §101 eligibility | Classen argues claims are a practical application of a new immunization method. | Defendants contend claims are abstract ideas or mental steps with no concrete application. | Claims pass §101 as eligible subject matter. |
| Whether '283 claim is §101 ineligible as abstract | Classen asserts '283 claims are linked to practical data analysis with potential applications. | Defendants argue '283 is a mere abstract idea (gathering and comparing information). | The '283 claim is not §101 eligible; deemed abstract and not transformative. |
| Anticipation by Merck's prior use | Merck's prior use of vaccination schedules anticipates Classen claims. | Merck contends the prior use lacks the full claimed method steps to anticipate. | Merck's prior-use argument not decided on this appeal; issues not ripe for summary judgment. |
| §271(e)(1) safe harbor scope as to Biogen/Glaxo | Classen contends Biogen/Glaxo infringed; activities relate to reporting/adverse events under FDA regimes. | Biogen/Glaxo rely on §271(e)(1) as premarket-related safe harbor. | Safe harbor does not uniformly immunize all activities; some activities fall outside safe harbor; remand for further proceedings. |
Key Cases Cited
- Diamond v. Diehr, 450 U.S. 175 (1981) (threshold §101; abstract ideas stay barred; transformation relevance)
- Bilski v. Kappos, 130 S. Ct. 3218 (2010) (machine-or-transformation not sole test; apply §101 narrowly)
- Research Corp. Technologies v. Microsoft, 627 F.3d 859 (Fed. Cir. 2010) (claims must be considered as a whole; functional and palpable)
- Prometheus Laboratories v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010) (transformation and specific applications; not mere abstract idea)
- Association for Molecular Pathology v. USPTO, 653 F.3d 1329 (Fed. Cir. 2011) (limits on abstract ideas; application in biotechnology context)
- Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) (§271(e)(1) breadth to information related to regulatory submissions)
- Gottschalk v. Benson, 409 U.S. 63 (1972) (abstract ideas remain non-patentable)
- Diamond v. Chakrabarty, 447 U.S. 303 (1980) (broad statutory language; enablement of broad subject matter)