## Facts

- A patent owner asserted three patents claiming methods aimed at reducing chronic immune-mediated disorders by selecting vaccination schedules based on analysis of immunization and disease-incidence data.
- The asserted claims generally involved: collecting or reviewing immunization and disease data; comparing risks across schedules; and, for some claims, immunizing according to a schedule identified as lower risk.
- The district court granted summary judgment that all asserted claims were invalid under 35 U.S.C. § 101 as directed to an abstract idea, and also ruled on infringement and 35 U.S.C. § 271(e)(1) safe-harbor defenses.
- After an earlier Federal Circuit affirmance was vacated and remanded following Bilski v. Kappos, the Federal Circuit reconsidered subject-matter eligibility and safe-harbor issues.
- The patent owner alleged infringement by Biogen and GlaxoSmithKline based on vaccine-related studies and related activities, and alleged infringement by Merck based on its vaccine-related conduct.

## Issues

1. Whether the asserted method claims are patent-eligible processes under 35 U.S.C. § 101 when some claims recite only collecting/comparing information and others also require immunizing in accordance with the analysis.
2. Whether 35 U.S.C. § 271(e)(1) shields defendants’ accused activities, including post-approval conduct, as acts “solely for uses reasonably related” to developing and submitting information to the FDA.
3. Whether the evidence was sufficient to create a triable issue that Merck performed (or induced performance of) all steps of the asserted method claims.

## Decision

- The court held that claims requiring analysis of immunization schedules and then immunizing in accordance with an identified lower-risk schedule are patent-eligible under § 101.
- The court held that claims limited to collecting/reviewing and comparing information, without a required immunization step or other concrete application, are not patent-eligible under § 101.
- The court rejected an interpretation of § 271(e)(1) that would broadly exempt post-approval commercial activity, vacated and remanded the safe-harbor ruling as applied to Biogen and GlaxoSmithKline, and required further proceedings consistent with the narrower view of the exemption.
- The court affirmed summary judgment of non-infringement for Merck due to insufficient evidence that Merck’s conduct met the claim limitations.

## Legal Principles

- A process claim that applies knowledge through a concrete, physical step tied to medical treatment (such as immunizing according to a determined schedule) can fall within § 101 even if it relies on analysis of collected information.
- Claims confined to obtaining, reviewing, or comparing information—without requiring a practical application step—risk being treated as directed to an abstract idea and therefore ineligible under § 101.
- The § 271(e)(1) safe harbor is limited to acts performed solely for uses reasonably related to the development and submission of information under federal drug and biologic laws; it is not a general exemption for post-approval commercial operations merely because information might later be reported to the FDA.
- Summary judgment of non-infringement is proper when the patentee fails to produce evidence that the accused party performed, or induced performance of, each required step of the asserted method claims.

## Conclusion

The Federal Circuit drew a line between ineligible claims that only study and correlate immunization data and eligible claims that require immunizing based on that analysis, and it limited § 271(e)(1) to genuinely regulatory-focused activity rather than broad post-approval commercial use, while affirming non-infringement for Merck on evidentiary grounds.


Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011)