## Facts

- Bayer owned U.S. Patent No. 5,264,446, claiming controlled-release nifedipine compositions requiring nifedipine crystals with a specific surface area (SSA) between 1.0 and 4 m²/g, plus related preparation and treatment claims.
- Bayer marketed Adalat CC, a product practicing the patent.
- Elan filed an ANDA seeking approval to market a generic version and made a Paragraph IV certification of noninfringement/invalidity.
- Elan’s ANDA specified nifedipine crystals with an SSA of 5 m²/g or greater, outside the patent’s 1.0–4 m²/g range.
- Bayer sued under 35 U.S.C. § 271(e)(2)(A), alleging the ANDA filing constituted infringement, literally or under the doctrine of equivalents.
- The district court granted summary judgment for Elan, finding no literal infringement and holding prosecution history estoppel barred Bayer’s equivalents theory.

## Issues

1. Whether an ANDA specifying SSA “5 m²/g or greater” can literally infringe claims limited to an SSA range of 1.0–4 m²/g.
2. Whether prosecution history estoppel prevents Bayer from asserting the doctrine of equivalents to cover SSA values above 4 m²/g.
3. Whether speculation that Elan might not comply with its ANDA specification creates a genuine issue of material fact defeating summary judgment in a § 271(e)(2)(A) action.

## Decision

- The Federal Circuit affirmed summary judgment of noninfringement.
- No literal infringement existed because the ANDA’s specified minimum SSA (≥ 5 m²/g) did not meet the claim limitation capped at 4 m²/g.
- The doctrine of equivalents was unavailable because Bayer’s prosecution statements and conduct constituted a clear and unmistakable surrender of SSA values above 4 m²/g.
- Potential future deviation from the ANDA specification did not create a material factual dispute; the ANDA applicant is legally bound to the described product for purposes of the § 271(e)(2)(A) infringement analysis.

## Legal Principles

- In a § 271(e)(2)(A) case, infringement is assessed by what the ANDA and its submissions describe as the product the applicant will market if approved; courts rely on those binding specifications rather than conjecture about noncompliance.
- Literal infringement requires the accused product to meet every claim limitation; a numeric range limitation is not met when the accused product is specified to fall entirely outside the claimed range.
- Prosecution history estoppel bars the patentee from using the doctrine of equivalents to recapture subject matter clearly and unmistakably disclaimed during prosecution, including subject matter beyond a numeric range emphasized to obtain allowance.
- Alleged manufacturing infeasibility or predictions of off-spec production do not defeat summary judgment when the ANDA specifies a noninfringing product and the applicant is obligated to conform to that specification.

## Conclusion

The Federal Circuit held Elan’s ANDA avoided infringement because it specified an SSA range wholly outside the patent’s claims, and Bayer could not extend the claims past the 4 m²/g ceiling through equivalence due to prosecution history estoppel; speculation about later noncompliance was legally irrelevant.


Bayer AG v. Elan Pharm. Rsch. Corp., 212 F.3d 1241 (Fed. Cir. 2000)