## Facts

- Astellas Pharma, Inc. owned U.S. Patent No. 4,935,507 covering crystalline cefdinir; Abbott Laboratories held exclusive rights and marketed Omnicef.
- The patent’s asserted claims used product-by-process language describing cefdinir “obtained/obtainable” by specified manufacturing steps.
- Lupin sought declaratory judgment of noninfringement in the Eastern District of Virginia; the court construed the claims and granted summary judgment of noninfringement (no literal infringement of certain claims and no infringement under the doctrine of equivalents for the asserted claims).
- Abbott sued multiple generic manufacturers, including Sandoz, in the Northern District of Illinois and moved for a preliminary injunction; the court denied the injunction, adopting the Virginia claim construction.
- The Federal Circuit consolidated the appeals and reheard en banc to resolve how product-by-process claim scope should be interpreted for infringement.

## Issues

1. For infringement, are product-by-process claims satisfied by any product meeting the claimed product description, regardless of how it is made?
2. Alternatively, do the recited process terms limit the claim such that infringement requires the accused product be made by the specified process (or its equivalent)?
3. Under the proper rule and the adopted claim construction, did Abbott show infringement or likelihood of success sufficient to defeat summary judgment and obtain preliminary injunctive relief?

## Decision

- The en banc Federal Circuit held that product-by-process claims are limited for infringement purposes to products made by the process recited in the claims (or its equivalent).
- The court adopted the approach associated with Atlantic Thermoplastics and overruled contrary precedent associated with Scripps to the extent it treated process terms as non-limiting for infringement.
- The court affirmed the Eastern District of Virginia’s partial summary judgment of noninfringement in favor of Lupin.
- The court affirmed the Northern District of Illinois’s denial of Abbott’s motion for a preliminary injunction against Sandoz and other generic manufacturers.

## Legal Principles

- In a product-by-process claim, process language appearing in the claim limits the scope of the claim for infringement.
- A product-by-process claim is infringed only if the accused product is made by the claimed process steps or their equivalents; making the same product by a different process does not infringe.
- When a patentee elects to define a product by how it is made, that choice restricts the claim’s boundaries and supports the public-notice function of patent claims.
- Under this rule, infringement analysis for product-by-process claims turns on the manufacturing process used to make the accused product, not solely on the product’s resulting characteristics.

## Conclusion

The Federal Circuit, sitting en banc, resolved a conflict in its precedent by holding that product-by-process claims are infringed only by products made using the recited process (or an equivalent process), and it affirmed noninfringement and denial of preliminary injunctive relief under that claim-scope rule.


Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009) (en banc)