## Facts

- Housey owned method patents claiming screening assays to identify substances that inhibit or activate a target protein by comparing responses in engineered and original cell lines exposed to test agents.
- Bayer conducted pharmaceutical research and sought declaratory relief that the patents were invalid, unenforceable, and not infringed.
- Housey counterclaimed, including infringement under 35 U.S.C. § 271(g), alleging Bayer imported into or used in the United States:
  - drug products allegedly “made by” the patented screening methods, and/or
  - information generated abroad by practicing the screening methods (e.g., pharmacological characterizations) that was then brought to and used in the United States.
- The district court dismissed the § 271(g) counterclaim for failure to state a claim, concluding § 271(g) concerns manufacturing tangible goods and does not reach imported intangible information.
- Housey appealed; the Federal Circuit reviewed the Rule 12(b)(6) dismissal and statutory interpretation de novo.

## Issues

1. Whether “a product which is made by a process patented in the United States” in 35 U.S.C. § 271(g) includes information generated abroad by practicing the patented process and then brought into or used in the United States.
2. Whether Bayer’s drug products were “made by” Housey’s patented screening methods within the meaning of § 271(g).

## Decision

- The Federal Circuit affirmed dismissal of the § 271(g) counterclaim.
- Section 271(g) is limited to physical goods manufactured by a patented process and does not treat information generated by a process as a “product.”
- Housey’s screening methods generated information used in later research and development; they did not manufacture Bayer’s drug products (directly or via a physical intermediate) for purposes of § 271(g).

## Legal Principles

- For 35 U.S.C. § 271(g), “product” refers to a tangible article, and “made by” is tied to manufacture.
- The statutory exceptions for products “materially changed” by subsequent processes or becoming “trivial and nonessential components” support a manufacturing-focused reading directed to physical goods.
- A process that merely yields information used to guide later work does not “make” the resulting downstream products under § 271(g) absent manufacture of the product (or a physical intermediate) by the patented process.

## Conclusion

The Federal Circuit held that § 271(g) targets importation or domestic use of tangible products manufactured by a U.S.-patented process, not intangible information produced by practicing a screening method abroad, and it rejected § 271(g) liability where the patented process only generated data later used in drug development.


Bayer AG v. Housey Pharms., Inc., 340 F.3d 1367 (Fed. Cir. 2003)