## Facts

- Abbott owned U.S. Patent No. 5,504,207, which included claim 4 directed to an anhydrous crystalline Form IV of terazosin hydrochloride (marketed by Abbott as Hytrin in another form).
- Geneva, Novopharm, and Invamed filed ANDAs seeking approval to market generic terazosin hydrochloride products, constituting acts of infringement under 35 U.S.C. § 271(e)(2)(A).
- Abbott sued the ANDA filers for infringement in the Northern District of Illinois; the cases were consolidated.
- The ’207 patent application was filed October 18, 1994, making the § 102(b) critical date October 18, 1993.
- A non-party distributor, Byron Chemical Co., made at least three commercial sales in the United States of terazosin hydrochloride later determined (by post-sale testing) to be the claimed Form IV, more than one year before the filing date.
- At the time of sale, the parties did not know the specific crystalline form being sold; later testing identified the material as Form IV.
- The district court granted summary judgment that claim 4 was invalid under the on-sale bar of 35 U.S.C. § 102(b), and Abbott appealed.

## Issues

1. Whether claim 4 was invalid under 35 U.S.C. § 102(b) because the claimed Form IV was the subject of commercial sales in the United States before the critical date.
2. Whether the invention was “ready for patenting” before the critical date when the specific polymorph was not recognized as such at the time of sale and was made by third-party manufacturers.

## Decision

- The Federal Circuit affirmed summary judgment that claim 4 was invalid under § 102(b).
- The court held the first Pfaff prong was met because Form IV was the subject of commercial sales in the United States before the critical date.
- The court held the second Pfaff prong was met because the invention was ready for patenting: it had been reduced to practice by third parties (including foreign manufacturers) prior to the critical date.
- The court rejected the argument that the on-sale bar requires contemporaneous recognition or characterization of the specific polymorph by the parties to the sale or by the patentee.

## Legal Principles

- Under Pfaff, the on-sale bar applies if, before the critical date, (1) the invention was the subject of a commercial sale or offer for sale and (2) the invention was ready for patenting.
- “Ready for patenting” may be established by reduction to practice, including reduction to practice by third parties.
- For § 102(b) purposes, commercial sale of a material later shown to fall within the claim can trigger the on-sale bar even if the parties did not know the material’s precise identity at the time of the transaction.
- Sale and use of the material for its intended, practical purpose can support a finding of utility and reduction to practice sufficient to satisfy Pfaff’s second prong.

## Conclusion

The Federal Circuit held Abbott’s polymorph claim invalid under the on-sale bar because the claimed Form IV was commercially sold in the United States before the critical date and was ready for patenting through third-party reduction to practice, without requiring contemporaneous recognition of the specific crystalline form.


Abbott Laboratories v. Geneva Pharms., Inc., 182 F.3d 1315 (Fed. Cir. 1999)