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
- 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.
- 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.