Abbott Laboratories v. Geneva Pharmaceuticals, Inc. SKH

• Patentee brought action against proposed competitors that had filed Abbreviated New Drug Applications (ANDAs), alleging infringement of patent covering anhydrous crystalline form of terazosin hydrochloride. The United States District Court for the Northern District of Illinois, Joan B. Gottschall, J., 1998 WL 566884, held one claim of patent invalid under statutory on-sale bar, and patentee appealed. The Court of Appeals, Lourie, Circuit Judge, held that third party's sales of claimed anhydrous crystalline form of terazosin hydrochloride prior to critical date rendered patent invalid under statutory on-sale bar, even if parties to those sales did not know that they were dealing with particular form claimed in patent.
• Affirmed.
• The ultimate determination whether an invention was on sale within the meaning of the statutory on-sale bar is a question of law which Court of Appeals reviews de novo.
• Parties challenging validity of a presumptively valid patent under statutory on-sale bar bore burden of proving existence of on-sale bar by clear and convincing evidence.
• Third party's sales of anhydrous crystalline form of terazosin hydrochloride prior to critical date rendered patent covering particular anhydrous crystalline form of terazosin hydrochloride invalid under statutory on-sale bar, even if parties to those sales did not know that they were dealing with particular form claimed in patent rather than with another anhydrous terazosin hydrochloride crystalline form.
• To be invalid under statutory on-sale bar, the invention must both be the subject of a commercial sale or offer for sale and be ready for patenting before the critical date, and invention may be shown to be ready for patenting, inter alia, by proof of reduction to practice before the critical date.
• Statutory on-sale bar, which may render patent invalid, is not subject to exceptions for sales made by third parties either innocently or fraudulently.
• Fact that material claimed in patent was sold under circumstances in which no question existed that it was useful meant that invention was reduced to practice, for purpose of statutory on-sale bar, and no proof of conception was required.
• There is no requirement that a sales offer specifically identify all the characteristics of an invention offered for sale or that the parties recognize the significance of all of these characteristics at the time of the offer, under statutory on-sale bar; if a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics.
• One of the primary purposes of the statutory on-sale bar is to prohibit the withdrawal of inventions that have been placed into the public domain through commercialization.