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Abbott Laboratories v. Geneva Pharmaceuticals, Inc., et al.

United States Court of Appeals for the Federal Circuit
182 F.3d 1315 (1999)
ELI5:

Rule of Law:

The on-sale bar of 35 U.S.C. § 102(b) is triggered if the claimed invention was the subject of a commercial sale more than one year before the patent application was filed, regardless of whether the parties to the sale knew or appreciated all of the invention's inherent characteristics.


Facts:

  • Abbott Laboratories markets the drug Hytrin, which contains the dihydrate crystalline form of terazosin hydrochloride.
  • Terazosin hydrochloride also exists in an anhydrous crystalline form known as Form IV.
  • On October 18, 1994, Abbott filed a patent application for the Form IV anhydrate of terazosin hydrochloride, which resulted in the '207 patent.
  • Before the critical date of October 18, 1993, a third-party company, Byron Chemical Company, made at least three commercial sales of anhydrous terazosin hydrochloride in the United States to Geneva Pharmaceuticals and Warner Chilcott Laboratories.
  • At the time of these sales, neither Byron Chemical nor the purchasers knew the specific crystalline form of the compound being sold.
  • After the sales were completed, subsequent testing by both Abbott and Geneva confirmed that the substance sold by Byron was, in fact, the Form IV anhydrate claimed in Abbott's patent.

Procedural Posture:

  • Geneva Pharmaceuticals, Inc., Novopharm Limited, and Invamed, Inc. each filed an Abbreviated New Drug Application (ANDA) with the FDA to market a generic drug containing Form IV anhydrate.
  • Abbott Laboratories sued the three companies for patent infringement in the U.S. District Court for the Northern District of Illinois.
  • The defendant companies raised the affirmative defense that Abbott's patent was invalid under the on-sale bar of 35 U.S.C. § 102(b).
  • The defendants filed motions for summary judgment on the issue of invalidity.
  • The district court granted the defendants' motions for summary judgment, holding claim 4 of Abbott's patent invalid.
  • Abbott Laboratories, as the appellant, appealed the district court's decision to the U.S. Court of Appeals for the Federal Circuit.

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Issue:

Does the on-sale bar of 35 U.S.C. § 102(b) invalidate a patent claim when the product embodying the invention was commercially sold by a third party more than one year before the patent's filing date, even if the parties to the sale were unaware of the product's specific, patented characteristics?


Opinions:

Majority - Lourie, J.

Yes, the on-sale bar invalidates the patent claim. A claimed invention is considered 'on sale' under § 102(b) if, before the critical date, it was both the subject of a commercial offer for sale and was ready for patenting. The court applied the two-part test from Pfaff v. Wells Electronics, Inc., concluding that both prongs were met. First, it was undisputed that the Form IV anhydrate was the subject of at least three commercial sales in the U.S. before the critical date. Second, the invention was 'ready for patenting' because it had already been reduced to practice by the foreign manufacturers who produced it. The court rejected Abbott's argument that the invention could not be 'on sale' because the parties did not 'conceive' of it, reasoning that if a product offered for sale inherently possesses each limitation of the claims, the on-sale bar applies regardless of whether the parties recognized those characteristics.



Analysis:

This decision solidifies the objective nature of the on-sale bar, affirming that the subjective knowledge or intent of the parties to a sale is irrelevant. By strictly applying the Pfaff test, the court reinforced that the key inquiries are whether a commercial sale occurred and whether the invention was ready for patenting, not whether the inventor or seller appreciated the invention's novelty. The ruling prevents inventors from patenting later-discovered inherent properties of products that have already been commercialized and placed in the public domain. This serves the policy goal of the on-sale bar, which is to prevent the withdrawal of inventions from the public domain after they have been commercially exploited.

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