Federal Circuit Supersedes Clinical Trial Public Use Holding

SmithKline Beecham v. Apotex (Fed. Cir., April 8, 2005) supersedes the panel opinion entered on April 23, 2004, amended April 28, 2004, and reported at 365 F.3d 1306 (Fed. Cir. 2004) holding that clinical trials constitute a public use under § 102(b) . This time around, the court avoided the public/experimental use issue by hoding that a claim to "Crystalline paroxetine hydrochloride hemihydrate" was inherently anticipated because the record contained clear and convincing evidence that production of PHC anhydrate in accordance with the a prior art patent inherently results in at least trace amounts of PHC hemihydrate.

. . . [E]ven though the ’196 patent discloses how to make PHC anhydrate and does not discuss PHC hemihydrate, PHC hemihydrate was not even discovered until years after the ’196 patent was filed. Nonetheless, the ’196 patent anticipates claim 1 of the ’723 patent because the ’196 inherently discloses PHC hemihydrate.

To show that manufacture of PHC anhydrate tablets necessarily created PHC hemihydrate, SmithKline offered expert testimony on the so-called “seeding� or “disappearing polymorph� theory. Under this theory, Ferrosan may have originally created a crystalline compound, namely PHC anhydrate, in a relatively unstable form. For presently unknown reasons, the PHC anhydrate “morphed� into a more stable form, namely the PHC hemihydrate discovered in SmithKline’s facilities. With this new form or polymorph in existence, SmithKline’s experts explained, the general environment became “seeded� with crystals of PHC hemihydrate. In this seeded environment, the PHC anhydrate converts to the PHC hemihydrate upon its inevitable contact with seeds of PHC hemihydrate. In other words, the creation of pure PHC anhydrate became extremely difficult, if not impossible; the old polymorph, PCH anhydrate, has effectively disappeared in its pure form because it changes naturally into the new polymorph, PCH hemihydrate.

Although the district court clearly accepts as true the theories of
"disappearing polymorphs" and "seeding," it did not make findings of fact regarding precisely how or when PHC hemihydrate first came into existence. Indeed, traces of PHC hemihydrate in PHC anhydrate pills were not detectible in amounts less than five percent before 1985. However, Curzons undisputedly made his serendipitous discovery of PHC hemihydrate while making PHC anhydrate presumably pursuant to the teachings of the ’196 patent. Moreover, although Curzons does not claim to have discovered PHC hemihydrate until March 1985, further review of samples of SmithKline’s PHC anhydrate revealed that SmithKline’s Harlow plant had unwittingly made PHC hemihydrate as early as December 1984. These undisputed facts conclusively establish that PHC anhydrate made in accordance with the ’196 patent converts into PHC hemihydrate both with and without seeding.