Applying a two-pronged test for public use as a statutory bar to novelty, the U.S. Court of Appeals for the Federal Circuit held a biotechnology invention used within the company to develop products that were never sold was not subject to a statutory bar. Invitrogen Corp. v. Biocrest Mfg., L.P., Case Nos. 04-1273,-1274 (Fed. Cir. Oct. 5, 2005) (Rader, J.).
Genetic engineering techniques use a transformation process to introduce genetic material into cells in order to produce recombinant products. Invitrogen is the assignee of a patent that claims a process for producing transformable bacterial cells having improved competence. The district court found that the defendants infringed the patent but held the claims invalid for public use. On appeal, Invitrogen argued that internal use of the claimed process for further development of research projects did not provide a commercial advantage triggering the public use bar because the claimed process or any products derived therefrom were not sold, offered for sale or otherwise placed in the public domain.
The Court instructed that the proper test for public use is, like the test for on-sale, a two-pronged inquiry. The first prong, adopted from the U.S. Supreme Court decision in Pfaff v. Wells, is whether the invention is complete and ready for patenting. The second is whether the invention is in public use. The first part of the test is based on the public policy consideration that underlies both the on-sale and public use statutory bars to preclude removal of existing knowledge from the public domain. As to the public-use prong, the Court held that the proper test was whether the purported use was accessible to the public or commercially exploited.
Analyzing the public-use prong, the Court held that Invitrogen’s use of the claimed invention did not trigger the bar because it was neither public nor commercially exploited. Noting that a public use requires the use to occur without any limitation, restriction or prohibition of secrecy, the Court found that Invitrogen’s invention was neither given nor sold to another and was maintained under a strict obligation of secrecy. Commercial exploitation of a secret use represents a public use only when a confidential sale or charge for the invention generates commercial benefit. Use of the invention for research and development of future products was found not to result in commercial exploitation because it did not occur in the usual course of producing articles for commercial purposes. The Court emphasized there was no evidence that Invitrogen received compensation for the secret, internal exploitation of its transformation process and that, without more evidence, secret use to internally develop future products that were never sold was insufficient to create a public use bar.
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