Chiron argues that (1) it was the first to conceive of the invention and reduce it to practice, (2) under the doctrine of simultaneous conception and reduction to practice, it prevails because it was the first to reduce the invention to practice, and (3) the alleged prior inventors did not exercise diligence in reducing the invention to practice, and/or abandoned it.
The court must first determine as a matter of law what constitutes conception and reduction to practice in the instant context.
Conception is the formulation of a "definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice." Burroughs Wellcome Co. v. Barr Labs., Inc. 40 F.3d 1223, 1228 (Fed. Cir. 1994) (citation omitted). It "necessarily turns on the inventor's ability to describe his invention with particularity," and the idea must be sufficiently formed so that "only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation." Id. However, in the ordinary context, an inventor need not know or demonstrate that the invention actually works for conception to be complete -- that discovery is part of reduction to practice, not conception. Id.
Chiron half-heartedly argues first that conception of the instant invention requires merely having the idea for a recombinant immunoassay based on env region polypeptides, and disclosure of that idea to others.
In the alternative, Chiron argues that because the instant invention involves isolation of proteins at the genetic level, the doctrine of simultaneous conception and reduction to practice applies, such that conception was not complete until there was actual reduction to practice.
Abbott contends that more is required for conception than just the idea of expressing an immunoreactive polypeptide from the env region of HIV; rather, Abbott argues, a specific DNA fragment that can be used to express an immunoreactive polypeptide must be identified by restriction sites (i.e., a restriction map of the DNA must be created). Abbott also argues that conception in this instance does not require actual gene sequencing of the env region -- that the doctrine of simultaneous conception and reduction to practice does not apply, and that all that is required for conception is creation of a restriction map identifying specific DNA fragments that possibly could be immunoreactive.
The court must determine whether conception of the instant invention requires (1) simply formulating the idea of a recombinant immunoassay based on env region polypeptides, as Chiron initially contends, (2) creating a restriction map and identifying specific possibly useful DNA fragments from the env region, as Abbott argues, or, (3) actual reduction to practice, including sequencing and analysis of the env region to ensure that the identified fragments actually are from the env, as Chiron argues in the alternative.
The Federal Circuit has held that
[a] gene is a chemical compound, albeit a complex one, and it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it. [citation omitted]. Conception does not occur unless one has a mental picture of the structure of the chemical, or is able to define it by its method of preparation, its physical or chemical properties, or whatever characteristics sufficiently distinguish it. It is not sufficient to define it solely by its principal biological property, e.g. encoding human erythropoietin, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property.