Modern life science research frequently requires collaborative research efforts between colleagues and even institutions. But which collaborators should be named as co-inventors on a resulting patent application? The simple answer is: whoever contributed to the conception of the claimed invention.
But how about the collaborator who proved that the idea actually works? Is the inventorship standard different in the unpredictable arts of chemistry and biology? These questions were answered in the negative on July 23, 2009, by the U.S. Court of Appeals for the Federal Circuit in the University of Pittsburgh v. Hedrick, with implications for future biotechnology patent validity challenges.
The standard for patent co-inventorship has been refined over the years; however, “conception is the touchstone of inventorship” (Burroughs Welcome v. Barr Laboratory). The test for conception is whether the inventor had a definite and permanent idea of the invention, which can be corroborated by evidence, preferably contemporaneous, and verified disclosures such as witnessed laboratory notebooks or grant proposals.
Co-inventors are jointly named researchers who must have at least some degree of collaborative communication in arriving at the invention. However, the co-inventors need not work physically together, and their relative contributions can be quite unequal. On the other hand, a co-inventor is not one who merely acts under the supervision and direction of another while contributing nothing to the concept of the invention.
As affirmed by the Federal Circuit in Hedrick, for conception to be complete an inventor need not know with certainty whether the invention will work, but rather only that he had a complete mental picture of the invention and could describe it with particularity as corroborated by evidence.
However, this simple inventive principle contradicts the doctrine of simultaneous conception and reduction to practice, as applied in the so-called unpredictable arts of the life sciences. In the experimental sciences of biology and chemistry, the element of unpredictability frequently prevents conception from being separable from actual experimentation (Smith v. Bousquet).
Therefore, under the doctrine of simultaneous conception and reduction to practice in the unpredictable arts, an inventor could not establish conception until the invention had been reduced to practice through successful experimentation (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.). In Amgen, the court held, in essence, that until the erythropoietin gene had been reduced to practice through actual sequencing, the claimed invention had not been conceived.
Despite this clear reduction to practice requirement for inventorship in certain unpredictable technologies, there have been no subsequent cases holding that those scientists who perform certain “routine” experiments such as gene sequencing must also be named as inventors on a patent. Instead, the Hedrick decision signals a continued movement away from the doctrine of simultaneous conception and reduction to practice for determining inventorship in biotechnology.