November 1, 2009 (Vol. 29, No. 19)
William L. L. Warren
S Alex Cao Ph.D.
Authorship Goes to Those Involved in Generating the Idea, Not Proving that It Works
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.
The Hedrick Case
University of Pittsburgh researchers Adam Katz, M.D., and Ramon Llull, M.D., Ph.D., developed a method to isolate progenitor cells from adipose tissues. They had preliminary evidence to suggest that these cells were capable of transdifferentiating into muscle, bone, cartilage, and neural cells. Shortly after Marc Hedrick, M.D., from UCLA joined the Pittsburgh laboratory in July 1997 for a yearlong fellowship, Drs. Katz and Llull filed a grant proposal summarizing their own prior work, which did not include Dr. Hedrick.
However, Dr. Hedrick was later included with Drs. Katz and Llull in a invention disclosure filed at Pittsburgh. Dr. Hedrick thereafter returned to UCLA and was the first to successfully demonstrate that the adipose-derived stem cells were distinct from the prior art bone marrow-derived mesenchymal stem cells.
The patent that issued naming the Pittsburgh and UCLA researchers (U.S. Patent No. 6,777,231) claimed “an isolated adipose-derived stem cell can differentiate into two or more of the group consisting of a bone cell, a cartilage cell, a nerve cell, or a muscle cell.” Pittsburg filed suit to remove Dr. Hedrick and the other UCLA researchers as named inventors on the patent.
The Federal Circuit found that the later work at UCLA to distinguish the claimed cells from prior art mesenchymal cells did not contribute to the conception of the claimed invention. The court found sufficient evidence in the laboratory notebooks and grant proposal that the Pittsburgh researchers already had a sufficiently definite and permanent idea of the cell’s inventive qualities to have a complete conception of the invention. Thus, even though Drs. Katz and Llull’s work was scientifically inconclusive at the time of conception, the later evidence providing scientific certainty was merely a reduction to practice and not an inventive contribution.
Implications for Life Science Patents
Therefore, it is clear from this case that confirmatory research is unlikely to result in a contribution to conception of an invention. Furthermore, one does not contribute to conception by proving that an invention is actually novel over the prior art.
The Hedrick case helps to clarify lingering ambiguities in co-inventorship, but has even greater implications for potentially finding inventions in the unpredictable sciences merely obvious. The decision is consistent with other shifting obviousness standards in the wake of KSR International v. Teleflex. In KSR, the U.S. Supreme Court stated that obviousness can result from the combination of known elements for their known purposes, particularly where only a limited range of selections and outcomes exists, regardless of any direct teaching, suggestion, or motivation to make the invention.
The Federal Circuit took gene-patent obviousness a step further in In re Kubin. The court held that a patent to DNA encoding a natural killer cell activation-inducing ligand protein was obvious because the protein had already been isolated, and the gene cloning and sequencing techniques were commonly available. This holding was despite the fact that the claimed sequence itself could not be described with particularity until it had actually been sequenced, as previously required by Amgen.
Therefore, to the extent that the law will not recognize the inventive contribution or the nonobviousness of an invention in the life sciences, based upon actual observations of an unpredictable outcome, there could be fewer valid biotechnology patents. Much research in the life sciences may be said to be “obvious to try,” but not so obvious that it will work as predicted until demonstrated through experimentation. Biotech companies should be concerned about the law’s increasing movement away from requiring evidence of a successful reduction to practice for patentability in the unpredictable arts.
On the other hand, the Hedrick decision allows researchers to more easily file patents on inventions that they have only conceived, but not yet demonstrated in a reduction to practice. Scientists can collaborate with other institutions and even outsource the experimental work to contract research organizations with more confidence that those conducting the defined experiments will not be able to lay claim to the invention.
This recent legal trend indicates that the patent system will increasingly reward the first applicants presenting a hypothesis, rather than those proving it.
William L. Warren ([email protected]) is partner, and S. Alex Cao, Ph.D., is an associate at Sutherland Asbill & Brennan. Website: www.sutherland.com.