It looks like Dolly, the cloned sheep, is not patentable subject matter. In a recent case called In re Roslin Institute (Edinburg), the Federal Circuit found that Dolly was too similar to the donor sheep and was essentially a copy of a naturally occurring organism, making her patent ineligible.
The Roslin Institute, which would own the patent rights to Dolly, argued that distinguishable, yet minor differences in Dolly’s physical appearance from the donor sheep made her patent eligible. The court disagreed, stating that not only were these differences unclaimed on the patent application, but also were unrelated to the work that Roslin had done in cloning Dolly having been the result of “environmental factors.” In an interesting twist, although the court rejected the argument that Dolly was patentable, the court also noted that “having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case.” It therefore seems possible that the door is not entirely closed on the future patentability of cloned animals. But in the current case, Dolly has been shut out.
A clone is an organism that is genetically identical to a donor organism. Clones can be produced naturally for some organisms. Some plants, for example, reproduce asexually to produce offspring that are genetically identical to the mother plant. This is not to be confused with organisms like bees, that can reproduce through parthogenesis where an unfertilized egg can grow and develop into a drone that has only half the genetic material of the mother bee. Dolly and other cloned mammals, on the other hand, are produced in a lab when a nucleus is extracted from the cell of a donor organism and transplanted into another organism’s cell from which the nucleus has been removed. The resulting clone cell has the nucleus of one organism and the cellular machinery of another. This cell must then be implanted in a surrogate in order to grow and divide into an embryo. Regardless of whether this grown process occurs through natural or artificial processes, clones look just like their predecessors and therein lies the problem. Courts struggle with whether a clone is patentable because the clone must be distinguishable from the donor organism to avoid confusing artificially created organisms with naturally occurring ones.
Although some genetic variability is present between clones and originals due to mitochondrial DNA inherited from the receiving somatic cell, no noticeable differences are likely to result. In fact, the most prominent differences will result from environmental factors. Identical twins, for example, even though born from the same zygote can develop different sets of fingerprints due to developmental differences. Two identical cats could develop different colored coats due to either temperature differences or random chromosomal deactivation. The court in Roslin, however, seemed to discount physical variation that resulted from environmental factors.
What if Dolly’s color could have been controlled environmentally, such that if kept in an air-conditioned room during development she grew into an entirely black sheep; would the court have deemed her to be substantially different from the white donor sheep? Depending on how stringently the courts will view the influence of “environmental factors,” they may conclude that all clones are patent ineligible. The only way to keep a clone genetically identical to the donor and also produce distinguishing characteristics is to manipulate environmental factors, whether they are temperature, chemicals, or some other method to force a change in development. It seems impossible to create a clone that is also patent eligible if any environmentally-induced change is disregarded.
Roslin actually raised the mitochondrial DNA argument to show that Dolly’s total DNA material was different from its donor. Unfortunately for Roslin, that component of the invention was left out of the patent application and the court called them out on it.
So, what is the best strategy for patenting clones? Using environmental factors to make clones “look” different yet retain the genetic similarity to the donor or incorporating genetic tags, such as mitochondrial DNA, which do not alter the physical appearance of the clone? Although the courts may see it differently, a genetic tag would be the better solution because they can be passed to subsequent offspring of the clone whereas environmentally-induced variations may not. Although Roslin didn’t succeed in patenting Dolly on this go-around, perhaps a “black sheep” is what they really need.