Dolly the sheep: the demise of biotechnology patents

The US Federal Circuit has recently been called upon to apply the Prometheus and Myriad decisions to a particularly famous project: the creation of Dolly the cloned sheep.

In March 2012, the Supreme Court pronounced in Prometheus v Mayo that a claim to a method of optimising a therapeutic regimen in which the method was defined by specific steps is ineligible for patent protection. Later, in The Association for Molecular Pathology v Myriad Genetics, Inc, the Supreme Court held that a naturally occurring DNA segment is a product of nature and does.

These decisions are directly relevant to the creation of Dolly the sheep, the first mammal to have been cloned out of a fully differentiated adult cell. Dolly was born after Ian Wilmut, Keith Campbell and colleagues at the Roslin Institute, part of the University of Edinburgh, and the biotechnology company PPL Therapeutics fused the nucleus of an adult, somatic mammary cell from a sheep with an egg from another sheep the genetic material of which (the nucleus) had been removed.

Once the nucleus of the somatic donor cell is removed, the nucleus is fused with an oocyte, which then develops into an embryo. Implantation of the embryo into a surrogate sheep allowed the embryo to develop into the baby sheep. Dolly— arguably one of the most famous farm animals—was an exact replica of the adult mammal from which the somatic cell nucleus was taken. This was hailed as a significant scientific breakthrough by many, not least the Federal Circuit in In re Roslin Institute.

In May 2014, with the court relying heavily on the precedent set by the Prometheus and Myriad decisions, Dolly the sheep was summarily declared ineligible for patent protection. The decision noted in passing that the method used to create Dolly was “a breakthrough in scientific discovery” but held firm in its belief that the fruits of that breakthrough are not patent-eligible because the animal was nothing more han a “naturally occurring animal”. The court observed that Dolly did not possess “markedly different characteristics from any found in nature”.

This decision that a cloned animal— something that previously had belonged in the realm of science fiction, and was brought into the realm of science fact only by the recognised ingenuity of the scientists at the Roslin Institute—is patent-ineligible is a direct extension of the Myriad decision and is emblematic of the demise of biotechnology patents and, more specifically, of gene-based patents.

Prior to these three decisions, there was a sense of comfort that the exceptions to patent eligibility under 35 USC §101 fell into three distinct categories: laws of nature, abstract ideas, and natural phenomena. Clearly, a clone of a living animal is not an abstract idea, nor a law of nature. It seems that nothing can be further from being a natural phenomenon than a cloned animal—an exact copy of a previously living organism.

However, the Federal Circuit held that the claims to a "live-born clone of a pre-existing non-embryonic, donor mammal" is patent ineligible because the DNA of the donor was "preserved" in the newly created animal so that the clone has a genetic identity that is identical to that of the parent.

“Could the Roslin Institute have described and claimed Dolly with pink wool or some other feature that could be engineered into the animal as a marker to distinguish it?”

With In re Roslin Institute, in combination with Prometheus, Myriad and the fallout of those cases, the courts and the US Patent and Trademark Office seem to be creating a fourth category of patent ineligibility: namely, where the product has “genetic identity” with something already found in nature, then that product is an exception to patent eligibility, regardless of the level of ingenuity involved in creation of that product, or the fact that such a product simply does not exist in nature.

It seems clear that these cases have provided significant fodder for challenging the validity of many patents, and those may be beyond redemption. But perhaps one can mine these cases for use in drafting future cases.

One possible area meriting further consideration is the wording in the In re Roslin Institute opinion that Dolly did not have “characteristics” that could be described as “markedly different” from any found in nature. This wording would seem to reflect a similar tone in Myriad, in which the court stated that the decision did not stretch to innovative methods of manipulating genes or new applications of knowledge about the new genes.

Perhaps this requires further consideration of functional claim limitations, which point to some characteristic that was not evident in the material in nature. For example, could the Roslin Institute have described and claimed Dolly with pink wool or some other feature that could be engineered into the animal as a marker to distinguish it from the parent and from nature? This may be an avenue to pursue, as the court did note that Roslin Institute’s arguments about differences between the clones and their donor mammals were unclaimed.

However, if this direction is followed, then the patentee may be forced to add meaningless limitations to its claims to ensure that the claims can be tested under 35 USC §§102 (anticipation) and 103 (obviousness).

Nabeela Rasheed is shareholder at McAndrews, Held & Malloy. She can be contacted at: nrasheed@mcandrews-ip.com