New APPS

A few days ago, the Federal Court of Appeals issued a decision denying patentability to Dolly the Sheep.  Dolly, as one will recall, was the first successful mammalian clone from an adult somatic cell.  Essentially, researchers at the Roslin Institute in Edinburgh took an unfertilized donor egg, replaced the nucleus with one taken from a different animal, induced the clone egg to divide, and implanted it into a surrogate.  Dolly thus came into the world with nuclear DNA identical to that of the sheep from which the donor nucleus was taken, although you could also plausibly say she had three “mothers:” the egg donor, the nuclear donor, and the surrogate.

The case in question was not about the method for producing Dolly – it covered the animal itself.  The Court cites the relevant claim to ownership:

“A live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats”

With a nod to Myriad, where the Supreme Court denied patentability to isolated genetic sequences last summer, the opinion notes that strong Supreme Court precedent establishes that “naturally occurring organisms are not patentable” (slip op, 5).  Nor are mixtures of naturally occurring substances which are not themselves modified in the process of mixing.  Organisms are patentable – here the precedent is a patent on an oil-eating bacteria – only if they possess “markedly different characteristics from any found in nature” (slip op, 6).   Since Dolly was the clone of an existing animal, and since that existing animal was found in nature, Dolly was not markedly different from something found in nature.

Roslin suggested two differences based on the other two mothers, neither of which the Court found compelling.  First, Roslin argued that “environmental factors lead to phenotypic differences between its clones and their donor mammals that render their claimed subject matter patentable” (slip op, 9).  In other words, beginning with implantation into the surrogate, Dolly’s environment was different from that of her nuclear-donor mother.  The court noted that these environmental factors are natural factors, and so not patentable.  Second, Roslin noted that the mitochondrial DNA came from the donor egg, and so Dolly could be differentiated on those grounds.  The court rejected this argument for analogous reasons.

 Roslin also proposed that there was a temporal difference:

 “Finally, Roslin argues that its clones are patent eligible because they are time-delayed versions of their donor mammals, and therefore different from their original mammals. But this distinction cannot confer patentability. As the Board noted, “[t]he difficulty with the time-delayed characteristic is that it is true of any copy of an original” (slip op, 11).

The case has already drawn some criticism: Jason Rantanen suggests that the court minimized the point about phenotypical differences: the animal with the same gene will be different from its genetic parent due to environmental factors, and it’s not clear why these can’t be sufficient.  Jeffrey Lefstin notes that the court seems to have missed the argument about mitochondrial DNA – which would be different in the clone because that DNA had to come from the egg donor.  Lefstein also noted the insistence on “markedly” different isn’t one the Supreme Court really makes.

I don’t know if Dolly should be patentable or not (my impulse is not), but there is a difficult conceptual problem raised by this decision – when are we to say that something is “markedly” different from another?  The court here doesn’t define the term, and it seems to me that it will increasingly cause trouble: markedly different with regard to what?  After all, tiny genetic differences can go a long way phenotypically.  Certainly we know that environment is critical to gene expression.  In particular, this doesn’t sound like a clear case of just “mixing,” since different environments will interact differently with the genetics.  Also, why isn’t a different mitochondrial DNA significant (this one strikes me as easiest: as I understand it, mitochondrial DNA doesn’t make a difference except insofar as we can use it for classification and for tracing evolutionary changes. Infosar as patents are concerned with function, then these differences won’t be relevant)? 

It seems to me that the problems run even deeper, as the decision seems to be vulnerable to the following objection: Assume that the inquiry is correctly restricted to nuclear DNA.  In that regard, Dolly is identical to her mother – and that is precisely why she is markedly different: at least in cases of sexual reproduction, no naturally-produced offspring can be genetically identical to its mother.  Sameness is difference!  Roslin was on the right track with the time-delay argument.

Or perhaps I am missing something?