The Roslin Institute of Edinburgh, Scotland (Roslin) is the assignee of U.S. Patent Application No. 09/225,233 (the ’233 application) and had appealed from a final decision of the Patent Trial and Appeal Board, which held that all of Roslin’s pending claims were unpatentable subject matter under 35 U.S.C. § 101. The Board also rejected Roslin’s claims as anticipated and obvious under 35 U.S.C. §§ 102 and 103. Having determined that genetic clones are not patent eligible the Federal Circuit, in a decision by Judge Dyk who was joined by Judges Moore and Wallach, did not reach the 102 or 103 issues, instead simply affirming the Board’s rejection of the claims under § 101.
To tell the story involved in this case we must travel back to July 5, 1996, when Keith Henry Stockman Campbell and Ian Wilmut successfully produced the first ever cloned mammal from an adult somatic cell: Dolly the Sheep. The cloning method Campbell and Wilmut used to create Dolly was a significant scientific breakthrough. Campbell and Wilmut obtained U.S. Patent No. 7,514,258 (the ’258 patent) on the somatic method of cloning mammals, which was been assigned to Roslin. The ’258 patent was not at issue in this case.
What was at issue in the case was the ‘233 application, which claims the products of Campbell’s and Wilmut’s cloning method: cattle, sheep, pigs, and goats. Claims 155 and 164 were deemed representative and are as follows:
155. A live-born clone of a pre-existing, non- embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.
164. The clone of any of claims 155-159, wherein the donor mammal is non-foetal.
These claims were rejected by the patent examiner and an appeal was taken to the Board. On February 7, 2013, the Board affirmed the examiner’s rejection of all of Campbell’s and Wilmut’s claims. The Board acknowledged that the claimed clones “may be called a composition of matter or a manufacture” as required by § 101, but ultimately concluded that the claimed subject matter was ineligible for patent protection under § 101 because it constituted a natural phenomenon that did not possess “markedly different characteristics than any found in nature.”
The Federal Circuit, per Judge Dyk, affirmed the Board after explaining the meaning of the Supreme Court’s recent patent eligibility cases. Ultimately concluding, as is required by this troubling line of Supreme Court cases, that even if something is made by man it is not patentable if what results is an exact copy of what occurs in nature.
Roslin did try and save these claims by arguing that the clone is not truly genetically identical to the original, but the Federal Circuit dismissed this line or argument saying: “There is nothing in the claims, or even in the specification, that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies.” Of course, it is hardly surprising the claims and specification wouldn’t provide support for that given the entire point of the invention was to create a clone that was identical.
I hate to say I told you so, but I explained that this would ultimately be where the law had to head, particularly after the Supreme Court decision in AMP v. Myriad, although I have been criticized by many who dismissed my predictions and erroneously proclaimed that this line of Supreme Court cases wasn’t so bad. Well, I suppose this line of Supreme Court cases isn’t bad — it is horrendous! Perhaps my claims that the Supreme Court functionally overruled Chakrabarty won’t be viewed so skeptically any more.
Recall that in Myriad, Justice Thomas, writing for a unanimous Supreme Court, wrote:
Justice Thomas also explained:
[T]he lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.
So, cDNA is patent eligible as long as the series is not too short, and so long as it is not “indistinguishable from natural DNA.” The importance of this, which was simply ignored by most in the field, is to say that as innovation becomes capable of replicating nature exactly then the resulting product is not patent eligible.
At the time of the Myriad decision I wrote this, which predicted the demise of personalized medicine:
Furthermore, you can expect a near complete cessation in many areas of personalized medicine. If creating something in a lab, such as a composite cDNA, does not make the underlying claims patent eligible because what results is indistinguishable from what appears in nature that means that the fledgling and potentially promising technologies to grow organs for transplantation will shrivel up and die. The whole point is to create an organ that is indistinguishable from what appears in nature so that it can be transplanted into a human body to prolong life. Given the breadth of this opinion and the uncertainty it will cause funding will dry up in the U.S.
The holy grail of personalized medicine, at least with respect to organ transplantation, is to create an organ that is identical to what occurs in nature. Now we know that if that is accomplished the resulting organ will not be patentable. That being the case, why is anyone going to spend the billions, or possibly trillions, of dollars it will require to make this branch or personalized medicine a reality? Without possibility of exclusive rights research will dry up, and the dream will never be realized. Sure, some universities will continue to use grant money to pursue as much as they can, but without the private sector working to engage in commercialization research it simply won’t happen, and no company is ever going to spend the money required to make this a reality without an expectation of recouping their investment in R&D plus a suitable return on that investment.
What this all boils down to is this: as innovation marches forward we are starting to bump up against the god question. We are in small ways close to creating things that are undoubtedly man-made, but which are identical to nature. It strikes me as extraordinarily peculiar that something man-made but imperfect would be patentable, but something man-made and perfect couldn’t be patentable. It is infinitely more difficult to create something identical to the way nature created it, yet we are willing to grant a patent on something that is easier to accomplish because it doesn’t offend our limited notions of humanity. Truthfully, the law and the public are not ready for scientists that can create like god, so there is a fearful retreat from extraordinary scientific accomplishment thanks to the enlightened 17th century thinking of jurists and Members of Congress.
Simply stated, there is no intellectually honest reason why that which is undeniably man-made should be denied a patent. Chakrabarty has clearly been overruled because that decision stood for the proposition that if something were man-made it was patent eligible. That was the correct decision.
And to those who don’t believe things like this should be patent eligible because giving a patent would allow the patent owner to sue everyone who has a kidney, for example, I say this: GROW UP! Granting a patent on a MAN-MADE kidney would NOT entitle the patent owner to sue everyone who has a kidney given to them at birth. Why? Because the kidney given to each of us at birth was NOT man-made!
Another nail in the coffin of innovation and a functioning patent system all because decision makers don’t have enough guts to state the obvious. Being able to create something that is identical to what nature creates is an extraordinary achievement that should be celebrated, should be fostered and incentivized, and should be awarded with a patent.
Sadly, until further notice, personalized medicine is dead!