In re Roslin Institute (Fed. Cir. 2014)

Dolly the Sheep Not Patent Eligible Subject Matter

By Donald Zuhn --

Earlier today, the Federal Circuit affirmed a determination by the Patent Trial and Appeal Board affirming the rejection of claims 155-159 and 164 of U.S. Application No. 09/225,233 as being directed to unpatentable subject matter under 35 U.S.C. § 101.  Coincidentally, the decision comes on the eve of the U.S. Patent and Trademark Office's public forum on the Myriad/Mayo Guidance, which will take place from 1:00 to 5:00 pm (ET) on Friday.

The inventors on the '233 application, Dr. Keith H.S. Campbell and Sir Ian Wilmut, were the first to produce a cloned mammal from an adult somatic cell -- Dolly the sheep.  Dr. Campbell and Sir Ian obtained U.S. Patent No. 7,514,258 for the method they used to produce Dolly:  somatic cell nuclear transfer, which involves removing the nucleus of a somatic cell that has been arrested in the quiescent phase of the cell cycle and implanting that nucleus into an enucleated oocyte.  The '233 application, however, is directed to the product of the cloning method.  Representative claims 155 and 164 recite:

155.  A live-born clone of a pre-existing, nonembryonic, 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.

The Examiner rejected the claims at issue as being directed to non-statutory subject matter under 35 U.S.C. § 101, and as being anticipated and obvious under §§ 102 and 103.  The Board affirmed the Examiner's rejections, finding 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."

In affirming the Board's affirmance of the Examiner's rejections, the Federal Circuit begins by noting that "[e]ven before the Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), the Court’s opinions in [Diamond v.] Chakrabarty [447 U.S. 303, 309 (1980),] and Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), made clear that naturally occurring organisms are not patentable."  With respect to Funk Bros., where the claimed invention was directed to a mixture of naturally occurring strains of bacteria that helped leguminous plants extract nitrogen from the air and fix it in soil, the opinion indicates that "while the method of selecting the strains of bacteria might have been patent eligible, the natural organism itself -- the mixture of bacteria -- was unpatentable because its 'qualities are the work of nature' unaltered by the hand of man."  In Chakrabarty, however, a genetically engineered bacterium that was capable of breaking down various components of crude oil was found to be patent eligible because "it was 'new' with 'markedly different characteristics from any found in nature and one having the potential for significant utility."  From these two cases, the Court concludes that "discoveries that possess 'markedly different characteristics from any found in nature' are eligible for patent protection [and] any existing organism or newly discovered plant found in the wild is not patentable."

On appeal, the Roslin Institute argued that unlike the donor sheep used to create Dolly, clones like Dolly are eligible for protection because they are "the product of human ingenuity" and "not nature's handiwork, but [their] own."  The Court disagreed, stating that "Dolly herself is an exact genetic replica of another sheep and does not possess 'markedly different characteristics from any [farm animals] found in nature,'" and thus, "Dolly's genetic identity to her donor parent renders her unpatentable."  Analogizing the instant case to Myriad, the opinion states that:

Roslin "did not create or alter any of the genetic information" of its claimed clones, "[n]or did [Roslin] create or alter the genetic structure of [the] DNA" used to make its clones.  Myriad, 133 S. Ct. at 2116.  Instead, Roslin's chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken.  Such a copy is not eligible for patent protection.

The Roslin Institute also argued that its clones should be patent eligible because they are distinguishable in at least two respects from the donor mammals used to create them.  In particular, the Roslin Institute argued that:  (1) environmental factors lead to phenotypic differences that distinguish the clones from their donor mammals, and (2) the clones are distinguishable from their original donor mammals because of differences in mitochondrial DNA, which originates from the donor oocyte rather than the donor nucleus.  In response to both arguments, the Court noted that neither the phenotypic differences nor the differences in mitochondrial DNA were claimed.  Moreover, with respect to the phenotypic differences, the opinion indicates that "Roslin acknowledges that any phenotypic differences came about or were produced 'quite independently of any effort of the patentee.'"  Thus, "[such] phenotypic differences do not confer eligibility on their claimed subject matter [because a]ny phenotypic differences between Roslin's donor mammals and its claimed clones are the result of 'environmental factors,' uninfluenced by Roslin's efforts" (citation omitted).

The Court did appear to leave the door slightly ajar for other cloned animals, stating that:

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.  The clones are defined in terms of the identity of their nuclear DNA to that of the donor mammals.  To be clear, having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case.  Here, however, the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies.

As a result, the Federal Circuit affirmed the Board's finding that the Roslin Institute's clones constitute unpatentable subject matter under § 101.

In re Roslin Institute (Fed. Cir. 2014)
Panel: Circuit Judges Dyk, Moore, and Wallach
Opinion by Circuit Judge Dyk

Image of Dolly in her stuffed form (above) by Toni Barros, from the Wikipedia Commons under the Creative Commons Attribution-Share Alike 2.0 Generic license.

Comments

[Heebie-Jeebies]

Two scientists devise a new process- how to clone a mammal - and make something that's never been made before - a cloned mammal. The US patent system devises a way to grant a patent on the process but deny not only substantive patentability but patent-eligibility for the product of the process. Welcome to the club of third-world countries, USA. Judge Rich must be rolling over in his grave.

[EG]

Don,

This decision doesn't surprise (or dismay) me. As Dyk's opinion clearly points out (and I'm certainly no fan of Dyk), the "unique" features of this cloned animal need to be put into the claim language. Unfortunately for the applicant here, that wasn't done. All the claim recites is a "cloned" animal which, while it may have been done "by the hand of man," doesn't establish why it's different from Mother Nature and thus fails the "new" component of 35 USC 101.

[Patrick P. Zaretski]

The thing is, however, you are talking about organisms in which one normally automatically has an ownership interest in anyway. Is it really necessary to superimpose a second form of proprietary rights over cattle and other farm animals?

[Skeptical]

Patrick,

There is a clear difference in the ownership aspect between the traditional form (an object of property itself) and the patent form (an object divorced from any sense of tracing an item's particular "hands-on" as it were objective possession).

This is a fundamental understanding point in the allowance of a method and a non-allowance of the item.

Allowing a patent on the method does not foreclose other methods of obtaining the item , preserving the notion that the item itself has the attribute of "freely available to all men." One should NOT be confused by this statement to think that OTHER property laws do not apply, as surely, the land I own gives my ownership of the PARTICULAR instances of all natural things on that particular land. But is should be readily evident that we as a society cannot countenance the corollary view that because I own particular land, and that a particular item can be found on that land, that I then can claim ownership of that TYPE of particular item, no matter where else that item is to be found.

[David Koepsell]

Let's suppose I invent the photocopier and begin photocopying Shakespeare's plays. I'm no more the author of Hamlet as a result of my copying an instance of it than I am the inventor of some naturally occurring product I might develop some method of replicating. The doctrine that seems to be emerging is logical: the inventor must have put some inventiveness, some creativity into the form of the thing, into the design of the thing, and not merely copied it from someone else or nature.

[Skeptical]

David Koepsell,

Your attempt at finding an "emerging doctrine" relating patent 101 to copyright law is a bit of stretch.

That anyone knowledgeable in patent law would even think to go there..., well, I am...

[EG]

David K.

I oompletely agree with Skeptical that you should avoid mixing copyright law with patent law. What's constitutes inventorship in patent law is vastly different from what constitutes authorship in copyright law. Unfortunately, these two concepts are often confused by academics.

[Skeptical]

EG,

The next thing you know is that we will have people calling for a Fair Use equivalency in patent law, further denigrating the exclusive right.

[David Koepsell]

It's an analogy, EG. Analogies are common in legal reasoning. In this case, it's useful for understanding the reasoning of why making a copy of some composition of matter isn't inventing that composition of matter (anymore than copying Hamlet is authoring Hamlet) as apparently the court seems to agree.

Trying to bring some logic to the debate is all, and while I'm no patent lawyer, the logic I have argued for seems to be catching on these past few years when it comes to products of nature.

Cheers to all, and may the trend continue. ;)

[Skeptical]

David Koepsell,

No one is saying that the item is not an analogy, nor is anyone saying that analogies are not used in legal discussions.

What IS being said is that your analogy is not helpful.

It is not helpful because it obfuscates rather than clarifies. It muddles a concept from copyright law that does not have a place in patent law.

I would also point out that you are deluding yourself if you think that your repeating an inapt analogy is "catching on," and that you are somehow even remotely responsible for any trend in patent law.

"In spite of" may be a better characterization.

[David Koepsell]

Skep... relax, I never said I was in any way responsible at all (read carefully), merely that similar reasoning to that which I made long ago to skeptical people like yourself has nonetheless been winning the day. Indeed, probably "in spite of" my arguments and "despite" yours, justice prevails and that's what matters.

[Skeptical]

That's just it, David Koepsell, I have read (even read carefully), and that is why I mention that nothing at all like "similar reasoning" is at play with the "reasoning" you advance.

If anything, you are retarding that movement of justice, as obfuscation and befuddlement can only get in the way.

It is not bad to celebrate justice. It is dangerous to celebrate irrational behavior, associate that irrational behavior with the march of justice and become lock stepped in that fantasy.

I've read up on some of your exploits. I suggest that you do not lose touch with reality and misconstrue the law.

[David Koepsell]

Skeptical, yes, my "exploits" if you want to call writing, speaking, and general academic work "exploits" why, go ahead ... I have written quite a bit on the subject, and the reasoning I explored reflects very closely the current "product of nature" cases. I was encouraged by some of your earlier comments when you seemed almost to get the type/token distinction we talk about in logic. In any case, here are some excerpts from my 2009 book, published before the Myriad case even began. Please do tell me in which respect they did not anticipate or reflect the reasoning that seems at work in Myriad and in re Roslin:

"Each instance of the un-engineered human genome is a naturally occurring object. Its existence as an abstracted ideal which is instantiated in you, me, and every other human, in its present form has no element of the type of expression described above. There is no mixing of labor with any present human genome’s form, nor is there any human intention involved." (Who Owns You? p. 111-12)

"All copyrightable and patentable objects are intentionally produced man-made objects and they are not merely ideas. Your DNA, or mine, or any other non-engineered being, is not an expression according to this description of intellectual property, and neither is any naturally-occurring subset of a genome (such as a gene or a SNP)." (Ibid, p. 112)

"Chemical formulas, for example, or natural laws, cannot be copyrighted or patented. The seminal Supreme Court case Diamond v. Diehr, specifically excluded from patentability “laws of nature, natural phenomenon and abstract ideas.” (Ibid, p. 113)

"Many gene patents are perfectly valid both legally and ethically. All valid patents use products of nature in some form, but they do not extend to protect the naturally-occurring parts of the invention. Most patents on new chemicals involve not just a patent on the new compound, but also a patent on the process of synthesizing the compound.These sorts of patents provide guidance for how gene patents can legally issue and still also promote innovation. New genes could of course be patented if they are man-made. New combinations of genes can also be patented if they are the products of human intention." (Ibid, p. 114)

"Many gene patents issue now in which the current use of the gene is in merely finding the same gene. This is quite absurd. It is like patenting the element iron, and then claiming that the use of iron is in finding iron, or patenting the Rock of Gibraltar and then claiming that the utility of the patent is in locating the Rock of Gibraltar." (Ibid., p. 115)

here's a general statement about the role that ontology plays in clarifying the underlying concepts too: http://whoownsyou-drkoepsell.blogspot.mx/2013/06/philosophy-and-public-policy.html

And yes, I do think it's just that the courts are finding that products of nature are distinct from artifacts due to their lack of human design and intention, which is what I have long argued, and what seems to me to be reasonable, and logical, and still leaves lots of room for patenting things that are are the products of human ingenuity.

In any event, you'll want some final snarky word no doubt, so knock yourself out.

[Skeptical]

David Koepsell,

Snark is in the eye of the beholder.

My posts have directly asked you not to conflate different legal realms, and failing that, to recognize the difference between ANY march to justice and your laying claim to contributing such a march (your continued view that you 'reflect' actual theory is simply as off as your conflation).

You seem unwilling to recognize what I am actually saying.

Whether you are aware of this or not, well, I remain...