By Professor Paul M. Janicke, University of Houston Law Center
The Myriad case from the Southern District of New York, involving patent eligibility of DNA isolates derived from naturally occurring DNA, drew a great deal of attention. The court basically held such isolates ineligible for patent coverage as being too similar to the natural substances, and hence barred by the product-of-nature case law. In the district court Myriad drew twenty-three amici briefs and a great deal of press attention. It is now on appeal at the Federal Circuit, where the first brief is due to be filed October 22. However, in a little-noticed partial dissenting opinion in another case, Circuit Judge Timothy Dyk has given a preview of his likely views on this important question.
The appellate case was Intervet Inc. v. Merial Ltd., decided by a Federal Circuit panel on August 4. The case involved DNA sequences encoding viruses harmful to pigs. According to the patent involved, knowledge of such sequences facilitates detection methods and production of vaccines against the harmful viruses. The patent specification gave full-length DNA sequences for five strains of these types of viruses, and a sequence for a similar but harmless pig virus for comparison purposes. The issues raised below and on appeal were: (i) whether the district court’s constructions of certain claim terms were correct; and (ii) whether a narrowing amendment made in the PTO while a claim was under prior art rejection foreclosed all access to the doctrine of equivalents for the territory between the original language and the amended language or left some of it open. No statutory subject matter issue was raised below or in the appeal.
The Intervet panel majority, consisting of Judges Prost and Bryson, decided those issues largely in favor of the patentee, Merial. Judge Dyk issued an opinion concurring in part and dissenting in part on the appealed questions. However, he also took the occasion to caution that the court’s decision in the case did not mean the court was acquiescing in the patent-eligibility of DNA, even in isolate form: “I write separately primarily to make clear that in construing the claims, we are not deciding that the claims as construed are limited to patentable subject matter.” He proceeded to address the main issue pending in Myriad, namely, whether isolates of DNA similar to DNA found in natural sources like humans or animals are eligible for patenting, or whether they run afoul of the Supreme Court’s pronouncements about products of nature in cases such as Funk Bros., Chakrabarty, and the recent Bilski decision. Judge Dyk indicated he did not think claiming the DNA in its isolated form was sufficient to distinguish it, for eligibility purposes, from the naturally occurring substance. He read the Supreme Court cases to require subject matter that is “qualitatively different” from the naturally occurring substance, and said it was “far from clear” that DNA isolates as claimed here met that test.[8] Perhaps foreshadowing his position in Myriad, he stated:
The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question. It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.
The impact of Judge Dyk’s views is difficult to predict. His is certainly an important judicial voice. However, he may not be on the panel drawn to hear the Myriad appeal, and the case may never be heard en banc. Moreover, these might not be Judge Dyk’s final positions on the issues. Only time will tell how this important case plays out.
* * * * *
[1] Association for Molecular Pathology v. United States Patent & Trademark Office, 2010 U.S. Dist. LEXIS 35418 (S.D.N.Y. April 2, 2010). Myriad Genetics was a co-defendant and co-owner of at least one of the patents in this declaratory action and exclusive licensee under others, hence Myriad has become the popular name of the case.
[2] 2010 WL 3064311 (Fed. Cir. 2010).
[3] See U.S. Patent 6,368,601, col. 1, lines 6-10.
[4] Id. at *9.
[5] Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948).
[6] Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
[7] Bilski v. Kappos, 130 S.Ct. 3218 (2010).
[8] Intervet, 2010 WL 3064311 at *11.
[9] Id.
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Awesome post dear.. Nice info
This issue cannot but go to the Supreme Court soon. Whoever loses on appeal in Myriad will take it all the way up to the SCOTUS, to be sure. Also, since the import and potential impact of this topic extend way beyond the usual confines of patent litigation, it is almost certain that the general public will weigh in. That being the case, I think Judge Dyk’s “leaf” analogy is pretty brilliant. He framed the issue in a way that members of the public can easily understand. Biotechnology specialists, on the other hand, may have a more difficult time making their case, unless they are able to communicate their perspective in comparably easy-to-understand terms.
Paul,
From a 101 point of view, absolutely nothing is wrong with such a claim.
My grammatical mistakes apart, from a purely philosophical basis, I do not like the removal of subject matter from the public domain that is presently in the public domain. This includes existing gene sequences simply because you manage to isolate it. It also applies to other kinds of bioprospecting. Discovering something that exists is not the same as inventing something.
Dosages should still be patentable as there may be a range that is particularly effective without being deadly, for example.
Suppose isolated penicillin G is not patentable.
What then is wrong with a claim to a pharmaceutical composition comprising penicilling G and a pharmaceutically acceptable carrier or diluent.
For licensing/infringement damages purposes the value of rhe composition is more than the value of the raw ingredient.
“If it hasn’t been found, then go ahead and patent it.”
Lulz.
I remember something about a new mineral in the earth, though just discovered…
My point was that any substance found in nature should not be. If it hasn’t been found, then go ahead and patent it.
That’s an anticipation issue, not a statutory subject matter issue. All the situations you listed as patentable do nothing to help 101 eligibility, they simply add credible utility or novelty, which generally are lacking when you find something on the ground.
The use of penicillin to kill bacteria also existed in nature, incidentally. And why should dosages be statutory if the substance itself is not? What curious magic makes penicillin non-statutory but this much penicillin statutory?
From a patentability standpoint, the concepts of “law of nature” and “object found in nature” are worlds apart.
The use of penicillin to kill bacterial infections or the designation of particular dosages and even modifications to the natural product itself should all be patentable.
My point was that any substance found in nature should not be. If it hasn’t been found, then go ahead and patent it.
I undercut my own post. I meant based in reality. Extra “not” in there was accidental.
“No, it’s the entirety of the physical structure of the thing itself, and that physical structure is what performs its function.”
Geez, IANAE, lighten up. You used to have a decent sense of humor.
Maybe if he’d read the book, he would get the joke.
Lionel-
Ever heard of these naturally occurring compounds – penicillin, taxol, Bt genes, etc. Almost all organic chemical compounds can be found in nature if one looks hard enough. Are all those unpatentable? If you really think academics can do all the medical science required, you are nuts and noone will do the work in industry without patent protection.
ACLU – don’t we have enough politics on the boards already?
“Can you make an argument not based on reality”
Sure – I can be just like Lionel and misstate the “isolated” term to indicate a bogus argument of “found in nature”.
That be so easy, even the ACLU can do it.
Pick you fights. Don’t get sucked in again.
“Yup, this thought by Dyk is certainly driving me to re-visit my opinion that the law was settled on this issue. Should the law be setled? Yes. To follow Dyk’s logic might make whole classes of compounds unpatentable and set back medical science decade”
Omigod, if non-inventors aren’t able to patent substances found in nature the world will end!
Seriously? Do you really believe that without patents on sequences found in nature that are recreated in a lab, medical science will be set back? Why? Can you make an argument not based on reality and not abstract theory or economic arguments?
No, it’s the entirety of the physical structure of the thing itself, and that physical structure is what performs its function.
Geez, IANAE, lighten up. You used to have a decent sense of humor.
“GATACA” is just printed matter, don’t ya know.
No, it’s the entirety of the physical structure of the thing itself, and that physical structure is what performs its function. Physically, or as near to physically as is possible on such a small scale.
How about a claim to an isolated politician? Nominations, anyone?
Given the importance of this case, they should take the issue en banc in the first instance, just as the did the Seagate case.
MM, dude I was just pulling your leg.
On a Monday?!?!??
The last sentence should say…. Why don’t these that are 3 months late have an OPAP stamp like the earlier ones that I received in a week?
Why in the mail today would I get two letters from the USPTO dated having been filed 06/09/10 then mailed 6/22/10, but I got them today 9/27/10 in My PO BOX? Not glued but taped shut? Is that a knee jerk reaction they are hoping for. And earlier ones I received from the USPTO have a blue OPAP Mail stamp, but these that are over three months late in receiving them in my PO BOX don’t? Does anyone have a clue? Is someone messing with my mail AGAIN? Why don’t these that are taped shut without an OPAP Stamp on the envelope?
MM, dude I was just pulling your leg.
It will certainly be interesting to see how the 3 CAFC judges who get picked to decide this appeal[and the odds are strongly that none will have ever practiced patent law] will react under the unusual, for them, glaring media attention this case has already gotten and will get there. I hope they can write a decision that even a newspaper reporter can understand, yet does not leave long-established patent law and hundreds of thousands of issued patent claims “isolated” [pun intended] in some kind of legal limbo or morass.
It would be a bonus if they could also deal with some of the prior PR miss-representations as to what all is actually being claimed and what such claims actually cover.
“The structure is recited in at least 99% of the granted claims and 100% of the valid ones. What exactly are you talking about?”
“GATACA” is just printed matter, don’t ya know.
6 if applicant’s are going to rely on those other arguments, like it being structurally different, way different, isolated, then they ought recite that structure eh MM?
The structure is recited in at least 99% of the granted claims and 100% of the valid ones. What exactly are you talking about?
Thanks, 6. Maybe the next time you and I are both at the Patent Office we could discuss. I may be on the IPO PTO Day panel on this topic.
Yup, this thought by Dyk is certainly driving me to re-visit my opinion that the law was settled on this issue. Should the law be setled? Yes. To follow Dyk’s logic might make whole classes of compounds unpatentable and set back medical science decades…
Very interesting article there Courtenay, we could discuss it over dinner if you’d like.
“Contrary to what Mooney states, the fact that a Judge announces this position is reason enough to worry. There is no sleeping dog here. That is a low guttural growl that should not be poo-pooed and ignored.”
I’m not poo-pooing him at all. I’m all for us drinking the same kool aid as the good judge here.
“you’ve visited the 500+ thread well”
Built that with mah own two hands thanks very much.
I wrote about this Dyk dissent also, and took a closer look at the Funk Brothers case that he draws from:
link to pharmapatentsblog.com
Now that I caught up on my reading of July 13, 2010. I know I am in good hands. And I think I am going to put my sneakers on and take a nice long walk.
“then they ought recite that structure eh”
“poor ol kev, so much of his ink wasted.”
Kev’s points seem pretty clear and his refusal to jump at the “software” bait you offered should not make you feel slighted, even as you attempt to troll this thread as well (there is a place for any “recite the structure” arguments you want to make – you’ve visited the 500+ thread well).
Contrary to what Mooney states, the fact that a Judge announces this position is reason enough to worry. There is no sleeping dog here. That is a low guttural growl that should not be poo-pooed and ignored.
“All I can say is that if Judge Dyk’s dissent represents his best arguments for finding synthetic DNA to be unpatentable subject matter, then applicants in that area have nothing to worry about.”
poor ol kev, so much of his ink wasted.
“All I can say is that if Judge Dyk’s dissent represents his best arguments for finding synthetic DNA to be unpatentable subject matter, then applicants in that area have nothing to worry about.”
That’s actually true, but I also think that if applicant’s are going to rely on those other arguments, like it being structurally different, way different, isolated, then they ought recite that structure eh MM?
Don’t know why the author called the dissent in Intervet “little noticed”. Over at patentdocs.org, Kevin Noonan took Judge Dyk to task for this dissent. link to patentdocs.org
Also, seems to me that, using the same logic ACLU et al. applied in asking Judge Rader to recuse himself, Myriad could now ask Judge Dyk to the same, since he’s now tipped his hand to reveal his prejudices, in a situation in which the question of DNA patentability wasn’t before him, just as the question wasn’t before Judge Rader when he spoke. I’m sure Myriad won’t do this – such a request would be as premature and would be as likely to meet with success as ACLU’s motion – but what’s good for the goose should be good for the gander, and it would interesting to see the ACLU oppose the motion on grounds that could only be hypocritical.
All I can say is that if Judge Dyk’s dissent represents his best arguments for finding synthetic DNA to be unpatentable subject matter, then applicants in that area have nothing to worry about.
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