U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible

By Donald Zuhn --

In its amicus brief filed in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad"), the United States focuses solely on applicability of the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. on the patent eligibility of isolated genomic DNA.  The U.S. brief takes no position with respect to the impact of Mayo on Myriad's method claims (in particular, claim 20 of U.S. Patent No. 5,747,282), and concedes that "man-made complementary DNA molecules (cDNA) -- which comprise nucleotide sequences that do not exist in nature -- are patent-eligible subject matter under 35 U.S.C. § 101."

The brief notes, however, that "[a]s the United States explained in its original amicus brief, unlike cDNA, isolated but otherwise unmodified DNA molecules are not patent-eligible because they are 'products of nature,' not 'human-made inventions.'"  According to the U.S. brief, the Supreme Court's guidance in Mayo that "[p]atent protection is not available to those who simply discover existing aspects of nature, even if the discovery requires arduous work, represents keen scientific insight, and is of great value to society," simply "reinforces the conclusion that Myriad cannot patent DNA it discovered in and isolated from nature."

The brief characterizes the "principal issue" on appeal as being "whether composition claims for isolated genomic DNA are directed to patent-eligible subject matter," or worded another way, as "whether such claims are impermissible attempts to patent products of nature."  Citing Diamond v. Chakrabarty, the U.S. brief contends that "[t]o be eligible for a patent, a claimed composition must be 'human-made' and 'markedly different' from a naturally occurring substance."  The brief points out that the last time the Federal Circuit decided this case, "[t]he members of this panel agreed on that basic proposition," but "disagreed about whether distinctions between isolated and genomic DNA are significant enough to render isolated DNA 'markedly different' for § 101 purposes."

According to the U.S. brief:

The Supreme Court's decision in Mayo provides guidance regarding that question.  To be sure, that guidance is indirect.  Mayo involves process, not composition, claims, and the Court's analysis focuses on the standards for determining whether a claimed process effectively claims a law of nature.  Thus, Mayo does not directly address the criteria to be used in deciding the parameters of the product-of-nature exception, and every nuance of the Court's analysis may not mechanically extend to products of nature.  Nevertheless, in at least one respect, Mayo provides an important point of reference for deciding whether a claimed composition and a naturally occurring substance are "markedly different" for purposes of § 101.

In analyzing the claimed methods in Mayo, the Supreme Court repeatedly emphasized the need to ensure that claims not "tie up" laws of nature by preventing the public from exploring and exploiting those laws.

For the U.S government, "[t]he concerns implicated by patent claims that 't[ie] up the use of the underlying natural laws,' and thereby 'inhibit[] their use in the making of further discoveries,' may also be present when a patent contains a composition claim that relates to a product of nature."  The brief notes that "Mayo suggests that a court should ask whether a patent on the claimed composition has the practical effect of preempting the public's ability to use the product of nature itself."  The brief explains, therefore, that the genetically altered bacterium in Chakrabarty constituted patent eligible subject matter because it "would not have interfered with the public's ability to investigate or further modify the original bacterium or to experiment on the DNA plasmids that the patentee inserted into it to create the 'new bacterium.'"  "Similarly," the brief indicates, "cDNA molecules, which must be synthesized by scientists in the laboratory, are not created in the process of studying native DNA and pose little risk of preempting study of naturally occurring DNA."  The U.S, argues, however, that "patents on isolated but otherwise unmodified DNA would significantly impair the public's ability to study and make use of genomic DNA."

As for "Chakranbarty's 'markedly different' rubric," the brief disagrees with how the panel applied that standard in its first opinion, arguing that "[i]n light of Mayo, this Court should not rest patent-eligibility on the bare fact that isolating genes or gene segments involves the breaking of chemical bonds, or on the fact that scientists can use small gene segments to exploit the inherent chemical properties of DNA in ways that cannot be done with complete genes," and instead should ask "whether the differences identified in the original panel decision are sufficient to leave the public free to study and exploit the native BRCA1 and BRCA2 genes."

The U.S. brief concludes by briefly noting that the Supreme Court's refusal in Mayo to determine whether it was desirable to increase protection for discoveries concerning diagnostic laws of nature further illuminates the § 101 analysis.  The brief suggests that "[i]n this case, Myriad has argued that the extension of patent protection to isolated DNA is necessary in order to preserve financial incentives for making DNA discoveries."  The brief argues, however, that "Mayo strongly suggests that the judicial inquiry should not focus on industry-specific incentive arguments of this sort, pro or con, and instead should focus on 'established general legal rules.'"

For additional information regarding this topic, please see:

• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012

Comments

[Bill Kline]

How do you think this decision will apply to stem cells, particularly Human Embryonic Stem Cells and the therapies developed from them considering the differentiation processes?
Wondering about the current case in patent interference 105734 and 105827Geron vs Viacyte?

[6]

So Kev, you told me that the claims at issue did not preempt on any of the judicial exceptions, why is the US gov telling me differently?

[Kevin E. Noonan]

Easy, 6. The government is wrong (you're familiar with that, right?)

[6]

Well Kev, this right here:

"The U.S, argues, however, that "patents on isolated but otherwise unmodified DNA would significantly impair the public's ability to study and make use of genomic DNA.""

Is patent [redacted] speak for "patents on isolated but otherwise unmodified DNA would effectively preempt the genomic DNA however used.

But you think that they're wrong. I'm supposing that you think they're wrong because there are many other uses for genomic DNA that wouldn't be hampered by such claims.

One question though remains, would their ability to use and/or study the genomic DNA be significantly impaired? And be honest with me.

[Kevin E. Noonan]

There have been more than 8,000 published scientific papers reported on the BRCA genes since the patents were granted. How inhibited can they be?

[6]

While I respect your lawlyerly ability to answer a question with nothing but another question and a statistic I'm afraid that I am going to have to say that such is not really a complete answer. However, I will take it from what you did say that you believe that their ability to study the genomic DNA is not significantly impaired because there is evidence of many articles. Ignoring for a moment that you don't bother to compare this against the number of articles published about a comparable gene which was never patented this still does not touch on whether the ability to use the genomic DNA is significantly impared.

[Kevin E. Noonan]

The problem with the statistic you want is that it depends on the scientific interest in the gene, which is a confounding variable. I think 8,000 papers is a lot.

[Robert Cook-Deegan]

I gotta say that my favorite sentence in the US Gov't brief is, "To be sure, that guidance is indirect."

I have to think that Melissa Patterson or whomever wrote that sentence was smiling.

BCD

[6]

Well yes Kev, I agree about the stat, but that isn't so much what I want. What I would like to eventually get at is what I asked at the end, specifically whether the ability to use the genomic DNA is significantly impared.

Hows about it? Is the ability to use the genomic DNA significantly impared?

[Kevin E. Noonan]

Sorry, 6, I have been traveling.

My answer is that in my opinion, based on many, many, many studies looking for a negative effect of patents on basic genetic research that have found no effect, is that these patents do not inhibit basic research on human genomic DNA.

[Kevin E. Noonan]

Dear Bill:

Stem cells are next. Dan Ravicher has been trying to get the WARF patents invalidated for several years.

[6]

Your answer is to evade the question as a whole? I have specifically noted, thought I may not have been clear enough, that I am not talking solely about "basic genetic research" or even "research" in general.

I am asking, as a whole, not limiting ourselves to a discussion about basic genetic research or research at all, is the ability to use the genomic DNA significantly impared?

[Kevin E. Noonan]

6:

Not sure what you need. Maybe I'll approach it another way. If you want to use an isolated genomic DNA molecule and charge people money fr it, then you may infringe. But that isn't what those who say DNA claims arm innovation are saying. They don't want to admit they think the rules don't apply to them.

[6]

"Not sure what you need. Maybe I'll approach it another way. If you want to use an isolated genomic DNA molecule and charge people money fr it, then you may infringe."

I'm trying to ask, in your way of phrasing this: if you want to use an UNisolated genomic DNA, do the claims to the isolated genomic DNA significantly impair your efforts? And this question is taking into consideration all uses, every last conceivable use, of the UNisolated genomic DNA including ones "for a charge of money" or not.

"But that isn't what those who say DNA claims arm innovation are saying. "

No, I think this is where you're talking past one another. They're (the gov) are telling you this, and you aren't listening.

And also, as an ASIDE, but not to freak you out, it is likely the reason that Myriad's claims are likely on the way to the chopping block.

[Kevin E. Noonan]

Aha - now I understand. Simple answer: if the DNA is NOT isolated, you can do whatever you want to your heart's content. No worries, because the UNisolated DNA is like the leaf - not patentable without more.

I know what the government (or at least a part if it - the PTO seems to still be granting patents) is saying, and they are wrong.

[6]

"if the DNA is NOT isolated, you can do whatever you want to your heart's content. "

K I hear you, but you're saying you can do whatever you want to your heart's content except isolate it ... right? And isolating it is pretty much required to do something useful with just that little sequence of unisolated genomic dna isn't it?

[Kevin E. Noonan]

Ah, no, actually. For example, you could amplify pieces of it to detect specific mutations associated with disease, and because you have not isolated ALL of it, you don't infringe.

Also, you forgot the part about charging people - if you are not charging people you are not making anything to sue over, and the public interest will impact whether there is an injunction granted against you. So it seems to me that these claims are not the problem (except that they make a great sound bite and are good for fundraising by groups who should have plenty of other opportunities to right wrongs, etc.).

Anything else?

[6]

"Ah, no, actually. For example, you could amplify pieces of it to detect specific mutations associated with disease, and because you have not isolated ALL of it, you don't infringe."

So... I could use pieces of it. That seems good. But not the whole thing. So if I wanted to say... oh, idk, use the whole UNisolated genomic DNA... then I infringe. K. Yeah. I'm seeing bit of a problem emerge here.

"Also, you forgot the part about charging people - if you are not charging people you are not making anything to sue over, and the public interest will impact whether there is an injunction granted against you."

No, I remember it. I'm not so much concerned about injunctions as I am $$$/royalties.

"if you are not charging people you are not making anything to sue over"

Hmmm, that's funny, because I'm not sure if Myriad shares your view on this. Somehow I doubt they'd appreciate some do gooders eating into their biz.

In any case, I understand your position Kev, and I thank you for the dance, I will trouble you no more. But, upon further inspection, I think we're going to see a bit of a problem emerge in this here case due to the government's reasoning (that just so happens to be my reasoning from like what? 2 years ago?).

[Kevin E. Noonan]

Not to leave you with a false impression, if the genomic DNA isn't isolated you DON'T infringe. Let me give you one more hypothetical and be done. You have a cell that cannot make metabolite X, so it requires X on the media to grow. The deficiency is due to a mutation in gene Y.

You take DNA from a cell that CAN make metabolite X and introduce it into the cell that cannot make X. Now this part is important: isolating the cellular DNA (ALL of it) does not infringe a claim to isolated gene Y.

You then grow the cells into which you have introduced ALL the DNA from the cells that can grow without X in media without X. Most of the cells die, but the cells that grow now contain the Y gene.

Guess what - you don't infringe. Added bonus: this is how people did these experiments in the '80's and it works just fine.

Ok?

[patent litigation]

I applaud the U.S. brief for acknowledging (albeit indirectly) that the most significant issues regarding gene patents revolve around policy, rather than hard science. In my opinion, any decision as to whether to permit such patents can only be satisfactorily resolved by considering their effects on society at large.
http://www.generalpatent.com/blog

[6]

Yes Kev, I understand that I could use the "whole unisolated genomic DNA and not infringe". Thank you for fleshing it out further though. I apologize for not having used the correct wording in the previous post where I said " use the whole UNisolated genomic DNA". I was referring to what you would, using this new wording, call "the whole unisolated gene Y".

It is a difficult dance to even keep up with how you're using the terminology as you seem to be bobbing back and forth whenever I adopt my language to yours. Never the less, it appears that what I'm actually referring to, for example the BRAC1 gene, as it exists in the human body, practically cannot be used in its entirety and by its lonesome (note I'm not referring to your "isolation" although even if I were it wouldn't much matter) without infringing.