As Predicted, Federal Circuit Rules Isolated DNA Patentable

Structure of a DNA double helix,
Fig. 1 from the CAFC majority opinion.

After much anticipation, the United States Court of Appeals for the Federal Circuit earlier today issued a decision in Association for Molecular Pathology v. Myriad Genetics.  The decision on first glance will seem to be a split decision, particularly by Federal Circuit standards.  The majority opinion was written by Judge Lourie, Judge Moore wrote a concurring opinion and Judge Bryson concurred in part and dissented in part.  Having said that, the outcome largely seems to be what was predicted by the patent community.  On the major substantive issue — are isolated DNA molecules patent eligible subject matter — the Federal Circuit reversed the decision of the district court and ruled that isolated DNA molecules do constituted patent eligible subject matter.  The Federal Circuit also ruled that methods relating to the screening for potential cancer therapeutics are, likewise, patent eligible subject matter.  All three Judges also found the “comparing” and “analyzing” claims to be ineligible for patent protection because they were not transformative, and thus were merely abstract mental steps.

On March 29, 2010, Judge Sweet of the United States Federal District Court for the Southern District of New York issued a 152 page opinion determining that isolated DNA molecules were not patent eligible subject matter, setting of 16 months of intense debate on the issue.  This lead me to on March 31, 2010, write Hakuna Matada, the ACLU Gene Patent Victory Will Be Short Lived, which in fact has turned out to be the case, but this fight seems far from over, perhaps with additional appeals yet to come. Notwithstanding, upon closer scrutiny the ultimate holdings in the decision are by and large 3 – 0, with only Judge Bryson dissenting relative to the BRCA gene claims.

[Bio-Pharma]

Judge Lourie was the linchpin vote regarding patent eligibility of all of the isolated DNA molecules and the diagnostic method claims, finding overlapping support with Judge Moore on most issues and also with Judge Bryson for the most part.  Judge Moore agreeded with the majority regarding patent eligibility of the method claims and the cDNA claims, both for the same reasons announced in the majority opinion.  However, Judge Moore only concurred in the outcome relative to the other sequences.  Judge Bryson agreed with the majority opinion relating to patent eligibility of the method claims and the cDNA claims, but would have found the BRCA gene claims to constitute unpatentable subject matter.  Finally, there was complete unanimity of the Judges on the standing issue.

For those keeping score, here is the breakdown:

1. Standing: 3 – 0
2. Method claims: 3 – 0
3. cDNA claims: 3 – 0
4. non-cDNA claims: 2 – 1

Nevertheless, with all of the hype surrounding this case, with three separate and lengthy opinions (by CAFC standards) and with the Federal Circuit showing interest in recent years to hear fundamentally important cases en banc, I suspect this case may be headed for en banc consideration by the entire Federal Circuit.  I suspect Judges Lourie, Moore and Bryson do as well, or perhaps they are anticipating an appeal to the Supreme Court.  Each of the decisions are written as if there is a broader audience in mind; namely others on the Federal Circuit or those 9 Justices located on the corner of First Street, NE and Maryland Avenue.

As for the ruling itself, in a nutshell, here is what the majority opinion held:

On the threshold issue of jurisdiction, we affirm the district court’s decision to exercise declaratory judgment jurisdiction because we conclude that at least one plaintiff, Dr. Harry Ostrer, has standing to challenge the validity of Myriad’s patents. On the merits, we reverse the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature. We also reverse the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle. We, however, affirm the court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent ineligible abstract, mental steps.

Given that Judge Moore’s opinion was the swing decision relative to the BRCA gene claims it deserves to be the focal point in any understanding of what this Federal Circuit decision really means.  Let’s begin with Judge Moore’s opening in her opinion, characterized as concurring in part:

I join the majority opinion with respect to standing and the patentability of the method claims at issue. I believe, however, that claims directed to isolated DNA sequences present a different set of issues. I join the majority with respect to claims to isolated cDNA sequences, and concur in the judgment with respect to the remaining sequences.

At one point in her concurring opinion, Judge Moore would wrote: “If I were deciding this case on a blank canvas, I might conclude that an isolated DNA sequence that includes most or all of a gene is not patentable subject matter.”  This sentence no doubt causes patent proponents to take a gasping deep breath.  This, however, comes across far stronger than it should and is an overstatement of Judge Moore’s considered views.

Earlier in her opinion Judge Moore explained that “the cDNA claims present the easiest analysis.”  Judge Moore wrote that “cDNA sequences do not exist in nature,” and they “have a distinctive name, character, and use, with markedly different chemical characteristics from either the naturally occurring RNA or any continuous DNA sequence found on the chromosome. The claimed isolated cDNA sequences are the creation of man…” Therefore, when Judge Moore writes of possibility of having decided the case differently had it been a matter of first impression, she is clearly referring to the BRCA claims, not all isolated DNA sequences.

Judge Moore then went on to write at length about settled expectations of the industry and the fact that Congress has long urged an expansive view of what ought to be considered patent eligible subject matter.  She wrote:

This case, however, comes to us with a substantial historical background. Congress has, for centuries, authorized an expansive scope of patentable subject matter. Likewise, the United States Patent Office has allowed patents on isolated DNA sequences for decades, and, more generally, has allowed patents on purified natural products for centuries. There are now thousands of patents with claims to isolated DNA, and some unknown (but certainly large) number of patents to purified natural products or fragments thereof… I believe we must be particularly wary of expanding the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved. Combined with my belief that we should defer to Congress, these settled expectations tip the scale in favor of patentability.

In the end Judge Moore was simply unwilling to support a new judicially created exception to patentability in light of the history of the patent laws and expectations within the industry.

Next, in a nutshell, here is what Judge Bryson wrote in his opinion, which was concurring in part and dissenting in part:

I concur with the portions of this court’s judgment that are directed to standing, the patentability of the cDNA claims, and the patentability of the method claims. I respectfully dissent, however, from the court’s holding that Myriad’s BRCA gene claims and its claims to gene fragments are patent-eligible. In my view, those claims are not directed to patentable subject matter, and if sustained the court’s decision will likely have broad consequences, such as preempting methods for whole genome sequencing, even though Myriad’s contribution to the field is not remotely consonant with such effects.

As you can probably imagine, there is much left to be said about this case.  Judge Lourie’s majority opinion was 54 pages, Judge Moore’s concurring opinion was 31 pages and Judge Bryson’s opinion concurring in part and dissenting in part was 19 pages.  Having just come out this morning it is impossible to have a considered, nuanced view of the case only hours later.  As many will do, I will study the case and cogitate.  Rather than enjoying any summer reading on my flight to Chicago on Monday (where I will teach the PLI patent bar review course next week) I will be pouring over this decision.  Many a discussion with John White will likely focus on the case, and I am looking forward to touching base with the Patent Docs, Kevin Noonan and Donald Zuhn, while in Chicago.

Check back in the coming weeks for additional analysis.  In the meantime, Hakuna Matada!  The Federal Circuit reached the correct decision!

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Join the Discussion

6 comments so far.

  • [Avatar for Molecular biologist]
    Molecular biologist
    September 15, 2011 11:42 am

    ‘…..the isolated molecule possesses different properties than when it is in the human body.’

    I don’t agree with this interpretation. It (cDNA) is chemically/structurally different but not in function. Hence, it should not pass muster under USC 101. And how do you define a gene? It is by its function and not by its DNA chemical structure. Patenting genes will have far-reaching adverse consequences and will actually hinder basic science advancement. I have no problem with the method claims of BRCA1 but patenting a cDNA is absurd!

  • [Avatar for Vincent]
    Vincent
    August 3, 2011 03:51 am

    Okay, I see that Jason. Then why don’t they just patent the particular protein that the DNA codes for?

  • [Avatar for Jason C.]
    Jason C.
    August 2, 2011 10:57 pm

    Vincent – Does cDNA having the particular sequence mutation leading to increased risk of breast cancer exist in nature? It does not. Just because cDNA is out there doesn’t mean every cDNA is now unpatentable subject matter. It however could be used to point to the obviousness of a particular isolated sequence. As the judge pointed out, although the information content is the same, the isolated molecule possesses different properties than when it is in the human body. This therefore passes the threshold of 101, however, it does not mean the isolated molecule is NON-OBVIOUS. With that in mind, this patent could have been attacked for being obvious considering that it is a well-known technique to isolate DNA from the human body and create cDNA. As judge Lourie noted, “Uses of chemical substances may be relevant to the non-obviousness of these substances…but the patent eligibility of an isolated DNA is not negated because it has similar information properties to a different, more complex natural material that embodies it.” I think many of the issues with this case come down to obviousness, not 101. 101 should be read expansively unless Congress decides otherwise.

  • [Avatar for Vincent]
    Vincent
    August 1, 2011 12:32 pm

    I have just started to study patent law, but is there a basic flaw in stating that cDNA is patentable subject matter? cDNA does exist in nature in certain viruses and I do not know for certain, but I believe the process in creating the human cDNA has it’s roots in mimicking this behavior in the viruses. According to USC 101 this would not be patentable because it is not a new invention or discovery of a composition of matter. To my knowledge it only seems that the process in which they used to create the cDNA from the mRNA would be able to be patented.

  • [Avatar for EG]
    EG
    July 30, 2011 10:17 am

    Oops, in the next to last paragraph I meant “molecular biology,” not “microbiology.”

  • [Avatar for EG]
    EG
    July 30, 2011 10:06 am

    Gene,

    Very interesting opinion. Lourie actually one his better and more understandable opinions. I definitely agree with his analysis on the isolated gene sequence quesiton. And can sort of go along with his analysis on the method claims. And I can live with the view of the entire panel on the standing issue which is a significant “kick in the gut” for the ACLU’s PR-inflated and disingenuous “broad standing” view.

    Judge Moore’s concurring is also interesting in that she recognizes the reality of of overturning what the USPTO has done for 30 or so years in granting patents to isolated gene sequences. She’s definitely “growing-up” as a Federal Circuit judge and I applaud her for that

    I would also qualify the “3-0” score keeping on the method claims. The Federal Circuit basically held all but one of the method claims patent-ineligible using teh M or T test (I don’t agree with their view of the patent-ineligibility of these claims BTW, but at least I understand where the current demarcation line is between patent-eligible and patent-ineligible for such method claims), but also ruled that Claim 29 of the ‘282 patent (“A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and compar-ing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.”) was patent-eligible as being transformative in at least the “growing” step. Method Claim 29 of the ‘282 patent (assuming there’s no en banc Federal Circuit or SCOTUS ruling that suggests otherwise) should give us patent attorneys/agents a pathway to how to write such claims to avoid issues under 35 USC 101.

    Judge Bryson is apparently in Judge Dyk’s camp on the isolated gene sequence issue. Their mystifies and annoys me from the standpoint of ignoring the science, chemistry, microbiology, and more significantly, the reality here.

    Overall, this decision should be viewed favorably by the biotech world. Let’s hope there’s no en banc Federal Circuit (or even worse, SCOTUS ruling) that messes this decision up.

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