Ariosa v. Sequenom – Novel Genetic Analysis Fails The Mayo Test

3d render of dna structure, abstract backgroundToday, the Fed. Cir. affirmed the district court’s holding that the method for detecting paternally inherited nucleic acid of fetal origin in a sample of the mother’s blood was a patent-ineligible natural phenomenon. Ariosa Diagnostics, Inc. v Sequenom, Inc., Appeal No. 2014-1139, 2014-1144. (Fed. Cir. June 12, 2015). (A copy is available at the end of this post.)  Although commentators have already begun to lament that this decision puts a stake in the heart of claims to diagnostic methods (what I call “If A, then B” claims), I am going to do my best to resist this conclusion.

Of the claims asserted in the case, only one (claim 21) recites “providing a diagnosis based on the presence and/or quantity and/or sequence of the foetal nucleic acid,” and no dependent claim identified what specific diagnosis (e.g., increased likelihood of Down’s syndrome) was provided (or to whom it was provided). Claim 1 was broadly directed to a method for detecting a paternally inherited nucleic acid of fetal original performed on a maternal serum or plasma sample from a pregnant female by amplifying a paternally inherited nucleic acid and detecting its presence in the sample.

Claim 17 simply recites “The method according to claim [13 dependent on 5 (ineligible) dependent on 1] for detection of pre-eclampsia,” and Claim 18 read: “the method according to claim 13 for detection on foetal chromosomal aneuploidy.” However, claims 17-18 were not asserted in the suit . Also, they are written as statements of intended use and it is not clear that they would have been given patentable or 101 weight for that reason alone.

So Judges Reyna, Linn and Wallace could and did go ahead and find that the asserted claims all failed the Mayo “two part test” – the claims are directed to a natural phenomenon – the presence of cffDNA in maternal blood – and the preparation, amplification and detection steps are routine and conventional, so the claimed method “begins and ends with a naturally occurring phenomenon.” Reyna writing with Wallace describes claim 21 as “[focusing] on a method for performing a prenatal diagnosis, using claim 1’s method for detecting.” Although they do not mention this aspect of the claim again, the legal world deserves an explanation of why this claim element did not “ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.” (The panel disposed of the lack of preemption argument by simply folding it into the Mayo test – if a claim fails the Mayo test, by definition it preempts the natural phenomenon even if it, in fact, does not.)

The need for a better or, at least a more complete analysis of the individual claims is especially true in view of Judge Linn’s half-hearted concurrence in which he argues that the ability to detect cffDNA was an advance in the art sufficient per se to impart patentability. To use my terminology, Judge Linn characterized the Prometheus method as no more than an “old use of an old compound” and he continued:

“The Supreme Court’s blanket dismissal of conventional post-solution steps [as failing to impart patent-eligibility to a natural phenomenon] leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers…. Unlike in Mayo, the ‘540 patent claims a new method that should be patent-eligible…[quoting R. Eisenberg] as noting that despite Mayo’s declaration that a claim to ‘a new way of using an existing drug’ is patentable…it is unclear how a claim to new uses for existing drugs would survive Mayo’s sweeping test.”

Given his issues with Mayo, this would have made a nice dissent.

The Fed. Cir. sitting en banc and the Supreme Court should feel duty-bound to clarify this “ball of confusion,” especially in view of the Supreme Court’s suggestion that Prometheus’ claims were not directed to diagnostic methods, but is this the best case for that level of scrutiny of the claim?  Claim 21 covers any diagnosis based on the detection/quantification of cffDNA and the pseudo-method claims 16 and 17 were not considered. Apart from new methods to diagnose conditions for which there is no diagnostic method at present I am reading about new R&D efforts aimed at companion diagnostics on a daily basis. These researchers, investors and yes, even patent attorneys, deserve to know if these fields have an IP future.

14-1139.Opinion.6-10-2015.1

 

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4 Responses to Ariosa v. Sequenom – Novel Genetic Analysis Fails The Mayo Test

  1. EG says:

    Warren,

    This decision proves how utterly broken the Mayo/Alice standard is for determining patent-eligibility, especially for any medical diagnostic method that relies upon discoveries of naturally occurring phenomena. Both the majority opinion and Linn’s concurring opinion agree that Sequenom’s diagnostic method is meritorious. At least Linn’s concurrence vociferously protests (and rightly so) the utter insanity of the Royal Nine’s reasoning in Mayo. We can only hope that Big Pharma, including BIO, will finally scream to Congress that Our Judicial Mount Olympus needs to be “taken to the woodshed” for causing such nonsense.

    Frankly, SCOTUS needs to be (and can be) stripped of all ability to hear patent cases unless there’s clearly a constitutional issue involved. There’s no other way to keep the “fingers” of this technologically ignorant and totally biased judicial body out of the of the patent jurisprudence “pie.”

  2. Denise K says:

    Warren:
    Thank you for the in-depth review of yet another Federal Circuit opinion that fails to apply the needed reshaping of the Supreme Court’s “two step” analysis of patent subject matter eligibility. In my view, instead of a “two step” analysis of the “claim as a whole” the Supreme Court model the Federal Circuit believes it must follow is more a search for any type of natural correlation or natural substance (which can be found in ANY claim), followed by a conclusion (with little or no analysis of the claim as a whole) that the natural correlation or substance is the only point of the claimed invention, despite significant claim language describing application of the correlation to a previously new and useful end. If there was nothing new and useful to claim, there would b no reason to undertake great expense to develop, test, attain regulatory approval, market, produce and sell/license the claimed product or method.

    Judge Linn’s concurrence suggests the Federal Circuit is required to follow the decisions of Mayo and Myriad…. but doesn’t the Federal Circuit also have duty to interpret these cases in view of all prior case law, and more importantly, in light of the words of 35 USC Section 101? Shouldn’t the Federal Circuit be rounding out the meaning of the statute in the face of the Supreme Court’s lack of analysis? And shouldn’t both be applying analysis and constuction of the claim “as a whole” to determine the “inventive concept”?

    In the words of 35 USC Section 101:
    Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

    Section 101 is a brief statute, never intended to usurp the role of sections 112, 102, and 103. It was intended to clarify and distinguish patent subject matter eligibility from obviousness under section 103.

    This concept is further stated in legislative history accompanying the amendment of section 101 to replace the term “art” with the term “process”:

    The corresponding section of existing statute is split into two sections, section 101 relating to the subject matter for which patents may be obtained, and section 102 defining statutory novelty and stating other conditions for patentability.

    “Process” has been used as its meaning is more readily grasped than “art” as interpreted, and the definition in section 100(b) makes it clear that “process or method” is meant. The remainder of the definition clarifies the status of processes or methods which involve merely the new use of a known process, machine, manufacture, composition of matter, or material; they are processes or methods under the statute and may be patented provided the conditions for patentability are satisfied.

    Instead of applying 101 as intended by Congress, the Supreme Court and the Federal Circuit perpetuate a non-analytical approach to eligibility that rejects new and useful statutory subject matter without regard to the impact on innovation, new business, entire technology sectors, and economics.

    The claimed subject matter at issue in this case, like the claimed subject matter in Sequenom, Mayo, Myriad, and countless other patent claims that have been invalidated since the Supreme Court’s decisions most certainly fall into one of the enumerated claim types and meets the requirements of section 101 where, as Congress intended “…the status of processes or methods which involve merely the new use of a known process, machine, manufacture, composition of matter, or material; they are processes or methods under the statute and may be patented provided the conditions for patentability are satisfied.” (Legilative history, above)

    What then permits the Supreme Court and the Federal Circluit to slice and dice the claim language and disregard the wording of the statute and its intent? Who’s minding innovation for the US?

    Perhaps after Congress finalizes its Troll busting legislation it will have time and the push from industry and law groups to consider what might be done to improve the culling of subject matter from US patents.

    The views in this comment are mine personally and are not necessarily those of my Sunstein Kann Murphy & Timbers LLP or any of its clients.

  3. Paul Cole says:

    The observation that more detailed claim analysis would have been more appropriate is well made.

    At one extreme, claim 1 as granted reads:

    A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

    Since the method is not defined as having any particular end in view and substantially all methods are covered, it is difficult to defend the position that the claimed subject matter represents more than mere recitation of the discovery of a natural principle plus the words “apply it”. That observation appears reasonable notwithstanding the different outcome before the EPO in T 0146/07 (Prenatal diagnosis/ISIS) of 13.12.2011.

    The devil, however, is in the detail. Claim 13 requires determination of the concentration of foetal nucleic acid sequence in the maternal serum or plasma is by quantitative PCR, claim 15 specifies the detection of a maternal or foetal condition in which the level of foetal DNA in the maternal serum or plasma is higher or lower than normal and claim 18 specifies the use of concentration determination to detect a foetal chromosomal aneuploidy of which Downs Syndrome is a well-known example. The provision of a test for this condition that is less invasive than amniocentesis and can potentially be carried out at an earlier stage of gestation not only represents an application of the natural principle but also involves the step of concentration determination which arguably goes beyond the level of merely “apply it.”

    It is therefore arguable that at lest some of the claims covered by the Federal Circuit’s decision should have been held patent-eligible. On the other hand the decision also shows the importance of not relying on broad brush claims but also of including claims to specific applications e.g. in this case the use of the method to detect anomalies indicative of Down’s Syndrome which is covered by the general term aneuploidies but not specifically claimed.

  4. Paul Cole says:

    There is a footnote with a confusing typo.

    In the body of the opinion the claims at issue are listed as claims 9-22. In the footnote they are erroneously listed as 19-22.

    It appears that claims 13, 15 and 18 were stipulated to be represented by the other claims in issue. So the decision of the court was by agreement – if claim went so did potentially valuable subsidiary claims. As an outsider to the litigation it is difficult to understand why the concession was made.

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