Genetic Technologies Ltd. v. Merial L.L.C. (Fed. Cir. 2016)

By Kevin E. Noonan --

The Federal Circuit affirmed the latest invalidation of genetic diagnostic claims last week, in Genetic Technologies Ltd. v. Merial L.L.C.  While consistent with (and expressly relying upon) recent Federal Circuit precedent on this question, this case presents additional aspects deleterious to genetic diagnostic method patent holders.

The patent at issue, U.S. Patent No. 5,612,179, was granted on March 19, 1997, filed September 23, 1992, and expired March 18, 2014.  Claim 1 is representative:

1.  A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:
    a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and
    b) analyzing the amplified DNA sequence to detect the allele.

The case was originally filed by GTG in Colorado against several defendants; this action was then "severed and transferred to the District of Delaware."  Defendants moved to dismiss under Fed. R. Civ. Proc. 12(b)(6) for failure to state a claim, on the grounds that the claims were invalid under 35 U.S.C. § 101.  The District Court granted this motion based on Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1298 (2012), without performing claim construction.  Before the Federal Circuit, the parties stipulated that "claim 1 is representative of claims 2–25 and 33–36 of the '179 patent with respect to eligibility under § 101."

The Federal Circuit affirmed, in an opinion by Judge Dyk joined by Chief Judge Prost and Judge Taranto.  The opinion begins with a curiously detailed explication of the scientific basis of the invention, which is linkage disequilibrium, i.e., the genetic phenomenon that certain portions of the genome can, in some individuals, be inherited together at frequencies higher than would be expected at random.  As stated in the opinion:

Claim 1 is thus broad in scope; it encompasses methods of detecting a coding region allele by amplifying and analyzing any linked non-coding region, which could be found within the same gene as the coding region, within a different gene, or within an intergenic region.

The panel dismissed any procedural objections to the District Court's decision below, stating that "[w]e have repeatedly recognized that in many cases it is possible and proper to determine patent eligibility under 35 U.S.C. § 101 on a Rule 12(b)(6) motion," citing OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362 (Fed. Cir. 2015); Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat'l Ass'n, 776 F.3d 1343, 1351 (Fed. Cir. 2014); and buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014).  In addition, claim construction is not always required according to the opinion: "[C]laim construction is not an inviolable prerequisite to a validity determination under § 101," the panel states, citing Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 1273 (Fed. Cir. 2012); see also Content Extraction, 776 F.3d at 1349."

Turning to the substance of the case and calling the Supreme Court's Mayo/Alice test "well-established," the opinion applied the two steps of the test: 1) determining whether the claim is "directed to" a law of nature, natural phenomenon or abstract idea, and 2) determining whether the claim included an "inventive concept" (or "something more") that would render it patent eligible.  The panel found that the claim satisfied the first step of the inquiry:  "Claim 1 is directed to the relationship between non-coding and coding sequences in linkage disequilibrium and the tendency of such non-coding DNA sequences to be representative of the linked coding sequences -- a law of nature."  Sub silentio, the opinion raised the issue of preemption:  "Claim 1 covers any comparison, for any purpose, of any non-coding region sequence known to be linked with a coding region allele at a multi-allelic locus . . . .  The '179 patent does not limit its scope to methods of detecting any particular alleles linked to any particular non-coding sequences, . . . .  Claim 1 broadly covers essentially all applications, via standard experimental techniques, of the law of linkage disequilibrium to the problem of detecting coding sequences of DNA" (emphasis added), and thus nicely introducing the second part of the analysis into its assessment of whether the first part of the Mayo/Alice test was satisfied.

The opinion then reached the crux of the philosophical disapprobation of most diagnostic method claims:  "[t]he product of the method of claim 1 is information about a patient's natural genetic makeup -- at least one coding region allele" (emphasis added), which depends on the existence of linkage disequilibrium, i.e., a natural law.  This, for the panel, made the claim "quite similar" to the invalidated claims at issue in Mayo, based on its reliance on a biological sample and with the identification of "allegedly newly discovered information about human biology" (despite of and ignoring all the other factual differences, including that all of the steps of the claimed methods in Mayo had actually been performed in the prior art).  Accordingly, the Federal Circuit agreed with the District Court that the fact that the claimed methods were dependent on a naturally occurring phenomenon was enough for these claims to be "directed to" a natural law.

The panel also relied on the Court's Ariosa v. Sequenom decision, which involved "genetic testing method claims remarkably similar to the claim here" according to the Court.  And the panel took the opportunity to foreshadow its consideration of the second prong of its analysis by stating that "the patent claim focuses on a newly discovered fact about human biology (the linkage of coding and non-coding regions of DNA), [which] involves no creation [not strictly correct] or alteration of DNA sequences, and does not purport to identify novel detection techniques."

The panel thus concluded that the claim is "directed to" a law of nature because "the sole function of the 'primer pair defining a DNA sequence which is in genetic linkage with [a multi-allelic] genetic locus' is to amplify a sequence of non-coding DNA in linkage disequilibrium with a sequence of coding DNA of interest" (a statement that acknowledges human effort to select appropriate primers and perform the amplification; while these considerations are important in making an assessment of the second prong they seem to beg the question when applied to determining whether the claims are "directed to" a law of nature).

At last turning to the second prong, the panel applied the language from Mayo that "well-understood, routine, conventional activity previously engaged in by researchers in the field" is not sufficient to convert a natural law to a patent-eligible invention.  Applying the same logic the Court used in finding Sequenom's claims patent ineligible, the panel supported this conclusion (as it has in prior cases) with patentee's statements regarding such methods from the prosecution history in response to rejection under 35 U.S.C. § 112.  And the panel used its Ariosa decision as express precedential support for its conclusion:  "claim 1 of the '179 patent is directly comparable to the claims invalidated in Ariosa."

The panel capped off its invalidating decision of GTG's claims by rejecting patentee's arguments regarding the "something more" its claims provide other than the natural law:  that the practice of the claimed methods enables detection of the linked (coding) allele, which is typically associated with (if not directly responsible for) a disease or genetic disorder.  This benefit the panel dismissed as a "mental step," supporting this determination with citations to the Court's precedents involving Section 101 invalidation of computer-related and business method claims.  This argument followed the same pattern as the rest of the court's analysis:  taking all the rest of the recited steps individually, the use of the genetic information becomes merely a mental step, which is isolation it well may be.  Ironically, the opinion cited Diamond v. Diehr in support of its "mental step" argument, missing the critical teaching from Diehr that claims cannot be deconstructed into their component steps but must be considered as a whole.  In addition, the opinion analogized the claims at issue here with the claims in Mayo, equating the expressly recited step here ("to detect the allele") with the "wherein" clauses that caused the Supreme Court to invalidate Prometheus's claims.

In addition, the opinion reflects the difference between the state of the art when these claims were filed (the appropriate frame of reference for determining patent eligibility) with the current state of the art.  The opinion states that:

The limitation "to detect the allele" merely asks the user to compare the non-coding sequence he has amplified and analyzed with a library of non-coding sequences known to be in linkage disequilibrium with certain coding region alleles.  This instruction to undertake a simple comparison step does not represent an unconventional, inventive application sufficient to make the claim patent-eligible.

Of course, that "simple comparison step" was not simple in 1992; the claimed method enabled the comparison otherwise unavailable in the art.

In this regard the panel once again relied upon its Ariosa decision, specifically claims 21 and 25 from U.S. Patent No. 6,258,540 that recited performing prenatal diagnosis in rejecting GTG's arguments for patent eligibility.  The opinion also cited In re BRCA1- & BRCA2-Based Hereditary Cancer Test, 774 F.3d 755 (Fed. Cir. 2014) (another opinion by Judge Dyk), for the proposition that the combination of the "non-patent-eligible elements" of the claim with a comparison step was patent ineligible –- again, ignoring the Diehr rubric that claims should be interpreted as a whole.

Finally, adding insult to injury the Court awarded costs to appellees.

The important conclusion from this precedential opinion is not whether these claims are (or should be) patent eligible.  The case is important because it again affirms the procedural legitimacy of attacking the patent eligibility of claims using a motion to dismiss under Rule 12(b)(6), and without the court performing claim construction.  It also illustrates the importance of having the Supreme Court render an opinion in Ariosa; without the Court's intervention and clarification, the Ariosa opinion is sufficiently broad that no diagnostic method claim will be safe from the logic set forth in that case and in this opinion.  At least some members of the Federal Circuit clearly believe that their hands are tied and that they are compelled to come to conclusions such as the ones in this opinion based on binding Supreme Court precedent (even if Judge Newman believes that there is room in that precedent to distinguish cases such as Ariosa and presumably this one).  But until such time that the Court deems it proper to render such clarification, it is hard to see how patentees of diagnostic inventions can rely on the U.S. patent system for any protection.

Genetic Technologies Ltd. v. Merial L.L.C. (Fed. Cir. 2016)
Panel: Chief Judge Prost and Circuit Judges Dyk and Taranto
Opinion by Circuit Judge Dyk

Comments

[Paul Cole]

The term "directed to" in the first stage of the Mayo/Alice framework is applied unduly broadly.

Consider the process for cooking an omelette. It starts with eggs. It ends with an egg product. That does not mean that the process is directed to eggs. It involves eggs, but it is an over-simplification to say that it is therefore directed to eggs.

Another unfortunate and grossly misapplied instance of the Mayo/Alice framework.

[skeptical]

I have seen the following notion expressed elsewhere: ALL pharma should be wary of this case and its logic, as all medicine is "directed to" natural law (what other law is there?) and the use of items that do nothing more than "apply it."

[Paul Cole]

@ Skeptical

Unfortunately I have to agree with you. That is why further explanation of the Myriad/Mayo framework is important, and in the absence of legislative action it can only come from the Supremes.

[Confused]

Although the procedure for invalidation is distressing, the claims looks like it fits well within precedent. My mental model is to look for specific compositions by sequence or structure, or it's too easy to say it pre-empts all uses of a natural law. Detection claims seem all done for.
I've been waiting for cases incorporating measured thresholds or multi-marker algorithms. The patent office is still issuing those kinds of claims, but there don't seem to be any cases to test them yet.

[Eric Grote]

What I find disturbing is the court's misunderstanding of the scientific basis of the invention. The court states that "the patent claim focuses on a newly discovered fact about human biology (the linkage of
coding and non-coding regions of DNA)." This is patently untrue. Linkage disequilibrium was discovered in the 1960's and was taught by standard genetics textbooks prior to the filing date. The court's concern about preemption is misplaced.

[The Memory Motel]

Kevin: "that "simple comparison step" was not simple in 1992"

Yes it certainly was, Kevin.

Kevin: "the claimed method enabled the comparison otherwise unavailable in the art."

The "claimed method" did not "enable" one to do anything new at all because there is no new technology recited in the claim. It's just PCR on a non-coding sequence that happens to be genetically linked with another sequence. People had looked at non-coding sequences before using other detection methods. Nobody in the art doubted that those non-coding sequences couldn't be detected with PCR.

By your logic, Kevin, the art also didn't "enable" me to use PCR to detect my son's DNA because my son wasn't conceived. I assume you can see the problem that result presents to the patent system. Let me know if you can't see the problem with that result and I'll simplify it for you even further.

[The Memory Motel]

Kevin: "no diagnostic method claim will be safe from the logic set forth in [Ariosa] and in this opinion"

That's not true, of course.

So why would Kevin say it?

It's pretty easy to answer that question. We'll give Kevin a chance to take a breath and walk his assertion back before we waste our time explaining the basics to him ... again.

C'mon, Kevin. You're a smart guy, on paper at least. You think you can swallow your pride, stop the fearmongering and get a grasp on reality? Give it the old college try.

[Kevin E. Noonan]

Tell you what, MM. Write me such a claim - a simple one - and I'll let you know what I think

[The Memory Motel]

Kevin: "Write me such a claim - a simple one"

I'll give you two such claims.

A. A diagnostic method, comprising [carrying out one or more steps utilizing a structurally distinguished novel non-obvious composition of matter or apparatus].

B. A diagnostic method, comprising [carrying out one or more steps that necessarily result in a previously undescribed non-obvious physical transformation of matter].

Let me know what you think. But please don't waste everyone's time pretending that the GTG's claims fall within the two classes I just described. They don't.

[The Memory Motel]

Eric Grote: "Linkage disequilibrium was discovered in the 1960's and was taught by standard genetics textbooks prior to the filing date."

The more granular "discovery" alleged by the inventors was the "discovery" that so-called "non-coding DNA" could be in linkage disequilibrium. The key word here is "alleged" because GTG's game from the beginning has been to kick up dust and flip/flop back and forth between so-called "non-coding DNA" and "junk DNA" whenever it suits them (not that their game affects the 101 analysis, which is the beauty of applying 101 to these claims).

"The court's concern about preemption is misplaced."

What's your reasoning, Eric?

[skeptical]

The A. and B. offered by M(alcom or emory) M(ooney or otel) cannot be the sum total of the law, as those options simply do not give full weight to the subject matter category of process.

In each of these simple examples, the invention is simply not in the process, but in the "hard goods" item that can be claimed independently of the process.

It is beyond clear that his attempt to use ONLY the Machine or Transformation "clue" is an attempt to elevate MoT to something more than a clue.

The Supreme Court has made this clear that such "thinking" is simply not correct. MoT is neither required nor sufficient.

It is also undoubtedly clear that M(whatever) M(whatever) is well aware of this fact.

So, to use his own words:

So why would [sockpuppet of the moment] say it?

It's pretty easy to answer that question. We'll give [sockpuppet of the moment] a chance to take a breath and walk his assertion back before we waste our time explaining the basics to him ... again.

C'mon, [sockpuppet of the moment]. You're a smart guy, on paper at least. You think you can swallow your pride, stop the fearmongering and get a grasp on reality? Give it the old college try.

OK, moment's over: simply put: his simple examples fail to cover what the statutory category of process allows.

This is analogous to pretending that one OPTIONAL claim format must be the de facto ONLY legal claim format - something no self-respecting attorney would attempt to do.

Will this commentator do what he asks others to do, to stop and think about these simple points?

Sadly, there is over a decade of evidence available that dictates otherwise.

Sadly, I remain...

[Kevin E. Noonan]

Dear Skeptical: there is no need to rebut our friend - he does it so eloquently in his own words.

But thanks for the comment

[A Rational Person]

Skeptical,

"OK, moment's over: simply put: his simple examples fail to cover what the statutory category of process allows."

Further to your point, the claim requirements being proposed by [sockpuppet of the moment] have not been required of patented chemical processes.

[The Memory Motel]

You have my problem with the claims I gave you, Kevin?

Let me hear your "thoughts" on why those claims are ineligible. I'm sure they are very serious and thoughtful.

Let's hear them.

[The Memory Motel]

Rational Person: "the claim requirements being proposed by [sockpuppet of the moment] have not been required of patented chemical processes."

Maybe you should learn to read English and take a look at the statement of Kevin's that I responded to.

Whether something or the other has "not been required before" is not the issue.

Kevin asked for a simple claim that would be safe from the reasoning in Ariosa and GTG. I provided examples of such claims.

[Kevin E Noonan]

MM: at that level of abstraction they are remarkably worthless. Give me a claim, not your interpretation of what such a claim should look like. You can craft it, or find it in an issued patent.

[Kevin E Noonan]

And I'll tell you what: I'll donate $100 to a charity of your choice if you do it (even if I disagree with you thereafter)

[The Memory Motel]

Kevin: "at that level of abstraction they are remarkably worthless."

No, they're not worthless at all for the purpose of this discussion, Kevin. I can understand why you would feel uncomfortable discussing these claims, of course, because they demonstrate why your broad assertion above (which I challenged) is complete baloney.

"You can craft it"

LOL! One of the key points to be made here, Kevin, is that a patent attorney should not be able to sit in front of the computer and pump out an eligible patent claim "on demand". I left out the parts that require some actual innovation for a reason: I'm not innovating an eligible diagnostic claim. I'm discussing what an eligible diagnostic claim will look like, in general. What I've done avoids the confusion created by discussing hypotheticals using non-realistic scenarios (e.g., "imagine that PCR was never invented blah blah blah). You should try it sometime.

"find it in an issued patent"

Why? You can do that as easily as anyone else. I've just given you the roadmap.

Is your "expert" position now that such claims don't exist?

[Kevin E. Noonan]

Used to. Not anymore.