Mayo Collaborative Services v. Prometheus Laboratories -- What Should We Do? (or Can These Claims Be Saved?)

    By Kevin E. Noonan --

Perhaps unintentionally, the Supreme Court issued a challenge to America's patent attorneys in its Prometheus decision, warning against "interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art.'"  As purveyors of "the draftman's art," then it behooves us to ask whether claims perceived to be directed to "laws of nature" can, in fact, be written to pass Constitutional muster (since, regardless of the Court's disdain, "the name of the game is [still] the claim").

A good place to start is with the Prometheus claims themselves.  Although the Court focused on claim 1 of U.S. Patent No. 6,355,623:

1.  A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
    (a)  administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and


    (b)  determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,


    wherein the level of 6-thioguanine less than about 230 pmol per 8x10⁸ red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and


    wherein the level of 6-thioguanine greater than about 400 pmol per 8x10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Claim 46 of of the '623 patent poses additional questions that must be addressed:

46.  A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:
    (a)  determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder,


    wherein the level of 6-thioguanine less than about 230 pmol per 8x10⁸ red blood cells indicates a need to increase the[] amount of said drug subsequently administered to said subject, and


    wherein the level of 6-thioguanine greater than about 400 pmol per 8x10⁸ red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8x10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

In the Supreme Court's decision the first step of claim 1 was discounted as merely selecting the population to be administered the drug and so could not impart any patent eligibility to the claim; the absence of this step in claim 46 would thus appear to do little to diminish its chances of being deemed patent-eligible.  The Court also considered the determining step to be "conventional and routine."  Recasting the claim as a method of treatment claim might improve its chances.  For example:

1.  A method of administering 6-thiopurine to a patient in need thereof for treating an immune-mediated gastrointestinal disorder, comprising the step of administering a therapeutically effective amount of the drug that produces no less than 230 pmol and no more than 400 pmol per 8x10⁸ red blood cells in blood from the patient.

This claim is not infringed by a doctor "thinking about" how to administer the drug, and its "conventionality" would need to be measured with regard to whether administering the drug to achieve these plasma levels was known in the prior art.  In this conformation, the "law of nature" informs the physician how much of the drug should be administered; while implicit in the claim is the need to determine whether the administered amount produced between 230 pmol and 400 pmol per 8x10⁸ red blood cells in blood from the patient, determining drug concentrations in blood from a patient is not recited as an affirmative limitation in the claim.  Of course, the literal infringer thus becomes the physician in this claim, and the "deep pocket" liability will lie against the hospital or drug company that specifies the required determination.  This is analogous to "companion diagnostic" testing recommended for certain drugs, for example, that determine sequence variants in drug detoxifying enzymes such as P450; here ultimate infringement liability would lie against a (generic) drug company that requires such testing under a regulatory scheme (like the Hatch-Waxman Act).

This stratagem apparently was employed by the drafters of the claims in Classen v. Biogen, where the Federal Circuit distinguished between claims that specified immunizing an individual according to a schedule for minimizing chronic immune-mediated disorder (claim 1 of U.S. Patent No. 6,638,739):

1.  A method of immunizing a mammalian subject which comprises:

    (i)  screening a plurality of immunization schedules, by

        (a)  identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and


        (b)  comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),


    (ii)  immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

And claim of U.S. Patent No. 5,723,283:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

Of course, the '793 patent claim might be cast even more directly as an immunization method claim:

A method of immunizing a mammalian subject comprising the step of administering to a patient an immunogen that is immunologically specific for an infectious disease-causing organism according to an immunization schedule that has a reduced risk for developing a chronic immune-mediated disorder(s).

While many of the claim terms ("immunization schedule," "reduced risk") will need to be defined expressly in the specification, the benefit of this claim structure is that it is specific (and can be made even more specific, e.g., the pathogen that the patient is immunized against) and does not require that the particular immunization schedule is determined as part of the claim.  A criticism of these claims could arise if the immunogenic antigen was known and administered in a conventional fashion; however, it is possible also that the manner, formulation, frequency, or other aspect of how the immunogen is administered is not "routine" or "conventional."

The Myriad claims invalidated by the District Court (affirmed by the Federal Circuit and not included in the certiorari writ) fail for reasons satisfactorily embodied in Bilski:

U.S. Patent No. 5,709,999:

1.  A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

U.S. Patent No. 5,710,001:

1.  A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.

U.S. Patent No. 5,753,441:

1.  A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

U.S. Patent No. 6,033,857:

1.  A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

2.  A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.

The ACLU did not challenge all of Myriad's method claims, however, and Myriad's counsel argued before the Federal Circuit that one of the deficiencies in plaintiffs' pleadings was that any alleged injury was not redressable in view of Myriad's unchallenged claims, including (perhaps):

2. A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer, wherein the detection in the alteration in the germline sequence is determined by an assay selected from the group consisting of
    (a) observing shifts in electrophoretic mobility of single-stranded DNA on non-denaturing polyacrylamide gels,
    (b) hybridizing a BRCA2 gene probe to genomic DNA isolated from said tissue sample,
    (c) hybridizing an allele-specific probe to genomic DNA of the tissue sample,
    (d) amplifying all or part of the BRCA2 gene from said tissue sample to produce an amplified sequence and sequencing the amplified sequence,
    (e) amplifying all or part of the BRCA2 gene from said tissue sample using primers for a specific BRCA2 mutant allele,
    (f) molecularly cloning all or part of the BRCA2 gene from said tissue sample to produce a cloned sequence and sequencing the cloned sequence,
    (g) identifying a mismatch between (1) a BRCA2 gene or a BRCA2 mRNA isolated from said tissue sample, and (2) a nucleic acid probe complementary to the human wild-type BRCA2 gene sequence, when molecules (1) and (2) are hybridized to each other to form a duplex,
    (h) amplification of BRCA2 gene sequences in said tissue sample and hybridization of the amplified sequences to nucleic acid probes which comprise wild-type BRCA2 gene sequences,
    (i) amplification of BRCA2 gene sequences in said tissue sample and hybridization of the amplified sequences to nucleic acid probes which comprise mutant BRCA2 gene sequences,
    (j) screening for a deletion mutation in said tissue sample,
    (k) screening for a point mutation in said tissue sample,
    (l) screening for an insertion mutation in said tissue sample,
    (m) in situ hybridization of the BRCA2 gene of said tissue sample with nucleic acid probes which comprise the BRCA2 gene.

(U.S. Patent No. 6,033,857)

26. A method for screening a tumor sample from a human subject for the presence of a somatic alteration in a BRCA1 gene in said tumor which comprises comparing BRCA1 polypeptide from said tumor sample from said subject to BRCA1 polypeptide from a nontumor sample from said subject to analyze for a difference between the polypeptides, wherein said comparing is performed by
    (i) detecting either a full length polypeptide or a truncated polypeptide in each sample or
    (ii) contacting an antibody which specifically binds to either an epitope of an altered BRCA1 polypeptide or an epitope of a wild-type BRCA1 polypeptide to the BRCA1 polypeptide from each sample and detecting antibody binding, wherein a difference between the BRCA1 polypeptide from said tumor sample from the BRCA1 polypeptide from said nontumor sample indicates the presence of a somatic alteration in the BRCA1 gene in said tumor sample.

(U.S. Patent No. 5,710,001)

These claims, while relying on the "natural law" that certain mutations are associated with breast cancer, do not recite assays that are "routine" or "conventional" according to the Prometheus analysis, inter alia, because they were unknown in the prior art.

So what are the take-home lessons from this inquiry?  First, it is apparent that claims reciting "active" steps will be much harder to pigeonhole into the "laws of nature" category than claims like the invalidated Myriad or Prometheus claims, because unlike in Prometheus it should be harder to categorize this as merely "selecting a population."  Second, claims reciting novel "determining" steps (wherein what is administered is novel, or the relationship between what is detected and a particular disease is novel, or the method by which a biological molecule is administered or detected is novel), should overcome the "merely routine" basis used by the Court in invalidating the Prometheus claims.  The Justices also did not "decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them."  Finally, placing the "law of nature" in context, wherein the claim steps recite a method performed only when a "law of nature" is satisfied, may also suffice.

These ideas are certainly not exhaustive, and absent circumstances permitting reissue of affected patents, it is plain that the "settled expectations" of the patenting community be damned in view of the Prometheus decision.  But that doesn't mean America's patent draftsmen are helpless.  It just means we will need to keep the Supreme Court's proclivities on subject matter eligibility in mind when drafting claims going forward.  After 30 years of a relatively benign patent law regime under the Federal Circuit, the skies have darkened and the seas are rough.  But this too shall pass so long as we keep our eyes on our pole star:  "the name of the game is the claim."

Comments

[6]

"1. A method of administering 6-thiopurine to a patient in need thereof for treating an immune-mediated gastrointestinal disorder, comprising the step of administering a therapeutically effective amount of the drug that produces no less than 230 pmol and no more than 400 pmol per 8x108 red blood cells in blood from the patient."

Don't let the fact that you just drafted all over the prior art stop ya bro.

Bottom line Kev, there was no challenge issued implicitly or explicitly. Save that to stop being evil draftsman and abide by the law. This is not an exercise of drafting skill to "save these claims", if you even think about making such an exercise then by definition those claims are supposed to be invalidated.

This isn't really that difficult Kev. Stop being a scofflaw. Period. It is really not that hard.

"while implicit in the claim is the need to determine whether the administered amount produced between 230 pmol and 400 pmol per 8x108 red blood cells in blood from the patient, "

Not really.

"and the "deep pocket" liability will lie against the hospital or drug company that specifies the required determination."

What "required" determination? There is no determination recited. I swear Kev. This is like a first year lawl student trying to draft a claim.

"irst, it is apparent that claims reciting "active" steps will be much harder to pigeonhole into the "laws of nature" category than claims like the invalidated Myriad or Prometheus claims, because unlike in Prometheus it should be harder to categorize this as merely "selecting a population.""

Genius Kev, pure genius.

"Second, claims reciting novel "determining" steps (wherein what is administered is novel, or the relationship between what is detected and a particular disease is novel, or the method by which a biological molecule is administered or detected is novel), should overcome the "merely routine" basis used by the Court in invalidating the Prometheus claims. "

Lulz, gl with that. I don't understand how you've come to this arse backwards notion that there is something that which will "overcome" a certain "merely routine" basis used by the court in invalidating the Prom claims. Nothing "overcomes" that, it simply either is present from the outset of the analysis or it isn't. No "overcoming" is required.

"Finally, placing the "law of nature" in context, wherein the claim steps recite a method performed only when a "law of nature" is satisfied, may also suffice."

O? You mean like Prom did?

"But that doesn't mean America's patent draftsmen are helpless. "

Nah, it just means they're going to need a little extra smacking down for a year or so until they simmer down and start claiming only inventions.

"After 30 years of a relatively benign patent law regime under the Federal Circuit, the skies have darkened and the seas are rough."

L U L Z. Having to invent something is a real bia ain't it Kev?

[EG]

Kevin,

Very perceptive thoughts. As you correctly say, while Breyer's opinion denigrates it, the "draftsman's art" is important here. I would also suggest looking at Claims 1 and 13 of related U.S. Pat. No. 6,987,097:

Claim 1. A method for optimizing therapeutic efficacy in a subject in need thereof, said subject receiving a drug providing 6-thioguanine, said method comprising: (a) determining a level of 6-thioguanine in said subject; and (b) increasing the subsequent dose of said drug when said level of 6-thioguanine is less than a member selected from the group consisting of about 230, 240, 250, 260, 280, and 300 pmol per 8 [times 10 to the 8th power] red blood cells.

Claim 13. A method for reducing toxicity in a subject in need thereof, said subject receiving a drug providing 6-thioguanine, said method comprising: (a) determining a level of 6-thioguanine in said subject; and (b) decreasing the subsequent dose of said drug when said level of 6-thioguanine is greater than a member selected from the group consisting of about 350, 370, 390, 400, 425, and 450 pmol per 8 [times 10 to the 8th power] red blood cells.

If Claims 1 and 13 of the '097 patent can't make the "patent-eligibility" grade under 35 USC 101, I frankly don't know what method or process claim would.

What we frankly need to bring back is the now discarded "tangible, concrete, and useful result" test. The TCU test would weed out method claims like those in Mayo Collaborative Services and Myriad which might make for some nice "theoretical discussion," but don't quite achieve a "useful result" in the patent method/process sense. We would do far better using the TCU test to judge patent-eligiblity under 35 USC 102; as I've said repeatedly, I could be just as objective as the reasoning in Breyer's opinion using a Ouija board.

[Kevin E. Noonan]

Ah, 6, the trenchant commentary we have come to expect.

Patent law isn't like the speed limit on the interstate - there are many creative ways to protect inventions, and I predict my brethren will rise to the task. Intentional or not, this is the world the Supreme Court has made with its decision, and we will live with it. After all, KSR was supposed to be the end of the world as we know it and we have adapted to that just fine.

Thanks for contributing.

[JK]

Kevin,

I've been reading your commentary for some time now and appreciate the lucid analytical viewpoint it offers.

I've been struggling, as I'm sure many will, to understand what will constitute an "unconventional" step that adds sufficiently to a method claim involving a law of nature, moving forward. I know the claims were unchallenged, but I think your comment regarding claims 2 and 26 of the '857 patent tees up a good opportunity to discuss this issue further in a defined context. I don't have a late 90s edition of Sambrook in front of me, but to me methods listed in the claims for comparing BRCA sequences and detecting a mutation read like a laundry list of methods that would have been familiar to a POSITA at the time and have been essentially "obvious to try." I realize that statement is loaded and plays into Breyer's alleged "conflation" of subject matter eligibility with obviousness criteria, but I'm interested in seeing additional viewpoints on this and these claims offer a perfect opportunity for further discussion. Simply because the methods would be more difficult, or less conventional, than simply sequencing the BRCA genes of a subject and analyzing or comparing them wouldn't seem enough to save the claims. If the methods are known, even though not the most conventional possible approach, at a given point in time, then isn't the necessary "inventive concept" still lacking?

[6]

"and I predict my brethren will rise to the task. "

I predict it as well, which is why I also predict more smack downs in the future. What we need are some lawls with harsher punishments being enforced on these scofflaw officers of the court.

[lean, finely textured beef]

6 - Thanks for providing your usual quantum of insight to the discussion.

In running with your "harsher punishments" chestnut, perhaps the PTO can begin to assess fines against the prosecuting attorneys for each rejection of claims they advance in an Office action. That would be great, particularly when I get a cut-and-paste 102(b) rejection from a completely different application that has nothing to do with my claims.

Or perhaps we can all take a deep breath and take inventory of where we are in the wake of Mayo.

[EG]

Kevin

The following quote is taken from Diamond v. Diehr. Breyer’s opinion should be “hung, drawn, and quartered” for it does exactly what this quote from Diehr says not to do in an analysis under section 101:

In determining the eligibility of respondents’ claimed process for patent protection under 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made. The “novelty” of any element or steps in a process, or even of the [450 U.S. 175, 189] process itself, is of no relevance in determining whether the subject matter of a claim falls within the 101 categories of possibly patentable subject matter.

[Kevin E. Noonan]

Dear JK:

I think what is needed is what is not in the prior art - i.e., some way to identify the gene or mutation. That would be what is "new" - not the "natural law" that the mutation causes an illness, but the reagent to specifically detect it combined with the method for detecting it. I think there is a strong argument that no matter how "obvious" it might be to "try" to detect such a mutation, unless and until it is identified it is not "routine" or "conventional" to detect it; how do you detect something you have neither identified nor isolated?

While I understand that someone might argue that this is just "natural law" + "natural phenomenon," the Prometheus decision says you need "something more" that isn't "routine and conventional." Unless we want to put all biological and chemical inventions off-limits to patenting, I think the fact that the prior art would not enable the skilled worker to detect the relevant mutation even if told about it (by God, presumably) should take such claims out of the ambit of Justice Breyer's mighty patent-slaying rhetoric.

But we shall see. Thanks for the comment.

[EG]

Kevin,

Having reviewed again the Federal Circuit remand decision in the Classen Immunotherapies case, that is the way home to keep the ruling from Mayo Collaborative Services from exploding into complete nonsense. Judge Newman's opinion (joined by Chief Judge Rader) very astutely points to the "immunization step" in the two patents (the ‘739 patent and the ‘139 patent) for why they made the patent-eligibility grade, while the '283 patent did not. These two patents might go down for other reasons (Newman also very carefully noted that the claims of these patents "may not meet the substantive criteria of patentability as set forth in §102, §103, and §112"). But the "law of nature" reasoning from Mayo Collaborative Services is completely inapplicable to these Classen claims. There may yet be some "light" in this currently "dark" patent-eligibility tunnel.

[Skeptical]

Dr. Noonan states in part "Unless we want to put all biological and chemical inventions off-limits to patenting..."

Careful sir, some really do want to do that.

[6]

"Or perhaps we can all take a deep breath and take inventory of where we are in the wake of Mayo."

I took that "deep breath" three years or so ago. I know precisely where you are. The same place I've been for a few years. But, I suppose, if you guys take a deep breath and decide to not scoff at the law then I will be satisfied. If this is just a moment of unwarranted panic then fine.

[EG]

Kevin,

As you, I and others have said, what those who are “cheering” this decision need to understand (and accept) is that the specific result isn’t the problem for us, but instead the abominable reasoning that is employed in Mayo Collaborative Services, including mischaracterizing and misusing basic patent claim terminology. As my patent attorney younger brother Mark has aptly pointed out, Breyer’s opinion characterizes the “wherein clauses” as a “step.” That, by itself is embarrassing in the extreme. (And Mark and I aren't making this up, it's right in Breyer's opinion.) Any beginning prosecuting patent attorney or agent would understand that characterizing “wherein clauses” as a “step” is nonsense. If Breyer can’t get the basic patent claim facts right, is it any wonder that the reasoning he provides won’t be accepted by patent law practitioners, notwithstanding his further nonsensical characterizaton of what the applicable patent law is?

What is also very unfortunate is that Breyer could have had his “cake,” and even gotten us patent practitioner’s (at least most of us) to “eat it” too if he had used the basic patent claim terminology correctly and had framed the applicable patent law issue appropriately. Characterizing Prometheus’ claimed method as not much more than patenting a “law of nature” was the absolutely worst way to go. Instead, he could have gone down the path of Bilski and said that Prometheus’ claimed method is nothing more than an “abstraction” because it does’t achieve a “use result” (i.e., simply providing numerical ranges of what dosages are too high or too low isn’t enough to reach the patent-eligibility zone). Even better, Breyer could have pointed to related U.S. Pat No. 6,987,097, and particularly Claims 1 and 13, and said “that’s what I mean by a ‘useful result’ that is more than an abstraction.” Prometheus would have been unhappy, and there might have been some grumbling by some patent practitioners, but such reasoning would have been accepted by the patent law bar at large (me included), and would have also given us meaningful guidance on how to craft method and process claims to reach the patent-eligibility zone. (Sigh).

As I said before, the path forward for getting us out of this Mayo Collaborative Services debacle is through the Classen Immunotherapies remand decision. Judge Newman’s opinion (joined by Chief Judge Rader) very astutely (and presciently) points to the “immunization step” in two of the patents (the ‘739 patent and the ‘139 patent) for why they made the patent-eligibility grade, while the other ’283 patent did not. And Newman's opinion primarily relies upon a legal basis other than the Federal Circuit's "transformative" step reasoning that was reversed in Mayo Collaborative Services. I've written an article to discuss this path forward that should be posted soon on IPWatchdog. Stay tuned.

[Sean Brennan]

Kevin:
I worry that your recasting of the Prometheus claim as a method-of-treatment claim would go down under Section 102 as inherently anticipated by any previous administration of a 6-thiopurine drug. Inherent anticipation seems to be the rejection du jour.

[Kevin E. Noonan]

Dear Sean:

Perhaps - unless it could be shown that administration in the past gave blood levels lower than 230 pmols and/or greater than 400 pmols. Inherent anticipation has to fall within the scope of the claim every time.

Thanks for the comment.

[Bob]

Kevin,

Nice write-up. I agree that the best path forward is to recast such "correlation" claims into MOT claims. The nature of such claims will vary, depending on the nature of the marker, the nature of the relevant disease, and the nature of existing prior art.

Folks who prosecute pharmaceutical patent applications should have plenty of experience drafting these kinds of claims, as prosecuting such applications is a routine part of lifecycle management.

Moreover, as you note, MOT claims have the potential to reach deeper pockets, as they implicate pharmaceutical companies as potential infringers under 371(b) or (c).

Of course, this begs the question: Why haven't the discoverers of these correlations been drafting MOT claims all along? I suspect that this failure is sometimes the result of unsophistication. But in other cases, I suspect that they don't because they can't: The resulting MOT claim may be anticipated, or, if not anticipated, no one has yet discovered any way to practically apply the discovery. So, in that vein, "correlation" claims seem to have become a popular means of skirting potential problems under 102 and 112 that their corresponding MOT claims may have suffered from.

[Dan Finkelstein]

Kevin "Inherent anticipation has to fall within the scope of the claim every time."

Just to be clear, if Mayo or another alleged infringer could show that a single previous administration of 6-TP resulted in the recited metabolite levels, that would suffice for anticipation. Remember: dosing and testing the metabolite levels was not old in the art.

[Kevin E. Noonan]

Dear Dan:

I don't think so. My understanding is the opposite - that the prior art method for administering the drug would need to inherently produce those blood levels each and every time. If not the method reciting this limitation is not inherently anticipated.

[Dan Finkelstein]

Kevin: "the prior art method for administering the drug would need to inherently produce those blood levels each and every time"

This is true only when there is a gap in the prior art and an inherency agrument is used to fill in that gap. I'm not talking about that situation, but rather about the situation where the evidence is provided showing that (1) the drug was administered (2) the metabolite level was measured to be lower than the low bounding range recited in the claim and (3) more drug was given (proving that a "need to administer more drug was indicated"). That's just plain vanilla anticipation. It need only have happened once.

With respect to the inherency issue, that's even easier given the extraordinary breadth of Prometheus' claims. It would not be difficult to find an expert to testify that certain extremely low doses of 6-TG that were surely administered in the past would never yield levels of metabolites below the lower bound recited in Prometheus' claims.