By Kevin E. Noonan --
Most people have had the experience of becoming lost and, having arrived at their destination, realizing that it was only one false turn that caused their confusion. For those with a physics background one can recall the feature of vector calculus that a small displacement at a first position can result in a large displacement at a later position further along the vector's path. Both these thoughts come unbidden when reading the Federal Circuit's decision on June 16th in Cleveland Clinic Foundation v. True Health Diagnostics LLC (where the one false turn was the Court's decision in Ariosa Diagnostics v. Sequenom and that initial "small nudge" can be found in the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories decision).
The case involved Cleveland Clinic's lawsuit for patent infringement against True Health over U.S. Patent Nos. 7,223,552, 7,459,286, and 8,349,581. The technology disclosed and claimed in these patents relate to methods for detecting myeloperoxidase (MPO) in a bodily sample; a fourth patent, No. 9,170,260, is directed to methods for treating a patient having cardiovascular disease. The following claims are representative according to the opinion:
For the '522 patent:
11. A method of assessing a test subject's risk of having atherosclerotic cardiovascular disease, comprising comparing levels of myeloperoxidase in a bodily sample from the test subject with levels of myeloperoxidase in comparable bodily samples from control subjects diagnosed as not having the disease, said bodily sample being blood, serum, plasma, blood leukocytes selected from the group consisting of neutrophils, monocytes, subpopulations of neutrophils, and sub-populations of monocytes, or any combination thereo[f]; wherein the levels of myeloperoxidase in the bodily from the test subject relative to the levels of [m]yeloperoxidase in the comparable bodily samples from control subjects is indicative of the extent of the test subject's risk of having atherosclerotic cardiovascular disease.
14. A method of assessing a test subject's risk of developing a complication of atherosclerotic cardiovascular disease comprising: determining levels of myeloperoxidase (MPO) activity, myeloperoxidase (MPO) mass, or both in a bodily sample of the test subject, said bodily sample being blood, serum, plasma, blood leukocytes selected from the group consisting of neutrophils and monocytes, or any combination thereof; wherein elevated levels of MPO activity or MPO mass or both in the test subject's bodily sample as compared to levels of MPO activity, MPO mass, or both, respectively in comparable bodily samples obtained from control subjects diagnosed as not having the disease indicates that the test subject is at risk of developing a complication of atherosclerotic cardiovascular disease.
15. The method of claim 14, wherein the test subject's risk of developing a complication of atherosclerotic cardiovascular disease is determined by comparing levels of my[elo]peroxidase mass in the test subject's bodily sample to levels of myeloperoxidase mass in comparable samples obtained from the control subjects.
For the '286 patent:
21. A method of assessing the risk of requiring medical intervention in a patient who is presenting with chest pain, comprising characterizing the levels of myeloperoxidase activity, myeloperoxidase mass, or both, respectively in the bodily sample from the human patient, wherein said bodily sample is blood or a blood derivative, wherein a patient whose levels of myeloperoxidase activity, myeloperoxidase mass, or both is characterized as being elevated in comparison to levels of myeloperoxidase activity, myeloperoxidase mass or both in a comparable bodily samples obtained from individuals in a control population is at risk of requiring medical intervention to prevent the occurrence of an adverse cardiac event within the next six months.
22. A method of determining whether a patient who presents with chest pain is at risk of requiring medical intervention to prevent an adverse cardiac event within the next six months comprising: comparing the level of a risk predictor in a bodily sample from the subject with a value that is based on the level of said risk predictor in comparable samples from a control population, wherein said risk predictor is myeloperoxidase activity, myeloperoxidase mass, a myeloperoxidase generated oxidation product, or any combination thereof, and wherein said bodily sample is blood, serum, plasma, or urine, wherein a subject whose bodily sample contains elevated levels of said risk predictor as compared to the control value is at risk of requiring medical intervention to prevent an adverse cardiac event within 6 months of presenting with chest pain, and wherein the difference between the level of the risk predictor in the patient's bodily sample and the level of the risk predictor in a comparable bodily sample from the control population establishes the extent of the risk to the subject of requiring medical intervention to prevent an adverse cardiac event within the next six months.
For the '581 patent:
5. A method of determining whether a patient who presents with chest pain is at risk of requiring medical intervention to prevent an adverse cardiac event within the next six months comprising: determining the level of risk predictor in a bodily sample from the subject, wherein said risk predictor is myeloperoxidase activity, myeloperoxidase mass, a myeloperoxidase (MPO)-generated oxidation product or any combination thereof, wherein said bodily sample is blood, serum, plasma or urine, wherein said myeloperoxidase-generated oxidation product is nitrotyrosine or a myeloperoxidase generated lipid peroxidation product selected from [list of products] or any combination thereof, and comparing the level of said risk predictor in the bodily sample of the patient to the level of said risk predictor in comparable samples obtained from a control population, wherein a subject whose bodily sample contains elevated levels of said risk predictor as compared to the control value is at risk of requiring medical intervention to prevent an adverse cardiac event within 6 months of presenting with chest pain.
The opinion notes that the prior art taught that MPO in blood was an early symptom of heart disease associated with atherosclerotic plaques that could be "indirectly" detected in blood, and that the inventors here "purportedly discovered how to 'see' MPO in blood and correlate that to the risk of cardiovascular disease." The specification (as was the practice prior to the Mayo decision) disclosed that MPO could be detected "by any of a variety of standard methods known in the art," and that commercially available kits could be modified to detect MPO according to the methods disclosed and claimed in these patents. In addition, according to the opinion, the patents disclosed and claimed statistical methods derived from populations of cardiovascular disease patients and "control" groups of individuals without disease to provide a basis for diagnosing cardiovascular disease using MPO detection.
The '260 patent, which claims methods of treatment, "builds on" the diagnostic patents according to the opinion; claim 1 is representative:
1. A method for administering a lipid lowering agent to a human patient based on elevated levels of myeloperoxidase (MPO) mass and/or activity comprising:
(a) performing an enzyme linked immunosorbent assay (ELISA) comprising contacting a serum or plasma sample with an anti-MPO antibody and a peroxidase activity assay to determine MPO activity in the serum or plasma sample;
(b) selecting a patient who has elevated levels of MPO mass and/or activity compared to levels of MPO mass and/or activity in apparently healthy control subjects; and
(c) administering a lipid lowering agent to the selected human patient.
Defendant True Health is a diagnostics company according to the opinion, that Cleveland Clinic sued for literal infringement of the '522, '286, and '581 patents, and for contributory infringement and inducement of infringement of the '260 patent. The District Court granted True Health's motion to dismiss under Fed. R. Civ. Proc. 12(b)(6) for failure to state a claim with regard to the diagnostic method patents, because the claims of these patents were directed to patent-ineligible subject matter (i.e., "laws of nature"). The Court also granted True Health's motion regarding the contributory and inducement claims. These motions were granted without claim construction, which the District Court justified based on Cleveland Clinic's purported failure to offer any proposed construction for any claim terms and for failing to point out any claim used by the Court as a representative claim that plaintiff asserted was not representative. With regard to the substantive basis for granting True Health's motion, the District Court relied upon the Mayo/Alice two-step analysis, finding that the claims were directed to the "law of nature" regarding the correlation between MPO levels in blood and cardiovascular disease. The Court then found the claims to lack the ineluctable "something more" required by the Mayo/Alice test, in view of the specification's disclosure regarding the use of conventional detection methods. In addition, the Court found that "comparing" MPO blood levels in patients with population control values constituted "a bare mental process." For the method of treatment claims, the District Court determined that a testing service was not a "material or apparatus" as required for contributory infringement to lie, citing In re Bill of Lading Transmission & Processing Sys. Patent Litig., 681 F.3d 1323, 1337 (Fed. Cir. 2012). Finally, the District Court based its finding that Cleveland Clinic had not sufficiently plead inducement on its appreciation that there were insufficient facts in the complaint to support the allegation.
The Federal Circuit affirmed, in an opinion by Judge Reyna joined by Judges Lourie and Wallach. Addressing the procedural issues, the panel held that considering (and granting) a motion to dismiss based on Fed. R. Civ. Proc. 12(b)(6) without claim construction was not error, nor was there error in considering certain claims to be representative. Curiously, the Court based its affirmance of the latter principle on substantive grounds, that it disagreed with Cleveland Clinic that other claims provided the requisite "inventive concept" that the representative claims did not. This basis does not address the underlying question, of whether generally a district court can cherry pick claims asserted by a plaintiff to find that the Mayo/Alice test is not satisfied, and while this conclusion may be the correct one, in this case affirming this procedural shortcut precludes future plaintiffs of the ability to overcome a Section 101 challenge based on there being at least one asserted claim that satisfies the test. Of course, the precedent regarding Cleveland Clinics' second challenge, that a district court can grant a motion to dismiss without claim construction, is as prevalent as it is mystifying, and the panel here relies upon some of it to affirm the procedural posture of the case (e.g., Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1373โ74 (Fed. Cir. 2016).
Turning to the substance, the panel easily found the diagnostic method claims ineligible, relying heavily on its earlier decision in Ariosa v. Sequenom. This manner of deciding the question has the benefit of efficiency; in a decision comprising about 6,000 words, it takes the Court less than 1500 to apply its Ariosa precedent here. With regard to step one of the Mayo/Alice test, many of the same tropes in the earlier case recur: that the method claims are directed "merely" to the "discovery that patients with cardiovascular disease have significantly greater levels of leukocyte and [MPO]," (constructively reading the word "discovery" out of Section 101); that the claims "do not purport to alter MPO levels in any way" (creatively analogizing these claims to those in Genetic Techs v. Merial, where the court stated those claims "involved[d] no creation or alteration of DNA sequences"); that the detected elevated MPO levels "exists in principle apart from human action"; and that Cleveland Clinic had not invented any new and useful laboratory technique to detect MPO levels, thus distinguishing these methods from the patent-eligible methods at issue in Rapid Litigation Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016).
Turning to step 2 of the Mayo/Alice test, the opinion dutifully recites the requirement that the claims be considered "as a whole" ("as an ordered combination"), but not surprisingly fails to find an inventive concept, again with frank reliance on the Court's Ariosa decision and based on the patentee's failure to invent a new method for detecting MPO levels in blood (not surprisingly, because that was not their invention). The panel's final application of its Ariosa precedent comes in dismissing Cleveland Clinics' argument regarding lack of preemption, because in Ariosa the Court held that "[w]here a patent's claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot." Even less is made of claims that the invention here was groundbreaking; as considered by the Federal Circuit any such characteristic does not imbue a claim with patent-eligible weight.
On the issue of contributory or induced infringement, the opinion finds that the District Court did not err, under Sixth Circuit precedent, in denying Cleveland Clinic the opportunity to amend its complaint to cure the purported deficiencies in its factual allegations. This precedent, abuse of discretion, is sufficiently deferential to the District Court that the Federal Circuit easily affirmed the decision below.
The outcome here is not surprising, and the failure of the Cleveland Clinic in an Ohio courtroom to defeat a motion to dismiss indicates how difficult it has become to assert claims such as the ones at issue here. There may be ways for the creative draftsman to work around the constraints created by the Mayo/Alice framework as elucidated in the Ariosa precedent and its related cases (now including this one) for new technologies. But unless the Supreme Court sees the error in its ways, or Congress overrules its Mayo/Alice decisions, technology transfer of university inventions will not be to startups and licensees but to copycats and pirates for the foreseeable future.
Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017)
Panel: Circuit Judges Lourie, Reyna, and Wallach
Opinion by Circuit Judge Reyna
"For those with a physics background one can recall... that a small displacement at a first position can result in a large displacement at a later position further along the vector's path... [This] thought[] come[s] unbidden when reading the Federal Circuit's decision on June 16th in Cleveland Clinic Foundation..."
Extremely well said, and an apt analogy. I dare say that Justice Breyer scarcely noticed the deviation of his opinion from the previous path of the law, but as the vector extends toward eternity, the effect of the deviation becomes progressively more pronounced (and absurd).
To my mind, perhaps the most noteworthy thing about this opinion comes in a footnote, where the court observes that the challenger did not bother to raise the ยง101 defense against the claims that recite a treatment step. Perhaps there is a way forward in that distinction.
Posted by: GrzeszDeL | June 26, 2017 at 11:09 PM
Hey Kevin,
This Cleveland Clinic decision is just one more hideous example of why the Mayo/Alice framework is nonsensical, broken, and a legal travesty by SCOTUS that has now infected the Federal Circuit. Sadly, we must rely upon Congress to avoid having medical diagnostic methods potentially become the new Dark Ages because Our Judicial Mount Olympus can't think beyond the 19th Century.
Posted by: EG | June 27, 2017 at 06:27 AM
And unsurprisingly here we are. I can't wait for the combined false logic of both Ariosa (if it begins and ends with a JE) and Merial (if it is founded upon a JE). Many thought that maybe the Federal Circuit was trying to punt the Ariosa ball to SCOTUS. Perhaps, the Federal Circuit would do better by issuing a completely nonsensical or unfounded opinion that flat out holds that ALL inventions relating to the life sciences are per se ineligible subject matter. It seems SCOTUS would have to grant cert then. After all, that's where the case law is heading for the life sciences... and the problem is that the series of wrong turns over a plurality of cases over years can be pointed to as stare decisis for the end result, whereas if a court simply goes straight to the absurd end result without all the stupid cases with the little wrong turns, there is a lack of case law to support the absurd end result.
Posted by: Suzannah | June 27, 2017 at 06:31 AM
The moment an invention can be described as a "correlation," it is dead in the water.
Posted by: Some Random Guy | June 27, 2017 at 09:31 AM
The Supreme Court has never overturned Diamond v. Diehr, has not found Section 101 to be unconstitutional in light of the Constitution Article I Section 8 Clause 8, which includes "discoveries." In 1789, the word "discovery" meant, and still means: "to uncover," or "to reveal."
Posted by: Ben Borson | June 27, 2017 at 10:34 AM
Ben's comments above are so true. And yet, there is no way Diamond v. Diehr would pass muster under the current 101 test. It is clear the courts do not want to see patent eligibility in anything diagnostic, yet they refuse to be honest about the clash with Diamond v. Diehr. This makes me think we need the completely nonsensical decision Suzannah calls for to force them to state a clear policy. I would also like the Supreme Court to be honest about how this whole area of law is entirely outside the statutory language.
Posted by: Karen Canady | June 27, 2017 at 02:11 PM
SRG: agreed
Posted by: Kevin E. Noonan | June 27, 2017 at 03:46 PM
You know, EG, I think the fault lies not in SCOTUS so much as in the seemingly spineless CAFC and the PTO (although the Office is trying to find ways to grant claims).
Posted by: Kevin E. Noonan | June 27, 2017 at 03:47 PM
@ Kevin E Noonan
I entirely agree with your last comment. If you read the CIPA and EPI briefs in Sequenom, you will see that they were written with precisely that point in mind.
Posted by: Paul Cole | June 28, 2017 at 04:43 AM
I think the 101 mess is mainly the fault of the CAFC. The CAFC could have distinguished and narrowly applied Mayo by explaining that the well-understood, routine, and conventional steps of the claims at issue in Mayo were actually already being performed in the art, i.e., 6-thioguanine was being administered to subjects and its levels were being determined. The CAFC could have distinguished and narrowly applied Myriad by explaining that nucleic acid molecules are unique and unlike any other molecule in this world because of their *informational content*--which SCOTUS emphasized throughout its decision, i.e., the claims were primarily concerned with the information contained in the sequence and isolating a nucleic acid molecule does not change its informational content. The CAFC could have explained that other purified natural products that because of their purity (which are changes in both chemical and physical characteristics) have a therapeutic utility that they do not have as found in nature and thereby distinguish such other purified therapeutic products from both Myriad and Funk Brothers. Instead, it seems that some CAFC judges acted out like petulant children, some CAFC judges have no spine or don't care to take the time to carefully craft their opinions, and some CAFC judges have an agenda and are using judicial activism to find inventions related to the life sciences ineligible. So I say "Shame on you CAFC. Shame."
And, to the patent bar as a whole, shame on us. Shame on us because when the decisions of Mayo and Myriad came out we ran around like our heads were cut off squawking about how many other methods and compositions in the life sciences could be found ineligible based on Mayo and Myriad, which squawkings were likely used by the courts and anti-patent peeps, rather than providing detailed reasoning as to how Mayo and Myriad could be distinguished, which courts could then use as a roadmap and patentees facing 101 challenges could use as citable fodder in support of finding eligibility.
Posted by: Suzannah | June 28, 2017 at 06:46 AM
Sorry Dr. Noonan, but not blaming the Supreme Court is purely nonsensical.
Posted by: skeptical | June 28, 2017 at 07:31 AM
Hey Skeptical,
I concur in your judgment that SCOTUS is the primary culprit for the utter mess that patent-eligibility determinations have now. But I also agree with Kevin that the Federal Circuit could have "pushed back" (they did so when Rader was the Chief Judge), yet have failed to do so now (I'm thoroughly unimpressed by Prost as the current Chief Judge). That leaves only Congress to truly fix this utter mess, and they are, unfortunately, consumed by other matters, including the false narrative on the so-called "patent troll" problem.
Posted by: EG | June 28, 2017 at 07:47 AM
Hey Skeptical,
Oops, should hit the preview button first. After "have now" in the first sentence of my comment, add "become."
Posted by: EG | June 28, 2017 at 07:51 AM
EG,
I concur that there is blame that can - and should - go around.
My post though is to the singular notion that SCOTUS is not to blame.
The CAFC has become spineless BECAUSE OF the Supreme Court.
Even when Rader was there, he was of extremely limited ability to "push back." Read again his "push back" in the en banc Alice decision (additional reflections).
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/11-1301.Opinion.5-8-2013.1.PDF
"Although Diehr and Diamond v. Chakrabarty, 447 U.S. 303 (1980), betokened decades of enforcing the patent law as written, these giants too have bowed to new judicial influences. Twenty years ago, Judges Newman, Lourie, and I still unanimously agreed on the outcome of Arrythmia. The intervening commotion leaves us with little, if any, agreement amongst us even though the statute has not changed a syllable."
Posted by: Skeptical | June 28, 2017 at 02:57 PM
The right decision, for the right reasons.
This junk (i.e., determine and infer garbage) doesn't belong in the system, and it never did. And it's not coming back so please quit the silly whining already.
Posted by: And Kevin knows why | June 28, 2017 at 04:35 PM
" Shame on us because when the decisions of Mayo and Myriad came out we ran around like our heads were cut off squawking about how many other methods and compositions in the life sciences could be found ineligible based on Mayo and Myriad, which squawkings were likely used by the courts and anti-patent peeps"
-------------------------------
Actually the "squawkings" were mostly laughed at by the grown ups in the room. And we were right: there's tons of eligible subject matter being filed all the time. I've got work coming out of my ears.
Correlation patents are a blight on the system. They always were. It takes about two seconds of educated sober thinking to understand why that's the case. But we're talking about the patent bar where clueless drunks and greedy bottom feeders abound.
Grow up people.
Posted by: And Kevin knows why | June 28, 2017 at 04:39 PM
AKky....
Your "dignified" prose "exemplifies" the grown up model....
Get well soon PatentDocs from yet another sockpuppet of Malcolm Mooney's.
Posted by: Skeptical | June 28, 2017 at 05:15 PM
@ Susannah Sundby
I completely agree with your comments - see my comment today in relation to Prism Technologies.
Posted by: Paul Cole | June 29, 2017 at 01:30 AM
There are diseases for which diagnostics won't be commercially available because the judiciary has said that diagnostic method patents are ineligible under 101. Which means that some people will continue to suffer from such diseases, and some will die sooner than they needed to, because of the lack of diagnostics. [Redacted]
Posted by: Atari Man | June 29, 2017 at 11:26 PM