Federal Circuit says Cleveland Clinic Diagnostic Patents Ineligible Under § 101

The Cleveland Clinic.

The Cleveland Clinic. CC BY-SA 4.0.

Cleveland Clinic Found. v. True Health Diagnostics LLC, No. 2016-1766, 2017 (Fed. Cir. June 16, 2017) (Before Lourie, Reyna, and Wallach, J.) (Opinion for the court, Reyna, J.)

The Federal Circuit affirmed a finding of Section 101 ineligibility and a failure by plaintiff to state a claim of contributory or induced infringement.

Cleveland Clinic’s diagnostic or “testing” patents at issue dealt with a process by which an enzyme was measured and correlated against known levels of the enzyme in patients who were healthy or had cardiovascular disease. The Court applied the two step Alice analysis. First, the Court found that the patents were directed to “multistep methods for observing the law of nature that [the enzyme] correlates to cardiovascular disease.” Second, the claims were not transformative and “merely tell those interested in the subject about the correlations that the researchers discovered,” using “only conventional [enzyme] detection methods and compare[ing] those values to predetermined or control values derived from conventional statistical methods.”

The Court also held that claims of contributory and induced infringement were properly dismissed for the “method of treatment” patent. It was not an abuse of discretion to deny the patentee leave to amend the complaint. On the facts of record, True Health does not provide a “material or apparatus,” which is required for contributory infringement. Cleveland Clinic also did not show that there was “specific intent and action” between True Health and doctors that may prescribe drugs based on the patented method, and could not show induced infringement.

Observed statistical correlations between healthy and diseased populations, such as correlating levels of an enzyme to cardiovascular disease, is not patentable subject matter. A defendant does not “contribute” to infringing a method of treatment when no material or apparatus is involved. A defendant does not “induce” infringement by knowing others might infringe; there must be evidence showing a “specific intent and action” to encourage infringing conduct. Absent such facts of record, it is not an abuse of discretion to deny amending a complaint to add allegations of contributory or induced infringement.

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Robert Schaffer

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

Robert Schaffer

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

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Discuss this

There are currently 12 Comments comments.

  1. Tesia Thomas June 24, 2017 10:05 am

    Wow. Cleveland Clinic pretty much owns the state of Ohio. (State owes them a lot of unpaid medical expenses or something like that.)
    This is completely bad news for the Cleveland entrepreneurship scene which is largely dominated by med devices and software.
    Not much that any med device company, software company, medical or biomedical researcher makes/invents is patentable under these laws.

  2. David McEwing June 24, 2017 4:17 pm

    I assume from the MPO mechanism that blood enzyme levels vary if the vessel experiences an injury but that the blood enzyme level increases in the event of cardiovascular disease. I think a medical procedure that makes multiple checks of blood level and compares with a data base to distinguish these scenarios may be patentable subject matter.

  3. CP in DC June 25, 2017 2:21 pm

    These patents were filed in 2002 and issued in 2007, Mayo was decided in 2012, so no surprise at the invalidity. There are many pre-Mayo patents that are worthless because in seeking claims with broad scope, many applicants opted to cover the correlations only. These broad claims are great to assert but don’t survive.
    The real challenge will be to write claims applying the discovered correlations to particular indications. Basically, use the correlation for a purpose other than mere observation.
    The current understanding of 101 is creating havoc in the electronics industry, and it’s doing the same with biotech and medical diagnostics. Until 101 gets clarified, practitioners will need to up their game in claim drafting.

  4. Anon June 26, 2017 7:33 am

    The (immediate) problem with your advice, CP in DC, is that it is ex post facto impossible to “up your game” for claim drafting in anticipation of how the Court may take not of “scrivining” and make up new decisions that rewrite 101 to the Court’s desired ends.

    Your advice “sounds great,” but is eminently impracticable – as long as the Supreme Court is in the loop, the only valid claim is one that has not yet appeared before them (with full credit for this description going to a former member of that august body itself).

  5. CP in DC June 26, 2017 1:35 pm

    Anon
    There is no retroactive correction unless you have a pending member in the family. I pointed out the practice of writing overly broad claims directed at the natural phenomena alone. The Univ. Rochester case taught us the weakness in such reach-through claims. A broad claim sounds great to assert but is full of problems.

    In Diamond v Diehr the Supreme Court taught practitioners that the application of a mathematical equation to curing rubber was patent eligible. That was in 1981. The same principle applies to all sciences, such as biotech and medical diagnostics. Application of the natural phenomena is patent eligible, and claim drafting has to claim that application. See Cellzdirect.

    It is not “eminently impracticable” just difficult, but that is the nature of patent work.

  6. Anon June 26, 2017 2:46 pm

    CP in DC,

    You quite missed the point that the Supreme Court “changes the rules” whenever they want to – and much, much, too late to do anything at all about claims written in the meantime.

    My comment about being able to forecast the future (or rather, no one having that ability) remains on point.

  7. CP in DC June 26, 2017 4:37 pm

    Anon

    Cellzdirect’s patent was filed in 2005 and issued in 2009 (both filing and issuance dates are after Cleveland’s dates). And yet, the patent claims survived an ineligibility challenge. Also Cellzdirect’s dates were before Mayo (decided in 2012), so someone knew how to draft claims without the benefit of the Supreme Court decision.

    These are just the facts.

  8. Gene Quinn June 26, 2017 4:46 pm

    CP in DC-

    Can you elaborate on how you think the Cellzdirect claims are drafted in a way to overcome an ineligibility challenge?

    I personally see no intellectually honest way to distinguish Cellzdirect from Sequenom, other than in one case the patent claims were found eligible and in the other cases they were found ineligible.

    -Gene

  9. CP in DC June 26, 2017 5:48 pm

    Gene

    I can do the comparison but it will take me some time. May I get back to you on this topic?

    However, I believe it will be difficult for me because, I believe Sequenom was wrongly decided. I agree with you, it is difficult to distinguish these two cases in an intellectually honest manner.

    CP

  10. Anon June 26, 2017 6:36 pm

    CP in DC,

    Your admission as to “it is difficult to distinguish these two cases in an intellectually honest manner” is exactly my point.

  11. CP in DC June 26, 2017 7:57 pm

    Anon

    Your point was directed to the Supreme Court decision making.

    Neither case is from the Supreme Court, so the difference in outcomes is not because “the Supreme Court ‘changes the rules.'” Both cases are Federal Circuit cases:
    Sequenom: Reyna (author), Linn, Wallach
    Cellzdirect: Prost (author), Moore, Stoll

    In Cellzdirect the panel refused to interpret the claim as directed to a natural phenomena, so the Alice analysis did not apply.
    In Sequenom, the panel decided the claim was directed to a natural phenomena and applied the Alice analysis.

    Unfortunately, a split in panel outcomes is not rare at the Fed Cir., such as Atlantic Thermoplastics and Scripps Institute. That split lasted a very long time before it was addressed. Therefore, asking a person to explain different outcomes from different panels is a difficult task, especially when there is no overlap in panels. So why do different judges decide cases differently? Is the question I addressed.

    Again, these are just the facts.

  12. Anon June 26, 2017 9:58 pm

    The CAFC has been whipsawed by the Supremes. Their inconsistency is a direct result of the Supreme muckery.