Split Federal Circuit Panel Holds That Method of Medical Treatment Claims are Patent Eligible

In Natural Alternatives Int’l., Inc. v. Creative Compounds, LLC, Appeal No. 2018-1295 (Fed. Cir., March 15, 2019) a divided panel of the Fed. Cir. held that claims to methods of increasing the anaerobic working capacity in a human subject by administering  an amount of a dietary supplement comprising beta-alanine, its ester or amide, effective to increase beta-alanyl histidine dipeptide synthesis in the subject’s tissue via the blood (Moore, Reyna and Wallach, Moore writing, Reyna concurring in part, dissenting in part.) A two-component composition claim comprising glycine and beta-alanine and these derivatives, and either beta-alanine dipeptide or beta-alanyl histidine dipeptide, that is a dietary supplement, was also found to be patent eligible. The panel found that the broadest composition claim reciting only beta-alanine was also patent-eligible:

  1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4-16 grams, wherein the supplement provides a unit dosage form of beta-alanine.

Claims to the use of beta-alanine in manufacturing a human dietary supplement for oral consumption by supplying the beta-alanine as a single ingredient or in combination with at least one other ingredient, in a manufacturing step of the human dietary supplement, whereby oral consumption of the dietary supplement in doses over a period of time increases beta-alanyl histidine levels in muscle tissue sufficient to delay the onset of fatigue in the human. See, U.S. Pat. Nos. 5,965,596; 8,933,610; 8,470,865 and RE45,947.

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Hikma and West-Ward v. Vanda – Are Methods of Medical Treatment Patent-Eligible?

Hikma Pharms. and West-Ward Pharms petition for cert. to reverse the Fed. Cir.’s decision in Vanda v. West-Ward that methods of medical treatment are patentable.

The Supreme Court’s now-infamous Mayo decision, invalidated claims to a method for determining the optimal dose range of an immunosuppressive drug by measuring the blood concentration of its metabolite. However, it contained language explicitly stating that claims directed to new uses for an existing compound were patent-eligible. Since such uses can include subsequently discovered second medical uses – as our UK colleagues would call them—The PTO and the Fed. Cir. in Vanda continued to allow diagnostic claims that included the further step of treating the condition that had been diagnosed. The basic rationale was that, while a diagnostic correlation may be a natural phenomenon, the treatment step is a practical application of the knowledge gained by the diagnosis. So, post-Vanda, we life sciences prep/pros folks could breathe a bit more easily.

Vanda has now filed its Brief in Opposition to Hikma’s Petition for Cert., so it seems appropriate to send you a few observations. To begin with, Hikma has framed the question presented is “whether patents that claim a method for medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps.” Vanda disputes the underlying premise, arguing that the Fed. Cir. ruling was not so broad, and did not, as Hikma argues, effectively reverse Mayo.

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Athena v. Mayo Part II – Iancu v. The Federal Circuit(?)

The 2019 Revised Subject Matter Eligibility Guidance published on January 7th purported to revise the procedures for determining whether a patent claim or patent application claim is “directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas) under step 2A” of the USPTO’s Mayo/Alice Rule Guidance in two ways. First, the Revised Guidance seeks to clarify just what an abstract idea is by stated that abstract ideas can be grouped as, e.g., mathematical concepts, mental processes and the like. More important to life sciences patenting, the Revised Guidance explains that a patent claim that recited a judicial exception is not ‘directed to’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception.” If the claim is [[not]] directed to a judicial exception, the dreaded 2B analysis must be carried out.

The majority of the Fed. Cir. panel clearly disagrees with this Revision in the case of any diagnostic claim that recites a naturally occurring correlation, along with the manipulative steps required to reach a diagnosis. The majority of the panel in Athena v. Mayo – and perhaps a majority of the Fed. Cir. Judges – inevitably find that a diagnostic claim that recites the application of a naturally occurring correlation reach a diagnostic conclusion is directed to a natural law, despite the presence in the claim of the steps wherein the “hand of man” is applied to convert the discovery of the in vivo correlation into a practical application of the natural law. Once the claim is found to be directed to a such a correlation, which is a natural law, the court moves on the Step 2B, in which it examines the remaining steps – sampling, measuring the biomarkers in question and comparing them to a reference amount of the biomarker, and drawing a diagnostic conclusion from the data – in isolation, to see if they represent an “inventive step” apart from their application to reach a diagnostic conclusion. In other words, the recognition of the utility of the in vivo correlation cannot provide the required “inventive step” when applied in vitro, unless there is a second “invention” that arises when the in vitro assay is carried out.

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Mayo Wins in Another s. 101 Appeal – Discovery of a Useful Natural Correlation is not Patent Eligible

By now, once you see the claim, I would not be surprised if any of my loyal readers could not predict how it would fare at the Fed. Circuit. However, this is a worthwhile decision to review, particularly since the dissent by Judge Newman brings the analytical flaws in the majority’s opinion into such sharp focus. A representative doomed claim is below, compressed for readability:

7. A method for diagnosing neurotransmission or developmental disorders related to [the marker protein MuSK] in a mammal comprising:

contacting MuSK… having a suitable label thereon with [a] bodily fluid,

immunoprecipitating any antibody/MuSK complex… from the,

bodily fluid and

monitoring for said label on any of said antibody/MuSK complex…,

wherein the presence of said label is indicative of said mammal suffering from said… disorder related to [MuSK].

The claim is the result of the discovery that 20% of myasthenia gravis (“MG”) patients do not express autoantibodies to the acetyl choline receptor, but do generate autoantibodies against MuSK, a membrane protein. “Prior to this discovery, no disease had been associated with MuSK.” Slip op. at 4.

So, this is an example of an “If A, then B” diagnostic claim, with some wrinkles. The user does not simply measure the level of a biomarker, following the administration of a drug known to yield the biomarker, as in the 6-TP metabolite used as the marker in Mayo. In this claim, a hypothetical user would need to obtain the labeled MuSK protein (e.g., radiolabeled), add it to the test fluid, so that any antibody/MuSK complex is immunoprecipitated, measure the level of the label, and conclude that the patient does or does not have MG. This looks a lot like the hand of man at work, but these steps did not impress the majority of Judges Lourie and Prost. Perhaps they have become “strict constructivists” of the Mayo/Alice Rule.

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