Patenting Therapeutic Use of a Natural Compound

by Dennis Crouch

I wrote earlier about a Natural Alternatives decision regarding priority.  A separate Natural Alternatives was also the subject of the annual patent law moot court competition in my 2017 Patent Law course at the University of Missouri.

In that case, Natural Alternatives v. Creative Compounds, the district court dismissed the lawsuit on the pleadings (12(b)(6)) — finding that the claims were improperly directed toward the natural phenomenon – beta alanine.  The amino acid is apparently useful in muscle building.

The case is now pending appeal before the Federal Circuit. As an example, Claim 1 of U.S. Pat. No. 7,825,084 is directed toward:

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

In my judges’ brief, I suggest that this is likely the weakest of the patentee’s claims and provide the argument that: Beta-alanine is a product of nature and thus unpatentable; The specific dosage is associated with a law of nature because the amount is designed to be the effective amount to work on the human body; and Formulating it as a supplement at a proper treatment dosage does not add an inventive concept.  The other side might argue here that the claim is a supplement for treatment — not an underlying product of nature (Myriad), and the effective amount is far in excess of any supplementation relied upon in nature. I’ll note here that a high-meat diet might get up to 0.4 grams per day, but remember that this case was decided on the pleadings — so any plausible factual disputes must be sided in the patentee’s favor.

Claim 34 of the ‘947 Patent is one of the best claim for the patentees:

A human dietary supplement for increasing human muscle tissue strength comprising

a mixture of creatine, a carbohydrate and free amino acid beta-alanine that is not part of a dipeptide, polypeptide or an oligopeptide,

wherein the human dietary supplement does not contain a free amino acid L-histidine,

wherein the free amino acid beta-alanine is in an amount that is from 0.4 g to 16.0 g per daily dose,

wherein the amount increases the muscle tissue strength in the human, and

wherein the human dietary supplement is formulated for one or more doses per day for at least 14 days.

My judges brief explained the issue of importance on the patentee’s side is that the district court’s conclusions appear to be based upon a number of factual conclusions that were decided on the pleadings without any evidence in support. (Berkheimer). The pro-infringer argument: that creatine, carbs,, and beta-alanin are all naturally occurring, and their mixture is not patentable (Funk Bros); although the claims use beta-alanine that is separated from other peptides, that breakage of chemical bonds does not make it patent eligible (Myriad); and the claimed increase muscle mass is simply a law of nature (result of taking the supplement).

In my mind, this is not the type of case that should be dismissed on the pleadings.  But, Judge Huff disagree.

The now pending appeal is interesting and Natural Alternatives has garnered Amici support from both BIO and a group of leading patent law scholars  that include Chris Holman (Drake and UMKC), David Lund (GMU), Adam Mossoff (GMU), Kristen Osenga (Richmond), and David Taylor (SMU).   The law scholar brief was filed by Kevin Noonan of MBHB.  In addition to the legal arguments made by the parties, the Scholars provide their view:

Amici contend that Natural Alternatives’ claims represent precisely how the patent system should reward discovery of a therapeutic use of a natural compound, and thus their invention should be eligible for patent protection. The Supreme Court has repeatedly emphasized that patents claiming new uses of known drugs or new applications of laws of nature are patent eligible, and these teachings properly applied provide patent eligibility for the kinds of claims at issue in this case. Assoc. for Molec. Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 594 (2013); Mayo Collaborative Servs v. Prometheus Labs., Inc., 566 U.S. 66, 87 (2012). The district court’s decision to the contrary conflicts with the Patent Act as an integrated statutory framework for promoting and securing innovation in the life sciences, as construed by this court as well as by the Supreme Court.

The case is pending before the Federal Circuit, although I don’t believe oral arguments have been scheduled (because of an attorney schedule conflicts).

Briefs in the pending case:

36 thoughts on “Patenting Therapeutic Use of a Natural Compound

  1. 9

    Great article Professor Crouch. Your blog is a huge reservoir on issues regarding patent laws. Hoping that the Federal Circuit comes out with a logical verdict soon enough.

  2. 8

    The case is pending before the Federal Circuit, although I don’t believe oral arguments have been scheduled (because of an attorney schedule conflicts).

    I think most appeals currently take about 6 months from when the joint appendix is filed to when oral argument happens. (www.law360.com/articles/999115). In this case, the joint appendix was filed at the end of July, so oral argument will probably happen in early 2019.

    1. 7.1

      WHAT HAPPENED TO YOU IS WORSE THAN A FALSE ACCUZATION WITCH IS TEH WORST THING THAT CAN EVER HAPPEN TO TODAYS YOUNG WHITE MAN

      1. 7.1.1

        …white…?

    2. 7.2

      BE VARY AFRAID! FIRST THEY COME FOR YOUR BEER THAN THEY COME FOR YOUR DIARY THEN THEY COME FOR YOUR COLLECTION OF STOLEN WOMEN UDNERWEARE

    3. 7.3

      YOU CAN BE THIS CLOSE TO ALL THE POWER THEN YOU DONT GET IT WHICH IS LIKE GOING TO ELECTRIC CHAIR IN TEH NUDE ON LIVE TV WE HAVE ALL BEEN THERE ARE YOU WITH ME GUYS

  3. 6

    What is the absorption of information if not a physical change to the human body? Where does the new information reside, how is it stored if not in a physical change to the human body?

    1. 6.1

      ooops that should be under 1.2.

    2. 6.2

      Les information is not corporeal just because physical apparatus is needed to hold and process it.

      Putting ink on a page is a physical act, but the information is not physical, it’s an abstraction if a human being processes it.

      1. 6.2.1

        LEAVE NON COLLEGE EDUMCATED WHITE MEN ALOOOOOOOOOOOONE

        1. 6.2.1.1

          Wtf?

          A p00persc00per is still needed for the “Sarah”-mode

      2. 6.2.2

        Martin, you said: “In my scheme, this process is eligible because the result of the process is NOT an item of information, but a physical change to the human body. ”

        When a human body receives information there is a physical change to that human body. Erg a process that provides information to the human body is eligible under your test.

        1. 6.2.2.1

          Did you mean to say that a physical change to a human body causes an information change to a human body by it’s inherent action?

          Sure, maybe, but an abstraction requires that information be processed by a human mind as information where that processing yields the utility of the invention. Cellular level biologic operations are not abstractions.

          1. 6.2.2.1.1

            Did you mean to say that a physical change to a human body causes an information change to a human body by it’s inherent action?” (emphasis added)

            That’s not what he said (you put the cart before the horse – note the emphasized portion).

          2. 6.2.2.1.2

            “Did you mean to say that a physical change to a human body causes an information change to a human body by it’s inherent action? ”

            No.

            I did mean to say Ergo, not Erg, however.

      3. 6.2.3

        Martin, this is not right.

  4. 5

    Totally off-topic, but has anyone around here tried to use the private PAIR migration tool since it went live yesterday? If so, did it work for you. I tried yesterday and again today, and it is not working for me.

    1. 5.1

      Not yet. Will advise.

    2. 5.2

      You need to have two factor authentication enabled in your myUSPTO account.

    3. 5.3

      One migration worked smoothly. One migration stalled signing into myuspto. Many more to go.

  5. 4

    Practical question: In litigation, how would you prove “wherein the amount [of beta-alanine] increases the muscle tissue strength in THE human.” And once you prove that it does, how hard would it be for the defense to prove that it has done so for decades in which it has been used by athletes? Note that the claim refers to THE human, which appears to lack antecedent basis, so litigation of this claim may be a fight to see who gets to take out the trash. Adding to Lackey’s point, if infringement depends on a manner of use, the claim is indefinite because you don’t know if the supplement infringes it until you know who uses it and how they use it. (something like EX PARTE TIMOTHY E. BRUMMER, 1989 WL 274386).

    1. 4.1

      A human is inherently recited wrapped around the explicitly recited human muscle tissue, if for no other reason than it is needed for there to be a diet to be supplemented.

  6. 3

    Amici contend that Natural Alternatives’ claims represent precisely how the patent system should reward discovery of a therapeutic use of a natural compound

    As a point of style, I think this is a silly way to frame the pro-patentee argument. Are all of these claims really perfect examples of what a patent claim to a therapeutic use of a “natural compound” should look like? I don’t think so. Some of them are pretty cr@ ppy and broad and comprise result-oriented limitations that are problematic. Plus it just sort of sounds like the kind of thing Kevin Noonan would say about any bio-related claim that got invalidated for any reason before he launched into some rant about diseased children.

  7. 2

    Dennis: “the claimed increase muscle mass is simply a law of nature (result of taking the supplement)”

    Some point in the future: The claimed cure for cancer is simply a law of nature (result of taking the medicine).

    No, No you say. That would only be a problem if the cure is “found in nature.”

    So, I guess you are saying we want to discourage looking in the rain forest or in cancer free organisms for the cure for cancer and only invest in the search for a man made cure…

    Also, how would we know that the “man made cure” is not found in nature? Have we found every naturally occurring chemical on Earth? Have we found every naturally occurring chemical on Mars? Europa? Phobos? Jupiter? Neptune? Tatooine? Vulcan? Riza?

    1. 2.1

      Some point in the future: The claimed cure for cancer is simply a law of nature (result of taking the medicine).

      No need for any such “future” (as the legal mechanism need not wait for “cancer”), and the mechanism exists NOW for most ALL pharma.

      Most ALL pharma only works by direct “natural” action of the body processing whatever the actual items sold by Pharma (as those items may be).

      Taking the legal mechanism to its logical conclusion already is at the place that you are thinking of for your “future.”

      1. 2.1.1

        Gotta agree with Dennis up to a point: the increase in muscle mass is the natural result of taking the supplement. If that makes it a law of nature then all of medical therapy is too. Headache relief is just the body’s natural response to ibuprofen. Immunity is just the body’s natural response to the vaccine. Curing hepatitis is just the virus’s natural response to the drug. It goes on and on.

        1. 2.1.1.1

          …exceptions that swallow the rule of law…

          Contrast these 101 exceptions to the exceptions to the judicial doctrine of printed matter (and the important — and clear — distinction there of “functionally related” to see how not to use exceptions (101) and how to use exceptions (printed matter).

          The contrast reveals not only difference in degree (which invites subjective line drawing), but the contrast reveals difference in kind (which provides clarity).

          Of course, those not wanting this clarity will expend tremendous effort trying to dissemble and obfuscate on this point.

  8. 1

    The headline here does not match the claim at issue.

    Patenting a “use” speaks to a process claim.

    Patenting an item “for a use” speaks to something different.

    One may patent a new use of NaCl for the process of use.

    One may not patent NaCl itself, and then say that the item is only patented “for a use.”

    This is a case where the choice of statutory category does make a difference (and does tend to show that the process category is meant to be quite extensive).

    1. 1.1

      Yes, and its also why claim 34 of the ‘947 patent runs into a problem with the limitation “wherein the amount increases the muscle tissue strength in the human.” The supplement would not increase the muscle tissue strength in the human until it is ingested by the human (ignoring the fact that “the human” lacks antecedent basis). When it is sitting on the shelf for sale, it does not increase muscle tissue strength in any human. Borderline IPXL indefiniteness.

    2. 1.2

      I agree with you anon

      In my scheme, this process is eligible because the result of the process is NOT an item of information, but a physical change to the human body.

      The process may be obvious or anticipated etc., but I think surely should be eligible. It should not be eligible as a composition or manufacture because it occurs naturally in the therapeutic form.

      1. 1.2.1

        I’d read what you wrote Martin, but it is a mere “item of information” so I do not think it worthy of reading.

        1. 1.2.1.1

          OMG MARTINI YOU JUST GOT TOTALLY OWNED IN NIGHT WIPERS MIND SU CK TO BE YOU RIGHT NOW HUH

      2. 1.2.2

        Marty,

        Your tangent of “process and result of a process” have nothing at all to do with the point presented.

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