The Federal Circuit Opens the Door Wider for the Subject Matter Eligibility of Methods of Treatment, Compositions and Methods of Manufacturing

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“We live in a natural world, and all inventions are constrained by the laws of nature . . . we must be careful not to overly abstract claims when performing the Alice analysis.”[1] These are the promising words from the Federal Circuit in its recent decision in Natural Alternatives v. Creative Compounds, in which the court held that dietary supplements, methods of treatment using the same and methods of manufacturing the same are directed to patent-eligible subject matter.

Natural Alternatives owns a number of patents that relate to the use of beta-alanine in a dietary supplement designed to increase the anaerobic working capacity of muscles and other tissues. Beta-alanine is a naturally occurring amino acid that, together with histidine and their methylated analogues, forms certain dipeptides that are present in the muscles of humans and other vertebrates.[2] The patents at issue claim methods of treatment, dietary supplements and methods of manufacturing the dietary supplements containing beta-alanine. On a Rule 12(c) motion (judgment on the pleadings), the district court held that the claims at issue are directed to patent-ineligible subject matter under Section 101. The Federal Circuit reversed and remanded. This decision is favorable for patent owners in the life science field.

 Method of treatment claims

Claim 1 of U.S. Patent No. 5,965,596 recites:

A method of regulating hydronium ion concentrations in a human tissue comprising:

providing an amount of beta-alanine to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue; and

exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the human tissue.[3]

Claim 1 of U.S. Patent No. 8,470,865 recites:

A method of increasing anaerobic working capacity in a human subject, the method comprising:

a) providing to the human subject an amount of an amino acid to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the tissue, wherein said amino acid is at least one of:

i) beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide;

ii) an ester of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; or

iii) an amide of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; and

b) exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the tissue, wherein the amino acid is provided through a dietary supplement.[4],[5]

The district court held that the claims were directed to the natural law that “ingesting certain levels of beta-alanine, a natural substance, will increase the carnosine concentration in human tissue and, thereby” 1) increase the anaerobic working capacity in a human or 2) aid in regulating hydronium ion concentration in the tissue.[6] The Federal Circuit disagreed because “[a]dministering certain quantities of beta-alanine to a human subject alters that subject’s natural state” and the claims “require that an infringer actually administer the dosage form claimed in the manner claimed.”[7] The court distinguished the claims from those in Mayo[8] because Natural Alternatives’ claims at issue:

  • “[R]equire specific steps be taken in order to bring about a change in the subject, altering the subject’s natural state.”[9]
  • “[S]pecify particular results to be obtained by practicing the method.”[10]
  • “[C]ontain a dosage limitation by virtue of the ‘effective’ limitation” and “the specification provides a method for calculating dosage based on a subject’s weight.”[11]

The court was also persuaded by Natural Alternatives’ argument that while beta-alanine may exist in nature, “the quantities being administered do not, and that the claimed consumption greatly exceeds natural levels.”[12]

Regarding step 2 of the Alice test, the court stated that there were fact issues going beyond the realm of what Rule 12(c) can resolve – in particular, whether or not the dietary supplement in the claims (large amounts) would have been well-understood, routine and conventional. Because the court found that the claims were eligible under step 1, however, this does not appear to be a particularly important point for remand.

Composition claims

Claims 1, 5 and 6 of U.S. Patent No. 7,504,376 recite:

1. A composition, comprising: glycine; and a) an amino acid selected from the group consisting of a beta-alanine, an ester of a beta-alanine, and an amide of a beta-alanine, or b) a di-peptide selected from the group consisting of a beta-alanine di-peptide and a beta-alanylhistidine di-peptide.

5. The composition of claim 1, wherein the composition is a dietary supplement or a sports drink.[13]

6. The composition of claim 5, wherein the dietary supplement or sports drink is a supplement for humans.

Claim 1 of U.S. Patent No. 7,825,084 recites:

  1. 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.

The district court held that these claims were directed to the natural phenomena of beta-alanine or beta-alanine and glycine. The Federal Circuit disagreed, stating that these claims “are directed to specific treatment formulations that incorporate natural products, but they have different characteristics and can be used in a manner that beta-alanine as it appears in nature cannot.”[14] The court put significant weight on the specific dosages recited by the claims – in the ‘376 patent claims, the dietary supplement or sports drink being sufficient to “effectively increase[] athletic performance” and in the ‘084 patent claims, “between about 0.4 grams to 16 grams.”[15] Evidence of record also suggested a synergistic effect of beta-alanine and glycine, a function different from the individual components alone in nature. Interestingly, the step 1 analysis used by the court involved an analysis of “utility” as set forth in Chakrabarty and Funk.[16]

Regarding step 2, the court notes that there is nothing in the specification to support an argument that the dietary supplement was well-understood, routine and conventional.

Manufacturing claims

Claim 1 of U.S. Patent No. 8,993,610 recites:

  1. Use of beta-alanine in manufacturing a human dietary supplement for oral consumption;[17]

supplying the beta-alanine, which is not part of a dipeptide, polypeptide or oligopeptide, as a single ingredient in a manufacturing step of the human dietary supplement[18] or

mixing the beta-alanine, which is not part of a dipeptide, polypeptide or oligopeptide, in combination with at least one other ingredient for the manufacture of the human dietary supplement,[19]

whereby the manufactured human dietary supplement is for oral consumption of the human 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.

The district court held the manufacturing claim to be directed to “the natural phenomenon beta-alanine and the natural law that ingesting certain levels of beta-alanine will increase the carnosine concentration in human tissue.”[20] The Federal Circuit disagreed, holding that, under step 1, the claim is “directed to the manufacture of a human dietary supplement with certain characteristics,” and neither the supplement nor its use is directed to a law of nature.[21]

Judge Reyna concurred in part and dissented in part, questioning the claim constructions and suggesting that under a correct construction, the analysis could be quite different. The majority appears to expect that if the claim construction changes the result of step 1, then there would also be step 2 issues to decide.

Although the eligibility of the claims at issue may ultimately depend upon the final claim construction (Markman hearing not yet conducted), this case offers a number of suggestions for drafting claims and the specification to increase the chances of obtaining patent-eligible subject matter. For example, factors that the court focused on when analyzing the method of treatment claims included the recitation of: 1) specific steps to be taken in order to bring about a change in the subject, altering the subject’s natural state; 2) particular results to be obtained by practicing the method; and 3) dosage limitations (even through use of the “effective” limitation). Because claim construction factors heavily in the subject matter eligibility of these types of claims, applicants will benefit from clear definitions provided in the specification consistent with this court’s analysis.

[1] Natural Alternatives Int’l v. Creative Compounds, LLC., No. 2018-1295, 2019 WL 1216226, *9 (Fed. Cir. March 15, 2019).
[2] U.S. Patent No. 5,965,596.
[3] For purposes of the appeal, the court accepted Natural Alternatives’ construction of “effective …” to mean “elevates beta-alanine above natural levels to cause an increase in the synthesis of beta-alanyl-histidine dipeptide in the tissue.”
[4] For purposes of the appeal, the court accepted Natural Alternatives’ construction of “increasing anaerobic working capacity” to mean “increasing the amount of work performed by the muscle under lactate producing conditions.”
[5] For purposes of the appeal, the court accepted Natural Alternatives’ construction of “dietary supplement” to mean “an addition to the human diet, which is not a natural or conventional food, which effectively increases athletic performance when administered to the human over a period of time.”
[6] Natural Alternatives Int’l, 2019 WL 1216226 at *3.
[7] Id.
[8] Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
[9] Natural Alternatives Int’l, 2019 WL 1216226 at *4.
[10] Id. at *5.
[11] Id.
[12] Id.
[13] For purposes of the appeal, the court accepted Natural Alternatives’ construction of “dietary supplement” to mean “an addition to the human diet, which is not a natural or conventional food, which effectively increases athletic performance and is manufactured to be used over a period of time.”
[14] Natural Alternatives Int’l, 2019 WL 1216226 at *7.
[15] Id.
[16] Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980); Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948).
[17] For purposes of the appeal, the court accepted Natural Alternatives’ construction of “[u]se of beta-alanine in manufacturing a human dietary supplement” to mean “making an addition to the human diet using beta-alanine, which is not a natural or conventional food, to be administered over a period of time and that effectively increases athletic performance.”
[18] For purposes of the appeal, the court accepted Natural Alternatives’ construction of “supplying the beta-alanine, which is not part of a dipeptide, polypeptide or oligopeptide, as a single ingredient in a manufacturing step of the human dietary supplement” to mean “providing the free amino acid beta-alanine, an ester of beta-alanine or an amide of beta-alanine in a step of making an addition to the human diet using beta-alanine as the only active ingredient, which is not a natural or conventional food, which effectively increases athletic performance when administered to a human over a period of time.”
[19] For purposes of the appeal, the court accepted Natural Alternatives’ construction of “mixing the beta-alanine, which is not part of a dipeptide, polypeptide or oligopeptide, in combination with at least one other ingredient for the manufacture of the human dietary supplement” to mean “making an addition to the human diet which is not a natural or conventional food, and which effectively increases athletic performance when administered to a human over a period of time, using the free amino acid beta-alanine, an ester of beta-alanine or an amide of beta-alanine and at least one other ingredient.”
[20] Natural Alternatives Int’l, 2019 WL 1216226 at *8.
[21] Id.

 

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