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: