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  • Shelly Albaum

Another Door Slams on Elysium


The Court of Appeals for the Federal Circuit decided an interesting case last week that might have implications for the ChromaDex Elysium litigation. The case is Natural Alternatives v. Creative Compounds. You can read it here:

Natural Alternatives v. Creative Compounds

First of all, the Court of Appeals for the Federal Circuit (CAFC) is the most the most important court for Patent Law. It takes all the appeals from the Patent Trial and Appeal Board (PTAB), including Elysium's current appeal of the PTAB's IPR decision, and it ALSO takes appeals in Patent cases from district courts all around the country. So courts around the country consider the CAFC to be peculiarly persuasive on patent matters, and if there is an appeal in Delaware, it will be to the CAFC.

There are five primary ways ways to attack the validity of a patent.

To win a patent, inventions must be (1) new, (2) useful, (3) non-obvious, (4) adequately described, and (5) eligible. Therefore...

1. Novelty. So one way to attack a patent is to argue that the invention is not "new" or "novel." This is accomplished by finding some "prior art" that reveals the essence of the invention prior to the patent date. That's what Elysium attempted to do before the PTAB.

2. Utility. A second mode of attack would be to argue that the invention is not useful -- either it does not do anything, or it cannot do anything (like a perpetual motion machine).

3. Non-Obvious. A third attack would be to argue that the invention is obvious -- that someone skilled in the art at the time of the invention would have found the invention a trivial combination of known elements lacking ingenuity.

4. Disclosure. Fourth, one could challenge the technical aspects of the patent, like whether the invention was adequately described, fully disclosed, and all the inventors listed.

5. Eligibility. Finally, and most fundamentally, one can argue that the subject matter of the invention is itself not patentable. For example, you can't patent natural laws, natural phenomena, or abstract ideas.

We can expect Elysium to raise all of these arguments in the Delaware patent infringement litigation, once it re-starts, if there is any possible argument.

Will any of them stick?

The PTAB is the most receptive audience one could wish for when attempting to invalidate a patent. Elysium already gave its best swing on Novelty before the PTAB, and it didn't work, so it is not particularly likely to do better before the CFAC or in Delaware with prior art.

Utility is a very low bar -- and it would be hard to argue that NR is not useful.

Obviousness will be a tough row to hoe, also, because Dr. Brenner is the one who discovered the NR Kinase pathway, and before his discovery it would not have been obvious to anyone -- even to him -- that you could use NR to replenish NAD.

I have not heard any suggestion that there are technical defects with the disclosures in the patent. Seems like a long shot.

Subject Matter Eligibility

Which leads us to subject matter eligibility. Is there some way in which Elysium could argue that that the '807 and '086 patents cover ineligible subjects, like natural laws?

I suppose the argument would be that Niagen isn't an invention so much as a discovery -- a discovery that ingesting NR raises NAD levels. NR itself can't be patented, because it's just a naturally occurring molecule, and the process of using NR to replenish NAD is just a natural biological process, or a natural phenomenon.

If that were the argument that Elysium was hoping to advance in Delaware, then it suffered a severe blow last week, because someone just made the argument in a similar case and lost.

Natural Alternatives v. Creative Compounds presented a scenario not unlike what we see in the ChromaDex-Elysium litigation.

Natural Alternatives is a health supplement company that owns a number of patents for using a naturally occurring substance to improve physical performance.

Specifically, the patents relate to the use of an amino acid in a dietary supplement to increase the aerobic working capacity of muscle and other tissue.

That's not so different from using a vitamin in a dietary supplement to increase the working capacity of mitochondria.

Natural Alternatives sued some competing health supplement suppliers for patent infringement.

The alleged infringers moved to dismiss the patent suit on the grounds that using amino acids in a health supplement to improve muscle strength was directed toward an unpatentable natural phenomenon.

A federal district court in California agreed with the alleged infringers, and dismissed all the patent infringement claims, saying that the patent:

simply acknowledges the natural law that providing beta-alanine to human tissue will increase the carnosine concentration in the tissue and aid in regulating hydronium ion concentration, and then merely instructs to do so. This is insufficient to render the claim patent-eligible.

Natural Alternatives appealed, and the CAFC reversed. The CAFC said,

...The district court held both claims are directed to natural laws. It held claim 1 of the ’865 patent is 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, increase the anaerobic working capacity in a human.” J.A. 22. It held claim 1 of the ’596 patent is 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, aid in regulating hydronium ion concentration in the tissue.” J.A. 21. We do not agree.

Administering certain quantities of beta-alanine to a human subject alters that subject’s natural state. Specifically, homeostasis is overcome, and the subject’s body will produce greater levels of creatine. See ’596 patent 5:27–35. This, in turn, results in specific physiological benefits for athletes engaged in certain intensive exercise. See ’596 pa- tent 5:21–23. The claims not only embody this discovery, they require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete’s physiology to provide the described benefits. These are treatment claims and as such they are patent eligible...

The Method Claims contain specific elements that clearly establish they are doing more than simply reciting a natural law...The Method Claims specify particular results to be obtained by practicing the method...The Method Claims specify a compound to be administered to achieve the claimed result...The Method Claims likewise contain a dosage limitation by virtue of the “effective” limitation...This goes far beyond merely stating a law of nature, and instead sets forth a particular method of treatment.

Similarly, the fact that the active ingredient in the supplement is a molecule that occurs in nature and is consumed as part of the human diet also does not alter our analysis...while beta-alanine may exist in nature, Natural Alternatives has argued that the quantities being administered do not, and that the claimed consumption greatly exceeds natural levels...

The Method Claims at issue are treatment claims. They cover using a natural product in unnatural quantities to alter a patient’s natural state, to treat a patient with specific dosages outlined in the patents. We hold, therefore, that the Method Claims are not directed to ineligible subject matter...

The CAFC goes on to apply this analysis not only to Method claims, but also to Product and to Manufacturing claims, concluding:

The supplement is not a product of nature and the use of the supplement to achieve a given result is not directed to a law of nature. We do not see, therefore, how a claim to the manufacture of a non-natural supplement would be directed to the law of nature or natural product.

Obviously, ChromaDex could not wish for anything better than to have the CAFC clarify for the world that inventions incorporating natural ingredients into health supplements in non-natural quantities to obtain specific results at effective doses are patent-eligible.

CONCLUSION

Elysium's novelty challenges have already failed before the PTAB

It's not clear that there could be any viable utility, disclosure, or obviousness challenges.

And a brand new authority from the second-highest-court-in-the-land on Patent Law -- mandatory authority in patent cases -- suggests that health supplement patents like ours are very likely to be found patent-eligible.

I can't wait for the Delaware case to re-commence.

#CDXC #ChromaDex #ElysiumHealth #Litigation

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