Beta Alanine Patents Invalidated by Hi-Tech Pharma and AllMax

Beta Alanine Patent

Another one bites the dust. Hi-Tech Pharma and ALLMAX Nutrition have INVALIDATED the CarnoSyn Beta Alanine patent!

CarnoSyn Beta Alanine is one of the most recognizable and widely used supplements in the world. It’s been proven time and again to enhance stamina, endurance, and time to exhaustion. Beta alanine is also known for its quintessential tingling sensation it gives to users first using the supplement.

But, we’re not here today to do a full in-depth analysis about the inner workings of beta alanine. We’re here to discuss a landmark legal decision involving Natural Alternatives International, Inc. (NAI), the former holders of five different beta alanine patents (including CarnoSyn®), and a battle with both ALLMAX Nutrition and legal heavyweights Hi-Tech Pharmaceuticals.

We’ve got all the case details down below, but first, take a moment to sign up for PricePlow alerts so you can stay on top of any and all legal happenings within the supplement industry, and note that beta alanine prices may be dropping soon:

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The Case

Figure 13 Carnosine

From Patent Application 8,470,865 —
FIG. 13 is a graph depicting muscle concentration (mean+SD) of carnosine before and post supplementation in three different treatment groups.

As stated above, NAI is the holder of five Beta Alanine patents, including the most well known beta alanine on the market, CarnoSyn®. On September 16, 2016, NAI filed suit against Hi-Tech. (16-cv-2343-Doc. No. 1.), and later amended the complaint where they alleged Hi-Tech was:[1]

  • In breach of contract
  • Guilty of patent infringement
  • In violation the Lanham Act § 3

NAI asserted that Hi-Tech was infringing specifically on U.S. Patent Nos. 5,965,596, 7,825,084, RE45,947, 8,993,610, and 8,470,865. In short, Hi-Tech was using beta alanine but not paying to license it.

However, co-defendants Hi-Tech and Creative Compounds argued that the case should be thrown out citing a previous case involving NAI and ALLMAX Nutrition (16-cv-1764-Doc. No 64 at 10-21, 23.), where the judge in that case ruled the beta alanine patents are all invalid under 35 U.S.C. § 101 for claiming ineligible subject matter.

What happened with ALLMAX?

CarnoSyn Beta Alanine Logo

Thanks to some savvy legal maneuvering on the part of Hi-Tech Pharmaceuticals and ALLMAX Nutrition, the CarnoSyn Beta Alanine patent is no more.

In the ALLMAX suit, the court dismissed NAI’s claims for patent infringement with prejudice, meaning they could not try the case again. On top of that, the judge also denied NAI’s motion for reconsideration. This was a major blow for NAI, but a big win for supplement manufacturers who believe beta alanine should be widely and inexpensively available.

Fast forward to the present case, and Hi-Tech / Creative Compounds argued that the patents were still invalid under § 101 in this case.

Beta alanine’s mechanism is a naturally-occurring phenomenon and thus not patentable!

Presiding over the case was the Honorable Marilyn L. Huff, who recalled previous patent infringement cases from the Supreme Court:

“The Supreme Court has ‘long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.’ Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116 (2013). The Supreme Court has devised a two-stage framework to determine whether a claim falls outside the scope of section 101.” Affinity Labs of Texas, LLC v. DIRECTV, LLC, 838 F.3d 1253, 1257 (Fed. Cir. 2016); see Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014). ‘The prescribed approach requires a court to determine (1) whether the claim is directed to a patent-ineligible concept, i.e., a law of nature, a natural phenomenon, or an abstract idea, and if so, (2) whether the elements of the claim, considered both individually and as an ordered combination, add enough to transform the nature of the claim into a patent-eligible application.’”

The five beta alanine patents clearly state that beta alanine is a naturally occurring phenomenon. An the act of placing a natural substance into a dietary supplement is also a natural phenomenon, which means it’s not patentable, by way of applying natural law.

NAI tried to argue that to “unnaturally over-supplement the normal/natural level of beta-alanine in the diet of an individual over time to force an override [in] the homeostatic nature of the individual’s muscle tissue to achieve an unnatural high level of carnosine synthesis.” However, the court ruled this idea would be insufficient to make the patents eligible under § 101, as it still pertains to a natural law.

The court concluded:

”In sum, the ’084 patent, the ’947 patent, the ’376 patent, the ’596 patent, the ’865 patent, and the ’610 patent claim ineligible subject matter and, thus, are invalid under 35 U.S.C. § 101.16 Accordingly, the Court grants Defendants’ motions for judgment on the pleadings, and the Court dismisses Plaintiff’s claims for patent infringement with prejudice.”

From the press release issued by Hi-Tech[2]:

”Today we eviscerated (5) Natural Alternatives International, Inc. (“NAI”; NASDAQ: NAII) patents related to Beta-Alanine. NAI alleges to be a leading formulator, manufacturer and marketer of customized nutritional supplements. However, Hi-Tech had warned NAI that their patent portfolio was bogus and they proceeded with filing a lawsuit anyway. NAI had sued dozens of supplement manufacturers and raw material importers over the past 5 years trying to intimidate them into stopping selling beta alanine.”

— Hi-Tech

Hi-Tech on a Roll Against Patents: A More Free and Open Market?

This isn’t the first time we’ve seen Hi-Tech take questionable patents to court either. One needs look no further than recent court proceedings against Thermolife, where they were awarded  $913,370.006 in attorney fees and $25,071.46 in expenses.

Hi-Tech Pharmaceuticals

Hi-Tech continues its legal dominance against overbearing patents, making for a more free and open market for manufacturers.

It’s interesting the companies are still attempting to win these lawsuits against Hi-Tech when they’ve established a pretty solid record the past few years of winning all sorts of legal cases. In the last 5 years alone, Hi-Tech has had a hand in invalidating patents on several compounds including:

  • D-Aspartic acid
  • L-Citrulline
  • L-Arginine
  • Creatine nitrate

You can now add beta alanine to that list as well.

Now, who’s going to be the next unfortunate soul to take the legal juggernaut that is Hi-Tech Pharma to court in the hopes of winning? Is the FDA next, as Hi-Tech appeals in their DMAA lawsuit, now that it’s convincingly clear that DMAA is a constituent found naturally in geraniums?

Stay tuned, but one thing’s for sure – Hi-Tech has deep legal pockets and they’d rather spend hundreds of thousands on invalidating patents than pay what they call “ransoms” to patent holders.

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References

  1. Order Granting Motion to Dismiss Patent Claims.pdf
  2. http://www.prnewswire.com/news-releases/hi-tech-pharmaceuticals-invalidates-five-beta-alanine-carnosyn-patents-held-by-nai-300514420.html
Posted in , by Mike | Tagged , , , .

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