Judith L. Grubner

Phoenix dietary supplement company ThermoLife International, LLC, has sued Denver competitor MusclePharm Corporation in U.S. District Court in Arizona, claiming that MusclePharm’s Creatine supplement is infringing ThermoLife’s U.S. Patent No. 7,777,074 for amino acid compounds, including creatine nitrate, a vasodilator that increases blood flow. In its Complaint, filed February 1, 2012, ThermoLife contends that the stiff competition and ever-increasing market demand for the “next great muscle building supplement” results in dietary supplement makers frequently copying the successful products and ingredients of competitors, such as ThermoLife’s supplements. One such supplement is ThermoLife’s creatine nitrate product C-BOL.

The patent notes that creatine, which provides muscles with energy, is used by the dietary supplement industry to increase muscle-mass gains, improve athletic performance and strength. It is a nonessential amino acid that does not have to be obtained directly through diet because the body independently manufactures it. Taking creatine supplements is said to increase creatine production in the body. By itself, creatine has no vasodilating effect.

The patent also discusses “tolerance,” a side effect of nitrate compounds that occurs when a subject’s reaction to nitrate decreases so that larger dosages are needed to achieve the same vasodilution effect. The patent states that the presence of the amino acid arginine may prevent the development of nitrate tolerance (but it does not say the same for creatine nitrate compounds).

ThermoLife, founded by professional bodybuilder and promoter Ron Kramer, charges that MusclePharm’s Creatine product contains a “Creatine Matrix” of five types of creatine, including creatine nitrate, which ThermoLife describes as “a desirable additive to dietary supplements for athletes and others.” ThermoLife’s patent states that the creatine nitrate compound it discovered improves vasodilation over creatine, nitrates or nitrites alone, provides better circulation and distribution of the creatine amino acid in the body, improves absorption of the amino acid and requires a much lower dose to produce the vasodilation effect.

According to the Complaint, MusclePharm’s competition with Creatine has been effective enough to make it the No. 15 top selling product on BodyBuilding.com, which ThermoLife describes as the largest sports nutrition company in the world and most visited bodybuilding and fitness web site on the Internet. However, when Ron Kramer contacted MusclePharm’s co-president Jeremy DeLuca (former co-owner of BodyBuilding.com) to inform him of ThermoLife’s patent, MusclePharm did not stop selling its Creatine product, resulting in the lawsuit that charges MusclePharm with patent infringement, inducing patent infringement and contributory patent infringement. ThermoLife is seeking a holding from the judge that its patent is valid and enforceable, an injunction preventing MusclePharm from selling Creatine, destruction of all Creatine products, MusclePharm’s profits or a reasonable royalty from its sales of selling Creatine, triple damages and attorneys’ fees.

U.S. Patent No. 7,777,074, issued August 17, 2010, has only one independent claim – “An Amino Acid Compound consisting essentially of a nitrate or nitrite of an Amino Acid selected from the group consisting of Arginine Beta Alanine, Agmatine, Citrulline, Creatine, Glutamine, L-Histidine, Isoleucine, Leucine, Norvaline, or Ornithine.”

If this case goes forward, we can expect to see MusclePharm attacking the validity of ThermoLife’s patent. ThermoLife has also sued Pure Assay, Sechel Holdings (Ergogenix), SciLabs Neutraceuticals and others for including their patented amino acid nitrates in supplements. However, Gaspari Nutrition has requested that the U.S. Patent and Trademark Office reexamine ThermoLife’s patent, based on publications it claims contain references that will invalidate the patent. ThermoLife’s attorneys have disputed the relevance of those references.

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Iovate Health Sciences, Inc. is the exclusive license holder of U.S. Patent No. 6,100,287 (the “’287 Patent”), owned by the University of Florida Research Foundation, Inc. The patent claimed a method for enhancing muscle performance or recovery from fatigue involving certain kinds of ketoacids and amino acids.  Iovate and the Foundation sued Bio-Engineered Supplements & Nutrition, Inc. (“BSN”) for infringing certain claims of the ‘287 patent.  BSN countered that the patent claims were invalid because the Flex ad was published before the critical date and was detailed enough to teach a “person skilled in the art” how to practice the method claimed in the patent.  The judge agreed, invalidating those patent claims.

Iovate argued on appeal that someone skilled in the art of nutritional supplements would not rely on an ad in a muscle magazine because of “the lack of scientific testing and the existence of false advertising in the industry.”  However, the Court agreed with BSN that the ad disclosed every limitation found in the patent claims on which Iovate relied , as well as how to administer the product to humans to enhance muscle performance or recovery from fatigue.  It was not necessary for the ad to disclose a specific dosage or an effective amount because the patent claims did not contain any required dosage amount.  A person skilled in the art could practice the invention by purchasing the ingredients listed in the ad, mixing them together and giving them to a person for the purposes described in the ad.  If necessary, anyone skilled in the art could figure out how much of each ingredient to include by reading publications listed in the patent that revealed acceptable clinical dosages of the two important ingredients.  No undue experimentation would have been required to make the method work.

This case shows that an invalidating “printed publication” does not have to be a scholarly article, Ph.D. thesis or issued patent.  Even an ad in a muscle magazine can do the trick.

Source:  Iovate Health Sciences, Inc. v. Bio-Engineered Supplements & Nutrition, Inc., U.S. Ct. Apps. Fed. Cir., No. 2009-1018 (11/19/2009)

Judith L. Grubner, Esq. is a partner in the law firm of Arnstein & Lehr and Intellectual Property Practice Group Leader.  Thanks to Judy for her excellent post!

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First there’s “Keeping trade secrets under wrap” published on NUTRAingredientsUSA.com which points out, and rightfully so, that trade secrets are both valuable and vulnerable at the same time.

Second, there’s “The Benefits of Patents for Nutraceuticals” on Mondaq.com [free registration required] which points out that obtaining patents for supplements can help establish exclusive markets.

The authors at Foley are Jim Ewing, Sharon Mollman Elliott, and Mike Morency.

Very topical and worth the read for sure.

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Ewing and Morency instruct that the filing of provisional patent applications “serve to expand the timeframe in which a third party may be liable to a patentee for their infringing activity to include the period beginning on the date of publication of the application through to the date the patent is issued.”

In fact, a provisional application provides the inventor with an additional year to file a non-provisional application. Moreover, when the patent finally issues it will have the advantage of priority dating back to the date of filing the original provisional application.

Provisional applications require only one claim and can be filed very inexpensively. So, if you have an invention worthy of patent protection, but need to develop the idea further before filing a full non-provisional application, file a provisional.

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To read the complaint, click here. For an article on the ADM litigation, including a discussion of ADM’s prior patent disputes, click here.

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On the other hand, applying for a patent means disclosing your formula to the world, and patent protection generally runs out twenty years after the application is filed (and the application must be filed within the first year of the first sale or public disclosure). So you get a monopoly on your formula for about a 20 year period, but after that anyone can make it and sell it.

Despite this drawback, for some patenting supplement formulations can be a viable intellectual property protection strategy. Take Bausch & Lomb, for example. On Dec. 9, 2003, the US Patent and Trademark Office issued patent no. 6,660,297 entitled “Nutritional Supplement to Treat Macular Degeneration.” The supplement is basically a combination of antioxidants including Vitamins C, E, A, Zinc, Copper, Lutein, and several other ingredients. In the patented combination, B&L claims the supplement strengthens retinal health.

Armed with its patent, this article in the Rochester, NY Democrat & Chronicle
reports that B&L has begun enforcing it against infringers, including the makers of allegedly infringing supplements sold in Walgreens, Medicine Shoppe and CVS stores.

Of course, not every supplement maker has the economic muscle of Bausch & Lomb. The company has hundreds of patents and the resources to prosecute infringers. This is important since one of the most valuable aspects of a patent is the ability to keep others from making and selling your invention.

Out of curiousity, I did a few searches at the USPTO site for patents and patent applications with the words “nutritional supplement” in the title. Since 1976, there have been 58 patents issued with those terms in their titles. Meanwhile, there are 55 patents currently pending all of which were filed in just the last five years that include the terms “nutritional supplement.”

While this is certainly far from scientific, my searching suggests that supplement makers are increasingly looking to patents as a way to protect their formulas.

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As the article notes, if pyridoxamine was available for sale as a dietary supplement prior to the passage of DSHEA, BioStratum could have some serious problems enforcing whatever intellectual property rights it may have to Pyridorin. BioStratum has requested that the FDA rule on the status of pyridoxamine, and it has made a preliminary determination that the substance is not grandfathered in under DSHEA. Comments are open until Dec. 19, 2005, if you wish to weigh in on the matter.

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