The Rescue of Creatine Ethyl Ester

by George C. Summerfield - lawyer with the firm of Stadheim & Grear in Chicago
March 2010

Foreword by James Collier, Nutrition Consultant and MuscleTalk Co-owner:
A few years ago I researched the then new sports enhancing supplement creatine ethyl ester (CEE) in some depth, as it was receiving extremely varied reports on MuscleTalk. This led me to write the article Creatine Ethyl Ester: The Best Creatine or a Supplement Fallacy. My findings were quite negative of CEE, leading me to conclude that it was an inferior product to creatine monohydrate.

The article has attracted a deal of attention, in particularly from George who met with me in December 2009 to discuss my findings and put me in the picture of the legal status of creatine ethyl ester. The meeting and his lengthy report were extremely interesting. Maybe my findings in the article Creatine Ethyl Ester: The Best Creatine or a Supplement Fallacy shouldn't be attributed to licensed CEE. George's editorial, certainly throws an alternative light on the use of CEE as a sports and bodybuilding supplement, and the information should be seriously considered when considering both if to use CEE to improve your performance, and, more importantly, which brand to purchase. Is this the rescue of CEE?

When Drs Donald Miller and Jonathan Vennerstrom, members of the faculty at the University of Nebraska Medical Center (UNMC) at the time, discovered a decade ago that esterified creatine had an aqueous solubility more than 30 times that of creatine monohydrate, it appeared as if creatine would finally realize its potential as a nutritional supplement. Creatine had previously been recognized as having significant nutritional benefits, but only if taken in large quantities. This, it turned out, was attributable to the inefficient absorption rate of basic creatine by the human body. Logically, if one could improve the absorption rate of creatine, less creatine would be required to accomplish the same results.

Although creatine ethyl ester (CEE), with its enhanced absorption rate, has enjoyed commercial success, the consuming public has been relatively ambivalent about the product, likely because of the variable results associated with creatine ethyl ester reported on various health- and bodybuilding-related blogs. The explanation for these reported variable results, in turn, may very well be the lack of any quality control regarding the manufacture of raw creatine ethyl ester.

After the discovery by Drs Miller and Vennerstrom, the University of Nebraska sought patent protection around the world directed to the use of esterified creatine as a nutritional supplement, succeeding thus far in obtaining issued patents in a number of countries around the world, including Great Britain. The University expects further patents to issue, including in the United States, where there is a pending patent application.

UNeMed Corporation is the patent licensing and enforcement arm for UNMC and, as such, is charged with the licensing and enforcement of UNMC's patent portfolio directed to creatine ethyl ester. In that capacity, UNeMed concluded a license agreement with Vireo Systems, Inc. of Nashville, Tennessee, which has been manufacturing raw and formulated creatine ethyl ester. The purity of Vireo's raw creatine ethyl ester is to be certified regularly by an independent laboratory, according to the Good Manufacturing Practices regulations implemented in the United States.

In searching for instances of infringement of its patent rights, UNeMed obtained and tested a number of products advertised as containing creatine ethyl ester. The products were tested in parallel by Dr Miller, who had since joined the faculty at the University of Manitoba, and Dr Vennerstrom, who has remained at UNMC. The tests revealed that several products advertised as containing creatine ethyl ester in fact contained none of that substance at all. UNeMed set out to ensure that its licensee, Vireo, did not encounter unfair competition from manufacturers that deceptively advertised those products, and that consumers were purchasing actual creatine ethyl ester.

Thus, at UNeMed behest, the United States International Trade Commission initiated an investigation regarding five companies that had falsely advertised their respective creatine ethyl ester products. One company, San Corporation, settled with UNeMed shortly after the investigation began. The remaining four companies, Bodyonics Ltd, Engineered Sports Technology Inc, Proviant Technology Inc, and NRG-X Labs, opted not to participate in the investigation at all and, as a result, have subsequently had decisions of default issued against them. These four companies, although apparently continuing to offer their CEE products for sale via the Internet, have no tangible presence that one would expect from a going concern. Importantly, none of these four companies have provided any explanation regarding the false advertisement of their respective products, and repeated efforts by UNeMed to contact these companies have proven fruitless.

In short, these companies (and likely others) are selling bogus products to consumers who, because of the stealth operations of such companies, have no real recourse against those companies. Further, Drs Miller and Vennerstrom succeeded only in determining that the subject products did not contain creatine ethyl ester. They were unable to determine what those products did contain. This riddle regarding the contents of the subject products is particularly troublesome, as the products are designed to be taken internally on a daily basis. The general consensus is that the vast majority of raw creatine ethyl ester comes from China, a country whose raw material production in general has received so much negative attention in the recent past.

With regard to Chinese production of food supplements generally, at least one discussion forum raises the prospect of Chinese use of melamine to alter product content analysis: http://proteinfactory.com/pfboards/showthread.php?t= 1054. That same forum contends that, "if you see things like creatine ethyl ester ... you are drinking Chinese made product."

UNeMed has also commenced the pursuit of infringers of its patents in Great Britain and elsewhere. UNeMed has done so by retaining local counsel in countries where it has patent protection, and by providing notice of patent infringement to the companies manufacturing and selling creatine ethyl ester products in those countries. One option that UNeMed has offered to these companies to resolve the infringement matter is for the companies to purchase licensed raw or formulated creatine ethyl ester from Vireo. For the companies that have accepted this option, such as Labrada Nutrition and Ultimate Nutrition, consumers can be confident that, when purchasing creatine ethyl ester products, they are purchasing the real thing.

UNeMed is hopeful that its licensing and enforcement efforts, apart from providing UNeMed a reasonable return on its intellectual property investment, will increase consumer awareness in creatine ethyl ester, and the need to be cautious in the selection of creatine ethyl ester products.

UNEMED ADVANCES THE BALL ON CEE ENFORCEMENT FRONT
Omaha, Nebraska August 6, 2010 - UNeMed Corporation, the patent licensing arm of the University of Nebraska Medical Center, brought to a successful conclusion the investigation before the United States International Trade Commission regarding the unfair importation of product falsely advertised as containing creatine ethyl ester. On April 1, 2010, the International Trade Commission issued exclusion and cease and desist orders against EST Nutrition LLC, Bodyonics, Ltd., Proviant Technologies, Inc., and NRG-X Labs in Certain Products Advertised as Containing Creatine Ethyl Ester, 337-TA-679. The period of Presidential review of those orders expired on May 31, 2010 with no modifications being made to those orders. Thus, those four companies are no longer permitted to import their falsely advertised products into the United States, or to sell any such products that have already been imported into the United States. UNeMed views this as an important step in its efforts to rid the nutritional supplements market of products that are not what they purport to be.

On the patent enforcement front, UNeMed has concluded a license agreement with Bio-Engineered Supplements & Nutrition, Inc. (BSN) of Boca Raton, Florida for all of UNeMed’s worldwide issued patents directed to creatine ethyl ester. BSN is a major supplier of nutritional supplements in the United States and around the world.

Finally, UNeMed continues to pursue its worldwide remedies for patent infringement. UNeMed has concluded its patent infringement litigation against Punch Supplements, a major online seller of nutritional supplements in New Zealand. UNeMed is considering bringing additional suits in New Zealand against other infringers there, and is looking to enforce its British patent against companies selling unlicensed creatine ethyl ester products in the United Kingdom.

UNeMed has a diverse technology portfolio that addresses significant medical and clinical needs in areas such as Therapeutics, Diagnostics, Medical Devices, Research Tools and Software. For further information regarding UNeMed and its patent portfolio, please contact Dr. Michael J. Dixon (mdixon@unmc.edu).