You may have heard about Immunocal and MaxGXL patents. What are Immunocal and MaxGXL, what do they do, and what's in them? Let's start by defining the products and listing the ingredients, discussing what the products do, then we will delve into the Immunocal and MaxGXL patents themselves.
Here is the information from a box label of Immunocal:
"Medicinal Ingredient Per Pouch: Whey Protein Isolate (Cow's Milk) 10g."
There has always been only one ingredient in Immunocal, and that is raw bovine or cow's milk. Initially, over 30 years ago when research began on this product, it was referred to as a whey protein concentrate, as this was the only term in common usage to describe it. As research into whey proteins grew, the term whey protein isolate came into use, which is a very specific form of whey protein concentrate that is higher in protein.
Whey protein isolate is the most pure and concentrated form of whey protein concentrate. It contains 90% or more protein and negligible amounts of fat and lactose. Whey protein concentrate has at least 29% protein by definition, and tends to be less biologically active. The PDR listing uses both terms whey protein concentrate and whey protein isolate to refer to Immunocal, so both terms are correct and proper as shown here:
"IMMUNOCAL® is a U.S. patented natural food protein concentrate..."
Immunocal is supplied in a box of 30 individually sealed pouches, and the recommended dosage is one to two packets a day, reconstituted with liquid or food. So one box will last you 15-30 days depending on how much you are taking.
Here is the information from a box label of MaxGXL:
Vitamin C (As Calcium Ascorbate) 250 mg
N-Acetyl-Cysteine 375 mg
L-glutamine 750 mg
N-Acetyl D-Glucosamine 125 mg
Quercetin 37.5 mg
Milk Thistle Extract 25 mg
Alpha Lipoic Acid 75 mg
Cordyceps 300 mg
Conjugated Linoleic Acid 100 mg
Other Ingredients : Gelatin Capsules
An updated product label combines several of these ingredients into a proprietary blend, stating the same amounts of Vitamin C, L-Glutamine, N-Acetyl-Cysteine, and Alpha Lipoic Acid, adding:
MaxGXL is suppled in packets of 3 capsules each. The recommended dosage is 3 capsules, twice a day. With 56 packets in a box, this will last for 28 days.
What do Immunocal and MaxGXL do?
Both products raise a beneficial protein in your body called glutathione. Both are nutritional supplements and do not make claims to diagnose, treat, cure, or prevent disease. Both products will tell you that statements made about their product have not been evaluated by the Food and Drug Administration. The FDA does not approve nutritional supplements.
Now we will compare the patents for Immunocal, as well as the patent for MaxGXL.
Immunocal has 75 International Method-of-Use Patents as of this writing in November 2009. Just exactly what does this mean?
Immunocal and MaxGXL Patents - Terminology
In my research for Immunocal and MaxGXL Patents, I found that there is some confusion out there about patent terminology.
So I called the US Patent Office and this is what I learned: There are three types of patents available, and they are Plant, Design, and Utility. All patents issued to nutritional products fall under the category of Utility Patents.
So Immunocal and MaxGXL Patents are all Utility patents.
Under the subheading of Utility Patents, there are four Categories of Invention, and they are : Composition of Matter, Article of Manufacturing, Machine, and Process.
A Process Patent is also sometimes referred to a Method-of-Use Patent. This refers to a guarantee that the product not only contains what it says, but also does what it claims in a specific situation. It includes steps or a process that you go through.
For example, there are currently four Method-of-Use Patents in the United States for Immunocal available for public viewing that indicate this product is not only proven to raise and sustain glutathione, but that this product is also used for very specific disease states, is highly bioactive, and has a beneficial effect on the human immune system.
Immunocal and MaxGXL Patents - Immunocal
Here are the titles for Immunocal's United States Patents:
"Anti-cancer therapeutic compositions containing whey protein concentrate"The abstract for this patent states: "This invention relates to a method of treatment of patients having lesions resulting from cancer cells and to an application as an anti-cancer composition of undenatured whey protein concentrate."
"Method of treatment of HIV-seropositive individuals with dietary whey proteins"
The abstract for this patent states:"Undenatured whey protein concentrate is administered to HIV-seropositive individuals to elevate their blood mononuclear cells, glutathione (GSH) level, body weight and sense of well being. In addition T-helper cells concentration and their T-helper cells/T-suppressor cells ratio are slightly elevated."
"Biologically active whey protein concentrate"
The abstract for this patent reads: "The present invention is concerned with a whey protein composition comprising a suitable concentration of whey protein concentrate wherein the whey protein concentrate contains proteins which are present in an essentially undenatured state and wherein the biological activity of the whey protein concentrate is dependent on the overall amino acid and small peptides pattern resulting from the contribution of all its protein components and a method of producing said whey protein composition. The invention also relates to several applications of said composition."
"Undenatured whey protein concentrate to improve active systemic humoral immune response"
The abstract for this patent reads: "This invention provides a method of improving the humoral immune response or increasing the concentration levels of glutathione in mammals, which comprises administering orally to a mammal a therapeutically or a prophylactically effective amount of undenatured whey protein concentrate which has a biological activity based on the overall amino acid and associated small peptides pattern resulting from the contribution of all its protein components. A method for improving the humoral immune response in mammals also is disclosed which comprises administering orally to a mammal the combination of a vitamin supplement containing vitamin B.sub.2 in an amount in excess of minimum daily requirements and an effective amount of undenatured whey protein concentrate. This invention further provides a dietary supplement for a mammal which comprises an effective amount of vitamin B.sub.1, and B.sub.2 and a therapeutically or prophylactically effective amount of whey protein supplement."
Immunotec currently holds 75 United States and International Method of Use Patents or Process Patents. The Domestic Patents for the United States may be viewed
here.
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The International Patents may be viewed online
here.
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Now let's discuss MaxGXL's Patent.
Immunocal and MaxGXL Patents - MaxGXL
The product MaxGXL holds one Composition of Matter Patent. What is interesting about this patent is that the description in the abstract varies from the product that is now sold as MaxGXL.
The patent reads: "The invention comprises a composition of matter, which comprises in admixture: N-acetylcysteine, Vitamin C and a pharmaceutically acceptable systemic carrier for oral administration. In preferred embodiments, the invention further comprises one or more of the following:
Alpha-lipoic acid, sylmarin, quercitin, l-glutamine, N-acetyl-d-glucosamine, a probiotic. "
Dr. Robert H. Keller, who filed this patent along with David W. Kirshenbaum, conducted a thorough study of the works of Dr. Gustavo Bounous, the discoverer of protein-based glutathione enhancement. Dr. Bounous is considered to be the "Grandfather" of natural glutathione enhancement, and he is the discoverer of Immunocal.
Dr. Keller realized the efficacy and proven benefits of Immunocal. This is demonstrated by the wording of the patent that he submitted. This patent refers to Immunocal throughout, and the patents that Immunotec holds, stressing that the usage of this dietary protein "is preferred and advantageous to supplement the nutritional needs of the mammal."
Now before we get into the patent itself, let's define a Composition Patent. A Composition Patent means that "this is composed of X, Y, and Z, and we have put X, Y, and Z together in this formula, and it belongs to us, and nobody else can put X, Y, and Z together and call it theirs and sell it."
This patent is entitled "Method of treatment of glutathione deficient mammals" and it is for the product MaxGXL, which raises glutathione through the use of its main ingredient N-acetyl-cysteine and other precursors. N-acetyl-cysteine or NAC on its own has been thoroughly researched and is a proven glutathione enhancer.
Interestingly, Immunocal and its patents (Numbers 5,290,571 and 5,456,924) are referred to in this patent's abstract and description.
The opening abstract states : "The disclosure is also of a unique combination of nutritional supplements including n-acetyl cysteine, vitamin C, l-glucosamine, n-acetyl d-glucosamine, quercitin, sylimarin, Alpha lipoic acid and high protein, low fat whey that are combined to support various bodily systems involved in glutathione synthesis, reutilization and storage; all intended to elevate glutathione concentration in the mammalian cell."
We have stated the actual ingredients in the current MaxGXL formula above. The high protein, low fat whey and L-glucosamine have been left out, and Cordyceps, L-Glutamine, and Conjugated Linoleic Acid have been added in.
This "high protein, low fat whey" is referring to Immunocal or what Dr. Keller hoped to formulate to reproduce the efficacy of Immunocal.
Later on in the patent, after describing the functions of each of the ingredients in MaxGXL, there is this rather long reference to using a concentrate available through Promod. TM , or by using Immunocal. The patents referred to here are specifically for Immunocal and are the patents that Immunotec exclusively holds:
"Finally, a source of dietary protein is preferred and advantageous to supplement the nutritional needs of the mammal. We have found that the compositions of the invention and the method herein described are optimized by inclusion of a biologically active whey protein composition comprising an undenatured whey protein concentrate obtained from raw mammalian milk. This concentrate contains substantially all of the heat labile whey protein found in the raw milk. Representative of concentrate which are commercially available include Promod.TM., available from Ross Laboratories, Division of Abbott Laboratories, Chicago, Ill. Concentrates may also be prepared by the method described in U.S. Pat. No. 5,290,571, incorporated herein by reference thereto. The undenatured whey protein concentrates also contain a rich variety of immunoglobulins which boast the immunologic response of the mammal treated with the concentrates; see for example U.S. Pat. No. 5,456,924 which is incorporated herein by reference thereto.
A high protein, low fat whey has immuno-supportive properties. It is rich in naturally active immunoglobulins, essential amino acids and other important nutrients critical for proper nutrient utilization within the gut.
We have discovered that the ingredients described above work synergistically to provide the necessary nutrients required for glutathione production while supporting the mammal's ability to produce and preserve existing stores of GSH. The effect of the admixture of ingredients is far more significant than the individual ingredients alone."
The patent also refers to a probiotic as part of the invention.
MaxGXL contains most of the ingredients listed in its patent. However, there is no protein, no probiotic and no L-glucosamine. Three ingredients not named in the patent have been added in their place.
The product being sold as MaxGXL today varies from the product that is described in this patent on file with the US Patent Office.
This Composition of Matter patent may be viewed in its entirety
here:
(this link opens in a new window)
In conclusion, what can we say about Immunocal and MaxGXL Patents? There are currently 75 Utility Patents that are specifically Process Patents for Immunocal. There is one Utility Patent that is specifically a Composition Patent for MaxGXL that is missing three ingredients as stated in the abstract. In their place, three different ingredients have been added instead.
In comparing Immunocal and MaxGXL Patents, if you would like to take the formula prescribed in the MaxGXL patent, you can take MaxGXL, Immunocal, and a probiotic. As mentioned in the patent, these will work synergistically with each other. "Synergistically" means they all work together to postively enhance each other's effects.
And as Dr. Keller himself said, "The effect of the admixture of ingredients is far more significant than the individual ingredients alone."
If you are using patents to decide which of these products to use to raise and sustain your glutathione, the choice is clear - Immunocal has multiple method-of-use patents, and MaxGXL has a single composition patent that possibly does not apply to the actual product being sold today.
There has always been only one ingredient in Immunocal, and that is raw bovine or cow's milk. Initially, over 30 years ago when research began on this product, it was referred to as a whey protein concentrate, as this was the only term in common usage to describe it. As research into whey proteins grew, the term whey protein isolate came into use, which is a very specific form of whey protein concentrate that is higher in protein. 
Here is the information from a box label of MaxGXL:
