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Message: RE: Our visit to BioAgra - Patent questions

RE: Our visit to BioAgra - Patent questions

posted on Nov 15, 2005 07:10AM
Geoff,

I don`t claim to be an expert on the patent issues, but here is what I have been able to determine through my own due diligence.

1) The beta glucan manufacturing process being set up at BioAgra is proportiantly more economical and more environmentally friendly than ANY process currently in use by a significant margin.

2) No manufacturer in the US is currently operating on the scale that is being planned by BioAgra (and which should be under way in January, as has been publicly announced).

3) Biothera (formerly BioPolymer Engineering) holds numerous beta glucan patents, beginning with a patent sold to them by Byron Donzis, founder and former CEO of Immudyne, Inc. Biothera has improved on the original Donzis patent and has been awarded several additional beta glucan manufacturing process patents.

4) Biothera (and BioPolymer Engineering) has successfully sued several companies for patent infringements. Those patent lawsuits were specifically claiming infringements of the process contained in US patents 5,576,015 and 5,702,719, specifically as concerns finely ground beta glucan for nutritional and dermatological applications.

5) I believe the operative phrase here is finely ground. One of the characteristics of beta glucan is that it tends to ``re-aggregate`` during the drying process. (For lack of a better term, it ``clumps together``.) The larger clumps are not easily assimilated. (Optimal assimilation is generally agreed to occur when particulate size is <2 microns.)

6) Biothera patented a process by which they place their extracted and dried beta glucan in a glorified food processer with blunt blades and ``grind`` the particles.

7) Biothera is currently suing Biotec Pharmacon ASA, a Norwegian company. Biotec Pharmacon produces MacroGard (an animal feed supplement) and Immutol, a dietary supplement for human consumption. The lawsuit by Biothera specifically names the product Immutol as being in violation of patents 5,576,015 and 5,702,719. The lawsuit does not address MacroGard, the animal food supplement.

8) Beta Glucan products were extracted and used long before Byron Donzis filed his first patent application. Zymosan was an early product that was discovered to boost the immune system. It was later found that the active ingredient in Zymosan was beta glucan. There are a number of companies and individuals that hold patents in the manufacture and use of beta glucan products for animal and human consumption. (These patents do not all depend on the work of Donzis, sold to Biothera.) I do not believe that it is possible that any one company could successfully defend the position that it owns the exclusive patent rights to all applications of beta glucan for human and/or animal consumption. One can go online and purchase very effective and high quality beta glucan products from companies that are not being challenged by Biothera. (i.e. www.Unisol.com or www.transferpoint.com)

9) The Patent application filed on behalf of PBI for the process upon which BioAgra is basing their manufacturing, has a clear history of prior art. It is based on the work of several earlier patents, beginning with Donzis, and ending with Biotec Pharmacon and and an Australian Brewery. (yes, beta glucan is very much a part of the brewing process, and beer IS a source of yeast beta glucan!)

10) From everything that I have been able to determine by reading the patents, (and I have read ALL that apply), there is nothing in the process licensed by PBI that uses nor that requires the fine grinding process that is being defended by Biothera.

I have based the above opinion on information I gained in the process of doing my own due diligence. The same work can be done by anybody else who wants to spend the time. I gained my information in the following ways:

1) Reading the patents, company websites and available legal documents online.

2) Conversations with several manufacturers and vendor representatives of beta glucan products.

3) Conversations with an avian veterinarian.

4) Reading of published medical and veterinary journal articles.

I do NOT believe, based on my due diligence, that Biothera`s patent claims extend to the manufacturing process that is being used by BioAgra, nor to our finished product.

Finally, I believe the manufacturing and producting of beta glucan products is an evolving art. Biothera may successfully defend its patents rights for the short term, regarding finely ground beta glucan for human consumption, but I believe it will only be a matter of time before another process comes along that will render the Biothera process obsolete. The companies that will thrive in this market will be the ones that are constantly improving the product and the manufacturing technology, while continuing to provide exemplary customer service. Based on what Kent and I observed and the business philosophy of the BioAgra personnel, I believe BioAgra has the vision and potential to become one such company.

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