BIG NEWS
BioExx Provides Update on Intellectual Property
Also Provides Product and Plant Updates
Press ReleaseSource: BioExx Specialty Proteins Ltd.On Monday November 1, 2010, 7:24 am
TORONTO, ONTARIO--(Marketwire - Nov.1, 2010) - In response to a large volume of questions in the past week,BioExx Specialty Proteins Ltd. (TSX:BXI - News;"BioExx" or the "Company") is pleased to provide this update andconfirmation of the integrity of its intellectual property relating toprotein and protein separation. The BioExx suite of Intellectualproperty is extensive, well protected, and has been intensively testedand analyzed by third-party experts.
Specifically, BioExx has nowreceived, after an extremely thorough review, an additional, and verydetailed "Opinion of No Infringement" (the "Opinion") against anypublished patents or patents-pending in the United States owned orclaimed by the only known alternative company reportedly developingtechnology to produce protein isolates from canola (the "AlternativeCompany"). The review work that resulted in the Opinion also carefullyinvestigated all claims made to support the initial patents filed by theAlternative Company, as well as prior art that was published beforethose patents were filed. Based on the extensive review of thosedocuments, it is concluded that the BioExx processes used to produce itscommercial products, and the BioExx protein products which are producedby those processes and are to be offered for sale, do not constitute aninfringement of any of the Alternative Company patent claims.
Of particular relevance, based on that analysis, it is specifically concluded that:
1. The methods to prepare the defatted meal for protein extraction are
materially different.
2. The protein extraction solvents are materially different.
3. The protein separation processes are materially different.
4. The resulting protein products and profiles are materially different.
Thereview was completed by Dr. Michael Ram with the firm Koppel, Patrick,Heybl & Dawson based in Ventura County, California. KPH&D focusexclusively on intellectual property matters, including patent,trademark, copyright, and trade secret law and in 2008 was named a"Go-To Law Firm" for the nation's Leading Technology Companies inAmerican Law Magazine's reference guide. Dr. Ram has more than 35 yearsexperience rendering patentability, infringement and state of the artopinions and has prosecuted patent applications in biomedical,biochemical, pharmaceutical, natural substances, chemicals, advancedmaterials, mechanical, computer software and general arts before theUSPTO. Prior to that he earned a B.S. degree in Chemical Engineeringfrom Lafayette College, a M.S. and D.Sc. in Chemical Engineering fromNew Jersey Institute of Technology, with a particular emphasis onchemicals, chemical processing, extraction techniques and advancedmaterials production. He also obtained a Juris Doctorate from Seton HallLaw School. A more thorough biography is available at www.koppelpatent.com.
Themassive global protein ingredient market presents a tremendousopportunity for any company that can successfully commercially produce ahigh quality plant-based protein that can be used in combination with,or as a substitute for, animal based protein ingredients in human foodmarkets. BioExx notes that canola proteins produced from a differentstarting point and by way of a different process (as is the case withthe technology developed by the Alternative Company) will necessarilyhave different characteristics. Given the application-specific nature ofpotential end-uses of protein products, it is likely that two suchcanola proteins may not be directly competitive. As the world's firstcommercial-scale producer of canola protein isolates, BioExx views thepossible commercial production by other companies at some future date asa positive for the industry, as it helps build critical mass and muchneeded capacity to serve the growing global demand for plant-basedproteins.
Patent Portfolio Update
As described in itsNovember 11, 2009 press release, BioExx has ten multi-jurisdictionalpatents issued or pending that are directly related to the specialtyproteins to be produced at BioExx facilities. This includes a patentapplication filed on a process to convert meal produced fromconventional high temperature extraction processes to feed-grade ProteinConcentrates at purity levels of approximately 65%.
Theincreasingly broad patent portfolio that BioExx has developed protectsits very unique and proprietary processes and products. The scope ofthis portfolio covers:
-- Protection of scalable, economic low temperature extraction methods
-- Protection of unique solvent combinations to effect such extractions
-- Protection of unique solvent separation and recovery methods
-- Protection of unique methods of producing protein concentrates, protein
isolates and hydrolyzed protein extracts from oilseeds and other
feedstock
-- Protection of the unique products resulting from the foregoing processes
TheBioExx protein patent claims also cover rapeseed, mustard seed, soy,flax, and micro-algae and hence are not limited to canola protein.
TheBioExx process that has been deployed for commercial protein isolateproduction does not use high temperatures or process additives thatcannot be fully removed from the end products, and specifically does notuse salt solutions, in any form, at any stage in the process. Theprocesses and products that BioExx has developed have undergone a seriesof extensive scientific and legal reviews, including substantialproduct testing, to confirm their unique properties and assessment offreedom to operate in the marketplace.
Product Testing Update
BioExxhas recently received excellent results from industry-standard ratdigestibility studies that were conducted in Germany. These studies havedemonstrated that BioExx protein isolate, Isolexx(TM)has a truedigestibility of approximately 95%, while the BioExx hydrolyzed proteinextract, Vitalexx(TM)has a true digestibility of over 98%. Bycomparison, milk proteins such as casein and whey are considered to havea standard digestibility of 95%.
Other recent testing has alsoconfirmed that the amino acid profiles for both Isolexx(TM)andVitalexx(TM)are particularly strong. When compared to the amino acidprofile recommended by the FAO WHO (2007), both proteins are shown to becomplete with more than 110% of each essential amino acid required forboth children and adults. Combined with the new digestibility results,the PDCAAS (Protein Digestibility Corrected Amino Acid Score) ofIsolexx(TM)is 1.11, and Vitalexx(TM)is 1.16, versus high-end andhigh-priced milk-based proteins, including whey at 1.12 and caseinatesat 1.11. The most widely available plant-based protein, soy, has a scoreof 1.02.
Previous testing has also demonstrated that the BioExxprotein products have functional properties (including solubility,foaming and emulsification) that are much closer related to theproperties of milk based proteins than they are to most plant-basedproteins.
These combined results are significant as they continueto affirm the Company's view that its proteins make an attractiveingredient for very high value applications such as Infant Nutrition,Child Nutrition, and Clinical and Therapeutic Nutrition. On-goingengagements with potential customers are increasingly affirming thisstrong product positioning. The Company expects to provide additionaland specific details of these engagements over the coming months.
Production Update
Finally,BioExx is pleased to confirm that it expects to commence continuousproduction of protein isolates at its Saskatoon facility the week ofNovember 15th. During the period since the first end-to-end run, theextensive food-grade clean-in-place system has been completed, a numberof other ancillary items required to be compliant with HACCP, ISO andGMP (collectively "HACCP") have been installed, personnel training forHACCP has been completed, and new operating and maintenance staff havebeen hired and trained.
BioExx also decided to accept therecommendations of its engineers, based on knowledge gained from recentproduction test runs, and use the period after the end-to-end run to adda new buffer tank system to its extraction plant. This system has beenadded to optimize process efficiency and extraction cycle times, as wellas afford an additional measure of redundancy within the process. Whilenot a significant capital cost, the system will have takenapproximately nine weeks to design and install which has added about twoadditional weeks before continuous operations could commence. It wasoptimal to install the additional systems presently, rather than aftercommencement of continuous production, to reduce future potentialdowntime and increase the probability of more immediate success ascontinuous operations commence. Generally, BioExx has been endeavouringto design and construct this facility to an enhanced qualityspecification level that will enable future production at standardsrequired for very high value specialty nutrition protein products asthose market opportunities unfold. As noted above, current market andcustomer engagements are confirming the strength of this thesis.