IRVINE, Calif., Sept. 22 /PRNewswire-FirstCall/ -- Cobalis Corp. (OTC:CLSC) (BULLETIN BOARD: CLSC) , a pharmaceutical biotech company specializing in the development of anti-allergy medications, announced that intellectual property attorneys Knobbe Martens Olson & Bear LLP have issued an interpretation of the company's most recent patent, defining its scope and outlining strict areas of infringement. Cobalis currently is conducting clinical trials and recently announced positive preliminary Phase III clinical results for PreHistin(TM), the over-the-counter anti-allergy medication the company is developing. Intended to be taken before the onset of allergy season, PreHistin is designed to prevent, rather than just relieve, allergy symptoms. U.S. Patent No. 6,255,294, entitled "Cyanocobalamin (Vitamin B12) Treatment in Allergic Disease," was issued to Cobalis on July 3, 2001 and expires in 2019. According to the legal opinion, the scope of the patent has 11 different claims covering methods for treating atopic allergy in humans by delivering vitamin B12. Each of the claims requires delivery of B12 to a mucus membrane, resulting in systemic uptake of an effective allergy-opposing dose of B12. Various claims also specify particular forms of dosage (such as lozenges, tablets, etc.) and delivery to various tissues in the body, as well as various treatment regimens and protocols. The patent also extends to all the forms of vitamin B12. In terms of protection against infringement, the legal opinion has found that: * Each of the 11 claims is considered separately in measuring infringement, and infringement liability occurs even if only one of the claims is infringed. * The doctrines of inducement of infringement and contributory infringement provide an avenue for pursuing the manufacturers or distributors of infringing product. If someone markets a product for delivering B12 through mucus membranes to treat atopic allergy, that person would be liable as an inducer of infringement in the same manner as a direct infringer would be. This doctrine covers labeling, as well as instructions provided verbally or on a Website. Anyone adopting the anti-allergy claims for an effective mucosal B12 product approved for the Cobalis label could be considered to induce infringement, and would be liable for monetary damages as well as injunctive relief. * Those who manufacture or sell B12 products for transmucosal delivery in concentrations that are effective to treat atopic allergy can be liable as contributory infringers. Those who market the product but do not adopt infringing labeling can still be liable for infringement. * The term "atopic allergy" is used very broadly in the patent, and should be considered to cover allergic rhinitis, allergic asthma, food allergies, atopic migraine, dermatitis or atopic skin disease. * To the extent that the Cobalis product requires FDA approval, the mere submission of a non-disclosure agreement (NDA) or ANDA by a third party is an act of infringement. "The legal opinion outlines the strict patent protection that PreHistin enjoys, clearly delineating the strength and security of our future market position," said Chas Radovich, Cobalis CEO. "It provides a strong foundation as we continue with the analysis of our Phase III clinical data and work toward FDA approval." About Cobalis Corp. -- PreHistin(TM) Headquartered in Irvine, California, Cobalis Corp. is an over-the-counter pharmaceutical company. Its flagship product, PreHistin(TM), designed to prevent the primary cause of airborne allergies, is currently in Phase III clinical trials and initial marketing in the U.S. will commence upon final FDA marketing approval. The U.S. anti-allergy medication market was $7.2 billion in 2003 and is expected to exceed $10 billion by 2010. PreHistin(TM), "the world's first pre-histamine," has shown in previous studies to modulate the body's level of the protein IgE, reducing the overproduction of histamines, the primary cause of airborne allergy symptoms. Prior studies have shown that the active ingredient in PreHistin(TM) appears to have essentially no risks of adverse effects to the general population, including sedation and drowsiness found in many of the allergy products currently available. For further information, please visit the Website at http://www.cobalis.com/. Safe Harbor Safe Harbor Statement: To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the ability of the Company to raise capital to finance the development of its Internet services and related software, the effectiveness, profitability and the marketability of those services, the ability of the Company to protect its proprietary information and to retain and expand its user base, the establishment of an efficient corporate operating structure as the Company grows and, other risks detailed from time-to-time in our filings with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statements. DATASOURCE: Cobalis Corp. CONTACT: Tim Clemensen of Rubenstein IR, +1-212-843-9337, , or Michelle Manoff of Rubenstein PR, +1-212-843-8051, ; or Chas Radovich of Cobalis Corp., +1-949-757-0001, Web site: http://www.cobalis.com/

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