Landmark Business Method Patent Issues Expected to Have Major Impact on The Pharmaceutical, Chemical and Other Industries;

Patent Allows Companies to Prevent Generic Competition by Patenting The

Disclosure of Adverse Event Information



Apr 17, 2001, 01:00 ET from Classen Immunotherapies, Inc.

    BALTIMORE, April 17 /PRNewswire/ -- Classen Immunotherapies was issued a
 US patent today (6,219,674) which is expected to fundamentally change the
 pharmaceutical, chemical and other industries by greatly increasing the
 emphasis on product safety. The business method patent covers the inhibition
 of generic products by patenting the disclosure of new adverse event
 information.
     The pharmaceutical and chemical industries among others have been
 criticized for not performing thorough safety studies on their products and
 not providing adequate warnings to consumers. Manufacturers of branded
 products have been reluctant to generate and disclose more detailed adverse
 event information in part because of the cost and the perceived negative
 impact on sales. Generic manufacturers have no incentive to perform safety
 studies.  The new patented business method is expected to create financial
 incentives to companies to discover new adverse event information and create
 financial hardship for those who do not adequately test their products.
 Consumers are expected to benefit tremendously by the improved warnings on the
 products.
     Manufacturers are required by law to disclose potential safety problems by
 providing warning labels with their products. If a manufacturer cannot
 properly warn about an adverse event then the manufacturer will have to remove
 their product from the market.  A safety conscious manufacturer of a product
 who continues to discover new adverse events associated with its product can
 patent the disclosure of this new adverse event information and there by
 prevent generic competition indefinitely.  Even in situations where a
 regulatory agency such as the FDA is unwilling to force a generic product with
 inadequate warnings off the market, courts of law have stepped in and taken
 harsh actions against companies for failing to warn about adverse events.
     Manufacturers who continue to perform inadequate safety testing of their
 products could lose exclusivity of their products long before the original
 patent on their product expires.  If a generic competitor licenses the new
 business method patent, discovers and patents a new adverse event associated
 with a brand name product, the generic competitor can then force the
 manufacturer to remove the product from the market or give the generic
 competitor a license to manufacture the product.  In such a situation a
 generic copy of a drug could appear within 3-4 years after the introduction of
 a new drug.
     The new patented business method is expected to increase profitability and
 boost the stock price of brand name manufacturers who license the patent.
 Generic companies may increase their profitability as well if they license the
 business method patent and discover new adverse events of products that are
 either currently generic or produced by branded companies who do not hold a
 license to the new business method.
     For further information on the new patent please contact Classen
 Immunotherapies.
     CONTACT:  Bart Classen of Classen Immunotherapies, 410-377-4549, or Fax,
 410-377-8526l, or Classen@vaccines.net.
 
 

SOURCE Classen Immunotherapies, Inc.
    BALTIMORE, April 17 /PRNewswire/ -- Classen Immunotherapies was issued a
 US patent today (6,219,674) which is expected to fundamentally change the
 pharmaceutical, chemical and other industries by greatly increasing the
 emphasis on product safety. The business method patent covers the inhibition
 of generic products by patenting the disclosure of new adverse event
 information.
     The pharmaceutical and chemical industries among others have been
 criticized for not performing thorough safety studies on their products and
 not providing adequate warnings to consumers. Manufacturers of branded
 products have been reluctant to generate and disclose more detailed adverse
 event information in part because of the cost and the perceived negative
 impact on sales. Generic manufacturers have no incentive to perform safety
 studies.  The new patented business method is expected to create financial
 incentives to companies to discover new adverse event information and create
 financial hardship for those who do not adequately test their products.
 Consumers are expected to benefit tremendously by the improved warnings on the
 products.
     Manufacturers are required by law to disclose potential safety problems by
 providing warning labels with their products. If a manufacturer cannot
 properly warn about an adverse event then the manufacturer will have to remove
 their product from the market.  A safety conscious manufacturer of a product
 who continues to discover new adverse events associated with its product can
 patent the disclosure of this new adverse event information and there by
 prevent generic competition indefinitely.  Even in situations where a
 regulatory agency such as the FDA is unwilling to force a generic product with
 inadequate warnings off the market, courts of law have stepped in and taken
 harsh actions against companies for failing to warn about adverse events.
     Manufacturers who continue to perform inadequate safety testing of their
 products could lose exclusivity of their products long before the original
 patent on their product expires.  If a generic competitor licenses the new
 business method patent, discovers and patents a new adverse event associated
 with a brand name product, the generic competitor can then force the
 manufacturer to remove the product from the market or give the generic
 competitor a license to manufacture the product.  In such a situation a
 generic copy of a drug could appear within 3-4 years after the introduction of
 a new drug.
     The new patented business method is expected to increase profitability and
 boost the stock price of brand name manufacturers who license the patent.
 Generic companies may increase their profitability as well if they license the
 business method patent and discover new adverse events of products that are
 either currently generic or produced by branded companies who do not hold a
 license to the new business method.
     For further information on the new patent please contact Classen
 Immunotherapies.
     CONTACT:  Bart Classen of Classen Immunotherapies, 410-377-4549, or Fax,
 410-377-8526l, or Classen@vaccines.net.
 
 SOURCE  Classen Immunotherapies, Inc.