Modified August 31, 2011
Method to Stimulate the Discovery and Disclosure of Adverse Events through Patenting the Disclosure of Adverse Event Information.
Classen Immunotherapies holds four US patents (6,219,674; 6,584,472; 7,653,639; 7,984,069) and has two US published patent applications (2001 002 0240, published September 6, 2001; 2002 008 3080 published June 27, 2002; 2006 019 5418 published August 31, 2006) covering methods that can be used to patent the disclosure of adverse events. The patents and published applications are available on the US Patent office's web site (United States Patent and Trademark Office Home Page ) . Our technology was also covered by Australian patent: 774,823 as well as related PCT/US00/30974 and PCT/US02/05491. In essence the patents cover the screening of adverse event information for patentability and commercial value as well as commercializing the information. All manufacturers of a drug, device or chemical must include labeling which describes adverse events such as drug interactions (21 CFR 201.57) . If a manufacturer can not warn consumers of this information, because the use of that information is patented, then the manufacturer can not market the product.
Classen Immunotherapies is in the business of finding safer ways of using commercially available products including chemicals, drugs and devices. We strongly believe that many currently unknown adverse events can be avoided if pharmaceutical products and chemicals are properly screened for possible rare adverse events and consumers are warned about these associations. The majority of our efforts over the last 14 years has been devoted to studying associations between vaccines and autoimmune diseases. Correspondence with our attorneys and many different patent examiners has convinced us that newly discovered information pertaining to potential adverse events is patentable in the US and abroad. The issuance of our US patents supports our view.
Potential patent claims relating to newly discovered adverse event information may include methods of screening patients for their risk of developing an specific adverse event, methods of administration that decrease the risk of the adverse events, and kits containing printed instructions or warnings. The discovery that a drug may cause liver toxicity may not be a patentable if this discovery does not provide any apparent utility, i.e. a way giving the drug while avoiding this toxicity. However, the discovery that a drug causes liver toxicity more frequently in a certain sub group of patients is patentable because the drug adverse event can be decreased by preferentially giving the drug to the sub groups not at high risk while preferentially decreasing the frequency of administration in the high risk groups. People at increased risk of an adverse reaction such as liver toxicity may include the elderly, people with preexisting liver conditions, and those concurrently taking potentially hepatotoxic drugs like acetaminophen.
Included below are sample claims that would be infringed by any manufacturer placing warnings on a package insert about an newly discovered adverse event. The manufacturer would be liable for induced infringement or contributory infringement.
* Sample adverse event: drug interaction between drugs A and B causing adverse event Y;
The method of administering drug B, the improvement comprising screening patients for the administration of drug A and if patient is taking drug A either
-discontinue drug A and administer drug B
-continue drug A and withhold drug B
-administer drug A and B but monitor for the adverse affect Y
The improvement resulting in a decreased risk and or severity of adverse event Y
* Sample adverse event: drug A associated with adverse event Y in a high risk subgroup (i.e. elderly);
The method of administering drug A, the improvement comprising screening patients for the presence or risk of condition Y and if a patient has or is at risk of condition Y either
-withhold drug A
-administer drug A and monitor for condition Y
The improvement resulting in a decreased risk and or severity of condition Y
These method patents are available for licensing.
Classen Immunotherapies seeks partnerships with
-Individuals who discover adverse event information
-Manufacturers interested in unitizing Classen's Patents
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