E-DRUG: US Patent on disclosure of Adverse event information
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[Apparently USA issued a patent for a an ADR database system. It will be
interesting to hear what the WHO ADR centre in Uppsala has to say about
this...
Can some E-drugger comment on the claim made for the patent?
Crossposted from Pharm-Policy with thanks. NN]
Greg Aharonian
DOES BUSINESS METHOD PATENT PREVENT GENERIC DRUG COMPETITION?
Patent Allows Companies to Prevent Generic Competition by Patenting
The Disclosure of Adverse Event Information
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.
Web Site: http://www.vaccines.net
6,219,674
System for creating and managing proprietary product data
Abstract
Systems and methods for creating and using product data to enhance the
safety
of a medical or non-medical products. The systems receive vast amounts of
data
regarding adverse events associated with a particular product and analyze
the
data in light of already known adverse events associated with the product.
The
system develops at least one proprietary database of newly discovered
adverse
event information and new uses for the product and may catalog adverse event
information for a large number of population sub-groups. The system may also
be programmed to incorporate the information into intellectual property and
contract documents. Manufacturers can include the information in consumer
product information which they provide to consumers or, in the case of
certain medical products, prescribers of the medical products.
Filed: November 24, 1999
Claims
What is claimed is:
1. A system for creating and using product data comprising:
at least one adverse event database for storing adverse event data
associated
with a commercially available product;
a processor for accessing and analyzing data from said at least one adverse
event database to assist in identifying new adverse events associated with
the
product and to assist in identifying at least one new use for the product
responsive to identification of at least one new adverse event associated
with the product;
an adverse event information storage device for storing at least new adverse
event data identified by said processor;
a user computer for making requests for adverse event information to and for
receiving adverse event information from said processor;
a user interface for interfacing said processor and said user computer.