Counterfeit Drug Comment -- Docket No. 2003N-0361

November 10, 2003

The present invention (Patent Pending) relates to a secure verification
and authentication control mechanism for prescription drugs, controlled
substances or other valuable items that require the transit cycle
disclosure and fail proof authentication of the origination and intended
destination of the item.

Some of the important issues pressing a prescription drug manufacturer,
the FDA and the consumer is the prevention, tracking and elimination of
tampering, deviation, dilution and counterfeiting of prescription drugs.
Pharmaceutical laboratories spend millions of dollars/man hours annually
in research and development in addition to government approvals, to
bring a product to market. Tampering, counterfeiting and dilution create
large financial losses to these manufacturers and in turn exert an
adverse financial impact and at the health of the end consumer.

In order to maintain control, the manufacturers have devised a number of
methods to track inventory at best through the origination, manufacture,
shipping and delivery via established industry norms. These steps have
proven time and time again to contain process and security loopholes
that enable the deviation, counterfeiting and tampering. A manufacturer
knows that a product with a specific LOT number should be delivered to
distributor 'X' but in turn it is diverted to the grey market and worse,
it is tampered, counterfeited or diluted to a point of posing a serious
health risk to the consumer.

The manufacturer does not have a way or means other than the
pre-established (and loophole prone) method of information reporting to
insure that the cargo that left the manufacturing facilities is the same
cargo that arrived at the distributor and so on. It only knows what the
cargo transfer company and distributor informs them. Since individual
medications come in a myriad of shape, sizes, liquid/solid/powder;
tracking and authenticating/proofing each individual drug container
becomes an attractive tool to discourage counterfeit and tampering.

Thus, there exists a need in the art for a method and system of
flexibly, inexpensively and conveniently authenticate and proof
drugs/valuables from the point of origination through the prescription
drug distribution system down to the end consumer. Allowing regulatory
and governmental entities to obtain valuable information to prevent
counterfeit and aid in the enforcement and regulation.

SUMMARY OF THE INVENTION

Accordingly, the present invention provides a method and means for
building programmable rules of operation where these rules and other
important elements of information are part of the authentication and
proofing method and device.

In accordance with an exemplary embodiment of the present invention, a
specific rules development language is provided with a predetermined
syntax. A rule set is composed of sentences comprising strings of
sequential operands terminated by a delimiter operand. Each operand
comprises a low-level operator and its corresponding argument. The
function of each low-level operator is predefined, with the number of
corresponding arguments varying according to the operator type. These
rules and subsequent manufacturer data elements and encryption keys,
serve as the basis for modifying the behavior of the authenticating
device where it guarantees the uniqueness and identification down to the
single element. This information is placed in an inexpensive substrate
of semi-reflective infrared film that will serve as the primary passive
carrier of information and prevent duplication via automated means. This
film will be affixed to the product's container without obstructing the
visual information on the product. This information will be read by an
optical scanner that in turn will modify its operational characteristics
to suit each particular product. In short, each label film affixed at
the package will essentially be a small computer program that will teach
the reading device on how to decode, read and handle the relevant
information. In order to increase security, an electronic translucent
"fingerprint" will be encoded outside of the data guard boundaries that
will essentially serve as second verification check backup in case of
duplication attempt.

In order to generate the unique serial information necessary for
encryption and identification, rather large sequences of pseudo-random
numbers are required. As part of this invention, a new method of number
generation is used to aid in the creation of the necessary digits to
insure a constant stream on non-sequential numbers. Once these numbers
are created, they are placed into a holding database where they are
applied to the label generation process. The label generation process in
turn selects one or more manufacturer pre-defined operational rules that
will reside within the label. By default, all reading devices will
respond to a specific "bootstrap" code that will allow them to read the
first set of commands without initially requiring any level of security.
In another embodiment of this process, a secure key is required to
decrypt the 'bootstrap' in order to use it. This method allows for the
creation of one or more operational rules to suit different needs
without interference.

Once the bootstrap is successfully read, one or more additional data
pools residing within the label can be accessed by using the method
dictated by the loader. These data pools can be compressed complex data
elements or simple serial numbers that can indicate origin, destination
and intended disposition of a particular product plus genus, batch and
manufacturer information. In another embodiment of this process, part of
the film overlay can serve as a tamper-proof indicator, thus once the
package is opened, the characteristics of the data film are compromised
and will yield no data or bootstrap facilities to an electronic reader.

As part of the process, when a label is created for a particular
product, the key used to generate the unique information is shared
amongst the industry in a 'key escrow' method thus guaranteeing access
to the information to all concerned parties or governmental and
regulatory entities.

Odelin Fernandez

Director,

Authentimed, Inc.

19331 SW 31 Court

Miramar, Florida 33029

Ph: 954-441-0569

Fx: 954-41-5120

<Odelin@bellsouth.net>