Question on use of PCR for diagnostic purposes

Dr. Duncan Clark Duncan at
Tue Aug 29 08:41:50 EST 2000

In article <20000829090810.23020.00005148 at>, Diana07
<diana07 at> writes
>I believe you actually need to contact Roche for a diagnostic license


which actually comes up as:

I apologise for taking up the bandwidth but it may be of interest to



Copy of the web info.

PCR Licensing, Patents & Trademarks

First, a little background. 
The polymerase chain reaction ("PCR") process is a Nobel Prize winning
advance in biotechnology. Many aspects of the PCR process are covered by
patents, including: the actual amplification process; DNA polymerase
reagents used in the PCR process; and automated instruments for
performing PCR. These patents are issued in many countries throughout
the world.

Applied Biosystems is the exclusive licensee of Hoffmann-La Roche, owner
of the basic PCR process and reagent patents, for the field of research
and development, and applied fields such as quality assurance and
control, environmental testing, food testing, agricultural testing
(including plant disease diagnostics), forensics and identity testing in
humans (other than parentage testing), and animal identity testing.
(Applied Biosystems applied fields do not include human and animal
diagnostics.) Applied Biosystems is the owner of basic PCR instrument
patents, as well as other related patents.

Applied Biosystems is proud of its role in developing PCR, and we want
to make the technology easily accessible to all scientists who want to
use it. Practicing PCR, whether it be for research or applied purposes,
does, however, require a license. 

Frequently Asked Questions
Q. Are these licenses available? 

A. Yes, and we want to make it as easy as possible for PCR users to
obtain appropriate licenses. Therefore, one Applied Biosystems strategy
has been to make commonly required rights automatically available
through the purchase of PCR-related products. These products include not
only Applied Biosystems, but also those of other suppliers of reagents
and instruments whom Applied Biosystems has licensed to pass on end-user
rights. To date, more than 25 suppliers sell reagents that convey
certain PCR rights and a number of manufacturers sell Authorized thermal
cyclers. However, if you choose not to use products from Applied
Biosystems or these other suppliers and manufacturers, you can obtain a
PCR license agreement from Applied Biosystems.

Q. How can I obtain a proper license? 

A. You can purchase PCR rights from Applied Biosystems, whether your use
of PCR is for your own research, for providing services, or for your
organization's internal testing in the applied fields. Many customers,
however, find it convenient to obtain at least some necessary rights
through the purchase of reagents and thermal cyclers from Applied
Biosystems or other licensed suppliers. The choice is the customer's,
and typically depends on the application and customer preference. 

Q. How do I know for sure whether I've obtained the rights I really need
when I buy a product? 

A. The literature accompanying reagents and thermal cyclers from
licensed suppliers spells out the specific rights included. Of course,
if you have any questions, you may contact one of us at the address
listed below. 

Q. What kind of license do I need if I'm just doing my own research? 

A. A license to use automated PCR for your internal research under the
basic PCR process patents has two components: an up-front fee and a
running royalty. Researchers need both components in order to have a
complete license. Although either or both components may be purchased
directly from Applied Biosystems, users can obtain them from
manufacturers who pass along a component with the purchase of their
products. The up-front component comes with Applied Biosystems thermal
cyclers and thermal cyclers purchased from licensed sources (called
"Authorized Thermal Cyclers"). The running-royalty component comes with
Applied Biosystems Roche-manufactured DNA polymerase enzymes and with
DNA polymerase enzymes marketed by numerous licensed manufacturers.
Labels on these instrument and reagent products convey the basic PCR
rights -- all the rights necessary for your internal research. For
clarity, internal research does not include PCR-based testing for a
third party, PCR performed under contract for a third party, or internal
routine PCR-based analysis of product or process quality. 

In addition to the basic PCR process patent rights, other patent rights
will also be needed in most cases. You can obtain rights under Applied
Biosystems thermal cycler instrument patents by purchasing a thermal
cycler from Applied Biosystems or a licensed manufacturer, or by an
agreement from Applied Biosystems. A license under Roche DNA polymerase
patents is obtained by purchasing either a Roche-manufactured DNA
polymerase from Applied Biosystems or a DNA polymerase from another
licensed source. 

Q. What type of license do I need if I want to offer a PCR-based service
in one of Applied Biosystems fields? 

A. PCR service providers need to obtain service rights for their
particular applications. In Applied Biosystems applied fields, service
rights may be obtained in several ways. First, specialized target-
specific Applied Field kits that grant service rights for specified
fields are available from Applied Biosystems and licensed suppliers.
Applied Field kits have labels that convey the running-royalty component
of the basic PCR rights and service rights for the specified field. If
the laboratory uses an Applied Field kit with an Authorized Thermal
Cycler, it has all the rights it needs to perform the test in that
applied field. If a laboratory uses applied field kits exclusively, it
does not need an additional service agreement. Alternatively, if no kit
exists for your application, or if you simply wish to develop and use
your own reagents, you need to obtain a service license from Applied
Biosystems to supplement the basic rights.

Q. What type of license do I need if I use PCR for my own organization's
internal use in an applied field (e.g., internal quality
control/assurance tests or food testing)? 

A. Even for these internal uses, your organization needs PCR applied
field rights. These rights may be obtained by purchasing an Applied
Field kit appropriate for your application. Alternatively, if no kit
meets your needs, or if you choose to develop your own primers and
probes, your organization needs to obtain the necessary license from
Applied Biosystems to supplement the basic rights discussed above. 

Q. Who do I contact if I have questions or need a license? 

A. The licensing department at Applied Biosystems welcomes your calls
and questions. 

Our address is:
Licensing Department 
Applied Biosystems
850 Lincoln Centre Drive 
Foster City, CA 94404 USA 
Fax number: (650) 638-6071 

For questions about end user thermal cycler agreements or for
information on licensed reagent and thermal cycler suppliers, please
Ms. Katie McBain 
Licensing Associate 
Telephone: (650) 638-5845

For information on service licenses and other user licenses, please
Sharon Dickson 
Licensing Manager 
Telephone: (650) 638-5614 

For all other questions, or if you are interested in becoming a licensed
supplier of reagents or thermal cyclers, please contact: 
Dr. Robert J. DeFranco 
Licensing Manager 
Telephone: (650) 638-5047 

The problem with being on the cutting edge is that you occasionally get 
sliced from time to time....

Duncan Clark
DNAmp Ltd.
Tel: +44(0)1252376288
FAX: +44(0)8701640382

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