Licensing of Inventions
Policy and Points to Consider
- FDA generally seeks to patent and license technology when commercial development
of the technology is anticipated.
- Federal laboratories' research leading to substantial benefits to the public
health depend in large part on the ability and willingness of technology transfer
partners to commercialize new technologies.
- FDA, as well as other PHS agencies, generally will not seek patent protection
for research tools, such as transgenic mice, receptors, or cell lines. Such
materials can be licensed without patent protection, under royalty-bearing
Biological Materials Licenses, or distributed to the research community through
nonroyalty-bearing Material Transfer Agreements.
- When commercialization and technology transfer can best be accomplished
without patent protection, such protection will not be sought. For example,
some technologies may be transferred to the private sector through publication.
- Where some type of exclusivity (and, therefore, patent protection) is necessary,
licensing of the patent rights is the primary vehicle for transferring the
technology.
- The following principles and objectives apply to marketing, negotiating,
executing and monitoring patent licensing agreements:
- Ensure development of each technology for the broadest possible application.
- Assert inventorship (and thus ownership) rights to technologies in accordance
with current patent law.
- Retain ownership rights through licensing instead of assignment (Assignment
would inhibit the ability of the Government to monitor the development of
the technology).
- Negotiate non-exclusive or co-exclusive licenses whenever possible. This
allows more than one company to develop a particular technology resulting
in products which may ultimately compete with each other in the marketplace.
- Negotiate and award exclusive licenses for specific indications or fields
of use. This prevents one company from tying up license rights to applications
that could be concurrently developed by another company.
- Negotiate provisions for mandatory sublicensing by exclusive licensees,
particularly where a abroad exclusive license is granted, as under a CRADA.
- Negotiate requirements for continuing availability of the technology for
further research.
- Ensure that commercial partners develop the licensed technology within a
reasonable timeframe (benchmarks).
- Ensure that technologies commercialized under PHS licenses are brought to
practical application, offered and maintained for sale, and made reasonably
accessible to the public. This enhances public access to the benefits of technology
by fostering the development of competing products for the same or similar
applications.
- Obtain a fair financial return on the public's research investment
through negotiating royalty-bearing licenses and obtaining payment of patent
expenses from licensees.
- Negotiate and obtain public benefits from licensees that are appropriate
and consistent with expeditious commercial development and accessibility of
the technology.
- Monitor the performance of PHS licensees and ensure that its licensed technology
is fully developed through the modification or termination of a license in
the event that a licensee is unable to fully develop the rights granted. Modifying
an exclusive license to a non-exclusive one, or narrowing the fields of use,
allows licensing the technology to other companies for further development
and sale.
Model licensing agreements have been developed for PHS-wide use and are available
for review. Please contact one of the Technology
Development Office Contacts listed on this Web site.
