Part of the excitement of medical research is seeing
a new discovery transformed
into a commercially successful invention that will improve public
health. As a Federal scientist you are required to seek patent protection
for your discoveries. Patent protection is important in order to
attract the commercial investment necessary for the development
of your invention. Patenting is utilized only for discoveries that
through commercialization are of potential benefit to further research
capability or promote public health.
What is a patent and what does it provide?
Patents are property rights authorized by the U.S. Constitution.
An issued patent gives the owner the right to exclude others from
making, using, selling or importing the claimed invention.
What makes an invention patentable?
A patentable invention must be something new, it must be useful
and it must be non obvious, meaning that the invention should not
be obvious to fellow scientists in the same field of study. Each
requirement must be proven in very specific ways before a patent
will be granted.
Why does the U.S. Public Health Service (PHS) patent inventions?
The mission of the PHS is to improve the health of the American
people. One way this is accomplished is by the PHS seeking patent
protection for some technologies so they can be transferred to the
private sector through licensing for further development, commercialization
and distribution to the public. Often, without patent protection,
commercial entities are unwilling to develop a product. The government
seeks commercial partners because it is not within the scope of
the government’s mission to turn a discovery into a useful
commercial product for wide distribution. Generally a patent is
most useful when significant resources from the private sector are
needed for further research and development of the technology.
The Patent Application Process at NIH
Employee Invention Reports (EIR)
Federal lab employees have a legal obligation to report inventions
to the TTO. The method of reporting is utilizing the EIR form, which
along with draft of proposed publication, supporting data, drawings
or other supporting documents is used to evaluate the strength of
a potential patent application. Such reporting should be done prior
to any public disclosure of the invention since such disclosures
result in the loss of ability to patent in foreign countries, weakening
the strength of the patent to draw commercialization partners rights
and could prevent your invention from being developed.
An Employee Invention Report (EIR) form is a standardized PHS form
used to report your invention. The purpose of the EIR is to document
the invention by asking you for specific information and to evaluate
whether or not the government will seek patent protection for your
invention. The EIR also serves as an aid in searching the technical
and patent literature to determine if there is prior art in the
literature or other patents that will prevent your invention from
qualifying for patent prosecution. If you think you have made a
discovery that would benefit the public health, contact the NINDS
TTO to assist you in completing the form.
It is very important that you work closely with your NINDS TTO representative
to provide all relevant information on the EIR form. In order to
expedite the evaluation process, the entire form should be completed,
including listing any and all participants in the discovery of the
invention whom you believe to be co inventors. You should be aware,
that qualifying as an author for publication is very different from
qualifying as an inventor. Inventorship is determined per statute
and differs from those that may qualify for authorship. You are
best to list all who worked with you on the project and let the
assigned law firm make the final determination. Omission of a legitimate
inventor or inclusion of a non inventor could invalidate a patent.
Copies of manuscripts, data sets, lab meeting reports or any other
printed matter describing your research, should be attached to the
EIR to assist in the evaluation of the invention by NINDS TTO, NIH
OTT, and the law firm.
Please Note: Please submit the EIR at least 12
weeks prior to any planned public disclosure.
For proper support of patenting application, good record keeping
must have been done in the form of lab notebooks with appropriate
witnessing. Once completed, the NINDS Technology Development Administrator
forwards the EIR in triplicate to the NIH Office of Technology Transfer.
After their review, they write a recommendation to the NINDS TTO.
That recommendation is submitted to review by a NINDS Technology
Advisory Committee (TAC) for scientific merit. The recommendation
from the TAC, the OTT Recommendation, and a recommendation from
the NINDS TTO are given to the NINDS Scientific Director, who makes
the final decision. You will be informed of each decision steps
outcome, and upon the decision of the Scientific Director, you will
have the opportunity to voice dissent if you disagree.
Should the NINDS Scientific Director agree to file a patent application,
the NINDS TTO notifies OTT. OTT sends the EIR to a contract law
firm for patent application preparation and filing with the U.S.
Patent and Trademark Office (PTO). The lead Inventor is the main
contact for the law firm and OTT. If you are the lead investigator,
you should do your utmost to keep all others informed. At times
in the process, all investigators will be contacted by either the
law firm or the NINDS TTO for signing official documents required
by the patent application process.
If you as an investigator do additional development of your research
being patented during the patent prosecution, it is important to
keep the NINDS TTO informed of all developments
NIH Policy on Patenting Discoveries
NIH generally does not seek patent protection for commercially valuable
research tools (e.g. knock out mice, receptors, cell lines and antibodies)
for which future therapeutic, diagnostic or preventive uses are
not anticipated. However, the NIH has the authority to license nonpatented
biological materials and substances through biological materials
licenses, and inventors can still receive royalties. It is still
important to complete the EIR form and let the review process take
place. NINDS TTO will inform you if a decision is made not to patent
your invention, in which cae you have the right to reqest waiver
of ownership to you as an inventor ( see later section ).
NIH policy requires certain inventions to remain in the public domain
(e.g. methods of performing surgical procedures) in order to ensure
that they are freely and widely available.
The invention is in such an early stage that a patent application
would not result in the issuance of a patent or the claims of the
patent are too narrow to encourage licensing by a commercial entitiy.
In this instance, the investigator is given feedback on further
research goals that would allow them to do further develop the concept
and reapply at a later time.