Intellectual Property Guidebook
Methods, terminology, policies, procedures and legalities
regarding technology transfer and licensing of Intellectual Property.
TABLE OF
CONTENTS
FOREWORD
INTRODUCTION
THE OFFICE OF RESEARCH AND BIOTECHNOLOGY
TECHNOLOGY TRANSFER
TECHNOLOGY LICENSING
THE TECHNOLOGY LICENSING PROCESS & ROLE
OF THE RESEARCH OFFICE
INTELLECTUAL PROPERTY
Copyrights
Patents
Trademarks or Service marks
Trade Secrets
Biological Materials
Software Licensing
Films, Video, and Multimedia
CD-ROMS
IMPLICATIONS OF THE INTERNET
FOR INTELLECTUAL PROPERTY
E-mail is not Necessarily Confidential
World Wide Web Publishing : What is Protected?
PATENTABILITY AND PATENTING
Elements of Patentability
Published Works and Public Disclosure
Confidentiality
Importance of Laboratory Notebooks
PATENTING PROCESS
Determining the Inventor(s)
Filing a Patent Application
After the Application is Filed
Intellectual Property Policy of UNTHSC
REFERENCES
APPENDIX Chosen I.P. Case Law and Articles.
FOREWORD
This document is organized to provide an introduction to the field of
technology licensing, management and technology business formation for
the University of North Texas Health Science Center faculty, staff
and students conducting research.
Methods, terminology, policies, procedures and legalities regarding technology
licensing and intellectual property are discussed in this document. Any
UNTHSC student, faculty or staff member who thinks he or she may have
discovery or a novel invention, is strongly encouraged to read this document
AND contact the Office of Research and Biotechnology.
Office of Research and Biotechnology
Homepage: http://research.hsc.unt.edu/
Email: ggrant@hsc.unt.edu
Mgr. Research and Technology
Office of Research and Biotechnology
University of North Texas Health Science Center
Medical Education I Building (ME-1-806)
3500 Camp Bowie Blvd. Rm. 806
Fort Worth, Texas 76107
Phone: (817) 735-5400
Fax: (817) 735-5485
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INTRODUCTION
Research drives the growth of basic scientific knowledge. In some instances,
however, issues of commercial value become crucial. Commercialization
of research is recognized as an engine of economic growth and a supporter
of increased well-being and standard of living. Due to a changing world
climate for technological developments, a number of legislative acts have
been passed to encourage the movement of university research findings
to the commercial marketplace.
The Health Science Center, University of North Texas, has initiated
a supportive infrastructure to promote commercial applications of university
research, in accordance with the changing social and legislative environment.
At the heart of that infrastructure, is The Technology Management
Division, Office of Research and Biotechnology.
The Office of Research and Biotechnology offers its services to
The Health Science Center and the University of North Texas academic community.
The office additionally seeks to establish cooperative, win-win relationships
between the university's research community and the private sector.
THE OFFICE OF RESEARCH AND BIOTECHNOLOGY
A primary objective of the Research Office is Technology Transfer;
to bring research results to public use by developing and commercializing
the technology of creators (faculty, staff or students). Working with
university personel, the Research Office staff develops strategies to
reach commercial objectives. The range of the Technology Transfer services
include:
--assisting researchers with patent searches.
--developing market assessments for potential patentable technology.
--negotiating agreements as they exist in the context of intellectual
property matters serving as a liaison between an inventor and a potential
company licensee.
The Research Office in conjunction with the Intellectual Property Advisory
Committee (IPAC) reviews all invention disclosures and evaluates their
legal protection and commercial potential. Legal rights to UNTHSC created
knowledge are secured through patents, copyrights and other agreements.
The legal status of particular inventors, and their innovations can be
found @ the Intellectual Property Policy of UNTHSC on the UNTHSC web site
and in the Research Office. This policy is established and approved by
the Board of Regents.
A plan is developed and formulated for each invention, to stimulate further
research funding from private industry. The formation of a new business
based on an invention is another possible course of action. The office
ensures that all obligations to sponsors are met and the Research Office
negotiates the contracts which grant commercial rights to private companies.
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TECHNOLOGY TRANSFER
Technology transfer is the movement of technological discoveries from
a university or research laboratory to the commercial marketplace. A transferred
technology may be as modest as a chemical additive for a coating process
or as notable as a vaccine to eradicate a disease. It can be a new way
of producing an old product, or a new product that can revitalize an old
company. Transferred technology may be computer software or hardware,
knowledge relating to biological, chemical or mechanical materials, or
the materials themselves. It can be a whole system, or a small part to
enhance an existing system; can be as subtle as a phone conversation or
as complex as the formation of a new company. Some of the ways in which
technology is transferred from a university to the commercial market include:
The graduation of students - The single largest transfer of technology
and knowledge occurs when a student is educated by the university and
then enters the workplace, his/her new found knowledge acquired in classrooms
and laboratories is transferred to a company, another academic institution,
an organization or a corporation.
Consulting practices of professors - Professors who use knowledge
gained through years of university research are transferring that information
to industry and the commercial sector through consulting assignments.
Publication of papers - Commercial companies and all academic
researchers follow university publications closely in order to keep abreast
of the latest techniques and technologies that may enhance their knowledge
in their specific areas of interest particularly with respect to processes
or products. Relationships are often formed specifically to exploit the
flow of information between industry and university.
Conferences - University faculty and staff transfer knowledge
gained from university research by attending conferences and presenting
lectures and papers on university research and technology. A transfer
of technology may also be achieved by networking with commercial professionals
and other universities.
License of intellectual property - In instances where a novel
discovery is made that has identifiable commercial impact, a university
may contact a company, or companies, that may best utilize the discovery
in the commercial market. If a company can not be identified, or if the
discovery is compelling, the university may elect to assist in the creation
of a commercial entity to nurture the introduction of the discovery into
the marketplace. In either case, a license is granted that allows the
technology to move from the university laboratory to the commercial partner.
TECHNOLOGY LICENSING
Licensing is the most formal and legally enforceable means of technology
transfer. A license is a written grant of rights by one party to another
party for specific purposes. Technology may be licensed to an established
company, a new company or another academic institution. For the purpose
of technology transfer, the university (licensor) owning the technology
(intellectual property) grants a company (licensee) the right to develop
and/or commercialize the intellectual property. In order to commercialize
a technology, the licensee will develop, manufacture and sell the product(s).
In effect, the licensor is transferring the technology, or rights to the
technology, to the licensee in return for financial consideration, which
is most often a royalty payment based on net sales, combined with some
signing considerations.
This process takes time, it is rare that a technology is discovered,
disclosed and licensed within a short period. Usual time-lines for such
processes generally exceeds 12 months.
A license can be granted either, as an exclusive, meaning
the licensor may not grant to another party the same access to the intellectual
property, or as a non-exclusive, meaning the licensor
may grant rights to other licensees. The scope of the license can be broad
enough to include all applications and industries, or narrowed to specific
applications, markets and/or geographic regions. License agreements typically
include up-front payments, equity, shares of stock, and/ or licensee fees
and royalties.
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ROLE OF THE RESEARCH OFFICE
IN THE TECHNOLOGY LICENSING PROCESS
Research workers and scientists at The Health Science Center, University
of North Texas are encouraged to contact the Research Office if they find
that their current research is likely to lead to a novel discovery. Therefore
the inception of an idea or the discovery of a novelty is a critical point
in the technology licensing process. Many legal issues hinge on actions
taken after this point. Timing of publications, ownership of the discovery
and the whole success of the licensing process are considerations that
need to be taken into account during this phase. It is in the best
interests of both the Health Science Center, and the researcher, to contact
the Research Office at the occasion of discovery for assistance in filing
an invention disclosure.
The invention disclosure form is the mechanism used by UNTHSC faculty,
staff and students to communicate an invention to the Research Office
and begin the technology transfer process. Invention disclosure is a formal
process that is the first step in ownership of your innovation. When a
concept is kept only in the laboratory and is then published, all ownership
rights are forfeit after one year. A disclosure document is the first
step in establishing your own and UNTHSC's ownership rights to your work
and discoveries helps to protect the rights of the researcher in future
patent law issues. Invention disclosures can be technical papers or project
reports with brief discussions of the findings of commercial significance.
Forms can be found at the UNTHSC web-site - http://research.hsc.unt.edu/disclosure.html
Submission of either formal or informal disclosures to the Research Office
should be made as a regular procedure. Often, either from modesty, because
of ego, or misunderstanding of the patent laws, inventors negate the significance
of patenting their inventions. WITHOUT DISCLOSURE AND FORMAL USPTO APPLICATION
YOU ARE NOT CLAIMING OWNERSHIP OF YOUR OWN DISCOVERIES. Usually, you cannot
sell or license what you don't own. The Research Office will work with
the researcher to evaluate the innovation and to determine the appropriate
course of action to gain permanent ownership and protect the research
findings. The Research Office will assist in filing proper forms.
Upon completion of the invention disclosure, the Research Office will
conduct a patent assessment, and review prior art. Through market research
and a literature search, the Research Office staff, in conjunction with
the inventor and other university departments, will make a business judgment
as to the desirability of investing in patent protection with outside
legal counsel.
Assuming there is unique technology that can be protected via patent,
the Research Office will proceed with a broad-based market assessment.
This will result in an estimate of market size, a list of potential licensees
and other market and industry data.
With this information at hand, the Research Office begins marketing the
technology to specific companies. The initial campaign consists of non-confidential
listings on technology transfer databases and direct contact with prospective
firms. Those firms that express interest based on their evaluation of
non-confidential material are asked to sign confidentiality agreements.
Occasionally, the inventor suggests a particular company that may be interested
and this company is approached under a confidentiality agreement. While
firms are evaluating the technology, the Research Office gathers detailed
information on the potential licensees. The Research Office assesses the
firms' product lines, production and marketing capabilities and financial
status. This process may yield one or two firms that are both interested
and qualified as potential licensees. The Research Office then seeks to
negotiate a license agreement that is beneficial to both parties while
seeking to ensure that the technology will reach the marketplace.
Management of the relationship between the licensee and UNTHSC following
execution of the license agreement includes monitoring to ensure that
commercialization milestones are reached, and collecting fees, royalties,
and reimbursable expenses. The Research Office maintains records of patent
expenses and licensing revenues for each invention and determines distribution
of licensing revenue according to University policy. In the case of technologies
with non-exclusive licenses, the Research Office is also responsible for
monitoring and protecting against unlicensed use "infringement".
Maintaining strong relationships with licensees is important, because
most licenses are re-negotiated every few years.
The Research Office is responsible for reporting inventions to research
sponsors in accordance with sponsorship agreements, and if co-owners for
the technology exist, reporting patent expenses and licensing revenues
to them.
If the technology is broad and market potential is compelling, the Fort
Worth MedTech Incubator Program may be approached to form a company around
the new technology. If the technology is found to be unpatentable or unmarketable,
and the Research Office chooses not to pursue a patent on a particular
technology, the Research Office may elect to release the technology to
the inventor who is given the option of pursuing patent protection and
commercialization independently.
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INTELLECTUAL PROPERTY
Intellectual property is an invention, an innovation, knowledge or an
expressed idea that are owned. I.P. can be bought, sold, bailed or licensed.
Legal protection of intellectual property is obtained through the acquisition
of patents, copyrights, trade secrets and trademarks. These protections
are used to create a 'toll' or 'royalty' position to prevent others from
free, unauthorized commercialization, through the manufacture, copying,
use or sale of the property. Inventions are novel and non-obvious,
and can be protected by patents. Expressed ideas consist of literature,
music, art, software, etc. when expressed in a tangible medium, they can
be protected by copyright. Commercial logos and symbols are protected
by Trademarks. Trade Secrets are those data kept from a public forum,
they are valuable but don't have legal statutory status. Although trade
secrets may be sold or licensed, when trade secrets are stolen, or infringed
upon, litigation must be invoked to obtain legal relief. Research data
prior to publication, or disclosure, would be considered to be a trade
secret. One year following either publication, or public disclosure, (without
a valid USPTO application) ownership is forfeit, and the technology can
no longer be bailed, sold or licensed.
Copyrights or ©
A copyright is a legal right granted by the United States government
to the author or creator of the "original works of authorship".
A copyright is used largely for the "creative arts", text and
software. Copyrights are granted for the term of the life of the author
and an additional 50 years. Once assigned, a copyright enables a work
to be the sole property of the author (exceptions occur when a work is
created by an employee governed by a work-for-hire arrangement). The copyright
allows either the author or persons deriving rights for the author, to
rightfully withhold others from copying or otherwise using the work without
permission. A copyright is automatically secured when the work is created
or "fixed" in a tangible medium. No publication or registration
or other action in the Copyright Office is required to secure copyright
registration; however, it is required that a copyright be registered before
a lawsuit is brought. The proper copyright notice consists of three aspects:-
1) The "copyright symbol" the letter "c" in a circle
©, or the word "copyright", or the abbreviation "Copr";
2) The year of the first publication;
3) The name of the copyright owner.
An example of a copyright notice is:
Copyright - 1998 UNTHSC All rights reserved
Items that may be copyrighted include literary works, computer programs,
CD-ROMs, maps, blueprints, textual material, pictures, graphics, sculptures,
motion pictures, and videos.
By law, an idea expressed in a tangible
medium is automatically copyrighted to the owner or proprietor.
This MEANS You OWN IT as soon as you create it -
Not SO with inventions. Inventions must be patented to acquire
statutory ownership. The patenting process means the invention must undergo
an equivalent of a peer review [conducted by the governments' examiners
].
Patents
A patent is essentially a contract between a government and an inventor.
The contract gives the inventor exclusive rights to make, sell or use
the invention for a definite period of time. During this period of time,
the inventor is afforded legal recourse through the court system against
anyone found infringing on the inventor's monopoly over the invention.
A patent grants the owner "exclusionary" rights.
All patents that were in force on, or that will issue from an application
filed before June 8, 1995, will have a term that is either 20 years from
the filing date of the application or 17 years from issuance, whichever
is longer. All patents filed after June 8, 1995 have a term of 20 years
from the filing date. Under certain conditions, patent terms can be extended.
When the term of the patent expires, the invention becomes public property,
and is available for manufacture, sale or use by anyone.
Patents can either be assigned or licensed. In the case of an assignment,
the inventor yields all rights provided under the patent to another party.
In the case of a license, the patent holder grants, to the licensee, the
right to use, manufacture or sell the invention.
Trademarks or Service mark [ ]
A trademark or service mark is an identifying symbol that distinguishes
one product or service from another. Trademarks and service marks protect
both the manufacturer, importer or seller, and the consumer by guaranteeing
the authenticity of an item. Trademark and service mark symbols can be
graphic, text or both. As with patents, trademarks and service marks are
protected through the court system. Any party found using a trademark
or service mark to identify a product or service without the express permission
of the marks owner is liable for damages sought by the owner. After a
legal period of use the trdemark becomes a registered trademark and the
owner can use the symbol [ R ] adjacent to the logo.
Trade Secrets
Trade Secrets are formulae, chemical compositions, recipes, devices,
or patterns that are not patented and are known only by the owner and
key employees. The trade secrets are valuable and can give a business
or organization a competitive advantage. Circumstances may exist when
inventors may not want to disclose information in a patent. There are
cases when an idea may not be patentable, but is still unique and commercially
significant. By maintaining close control over the knowledge of processes,
or the compositions that characterize a product, an owner is afforded
protection of these "trade secrets" under the law from others
using that knowledge when it is gained confidentially. Sharing secret
information, with and outsider, requires that the owner insists that a
confidentiality agreement is signed to protect the property value of the
information.
Trade secrets, like patents, trademarks and copyrights, can be licensed
or sold. In situations where patentability may be in question, the secret
behind the technology may be esoteric enough to preclude duplication by
others, the owner of the information can license the trade secret to another
party. Because universities are generally open institutions, protection
of intellectual property through a trade secret approach is uncommon.
Biological Materials
Biological materials such as antibodies, hybridomas, cell lines, sera,
and supernatants can be either patented or unpatented. Unpatented property
is known as Tangible Research Property (TRP). The Research Office may
forgo patenting biological materials, and license the materials as TRP
to:
(1) reduce the risk and cost of monitoring many non-exclusive licensees;
(2) save money by not filing a patent application; and
(3) license the TRP for diverse uses and in a wide geographic area.
Biological materials or TRP are usually distributed by the developing
scientist(s). The distribution of TRP can be accomplished by making it
available under a Materials Transfer Agreement (MTA). This agreement provides
for the understanding that the materials are made available only for scientific
research and may not be used for commercial purposes.
Software Licensing
Licensing software involves the licensing of a tangible product, as opposed
to only intangible ideas and concepts. The licensee is given a copy of
the software product and authorized to use it for specified purposes.
In order to protect the software through copyright, it has to be fixed
in a tangible medium, such as being stored on a hard disk CD-ROM or floppy
disk. Registration with the US Library of Congress Copyright Office is
optional, although it is mandatory before you file an infringement suit.
Software usually comes in two forms: source code and object (binary) code.
Source code is in the form in which software is usually developed, is
human readable and cannot be read directly by a computer. It is usually
kept as a trade secret by a developer and used to develop improvements
and variations to the program. Source code is translated using a 'compiler'
into object code. The object code is read directly into the computer.
Object code is not normally readable and in order to modify a program,
the source code is required.
The primary issues of software licensing are liability, access to source
code, and licensing rights. Software is a product, therefore warranty
disclaimers and limitations on liability are very important. Liability
for product malfunction, and infringement of third party intellectual
property rights is disclaimed or limited. Software is primarily protected
by copyright protection, and so the basic license grant involves the grant
of the basic copyright rights: reproduction, distribution, modification,
public display and performance and the right to rent or lease copies of
the software.
Software license agreements come from the following combination of rights:
Use Rights - the right to use the software in a trade or business
for a specific purpose.
Modification Rights - the right to modify the software ( usually
only granted in connection with a source code license ) - usually coupled
with the right to use the modified software in the licensees trade or
business, or with the right to distribute the modified software.
Reproduction Rights - the right to reproduce copies of the licensed
software, for the purpose of internal (within a company, for example)
or external (customers) distribution.
Distribution Rights - the right to distribute copies of the
software (typically only in object code form) to end-users or customers.
Public Displays or Performance Rights - the right to publicly
perform or display the software.
Rental Rights - the right to rent the software. With rental
now prohibited without authorization of the copyright holder, this right
needs to be expressly granted in a license agreement.
Escrow Rights - not really a copyright right, but a common licensing
device wherein the source code is held in escrow for the benefit of
the licensee.
Films, Video and Multimedia
In the age of ever-changing technologies, new considerations are focused
on University personnel authored multimedia entertainment and educational
materials. Multimedia courseware is defined as interactive teaching aids
created and deployed with electronic tools. This may include text, graphic,
video and audio elements. They may be mounted for remote access on a file
server or "pressed" onto a CD-ROM. These course materials include
electronic "textbooks", hypertext modules, simulation software
and databases containing numbers, images or text.
In regard to the policies on the use of copyrighted materials in the
classroom, the guidelines of copyrights will be enforced with an exception.
Professors or teachers may reproduce copyrighted works for classroom use
and for research without securing permission and without paying royalties
when the circumstances amount to the "fair use" law. The considerations
for determining "fair use" are as follows:
- the purpose and character of the use, including whether such use
is of a commercial nature or is for nonprofit educational purpose.
- the nature of the copyrighted works.
- the amount and substantiality of the portion used in relation to
the copyrighted work as a whole.
- the effect of the use upon the potential market
for or value of the copyrighted work.
CD-ROMS
A CD-ROM is a compact disc with Read Only Memory. It is physically identical
to a Digital Audio Compact Disc used in a CD player, but the information
on it is interpreted as computer data. The information or content of a
CD-ROM can be divided into subdivisions. In order to explain the subdivisions
or "meat" of a CD-ROM, an example of motion picture components
or contents are explained. The main part of what the public sees is the
whole content or the finished product. The content of the movie is often
overlooked. The content of a motion picture is broken down into the script.
Script includes the storyboard, organization and names of the characters;
the film or video, also the actors, the director, producers, and writers;
the text or content that appears on screen; the audio component which
includes music and background; and other factors that contribute to the
overall picture.
A CD-ROM creation, as a item, may be copyrighted by the creator; however,
before the CD-ROM creator may show, sell or otherwise transfer the CD-ROM
to the public, the creator must receive permission from any creators of
the content contained in the CD-ROM to use that content. Often this permission
comes in the form of a license.
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IMPLICATIONS of the INTERNET
and INTELLECTUAL PROPERTY
The information superhighway or information infrastructure includes physical
facilities used to transmit, store, process and display voice, data and
images. It incorporates a range of equipment including cameras, scanners,
keyboards, telephones, fax machines, computers, switches, compact discs,
video and audio, cable, wire, satellites, optical fiber transmission lines,
microwave nets, switches, television, monitors, printers and more. These
aspects are generating both challenges and opportunities for the copyright
marketplace. Technology has altered the copyright balance.
E-mail Is Not Necessarily Confidential
Another challenge that exists is the use of electronic mail. E-mail that
is routed through servers and then to network stations is not considered
confidential under law, but if the e-mail sender uses encryption to encode
the message it is then considered confidential. The result of this is,
if an inventor sends data about a possible invention over the Internet,
and does not use encryption technology, the data transmission is considered
public disclosure. All inventors and content developers should learn the
facts before sending information over the Internet.
World Wide Web Publishing : What is protected?
Publishing of a Web page on the Internet is not different than a magazine,
book, or multimedia CD-ROM. A Web page may contain text, graphics, audio,
and video. As long as the Web page arrangement is original, the design
of the page will be protected by copyright. However, the practice of "borrowing"
HTML codes from other Web pages for use in one's own Web page design raises
two separate issues.
(1) Is saving HTML source code a copyright violation? And
(2) Is reusing the HTML source code as a template for a web page a
copyright violation?
When a Web browser (client) accesses a Web page (server) the server sends
the HTML information to the browser. The HTML information includes information
regarding the location of the other elements on the page, including graphics,
audio files, video files, and links to other Web pages. The browser then
uses the information that it now holds in Random Access Memory (RAM) to
arrange the graphical display of the Web page on client's terminal. It
has become a controversy over whether it constitutes copying, but most
commentators would not consider accessing a Web page an act of infringement
of the Copyright Act. However, when the information or codes are saved
on hard drive space, the material has been copied. The "fair use"
law allows exceptions for educational purposes, but not for commercial
use.
Links or URL locations are not copyrightable; however, a list may be
if it contains some originality. There are exceptions if several links
from a list are copied and separated. Certain materials are permissible
to use or copy for the use of Web publishing. Original material or text
that are individually created are permissible, materials can be used that
are licensed to the user, or the right to use the materials has been given
by the copyright owner, and materials or information available under public
domain.
The Doctrine of Implied Access on the Web was created on the basis of
being able to attach hypertext links to any other location on the Internet.
By putting yourself on the Web, you have given implied permission to others
to link to your Web page. There is insufficient legal precedent in this
area, so it is advised to go by the law of net - netiquette.
Netiquette dictates that:
(1) Websites be informed when you plan to link to them;
(2) Links to Websites be removed if the object of the link requests,
and
(3) Making copies of materials or text on the Internet for commercial
use without permission is restricted.
It is compared to photocopying and distributing a magazine article. The
law does recognize situations where private, non commercial copying can
be permitted according to the "fair use" law.
copyright - The owner of a registered copyright enjoys the ability
of blocking the unauthorized copying or public performance of a work protected
by copyright. Depending on how old a work is, whether or not copyright
was renewed, when the work was published (if at all), and whether or not
it is a work for hire, the U.S. copyright term for a work may be 28 years,
56 years, the life of the author plus 50 years, 75 years from the publication
date, or 100 years from the date of creation. The reader will appreciate
that these terms are much longer than the 17-year or 20-year
term of a U.S. utility patent.
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PATENTABILTY AND PATENTING
Elements Of Patentability
Inventive Process. Under patent law, two major occurrences must
transpire before an invention is generated. There first must be a conception
of the invention. Conception is the formulation in the inventor's mind
of a definite perception of the complete invention. However, an idea
alone is not sufficient to form an attainable invention. Second, it
should demonstrate that the concept actually works, which can be done
through detailed drawings, formulas, etc. It is the reduction to practice
that completes the inventive process and produces an invention.
Requirements - United States Patents. The purpose of a patent
is to convey or "teach" the invention to the public. In exchange
for this instruction, the inventor is granted 20 years of exclusive
rights beginning from the date of patent application. These rights legally
exclude others from making, using or selling the invention unless such
right is granted by the owner of the patent. Not all inventions are
patentable. In order to be patentable, an invention must have the following
elements:
an invention must be new - termed the novelty requirement;
an invention must be useful - termed the utility requirement;
an invention must be not be obvious - the non-obviousness
requirement
Novelty Requirement. To receive a patent an invention must be
new and cannot have previously been known publicly. The novelty requirement
means that the invention:
cannot have been conveyed publicly through publication, display,
Internet or other descriptions;
cannot have been sold or offered for sale at least one year
prior to the patent application and;
cannot have been the subject of a patent issued elsewhere
more than one year prior to filing a US patent application.
The novelty of the invention in a patent application is decided by
an examiner in the United States Patent and Trademark Office (USPTO).
The Examiner conducts a patent search to find similar inventive work,
which is referred to as "prior art". The submitted invention
must be distinguishable from all prior art.
Utility Requirement. To be patentable an invention must be useful,
not frivolous, and reproducible by others of ordinary skill in the relevant
art. At least one specific use for the invention must be stated in the
patent application. Some types of inventions are not patentable because
society does not approve of the manner in which the invention would
be used. However, it is relatively easy to claim an appropriate use
for most inventions.
Non-Obviousness Requirement. Non-obviousness means that a person
with "ordinary skill in the art" and knowing all there was
to know about the prior art, would not be likely to develop the same
invention. The Patent Office may reject a patent application, even though
it is novel, if it can show that the invention would have been apparent
if someone skilled in the art had combined elements of prior art to
arrive at the same result as the inventor. Often this is easy for the
Patent Office to show, thus making the non-obviousness requirement a
tough barrier to patentability. For an examiner to reject a patent application,
all that is necessary is to show that someone could have combined various
aspects of prior art and arrived at the same invention.
A key concept in the non-obviousness requirement is the person having
"ordinary skill in the art". This does not mean someone with
exceptional skill, nor does it mean someone who is just beginning an
understanding of a technical discipline. The standard has been set to
mean a "journeyman researcher" -someone with a fair level
of experience, but not a leader in the field.
Miscellaneous Requirements. As previously mentioned, the purpose
of a patent is to teach the invention to the public. In order to do
so, the patent must be explicit and detailed enough to allow someone
with ordinary skill in the art to reproduce the invention without undue
experimentation.
Patent law also states that a patent may be denied to someone who has
abandoned his or her invention for a period of time, if another inventor
duplicates the invention during this time period. What constitutes abandonment
depends on the facts of the individual situation, but it has generally
been held that if a substantially unbroken effort was made to finalize
the invention, then there will be no ruling of abandonment.
Some inventions are not patentable even if they are new, useful, and
non-obvious. These include printed matter, theories, ideas, plans of
action, laws of nature, mental processes, mathematical formulas, methods
of doing business, and naturally occurring substances.
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Published Works And Public
Disclosure
As mentioned earlier, prior art is a key issue in patent law. It can
either show that an invention is not new or declare that it is obvious,
and therefore not patentable. Information that enables an individual to
replicate what is claimed in a patent and disclosed to
the public constitutes prior art. Thus, a critical question concerning
patentability is:
What is a public disclosure?
Generally, public disclosure is any communication to someone not obligated
to keep the communication confidential. Patentability may be denied if
such public disclosure contains enough detailed information about the
invention which enables a person with ordinary skill in the art to duplicate
it. Like many areas of law, there are a number of details which make the
definition of "public" somewhat ambiguous. However, the following
guidelines are basic in determining publication:
Written Publications. The publishing of a manuscript,
book chapter, journal article, proceedings, thesis, pre-print, abstract
and similar works are forms of publication. The publication must actually
be available to the public. Thus, before a thesis is in a library and
indexed, or before a journal article is actually published, they are
not considered to be public information.
Oral Presentations. Oral presentations may also form
public disclosures, but in the United States are often held not to be
public disclosures for two reasons---it is harder to communicate the
nature of an invention orally, and it is harder to establish exactly
what was communicated. The US rules regarding oral disclosure are gray,
but less so in foreign countries, therefore oral presentations should
be given with caution.
Prototypes and Samples. Providing prototypes and samples
of an invention can constitute a public disclosure depending on the
circumstances. If they are supplied to be used for their intended purpose
(or if they are used in this way despite the intent), then disclosure
has occurred. If they are supplied only for testing or evaluation, then
disclosure probably has not occurred. Often it depends on whether there
are written restrictions concerning the use of the prototype or sample,
and whether these restrictions are communicated at the time of delivery.
The proper way to handle this issue is through a formal Materials Transfer
Agreement.
Sale or Public Use. Any sale or public use of an invention
is a disclosure. It has also been held that merely offering a product
for sale is a publication (even if no sale occurs). Sales for experimental
purposes are an exception as long as strict rules limiting the convergence
of the materials are followed.
Meetings. Talking about an invention to an audience as
small as one person can be sufficient to comprise disclosure. For example,
a meeting with a single employee from a corporate sponsor can be grounds
for patent denial. Meetings with employees of the same organization
as the inventor generally are not considered to be disclosures, but
meetings with employees from other institutions do constitute disclosures.
Grant Proposal Public Submittals. It is not uncommon
for technical details to be included in public proposals to potential
research sponsors. To protect patentable details revealed in a grant
proposal the first page of the proposal should carry the caption: "CONFIDENTIAL,
THIS PROPOSAL CONTAINS POSSIBLY PATENTABLE SUBJECT MATTER ON PAGES XX-XX".
List only those pages containing technical details, then write the word
"CONFIDENTIAL" on the top of each such page. "CONFIDENTIAL"
stamps are available from the Research Office
Protecting Patentability While Still Publishing
One easy way of protecting patentability is to have a US patent application
on file before the publication, oral presentation, meeting, etc. It is
important that researchers think of patentability before they publish.
It is suggested that the Research Office be notified at least two months
prior to publication to assure that patent rights are protected and that
publication can go forward without problem or delay.
Confidentiality
As a general rule, complete technical information should not be volunteered.
Abstracts or oral presentations can be given to reveal only the general
objectives and results of the work, without revealing significant details
that would enable someone to replicate the invention. As noted earlier,
when in doubt, potentially patentable material should be marked as "CONFIDENTIAL".
In situations where sensitive information must be discussed with individuals
outside the laboratory, be sure to have them sign a confidentiality disclosure
agreement. This will protect the patentable rights of research in such
conversations. Contact the Research Office for standard Confidential Disclosure
Agreements for researchers' use.
Confidentiality agreements can be either one-way or two-way agreements.
A one way agreement protects a party that is releasing confidential information
for review to another party. A two-way agreement protects the exchange
of confidential information from either party to the other.
Legal rights to future work can be affected by a confidentiality agreement.
Researchers, faculty and staff are encouraged to consult with the Research
Office before entering into a confidential arrangement with organizations
outside of the University of North Texas and the Health Science Center.
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OF CONTENTS
Laboratory Notebooks ** IMPORTANT **
Good record keeping is an important practice for any researcher to follow
and is essential for effective patenting. Patents are awarded to the person(s)
who first invents something (novelty requirement). Thus, the dates on
which an invention is conceived and reduced to practice can be of critical
importance in determining who is the first inventor(s). When challenges
are made against a patent application, a patent can be lost if good record
keeping has not been practiced. Two important considerations are:
(1) All lab employees, including technicians, should keep a bound lab
book, and
(2) Loose leaf and computer files are improper methods for recording
laboratory inventions.
The established principles to follow when record keeping:
Maintain an ongoing record of experimental activities and thoughts in
a bound notebook, preferably with numbered pages. Separate subject fields
require separate notebooks. Use full sentences and complete figures to
explain the hypothesis, experiments, procedures, protocols and results.
Date and sign all entries. When ideas are conceived that improve the invention,
they should be included along with a discussion of the conceptual basis
for the idea and who contributed to the idea.
Firmly glue additional materials relevant to the research (such as photos,
graphs, charts, etc.) to pages in the notebook, making reference to the
inserted materials in your comments. Sign and date each glued in material.
Have a colleague familiar with the work, but not involved in it, act as
a witness to sign and date each page. NEVER erase any portion of an entry
once made. If later information changes a previous entry, draw a single
line through the original information (leaving it clearly readable). Then
enter and date the new information.
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NOTEBOOK -A Laboratory Diary
This notebook is the property of UNTHSC and will contain confidential
material. It should be treated as such and must not be taken from the
Laboratory premises except in those cases where field work makes this
necessary or permission has been authorized. This notebook is specifically
assigned to you on a charge from the university. It is your responsibility
while it is in your hands. Upon being filled it should be copied and the
original returned. If needed again it may be obtained on a loan basis,
with an appropriate sign-out.
Original entries systematically and properly made in the usual course
of your work are the best record of your accomplishments. This Notebook
may be the deciding factor in litigation involving a question of inventorship.
It may also be the only complete source of information for future experiments,
or for the preparation of reports you may be required to write.
THEREFORE: _
1. As part of your daily routine enter clearly and concisely in this
notebook all your experimental data, plans for experiments, analysis
of results, calculations, observations or ideas. This data shall be
placed in the notebook immediately and directly. Do not use loose leaf
books or loose pieces of paper for this purpose. Make all entries in
ink.
2. Each page and entry must show the date on which the entry is made
and the signature (or initials) of the worker making the entry. The
nature of the problem and the number of the project should also be indicated.
To Make The Lab Notebook most functional:
1. Plan the presentation before writing so it can be easily
read and understood.
2. State clearly and completely the procedure followed, giving
all conditions of the experiment (temperatures, pressures, time required,
etc.) and apparatus used (include sketches if necessary). This notebook
should provide sufficient data to enable any of your associates to duplicate
the procedure and results.
3. Give all results and observations including references to
literature, analytical data, and pertinent calculations. Data may be
presented in tabular form and in graphs to great advantage. Cross sectional
ruling is provided for your convenience in aligning tables and making
graphs and sketches.
4. Make all entries in ink. Always be neat and legible. Do not
make erasures. Cross out by straight lines any material to be deleted.
5. Make all entries consecutively, leaving no blank pages.
6. When a page or a day's entry is completed, sign your name
at lower left. If blank space's left on the page, draw a diagonal line
to show its extent at the time of signing. Have your signature witnessed
at the lower right. This witness means that the page was filled at the
time of signing.
7. Promptly disclose any new and possibly patentable ideas occurring
thereon to one of your associates who is familiar with the work you
are doing (preferably the section chief or one who has actually seen
the experiment carried out), and have him affix his signature and the
date. He should write in "disclosed to. " at the time of signing.
8. When an idea, process, etc., of any importance is finally found
to be workable, the process, etc., should be demonstrated in
the presence of witnesses, other than co-inventors, who are able to
understand the process. These witnesses should sign the page in the
notebook describing the demonstration carried out in their presence,
writing in demonstrated to and understood by. "_________"
Before this procedure is followed, the section chief in charge of the
project should be notified.
9. Pages are provided for a Table of Contents. This should be
completed to enable ready access to the contents in the future.
PREFACE PAGE OF THE NOTEBOOK
Book Issued To :-_________________________________________
Issued By:_________________ Date Issued :_________________________
When Filled. Date copied and Archived.:-
Archived By __________________ Dated Received __________________
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PATENTING PROCESS
Patent
Terms, Terminology and Glossary
Determining the Inventor(s)
It often happens that two or more persons make joint contributions to
a potentially patentable invention. In such cases the effort put forth
by all involved parties may be so interdependent that credit for the invention
cannot go to any single person. When this situation occurs, all inventors
or technicians must join in the patent disclosure and application. In
cases where an assistant merely carries out the directions of another
and in so doing, constructs a new device or employs a new process, the
assistant does not become a joint inventor, since the assistant was merely
following the suggestions of the true inventor. Incorrect claims of inventorship
can result in the denial of an otherwise good patent.
The determination of the inventor is a legal matter. Throughout the patenting
process the patent attorney will work with all interested parties to determine
the rightful inventor.
Filing A Patent Application
A US patent application, on average, costs $4,000 to $7,000 and almost
that much to obtain an awarded patent. International coverage can amount
from five to ten times this amount. In order to justify and minimize these
costs, it is important to determine that the invention is actually patentable,
technically feasible and marketable.
A patent application contains the following elements:
Specification. The specification typically describes
the background and details of the invention along with a description
of its use or uses. It may include examples or experimental results
showing application of the technology.
Drawings. When necessary for a complete understanding
of an invention, the patent must include drawings and description of
how the drawings are to be interpreted.
Claims. A patent application's claims become the heart
of the protection offered by a patent. After describing the invention,
its background and its utility, the inventor claims what is new in the
invention. The claims are the enforceable part of a patent; an inventor
may exclude others from practicing that which is embodied in the patent's
claims.
Oath of Declaration. This is a sworn statement
by the inventor that to the best of his or her knowledge, he or she
is the first inventor, is not aware of any restrictions to patentability,
and is aware of his or her duty to disclose any relevant information
to the Patent Office.
After The Application
Is Filed
When an application is received by the United States Patent and Trademark
Office (USPTO), it is assigned a serial number and the current date. The
application is then assigned to a specific Patent Examiner who deals exclusively
with the technical area involving the invention. The Examiner reviews
the proposed claims and evaluates the invention according to the patent
requirements mentioned earlier.
After the Examiner's review, which can take anywhere from six months
to two years (depending on backlogs in that technical area), the Patent
Office issues its First Office Action. This is the Examiner's conclusion
about the patentability of the invention. In rare cases, this First Office
Action concludes that the invention is patentable. Far more frequently,
however, the First Office Action will be a rejection based on the novelty,
utility, or non-obviousness requirements. The applicant has the right
to require the Patent Office to reconsider its conclusion by distinguishing
the invention from prior art, demonstrating that it was not obvious, or
by modifying the application's claims to avoid the objections.
The Patent Examiner then responds to the applicant's arguments (a Second
Office Action) by either accepting, rejecting, or responding to the arguments
with some mixture of acceptance and rejection. When the decision is a
full rejection, the Second Office Action is often a final rejection because
the applicant does not get an automatic right to additional reconsideration.
However, frequently the door is still open for further argument because
other approaches, within the USPTO and the courts maybe used to overcome
an Examiner's rejection.
Ultimately, the Examiner either accepts or rejects the arguments of the
applicant. If accepted, the Patent Office issues a Notice of Allowance.
After payment of the required fees, the patent issues in due time. If
rejected, a notice of Final Rejection is issued.
Intellectual Property Policy
of UNTHSC
The University Intellectual Property Policy defines ownership of intellectual
property, inventors' disclosure of inventions, and distribution of royalties,
and related policies. The information provided here is an overview only;
interested parties are encouraged to refer to the Health Science Center,
University of North Texas Policy and Procedures manual for the current
complete text.
In accordance with state law, patentable inventions created by UNTHSC
faculty, staff and students are the property UNTHSC if the work was supported
by University funds or performed in UNTHSC controlled facilities. Computer
software and databases are the property of UNTHSC if created as part of
university-assigned duties. Inventors are strongly encouraged to disclose
all potentially patentable intellectual property to the Research Office.
The Research Office will review the intellectual property disclosure,
and a decision will be made, quickly, as to UNTHSC interest in pursuing
commercialization.
UNTHSC staff and faculty may not become directly involved in negotiating
commercial agreements for intellectual property that is owned or otherwise
controlled by the UNTHSC. This is the responsibility of the Research Office.
Royalty income for a particular technology is first applied to covering
the associated patenting and licensing expenses before being subject to
distribution. Royalty income in excess of such expenses is distributed
to inventors, their departments, and UNTHSC.
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REFERENCES
Association of University Technology Managers;
Technology Transfer Practice Manual. Volumes I -III,
The Association of University Technology Managers, Inc. , 1995.
McCarthy, Thomas J.
McCarthy's Desk Encyclopedia of Intellectual Property.
The Bureau of National Affairs, Inc., Washington, D. C. 1995.
von Bargen Mueller, Lisa.
The AUTM Educational Series No. 1:
"An Inventor's Guide to Patents and Patenting."
The Association of University Technology Managers, Inc., 1995.
Web Site references
Association of University Technology Managers, Inc.
Center for Intellectual Property Law
Edison Biotechnology Institute
United States Patent and Trademark Office
Virginia Community College Intellectual Property Policy Manual
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This document originated from Ohio University it has been heavily
edited.
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APPENDIX
1. US Supreme Court clarifies "ON-SALE BAR"
to obtain a US Patent
US law is unique among the major developed countries in providing a one
year grace period for filing a patent application after a completed invention
is "on sale", has been published or otherwise available to the
public. The grace period can be, possible, even longer if the "experimental
use" doctrine is applicable.
In a recent decision (Pfaff V. Wells Electronics [Nov 1998])
the supreme court specifically held that a working prototype or other
similar "reduction to practice" was not required to start the
one year grace period. In particular, assuming there has been an offer
for sale, the bar period commences to run as soon as sufficient documentation
is available to the inventor to file a patent application (i.e. to satisfy
the "enablement" requirements of US Patent law).
Since determination of when an invention is "complete" or "enabling"
or what constitutes "commercial exploitation" or "public
use" is highly subjective, it is recommended that patent applications
be filed as early as possible. Especially if no patent application has
or will be filed within a year of the original conception of the idea.
John May jmay@fulbright.com
2. Approval Clauses in Licensing Agreements
The approval process is one of the critical aspects of a licensing agreement,
and for a variety of reasons it should always be enforced.
Enforcement is central to maintaining integrity of a property. Omitting
an enforcement clause can throw ownership into question. Especially in
design patent and copyright licenses the agreement should always have
the right to approve products.
There should be a definitive process/procedure in place for dealing with
this aspect of a license.
It is vital to an artists' rights, reputation and the long-term life
of the licensing program to address the approval process with consistency
and diligence.
Why include an approval clause.?
1. To ensure the integrity of a property is maintained.
Reproduction and use of artwork meets standards and reflects the integrity
of the artwork. Products, packaging, catalogs, advertising and promotional
materials should accurately reflect the property.
2. To allow one to track every SKU [Stock Keeping Unit] Approval
ensures that property is monitored in inventory, correctly and accurately.
3. To assist in keeping track of marketing dates and deadlines.
4. To provide an opportunity to insure all items bear correct and
legal notices of ownership. © DATE, NAME, All rights reserved.
5. To obtain a physical prototype in which to judge production.
6. To determine if other property rights are being commingled.
7. To review copy and packaging.
8. To insure ownership rights. An artist must enforce their
rights to review and approve all products, packaging and promotional
material so that ownership does not pass to the licensee.
9. To monitor compliance with government standards.
10. To ensure product quality and does not have a diminished
value or offend the public
HEAVY DUTY APPROVAL CLAUSE
Before commencing or authorizing third parties to commence the design
and/or development of the licensed product and/or promotional material
the licensee shall submit in writing at its own cost to the licensor,
for approval, a detailed description of the proposed licensed product
including how and where the licensed copyright, licensed trademarks and
all other copyrights and text will be used thereon..
Any such proposal shall conform to the production criteria set forth
on Schedule " ". If approved, the licensee shall next furnish,
at its own cost to the licensor, for licensors written approval, six samples
of the proposed products. The licensee shall not proceed beyond any of
the approval stages where approval is required without securing the prior
express written approval of the licensor, which may be granted or withheld
at licensors sole discretion.
The licensee may not manufacture, use, offer for sale, sell, advertise,
promote, demonstrate, ship and/or distribute any licensed product until
licensee has received written approval of same from licensor.
Such approval may be granted or withheld as the licensor, in its sole
discretion, may determine.
Should the licensor fail to approve in writing any of the submissions
furnished it by licensee within 14 days from the date of submission thereof,
such failure shall be considered to be a disapproval thereof. Licensor
shall notify licensee as to the reason of any disapproval.
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