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The section below is meant to provide answers to commonly asked questions about intellectual property issues & technology management. We encourage you to contact us directly if you have more specific inquiries.
We also encourage you to view this website created by UCSF if you are uncertain how to engage in alliances with companies, protect your research/publication rights and intellectual property, or avoid conflict of interest when consulting for companies.
Why should I disclose an invention to the OTM?
Under your Patent Acknowledgement contract with the University, you
have an obligation to disclose your inventions, whether or not patentable,
to the OTM for evaluation. The development and commercialization of your
invention may provide significant public benefit and generate income for
research and education at UCSF. A licensee of your invention may wish to sponsor
research in your laboratory. Also, inventors receive a portion of net income
generated by their inventions.
I've made a discovery. Should I submit an invention
disclosure form?
If you are not sure, kindly call a licensing professional
at the OTM to discuss your invention. If you have evidence of a discovery
that may have practical utility and represents a potentially attractive business
opportunity, you will be asked to complete an invention disclosure form,
sign it, have your signature witnessed (notary not necessary), and send
it to the OTM by campus mail (box 1209).
I've been working on something interesting. When
should I disclose an invention to the OTM?
The ideal time to disclose an invention to the OTM is as soon as you believe you made an invention, i.e. after it has been reduced to practice and well before it has been published or publicly presented. If you disclose an invention to the OTM after it has been published or publicly presented, there is no longer an opportunity to obtain patent rights in most countries outside the US. The opportunity to obtain patent rights in the US ends on the first anniversary of the date of the first publication describing the invention.
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I've been working on something in an outside
collaboration. Should I disclose to the OTM?
Yes. Please disclose to the OTM, even if your collaborator offers to handle the invention with his/her university or company, as the case may be. It is safe to assume that each inventor has an obligation to inform his or her employer and that the employer of each inventor may most likely have ownership in the invention. We are pleased to coordinate with other joint owners of inventions whether they be other universities or companies. For example, if the joint owners of an invention are academic institutions, we negotiate how the invention will be managed. Not-for-profit joint owners usually establish an inter-institutional agreement that assigns responsibility for managing the invention to one of the institutions and specifies how income and expenses will be shared among the institutional owners. If a joint owner of an invention is a commercial entity, we investigate the possibility of licensing the university's rights to the commercial joint owner.
What will the OTM do with my invention disclosure?
In those cases where the OTM's analysis of the patentability and licensability of the invention suggests it represents a potentially attractive business opportunity, the licensing professional responsible for the case will try to find a good way to commercialize the invention for the benefit of the public while generating university income for education and research. After discussing the invention with the inventor(s), the licensing professional will first contact prospective licensees with a non-confidential description of the invention. A prospective licensee that is interested in learning more about the invention may then sign a confidentiality agreement prepared by the OTM in order to speak with the inventor in confidence and review confidential information about the invention, such as a scientific manuscript, drawings, working prototype, etc.. The strategy for commercialization may or may not involve seeking patent protection and licensing patent rights. Not every invention has to be patented in order to be licensed.
Will every invention disclosed to the OTM result
in a patent application?
No. The substantial expense of obtaining patent rights is only justified when the patent rights are demonstrably valuable to a potential licensee. The licensing professional will determine whether and when the filing of a patent application is appropriate in order to commercialize the invention. Typically, a potential licensee accepts responsibility for reimbursing the university for patent costs before the patent application is filed and in this way can collaborate with the OTM on drafting the patent application. However, the OTM does not require having a licensee in hand in order to file a patent application. Patent rights are most important and valuable when a licensee requires market exclusivity in order to justify the risk and expense of developing a product based on the invention.
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What is a license?
A license is a contractual instrument by which the University grants a party permission to use an invention that belongs to the University for specific purposes, subject to certain terms and conditions that typically include fair consideration to the University based on the estimated value of the invention. A license may be exclusive, co-exclusive or non-exclusive. A license may be restricted to a particular field of use and/or geographical area.
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If the university licenses my invention to
a company, will I still be able to do research on it?
Yes. Our license terms always provide that the
University retains the right to use the invention for educational
and research purposes and to share the invention with other universities for their educational and research purposes.
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Who is an inventor?
Unlike authorship of a scientific publication, inventorship is a matter of law and a patent that fails to name the correct inventors may be ruled invalid under certain circumstances. The law does not recognize individuals as inventors who merely follow someone else's instructions or simply provide lab space, funding and/or equipment. The lawful inventors on a patent depend on what is specifically claimed in the patent as written. Because patent claims may change while the patent application is undergoing review by the patent office, inventorship may change as well. For the purpose of your invention disclosure form, simply name any individual who has made a creative contribution to the invention. When necessary, the OTM will initiate a formal inventorship determination using outside patent counsel.
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What if someone who is not a UCSF employee
makes a creative contribution to my invention?
It is safe to assume that each inventor has an obligation to inform his or her employer of the invention and that the employer of each inventor will have ownership in the invention because of the state labor laws that apply. Each owner of an invention has an undivided interest in the intellectual property, which is called a joint invention. Sometimes, two or more universities own an invention jointly. In such cases, the universities typically establish an inter-institutional agreement that assigns to one university the responsibility for managing and licensing the invention on behalf of all the joint owners and provides for sharing costs and income among them. If the co-inventor is employed by a company, then the company and the university jointly own the rights in the invention. In this case, if the company wants exclusive use of the joint invention, it will have to license the university's ownership interest in the invention. However, in the absence of any such agreement, under the laws of the U.S. each co-owner is free to license its rights in the invention independently of the other co-owner(s), without notifying them, seeking their permission, or sharing income with them.
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What are "property rights?"
Tangible materials created by UCSF scientists may be useful and commercially important although not necessarily patentable or important to patent. Examples of such materials include cell lines, transgenic mice, plasmids, software disks, and integrated circuit masks. The university owns property rights related to such materials. Unlike patent rights or copyrights, property rights do not expire. The OTM can transfer property rights under a Material Transfer Agreement or under a license for property rights known as a bailment. A bailment may be exclusive or non-exclusive. A bailment may be restricted to a particular field of use and/or geographical area. An exclusive bailment must be reviewed and approved by the Chancellor.
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Are licenses to property rights worth less
than licenses to patent rights?
Sometimes, but not necessarily. Some biological
materials are quite valuable and if they are difficult or too time-consuming
for a user to reconstruct from the public record, they may be licensed
as University property under fairly attractive terms in the absence
of patent rights.
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Why do I need to use an MTA when I give
materials to other researchers?
Material Transfer Agreements protect the provider of materials. In addition to addressing liability and indemnification issues, MTAs help to maintain the University's property rights associated with materials "outbound" to other researchers. The OTM is responsible for negotiating Material Transfer Agreements on behalf of the campus for transferring all materials other than human specimens. MTAs are suitable for transferring materials to non-profit institutions for their research and educational purposes. Although the OTM may also use an MTA to transfer material to a company, it may prefer to negotiate a license (known as a bailment) with the company, depending on the circumstances. In this case, the OTM will share the license income with the developer. To transfer human specimens and human data from a clinical study, contact the Industry Contracts Division of the Office of Sponsored Research.
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What is a provisional patent application?
A provisional patent application makes it possible for an applicant to establish a priority date for patent purposes. Unlike a regular patent application, a provisional patent application is not examined by the patent office for patentability and cannot be amended. Moreover it must be converted to a regular application within one year of being filed. However, to secure a priority date, the provisional application must meet the same statutory disclosure requirements as a regular application. Hence, in practice, a provisional application should be drafted exactly as a regular application, and since attorney drafting-time constitutes most of the cost of a patent application, a properly drafted provisional application will cost about the same as a regular application. The most significant practical difference is that the 20-year life of a patent begins at the time a regular application is filed; hence, a provisional application can be used to shift forward, by one year, the 20-year patent term. Doing so would be advantageous for a highly valuable invention that was expensive to commercialize because a licensee would get an additional year of patent-protected product sales (e.g. a billion dollar/yr. therapeutic drug). On the other hand, using a provisional patent application to shift the patent term also delays when the patent issues and thus can delay the ability of the patent holder to assert its rights under the issued patent against infringers. Strategically, provisional patent applications may thus require one to think about how soon the patent holder needs the issued patent versus how valuable it will be 20 years hence.
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How much does it cost to file a patent
application in the US?
Depending on the complexity, writing and
filing a patent application may cost roughly $8,000 to $15,000.
Additional costs are incurred as the patent office reviews
the application (the patent prosecution process) and even after the
patent issues so that a single US patent, over its lifetime, may
cost on the order of $30,000 and often more.
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How much does it cost to file a patent
application outside the US?
The cost of filing, prosecuting and maintaining
a single application in Europe and Japan is roughly $100,000
(often more) but foreign rights can in some cases easily exceed $200,000 over
the life of the patent (and can be as high as around $500,000). Patent rights outside the US are
not available for inventions that have been made public unless
a US patent application was filed prior to the public disclosure.
Patent rights outside the US are available if applications
in other countries are filed within one year of the US filing.
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Will the OTM license my invention to
my start-up company?
The licensing professional with responsibility
for the invention has an obligation to seek the best means to
commercialize the invention for the benefit of the public
and to generate income for education and research. Your start-up
company will be considered along with any other opportunities
for commercialization, and may or may not be the best alternative
available.
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Will the OTM release its ownership
of an invention back to the inventors?
Yes, if possible and if other opportunities for development do not exist. Under your Patent Acknowledgement with the University, you agree to assign your rights, title, and interest in your invention to the Regents of the University of California and you execute such assignment documents as part of the OTM's Technology Disclosure Form each time you disclose an invention to the OTM. If the University decides to release its rights in the invention back to the inventors, the inventors must sign an agreement called a "release letter" in which they assert they will not use University funds and facilities for further research or development of the invention. They also promise to apprise the University in writing of their attempts to commercialize their invention on a regular basis. This agreement becomes void if they do not report progress towards commercialization, and their rights revert back to the University. When an invention is released to the inventors, patent prosecution and licensing become their responsibility. Sometimes the research sponsor puts restrictions on the release of inventions made with its funding. Inventions generated with federal money, in whole or in part, must be first referred to the federal government so that the government, if it so chooses, can assert title to the invention. The inventor must then ask the federal government to release rights to the inventor for inventions made in whole or in part with federal funding.
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Who is authorized to sign agreements such as
Licenses, Material Transfer Agreements, or Confidentiality Agreements
on behalf
of the University?
- UCSF conducts business under the aegis of the Regents of the University of California, which is a California constitutional corporation, and only individuals with Regential authority can sign legal agreements that bind the Regents. The OTM Director has this signature authority for managing the intellectual property UCSF's employees have created.
- OTM staff negotiate all licenses for inventions managed by the OTM on behalf of UCSF and the State of California. These licenses are signed by the OTM Director subject to their compliance with legal form as determined by UC's Office of the General Counsel. In addition, the OTM a) reviews and negotiates as necessary Confidentiality Agreements covering UCSF proprietary information related to inventions under the OTM's management, and b) is responsible for outgoing Material Transfer Agreements for all materials generated at UCSF, other than human specimens.
- The Industry Contracts Division of the Office of Sponsored Research will review and negotiate: a) Confidentiality Agreements related to the company research agreements handled by the OSR, b) incoming Material Transfer Agreements for all materials regardless of the nature of the provider (e.g. a company, university, government laboratory, research institute, etc.), and c) outgoing Material Transfer Agreements only for human specimens.
- Principal Investigators and other laboratory members are generally not authorized to sign such agreements on behalf of the University. However, PIs on occasion may be asked by the OTM or the OSR to sign such agreements, not as a party to the agreement, but rather to indicate that they have read and understood the document and its terms. Investigators should feel free to ask the OTM or OSR staff for clarification if specific terms in the agreement appear problematic or are not clear.
- PIs may sign Material Transfer Agreements (MTAs), without review by the OTM, when transferring non-patented, non-licensed, non-human specimens to another non-profit educational or research institution via the Non-Profit Material Transfer Agreement found on the OTM website, provided no changes are made to the agreement template. If the materials are related to a Technology Disclosure (http://www.otm.ucsf.edu/docs/otmTDForm.asp) filed with the OTM, the PI should contact the OTM so that the OTM can review and handle the request. The investigator should provide the OTM with a copy of the fully executed Non-Profit MTA for its files. If the recipient investigator or institution requests modifications to the Non-Profit MTA template, the PI must direct these requests to the OTM before signing the modified MTA.
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I
have received a request from another academic institution or company
for biological materials that are not human specimens and that were
generated in my lab. What process should I follow at this point?
- If a colleague at a non-profit educational or research institution has requested the materials, the UCSF laboratory PI may transfer the materials using the standard UCSF Non-Profit Material Transfer Agreement (MTA) found on the OTM website. PIs may sign this standard UCSF MTA without review by the OTM only when transferring non-patented, non-licensed, non-human specimens to another non-profit educational or research institution. If the recipient investigator or institution requests modifications to the agreement, the PI must first direct these requests to the OTM for review before signing the modified MTA. If the materials are related to a Technology Disclosure filed with the OTM, the PI should first contact the OTM so that the OTM can review and handle the request. A copy of the fully executed MTA should be supplied to the OTM for its files
- If a colleague at a company has requested the materials, notify the OTM. The OTM will negotiate and draft the MTA or, in some cases, may require the company to take a license that the OTM will negotiate. The OTM will share the license income with the developer.
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I
would like to request materials from
another academic
or industry laboratory. What process should I follow at this point?
- The OTM is not responsible for incoming material transfers. The responsible office is the Industry Contracts Division of the Office of Sponsored Research which handles incoming materials from all types of providers, e.g. government labs, research institutes, companies, universities, etc.
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I would like to arrange a mutually beneficial collaboration, unfunded
or funded, with a colleague in industry. What
process should I follow at this point?
- If the collaboration involves an invention you made at UCSF, contact the OTM.
- For all other collaborations with industry, contact the Industry Contracts Division of the Office of Sponsored Research.
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A company has approached
me and asked me to speak with its scientists
about some of my unpublished work. Do I need
to notify anyone at the University?
- Contact the OTM to discuss your intended presentation/discussions.
UCSF employees have an obligation to disclose their inventions,
whether or not patentable, to the OTM so that the OTM
can develop a management strategy that maximizes the
value of campus research by preserving potential patent
rights.
- The OTM likely will put a confidentiality agreement in place for you with the company prior to any discussions in order to protect any inventions you have made and the University's potential patent rights.
- Notify the OTM as far in advance as possible
in order to allow the OTM and the company to negotiate
and execute the confidentiality agreement.
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A colleague at another university
has invited me to visit and discuss/present my latest
research. What should I do if some of my findings might
have commercial
value?
- Contact the OTM to discuss your intended
presentation/discussions. UCSF employees have an obligation
to disclose their inventions, whether or not patentable,
to the OTM so that the OTM can develop a management strategy
that maximizes the value of campus research by preserving
potential patent rights.
- Please refer to "What is a public disclosure?" below and its possible consequences.
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A
scientist has asked me to attend an informal meeting (dinner, etc.)
to discuss a possible
invention and asks for my expertise in a given area. The scientist has
some connection with a funded or start-up company. Are there guidelines
for disclosure? Should I be compensated for such a discussion?
- If you will be discussing any of your unpublished work/research, please contact the OTM prior to your discussions with the scientist. The OTM will see that a confidentiality agreement is put in place prior to any discussions in order to protect any inventions you have made and the University's potential patent rights.
- Notify the OTM as far in advance as possible
in order to allow the OTM and the company to negotiate
and execute the confidentiality agreement.
- Notify the OTM if, after your discussions, you
feel that you have contributed to the conception
or the reduction to practice of an invention.
- In terms of compensation, please refer to the
question below regarding consulting arrangements.
- It is generally unrealistic to expect to be compensated
for such a one-time meeting unless a prior consulting
agreement is in place.
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A company has requested my consulting services.
Am I able to consult while maintaining my position as a faculty member?
- Faculty are able to consult as long as their obligations as consultants do not conflict with their obligations as University employees. Guidelines for policies on commitment of time for faculty can be found at http://www.ucop.edu/services/conflictofinterest.html#b and http://www.ucop.edu/acadadv/acadpers/apm/apm-025-07-01.pdf. Also, guidelines specific to consulting can be found at http://www.ucop.edu/ott/pdf/consult.pdf and at http://medschool.ucsf.edu/academicaffairs/faculty/policy/facultyconsulting/index.aspx, which provides sample consulting agreement language.
- The University is not a party to consulting agreements, which are agreements between the company and faculty member and personal to the faculty member. As such, the OTM will not negotiate consulting agreements on behalf of University employees.
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there established guidelines for compensation for involvement on
the Scientific Advisory Board of a start-up company?
- The
University is not a party to these agreements and does not negotiate
financial terms on behalf of the advisor.
- Each company sets its own compensation which can vary widely and can comprise cash, stock options, or some combination of the two.
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I
made an invention while consulting for a company and my client
wants to file a patent application on it.
Do I need to do anything besides helping the client with the application?
- Your Patent Acknowledgement with the University and the employer/employee relationship under the California labor laws dominate your obligations to your client. You must disclose the invention to the OTM as per your Patent Acknowledgement, but do not sign the Technology Disclosure Form because doing so assigns your rights to the University.
- The OTM will work with you and your client company to determine if the University has any ownership rights to the invention, in whole or in part, based on Section 2870 of the California Labor Code and UC policy.
- The company can take title to your invention if: a) you made the invention without using any University facilities or resources administered by the University, b) the invention is not subject to a third party obligation the University must honor, and b) the subject matter of the invention falls outside the scope of the subject matter of the research you and your immediate work group conducts at the University.
- If the OTM determines the University has an ownership interest in the invention, and if the OTM decides to assert its rights in the invention, it will ask you to sign the unsigned Technology Disclosure Form you already submitted, thereby assigning your rights to the University.
- The company then may negotiate a royalty-bearing license with the OTM for the University's rights in the invention.
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If I consult for a company, can I also receive
funds from the company for my own research at UCSF?
- The compensation you receive from your client means that you have a financial interest in the company. Before you can receive research funds from the company you must formally disclose your proposed research and company financial interest (Form 700U; "Statement of Economic Interests") to the Chancellor's Advisory Committee on Conflict of Interest. The Committee, which meets once a month, will review your disclosure to determine to what extent your financial interest in the company might bias your objectivity as a researcher performing research that is funded by the company.
- If the Committee determines there is a financial conflict of interest in research, it will inform you of ways to manage that conflict which can range from barring you from accepting the research money to allowing you to accept the funds subject to certain steps you must take, subject to the specifics of the case.
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do I initiate communication with the OTM regarding a possible invention
in my lab?
- Call or email any licensing professional listed on the OTM website.
- After speaking with the licensing professional, he or she may ask you to file a formal Technology Disclosure Form, which you can download from the OTM website and complete as a Word document.
- Through the Technology Disclosure Form, you will be asked to describe the invention and the events leading up to the invention, and to list all inventors, funding sources, related MTAs, and any prior or anticipated public disclosures. The form is a legal document that you must sign and date. It must also be signed and dated by two witnesses (notary not necessary) who do not have a vested interest in the invention but who are competent to generally understand what the invention is.
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made an invention on my own time without any University resources.
Am I free to license and commercialize my invention on my own?
- Under the Patent Acknowledgement, you have an obligation to disclose any inventions (even those made on your own time or as a consultant) to the OTM that you make concomitant with your employment by the University so that the OTM can determine if the University has any rights to the invention under the California labor laws.
- You will be entitled to own your invention if: a) you made the invention without using any University facilities or resources administered by the University, b) the invention is not subject to a third party obligation the University must honor, and c) the subject matter of the invention falls outside the scope of the subject matter of the research you and your immediate work group conducts at the University.
- If the University has no rights to your invention, the OTM will at your request provide you with a no-rights-claimed letter that you can show investors, licensees, business partners, etc. that states that the University has determined it has no rights, title, and interest in the invention.
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Should
I disclose to the OTM before or after I have submitted my work
in abstract or manuscript form?
- It is critical to disclose your invention to the OTM as soon as the invention is in hand. Thus, you should be disclosing well before a manuscript or abstract is drafted.
- Disclosing early affords many advantages, including proper assessment of the technology by the OTM (which can take months), development of an appropriate management and marketing plan by the OTM, and the ability for interested companies to evaluate the licensing opportunity before the opportunity to obtain patent rights is lost.
- Depending on the invention, many companies may have no interest in licensing the invention unless they can obtain a license well in advance of any enabling public disclosure of the invention in order to have lead-time over their competitors.
- Importantly, the ability to obtain foreign patent protection in most foreign countries for an invention is lost immediately upon the enabling public disclosure of such an invention (please see question 25 below for a description of an "enabling" public disclosure).
- Many companies are not interested in licensing rights to inventions for which foreign patent protection no longer is available.
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Who
should be listed as “inventors” on
the Technology Disclosure Form?
- Unlike authorship of a scientific publication, inventorship is a matter of law. A patent that fails to name the correct inventors may be ruled invalid under certain circumstances.
- A lawful inventor is one who makes an inventive contribution to one or more of the patent claims that formally define the invention. Someone who provides equipment, space or money, no matter how critical to the development of the invention, is not an inventor. Also, someone who performs work under the supervision of another party is not an inventor, even though that person may have worked long hours or conducted a critical experiment.
- Because patent claims may change as the patent application is being drafted and also while it is undergoing prosecution by the patent office, inventorship may change as well.
- For the purposes of filing your Technology Disclosure Form with the OTM, simply name as inventors any individuals who have made a creative contribution to the invention (a creative contribution may include contributing a seminal idea towards the conception of the invention or overcoming a technical hurdle in the reduction to practice of the invention). The licensing professional whom you contact regarding your invention can provide you with a brief description of inventorship and a few relevant guidelines. More information also can be found on the OTM website. When necessary, the OTM will initiate a formal inventorship determination using outside patent counsel.
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Does
filing an invention disclosure with the OTM protect patent rights?
- Filing even a formal Technology Disclosure Form with the OTM does
NOT directly or automatically protect patent rights.
- The OTM may file a patent application after thoroughly reviewing the invention and determining if the invention meets the OTM's business criteria. Often, the filing of a patent application will not occur until a committed licensee has been identified so that the licensee can participate in drafting the patent application but the OTM does not always have to have a licensee in hand in order to file a patent application.
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What
happens once I have filed a Technology Disclosure Form with the
OTM?
- The OTM's Director will review the Technology Disclosure Form and then assign it to an OTM licensing professional who will also assess the invention and assume day-to-day responsibility for its management. All Technology Disclosure Forms received by the OTM are acknowledged by e-mail giving the name of the case manager, file number, and other useful information. Please contact this person for all matters pertaining to your invention.
- The licensing professional will evaluate the patentability, licensability and business opportunity the invention affords and develop an IP management plan accordingly. This individual also will work with you and the other inventors to understand prior public disclosures, involved funding sources and MTAs, and the technology's commercial viability.
- If the technology appears to be a licensable invention, an IP management, licensing, and marketing plan will be developed and implemented by the licensing professional.
- Once a committed licensee is identified, the licensing professional will be responsible for negotiating and drafting the license to the technology. An exclusive patent license can, for example, range from 30-50 pages and must pass independent legal review by UC's Office of the General Counsel. Often, it is at this point that a patent application is first drafted so that the licensee can participate in drafting the patent application, but it is not always necessary for the OTM to have a licensee in hand in order to file a patent application.
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Under
what circumstances will OTM finance filing a patent application?
- The OTM operates as a business and has specific business criteria that each invention must meet before the OTM will invest University funds in filing a patent application. Over its lifetime, a U.S. patent application can cost roughly $30,000, and often more, and the foreign equivalent can cost, over its lifetime, up to $200,000 or more (possibly as much as around $500,000). Thus, deciding to file a patent application worldwide can trigger a substantial investment commitment on the part of the OTM.
- The OTM seeks to recover its investment by licensing the patent rights to competent, committed, commercial developers. Failure to secure a licensee causes the OTM to incur a significant financial loss and results in wasting campus funds that could have been better spent on research and education.
- The OTM's objective thus is not to file patent applications for the sake of filing patent applications, not only because of the high cost of patent protection but also because not every patentable invention is licensable. Also, not every invention must be patented in order to be licensed. Rather, the OTM's objective is to file patent applications strategically in order to maximize the value of those inventions that the OTM has determined are licensable because they represent a sound business opportunity and will afford a licensee a competitive advantage in the marketplace.
- In order to best manage the costs and risks inherent in patent applications, the OTM typically will not file a patent application until it has first found a committed licensee, and then it will file the patent application at the licensee's expense. In this way, the OTM minimizes its financial exposure, conserves campus funds for research, and patents those inventions with true commercial potential as demonstrated by actual market demand. In addition, this strategy allows the licensee to participate in drafting the patent application so that the patent claims better support the licensee's specific business needs. By providing greater value to the licensee in this fashion, the OTM captures more value from the licensing opportunity in the form of more favorable financial terms.
- In some circumstances, the OTM will file a patent application "at risk", i.e. without having first found a licensee to pay patent costs. Such filings are usually prompted by an imminent public disclosure of an invention that would result in the loss of foreign patent rights unless a U.S. patent application is filed prior to the enabling public disclosure. The OTM will make an at-risk filing if its business analysis of the invention leads the OTM to believe there is an excellent probability that a future license will result. Such analyses take months when done properly so it is imperative that you discuss your invention with the OTM well in advance of any public disclosure. Waiting until the last minute deprives the OTM of the opportunity to do a proper analysis, is counterproductive, and can result in a faulty analysis due to lack of time.
- Importantly, many technologies, including tangible materials such as cell lines, transgenic mice, plasmids, and integrated circuit masks, are licensable without requiring a patent application. Also, software can be licensed under a copyright license, and a copyright license for high quality, value-added software can be more lucrative than some patent licenses.
- In summary, the substantial expense of obtaining patent rights is only justified when the patent rights are demonstrably valuable to a potential licensee who wants to license those rights. The licensing professional will determine whether and when the filing of a patent application is appropriate in order to commercialize the invention. Typically, a potential licensee accepts responsibility for reimbursing the University for patent costs before the patent application is filed. Patent rights are most important when a licensee requires market exclusivity in order to justify the risk and expense of developing a product based on the invention.
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I
am currently working on a research project that may be commercially
attractive. How do I apply for a patent?
Please
refer to the relevant questions above. The following summary is provided
for your convenience:
- Contact the OTM as soon as you have an invention in hand. This contact should occur well in advance of the drafting of an abstract or manuscript or any public presentation.
- You may be asked to file a formal Technology Disclosure Form with the OTM (found on the OTM website).
- As a condition of your employment with the University, you must assign your rights to The Regents of the University of California through the Technology Disclosure Form.
- The technology is an asset that belongs to the State of California, which has authorized the OTM to manage the technology on the state's behalf.
- The OTM will determine whether the technology meets the OTM's investment criteria and hence whether or not a patent application should be filed. A formal disclosure does not provide an automatic patent application filing. The disclosure simply informs the OTM of your invention so that the OTM can evaluate it and determine next steps.
- Not all patentable inventions are licensable. The OTM files patent applications only for inventions it determines will be likely to be licensed. Nationally, roughly 20-25% of university inventions get licensed (including inventions that are unpatented).
- Patent applications generally are filed only after a committed licensee is identified, but the OTM does not always have to have a prospective licensee in hand to file a patent application.
- Once an invention is licensed and income is generated, the inventors will receive, in total, 35% of the net licensing income, as provided under UC's patent license policy.
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The
OTM decided not to file a patent application on my invention and
I disagree with its assessment. What recourse do I have?
- The OTM will allow you to file the patent application at your own expense using a law firm that has been approved by The Regents of the University of California. The invention remains property of The Regents and OTM will manage the patent prosecution at your expense. If the OTM finds a licensee, it will reimburse you your full costs and provide you with your share of the license income, as per the UC patent license policy.
- Alternatively and at your request, the OTM may agree to assign its rights in the invention back to you, making the invention your personal property subject to certain terms and conditions. They include the restrictions that you cannot do any further work on the invention using University resources and that you must keep the OTM apprised of your diligent efforts to commercialize the technology. Moreover, you will be responsible for filing the patent application, marketing, and licensing the invention all at your own expense with no participation from the OTM.
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If
the University licenses my invention to a company, will I still
be able to perform related research?
- Yes. Our license terms always retain the right for the University to use the invention for its own educational and research purposes and also to share the invention with investigators at other not-for-profit institutions for their research and education purposes.
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What
is a “public disclosure”?
- Any
of the following may be considered a public disclosure:
- Information discussed in a non-confidential setting with non-UC employees
- Web posting
- Oral presentation away from the University of California or a presentation at the University attended by non-UC employees
- Poster presentation at the University or elsewhere
- Abstract publication, available to scientific public or meeting attendees either in print or online
- Manuscript publication, including online publications prior to the journal's hardcopy release
- Thesis submission to a library or outside source
- Thesis publication
- Funded grant application - the NIH posts the title and abstract online and makes the application available in response to a Freedom of Information request.
- etc.
- A public disclosure immediately bars one from obtaining patent protection in most foreign countries on such work if the disclosure is "enabling".
- An "enabling" public disclosure is one that describes the invention in sufficient detail such that one of "ordinary skill in the art" could reproduce the invention without undue experimentation. However, not all public disclosures are enabling in which case those disclosures to do trigger a loss of foreign patent rights.
- In the U.S., an enabling public disclosure establishes a one-year grace period from the date of the disclosure during which time a patent application can be filed. If no application has been filed within this one-year period, U.S. rights are lost.
- Many companies are not interested in licensing inventions for which no foreign patent protection is available. Also, depending on the invention, many companies are not interested in licensing the patent rights unless they can get a license well in advance of the public disclosure in order to have lead time over their competitors. Therefore it is imperative that you disclose your invention to the OTM as soon as you have it in hand.
- If you are uncertain if a disclosure will be considered an enabling public disclosure, please contact the OTM.
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I have filed a previous invention disclosure
with the UC Office of Technology Transfer (OTT) in Oakland. Does this
mean that all further intellectual property issues should be handled
through that office?
- The UC system completed its technology transfer decentralization initiative which means that all UCSF inventions (past, present, and future) are managed by UCSF's campus Office of Technology Management. Direct all questions you have regarding invention disclosures you filed with the OTT to the OTM.
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I am thinking of starting a company that will
focus on the technology developed in my lab. Should I contact anyone
at the University?
- As for any invention developed at UCSF, as a condition of your employment you have an obligation to contact the OTM to disclose your work and to assign your rights in the invention to the University. The OTM will manage the invention on behalf of the University.
- The OTM will also discuss with you the impact of founding a company on your ability to receive research funding from the company or the NIH for work at UCSF that will be related to the company's business interests.
- By mentioning your company is interested in licensing the rights to this invention, you put yourself in conflict with the California Political Reform Act of 1974. The OTM has procedures (below) it can implement that will mitigate this conflict and provide a safe harbor for both you and the OTM regarding the licensing decision.
- The licensing professional contacted will ask you to file a formal Technology Disclosure Form with the OTM.
- As an inventor, you will receive, along with the other inventors, in total, 35% of any net licensing income generated from the licensing of this invention, as determined under UC patent license policy.
- The licensing professional handling your case will determine the appropriate licensing strategy for this technology which may or may not include licensing to your start-up. The licensing professional has an obligation to seek the best means to commercialize the invention for the benefit of the public.
- If the licensing professional decides to license the invention to your start-up company, before doing so the licensing professional must first market the invention so that the public is made aware of the licensing opportunity. If no companies express interest, then the OTM Director can issue the license to your start-up. If one or more companies express interest in a license, then the licensing professional has to determine if your start-up will be the preferred commercial development partner. If your start-up is deemed superior, then the licensing professional must then submit his/her decision to an independent and substantive review that the OTM typically outsources to another UC campus technology transfer office. If the independent review supports the OTM's assessment, the OTM is allowed to license to your start-up. In this case, neither you nor the other UC inventors can represent the company in negotiating license terms with the OTM due to conflict of interest because you and they will derive personal income as UC employees from the license. Therefore, you should retain the services of legal counsel experienced in high-technology transactions to negotiate with the OTM.
- Above all, realize that your relationship with the OTM is just as critical to the success of your new venture as is your relationship with your investors and you should accord the OTM the same care and respect. Without either one, you have no company. You need the OTM to create and maintain the patent protection you need to attract investors and key employees, and to issue to your company the license that enables the company to practice your invention, without which the investors have no incentive to invest. Your reliance on the OTM does not end with the issuance of the license. Your company will have specific obligations to meet under the license, such as meeting certain technical, financial, and business milestones and filing progress reports on a regular basis to demonstrate diligence in commercializing the licensed technology. Failure to meet any of these obligations is grounds for the OTM to terminate the company's license for non-compliance, which could in turn devastate your business and alienate your investors. Therefore, you should regard the OTM as a valued business partner and treat it accordingly. It is in your best interest to form a close working relationship with the OTM at the very outset (even before talking to investors) and to nurture that relationship throughout the term of the license. Timely, candid communication is key, and keeping the OTM at arm's length is in neither party's best interest. Should your company falter and have difficulty meeting the requirements of the license, if you and your company have invested wisely in their relationship with the OTM and have kept it informed of the company's progress, the reasons for its ups-and-downs, and its plans to take corrective action, the OTM, at its sole discretion, may elect not to terminate the license if it feels the company has been a diligent and valued business partner.
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