The following sections explain the various aspects of technology commercialization at UNM. Click on any section heading to go directly to that section.

1. Helping UNM Inventors
2. Intellectual Property Protection
3. Inventors and Owners
4. Preparing for Successful Patents
5. Disclosure and Evaluation
6. Patent Prosecution
7. Marketing
8. Commercialization

1. What are the roles of STC, RTL, and IPC?
2. What is the current IP policy and where can I get a copy?
3. Where can I find information on commercialization of UNM technology?
4. If I have questions, whom should I contact?

What are the roles of STC, RTL, and IPC?
The recently revised Intellectual Property Policy (approved by the Regents on June 8, 1999) is administered by the IPC, RTL, and STC. All have roles in carrying out the Intellectual Property Policy.

IPC is a Faculty Senate Committee and their role is to provide faculty oversight of intellectual property management by the University and STC. IPC does this by adjudicating and mediating intellectual property rights issues among inventors or between inventors and UNM.

RTL, a department within UNM, is available to provide legal advice and support to the faculty, staff, students, and administration in the areas of copyright, trademark, patenting, material transfer agreements, federal statutory compliance, and other intellectual property matters. As a practical matter, RTL receives all new invention disclosures, dockets the disclosures and routes them to STC for review. RTL is responsible for obtaining assignments from inventors and providing assignments to STC. RTL maintains a documentation archive of UNM IP for the University.

STC began initial operations mid-1995 under a Memorandum of Agreement between the Regents of the University of New Mexico and STC for the purpose of commercialization of UNM IP. STC's responsibility is to pursue licensing of UNM IP by assessing the market for the IP, selecting the means for intellectual property protection and commercialization, negotiating commercialization agreements, overseeing commercialization activity, and receiving and distributing royalties to creators and the University. Additionally, STC manages all patenting and patent prosecution, and other intellectual property protection of UNM IP.

STC is wholly owned by UNM with the oversight of a Board of Directors consisting of UNM administrators and outside (non-UNM) directors.

What is the current intellectual property (IP) policy and where can I get a copy?
The current UNM IP policy as approved by the University of New Mexico Regents can be downloaded from the Research & Intellectual Property Legal Services website.

Where can I find information on commercialization of UNM technology?
You can always check the STC website for the latest information concerning our licensing activity as well as other commercialization activities.

If I have questions, whom should I contact?
If you have questions regarding patenting or commercialization, email us or call us (505-272-7900). For general legal advice regarding intellectual property, contact the RTL. Because STC and RTL work so closely together, either party will be able to quickly determine who can best answer your questions.

1. What is a patent?
2. What is patentable?
3. What are the different types of patents?

What is a patent?
The United States Patent and Trademark Office (USPTO) defines a patent as a grant by the government that gives the owner of the patent the right, for a period of time, to prohibit others from making, using or selling the invention described in the patent document. A patent is considered the personal property of the owners and may be licensed or assigned by the owner to others. This permits others to make, use and/or sell the invention. It is important to note that the owner may not be the same party as the inventor.

What is patentable?
To be patented, an invention must be novel, have utility, and be non-obvious.

In order to be considered novel, the invention must be new. This means that it must be different in some way from all "prior art", or other ideas that have already been patented or disclosed to the public. Novelty means that even the inventor cannot have publicly disclosed the invention more than one year before the patent was filed through publications, presentations at conferences, or any other public use including dissertations, abstracts, posters, etc.

To have utility, the invention must perform some useful function and must also be capable of doing what the inventor claims it will do. The invention must benefit society in some way.

Finally, the invention must not be obvious to anyone knowledgeable in the area, or be an obvious extension of prior art, before the invention is made. Prior art refers to the complete set of technical experience and knowledge that exists in the field pertaining to the invention to be patented. This art includes trade journals, scientific presentations, journals and other patent applications that have been published. For more information on avoiding obviousness, please visit http://www.nature.com/bioent/2008/081201/full/bioe.2008.12.html.

A three-pronged test must be met in order to establish a prima facie of obviousness over a reference. The MPEP states, in relevant part:

Anything that meets these requirements is patentable, excluding such things as abstract ideas, laws of nature, and naturally occurring substances.

In the U.S., there is a grace period of 12 months for an inventor to file a patent application after he or she has publicly disclosed the invention. This grace period does not apply in most foreign countries. Therefore, in almost every case STC endeavors to protect all rights including foreign rights at the earliest possible time so that global companies have the opportunity to utilize an invention throughout their worldwide operations.

What are the different types of patents?
There are three different types of patents:

• Utility
  Utility patents may be granted to anyone who discovers or invents a new and useful process, machine or device, article of manufacture, composition of matter, or any new and useful improvement in any of these areas. Some bioscience examples would be drugs, transgenic animals, peptides, antibodies, proteins and their uses. Examples of physical science inventions would be new instruments, tools, new uses or methods for producing chemical compounds and electronic circuit designs. The majority of patentable inventions from UNM are filed as utility patents.
• Design
  Design patents may be granted to anyone who invents a new and original ornamental design for an article of manufacture. These patents would rarely be filed at UNM.
• Plant
  Plant patents may be granted to anyone who invents or discovers and asexually reproduces a distinct and new variety of plant. These patents would rarely be filed at UNM.

1. Who is an inventor and how is inventorship defined?
2. Are graduate or undergraduate students allowed to create patents without their advisor?
3. If there is collaborative research with a non-UNM researcher, who is to be designated as an inventor?
4. Who owns the invention?
5. Does the government own inventions developed with federal funds?
6. Under what conditions is IP returned to an inventor?

Who is an inventor and how is inventorship define?
Inventorship is a matter of law and is defined as anyone who devises, contrives, and produces something not previously known or existing, by the exercise of independent investigation and experimentation.

For a person to be considered an inventor, that person must have either created something new or contributed intellectually to a new invention. Intellectual contribution to the invention must have significant substance or have made a difference in the development of the invention itself. Suggesting use of a different material or cell line to would be examples of inventive contribution, even if the person making the contribution did not conduct the experiments proving its usefulness.

Normal assistance to create an invention such as, testing, lab work etc., is not an intellectual contribution. For this reason, it may prove useful to have written record of what experiments were conducted, who performed each aspect of the work, who made important inventive suggestions, and so forth.

Are graduate or undergraduate students allowed to create patents without their advisor?
Yes. The legal definition of "inventor" defines who the creator of the patent is. Ordinarily, a graduate student or even undergraduate student may have been funded by the University or used University facilities to develop an inventive concept. In these cases, the invention is the property of the University.

If there is collaborative research with a non-UNM researcher, who is to be designated as an inventor?
The purpose of a collaborative research agreement is to agree upon confidentiality and to outline the area of collaboration. Additionally, a collaborative research agreement states that intellectual property that was developed prior to the collaboration by the involved parties will remain their sole property and that any intellectual property developed as a result of the collaboration will be shared according to the terms of the agreement. The question of inventorship is the same for inventions developed solely within the institution as it is for inventions developed with outside investigators.

Who owns the invention?
Per the IP policy, Section 2.3.3, all rights in Technological Works and Technical Information, as such terms are defined below, created by University creators with the use of University facilities and funds administered by the University are owned by the University, with income from commercialization of Technological Works distributed to creators, UNM and STC.

Technological Works are defined as all inventions, discoveries, and other innovations that are protectable by patents, copyright, mask works or other means. Innovations include, for example, computer programs, integrated circuit design, databases, and other technical creations.

Also, all rights in Technological Works and Technical Information created by creators without the use of University facilities, with the exception of the University libraries, or funds administered by the University, but that fall within the creators' scope of employment at the University are also owned by the University. However, the University ordinarily will assert no ownership rights or interests in the following two instances:

• Technological Works and Technical Information created pursuant to outside employment under a consulting agreement between a faculty member and an outside entity. However, in this case it is expected that faculty members will try not to conceive an invention under a consulting agreement that is closely related to their UNM research.
• Technological Works and Technical Information created pursuant to independent research or other outside activity. In each case, the consulting agreement or outside activity must be consistent with University policies, including conflict of interest policies, and must be disclosed in writing and agreed to in advance by the faculty member's Chair and Dean or Unit Director.

Does the government own inventions developed with federal funds?
With the passage of the Bayh-Dole Act in 1980, the government enabled universities to retain ownership of inventions made with government funds. However, this right requires that the institutions make reports to the funding federal agency and pursue commercialization of these inventions. The federal government also requires that a U.S. patent be filed within two years of disclosure. And the government will continue to retain non-exclusive rights to use the invention for government purposes.

Under what conditions is IP returned to an inventor?
STC may release domestic and/or foreign rights to an invention that it elects not to pursue for commercialization. These rights are returned to UNM at which time UNM may elect to commercialize or ask the creators if they would like to pursue these rights. There are many possible reasons for releasing rights. There may not be sufficient commercialization potential to warrant the cost of patenting (which for US patents may be $5,000 - $10,000 just for initiating the patent filings, and for foreign patents significantly more), the patent claims that may be obtained are too narrow and the field too crowded, or other technology has superseded the inventive concept.

1. How do I document an inventive concept?
2. Is it important to consider the intellectual property provisions of an industry-sponsored research agreement?
3. What are some guidelines for managing the intellectual property aspect of research?

How do I document an inventive concept?
Documentation, including lab notebooks, may be needed to prove in court the date of conception and fully enabling the invention, both key issues for valid patents. Also, these records can help establish inventorship: who is an inventor and who is not, which is a different question than authorship. Furthermore, such records can be helpful in showing that a faculty or other researcher at the university properly used a company's research materials (a drug or protein perhaps) according to the materials transfer agreement.

Keep in mind the following:

• Entries should be legible, complete and correct. Including the purpose of the experiments is very helpful.
• Use permanently bound notebooks and update in ink regularly (with NO erasable marks) including the date and initials or signature for each page, and often for each picture or other such addition to the notebook.
• Do have these witnessed with signature and date. It is best to have as a witness someone who can understand the science or other content, but not a coworker, supervisor, or other collaborator in the research. They may be perceived to have a conflict, and an objective witness is more believable if the need arises.
• Mark out blank portions of pages with a diagonal line and use a fresh page for new experiments.
• Draw a single line through errors with an initial and date, don't erase or cross out completely.
• Record observations of results, even if the significance is unknown or not appreciated at that time.
• Note thoughts on future experiments that should be done while you have conceptualized them, rather than later when you actually get around to doing them. This can be very helpful in beating someone else who claims to have done it before you finished gathering your data.
• Other data sheets from lab equipment should be entered into the notebook permanently when possible or feasible with handwritten initials and date to further illustrate the date (with witness of course). Computer files, diskettes, and similar examples of the data may be useful, but do not have as much proof as the notebook entry because they may be believed to have been altered to show a particular date.

Is it important to consider the intellectual property provisions of an industry sponsored research agreement?
Yes. A typical agreement gives the research sponsor an option to license any inventions created under the research contract. However, the option should be given a time limit and STC should be able to seek other licensees if the sponsor does not make a offer.

What are some guidelines for managing the intellectual property aspect of research?
At the time a research agreement or grant application is in preparation, the prospect of creation of intellectual property should be contemplated and in some way considered in the agreement. All standard research agreements used at UNM have provisions for the creation and management of intellectual property. These aspects should be fully understood by both parties and any verbal understandings embodied in the agreement to avoid misunderstandings in the future.

1. What do I do if I believe I have a novel invention?
2. What if I am going to publish or present a paper in the next few weeks?
3. How does public disclosure affect the ability to protect IP and what can an inventor do to avoid killing his patent?
4. Where can I find a copy of the invention disclosure form?
5. How is the lead inventor identified and what are the lead inventor's responsibilities?
6. Under what circumstances do I need a UNM or STC Confidential Disclosure Agreement (CDA) or Nondisclosure Agreement (NDA)?

What do I do if I believe I have a novel invention?
The first step is to complete an invention disclosure form (IDF) and send it to the Research & Technology Law (RTL) office. That will start the process. Note that the IDF requires submission of detailed information, including a literature search, so it is prudent to plan ahead.

What if I am going to publish or present a paper in the next few weeks?
Call STC immediately. IF STC finds that the publication or presentation is enabling and the invention has commercialization potential, a provisional patent application can be filed in a short period of time. If a patent application is not filed, foreign rights will be lost and if a U.S. patent is not filed within one year, U.S. rights will also be lost.

How does public disclosure affect the ability to protect IP and what can an inventor do to avoid killing his patent?
United States patent law permits an inventor to obtain a patent if a patent application is filed within one year of the date of the first publication, abstract, conference presentation or any other public use that discloses the invention. If an invention is disclosed more than one year before a patent application is made, the disclosure will be considered prior art and the invention will not be patentable.

In most foreign countries, the one-year grace period does not apply. Most countries require "absolute novelty", meaning that they do not allow for any grace period between the first public disclosure of the invention, including the issuance of a patent in another country, and the filing of a patent application.

In countries that require absolute novelty, failure to file a patent application before any form of public disclosure often results in the loss of patent rights in that country. In the United States, failure to file a patent application within one year of the first public disclosure results in the loss of patent rights within the United States. Notably, failure to get certain foreign rights may in fact doom the entire invention in many potential licensees' eyes.

Where can I find a copy of the invention disclosure form?
The most current invention disclosure form (IDF) can be found from our Downloads page.

How is the lead inventor identified and what are the lead inventor's responsibilities?
The group of inventors should identify the lead inventor to act as the point of contact with respect to the disclosure and patenting. Typically, the inventor with the greatest knowledge of the idea is the best person to act as the lead inventor. The lead inventor will receive all information requests, U.S. and Foreign Patent Office documents for review with the other inventors, if any. It is the lead inventor's responsibility to have an integral role in preparation of the patent application responses to Office Actions, additional questions, etc.

Under what circumstances do I need a UNM or STC Confidential Disclosure Agreement (CDA) or Nondisclosure Agreement (NDA)?
Generally, if the inventor is entering into a collaborative agreement or discussing the possibility of research, the UNM Confidential Disclosure Agreement (CDA) should be used. If the intent is to have a technology patented and licensed, then a STC CDA should be used. CDAs can only be signed by an authorized UNM or STC official. Note that CDAs are also commonly referred to as confidentiality agreements. To obtain an UNM CDA, contact RTL. HSC inventors can obtain a copy from the HSC Legal Counsel.

1. What is a provisional patent application?
2. What happens once a utility patent application is submitted to the USPTO?
3. What are the costs associated with patenting?

What is a provisional patent application?
A provisional patent application is an abbreviated, temporary patent application that establishes a filing date and subject matter and utility of proposed invention, but does not start the process of evaluation by the U.S. Patent and Trademark Office. Filing a provisional patent application provides the inventor with up to one year to further develop and support the invention, evaluate the marketability and cost benefit of patenting, and make a decision whether or not to complete the patent application process.

To obtain a patent, the inventor must file a utility patent application within one year of the filing date of the provisional application.

What happens once a utility patent application is submitted to the USPTO?
If the application submitted to the USPTO is accepted as complete, it is assigned to an examining group for examination. The patent application is checked for compliance with all legal requirements associated with patenting. The examiner then performs a search for related US and foreign patents and other publicly available literature. The examiner reviews the information obtained by the search to confirm that the claimed invention is new, useful and non-obvious.

After the examiner's review, which can take anywhere from 6 months to 2 years, the Patent Office issues its first Office Action. This is the examiner's conclusion about the patentability of the invention. The examiner rarely concludes that an invention is patentable in the first Office Action. More often the patent application is rejected based on the novelty, utility or non-obvious criteria.

At this point, in a written response, the inventor and the patent attorney either offer more information that may help further distinguish the invention from the prior art, or may modify claims to avoid the examiners objections.

Upon review of the modifications, the examiner either accepts or rejects some or all of the modifications. Unless, the second office action is a full rejection, the inventor again has the right to make modifications to the application and ask the USPTO to reconsider its conclusion.

Ultimately, the examiner will accept or reject the patent application and its modifications. If the application is accepted, the USPTO will issue a Notice of Allowance. If rejected, the USPTO will issue a notice of Final Rejection.

What are the costs associated with patenting?
A prior art search costs approximately $700 including associated legal fees. To file and prosecute a U.S. patent application can cost between $6-15K including attorney and filing fees. These fees are paid by STC, if it decides to commercialize the invention. However, complicated bio tech inventions may be split into multiple "divisional applications", each costing up to $15,000 each.

1. What are the general steps for commercializing an invention?
2. What is a license?
3. What are typical license terms?
4. What is the inventor's role in licensing?
5. Can an inventor start a company with his own invention?

What are the general steps for commercializing an invention?
The process of commercialization depends of the type of invention. For non-life science related inventions, the process may generally be broken down into three general stages: Exploration, Development, and Implementation. The Exploration stage develops the conceptual model and addresses issues such as identifying customer needs and early stage manufacturing issues. The Development stage consists of building a functional model and prototype. Lastly, the Implementation stage evolves the prototype to low-level production through to full production startup. Each stage requires a project team with a wide range of skills but generally include technical development, market development and business development.

What is a license?
A license grants the right to use intellectual property owned by the University to another party. The license does not transfer ownership.

What are typical license terms?
A license agreement includes several elements:

1. Specific and clear definition of the technology rights being granted including the specific fields of use.
2. Fields of Use - There may be many potential applications for a given technology. If the licensee may take advantage of all these possible applications, then all fields of use are specified. However, typically a Licensee will only license for a specific use and therefore the specific field of use is defined in the license. This permits license of the invention to another party in other fields of use, if any.
3. Exclusivity of the license - An exclusive or non-exclusive right to the technology rights may be granted. In the case of exclusive rights, the technology for the applicable fields of use will not be licensed to any other entity. In the case of non-exclusive rights, STC is able to license to other parties as well. Typically, an exclusive license garners higher fees and royalties than a non-exclusive license. May also address worldwide, domestic or rights to commercialize in specific countries.
4. License Fee - An upfront fee paid by the licensee for the right to the technology. Sometimes the license fee will be paid in stock of the licensee, at the option of STC.
5. Milestone Payments - Where commercialization by the licensee will require an extended period of time, fees will be required at the completion of specific, agreed upon tasks, such as completion of Phase I, II, or III clinical trials, etc.
6. Royalties - typically a percentage of net revenues based on the sale of products or services using the technology rights.
7. Term - typically 10 years or the life of the patent, whichever is longer.
8. Due Diligence - the reporting requirements by the licensee to STC regarding commercialization activities. The milestones the licensee must meet, or minimum royalties assuming that the technology is being commercialized.
9. Provisions for sublicensing, termination, technology right grantback, etc.

What is the inventor's role in licensing?
The inventor is an important resource in the licensing negotiation. The licensee will rely on the integrity and skills of the inventors. While the inventors' views are welcomed, the Regents have imposed on STC the responsibility to obtain fair and reasonable compensation for UNM technology and so STC's decision will be final.

Can an inventor start a company with his own invention?
Yes, if that appears to be the best option for commercialization of the invention. To determine that, a business plan must be submitted to STC. Usually, association by the inventor with an experienced business person will enhance an inventor's chances of being granted a license.