Patenting

Are all inventions patentable?

Patentable inventions are defined in the Patent Act, United States Code Title 35. To be patentable, an invention must be useful, novel, and non-obvious. This means an invention must not have been previously described in a publication; it must have some real-world use; it cannot be something found in nature or be a naturally occurring process; and in the judgment of a person of ordinary skill in the art, the invention must not be obvious when looked at in comparison to prior literature in that field.

The conditions for patentability constitute a very large body of law, and UT Southwestern retains professional and experienced patent attorneys to apply for patents on our inventions. The Office advances all legal fees and costs – the UT Southwestern inventor does not have to provide any such funding.

Note that inventions comprised of known elements, whose combination is non-obvious, may be patentable, as are new uses for known compositions or devices.

How does UT Southwestern decide to patent inventions?

Filing a patent application is an expensive process. Thus, before UT Southwestern files any patent application on behalf of the Board, it considers the following with respect to the invention:

• Needs of a patient population
• Commercial utility
• Obligations to the sponsors of the research
• Competitive superiority
• Necessity for extensive development work
• Licensee interest

How is inventorship determined?

Inventorship is determined in accordance with U.S. patent law. Inventorship is limited to those individuals who have made an intellectual contribution to the conception of the invention which is embodied by one or more claims described in the patent application. The Office for Technology Development does not determine who should be named as an inventor. This is the responsibility of outside counsel assigned to the file. Inventorship may be amended during the course of patent prosecution. No individual at UT Southwestern can decide inventorship, although it is important to identify any individuals connected with the project.

Sometimes, patent prosecution may require dividing the claims into separate applications, which may require amendment of the inventors on each case. In rare circumstances, an inventor may be named in the case in error or an inventor may have been omitted. Provided there was no intent to deceive the USPTO, these errors can be fixed. In fact, it is important to fix any such errors. If inventors are intentionally named incorrectly, any resulting patent may be invalidated.

Can software be patented?

Yes, software can be patented, but in many cases, copyrighting the software provides adequate protection much more efficiently. Under Board policy, software created by faculty, staff, and students for educational or training purposes is not owned by the Board of Regents.

Where the creator or author may own the copyright, educational uses are still reserved to UT Southwestern. For this reason, the OTD encourages the disclosure of the software to the Office by submitting an Intellectual Property Questionnaire (IPQ). Any media intended to be protected should carry a notation on the title or cover page (e.g. "Copyright, UT Southwestern Medical Center, [year]").

How can I preserve UT Southwestern's ability to claim patent rights?

To preserve U.S. patent rights, a patent application must be filed within one year of an enabling public disclosure of the invention. To preserve foreign patent rights, a patent application must be filed before enabling public disclosure of the invention. To preserve foreign patent rights, a patent application must be filed before any enabling public disclosure of the invention. An inventor should complete an Intellectual Property Questionnaire (IPQ) describing an invention to facilitate the filing of a patent application before disclosing it to the public.

An enabling public disclosure may occur when a poster, abstract, or manuscript appears in public. Posting anything on the internet and speaking to an audience that may include individuals not employed by UT Southwestern can also be an enabling public disclosure.

Are all inventions patentable?

Patentable inventions are defined in the Patent Act, United States Code Title 35. To be patentable, an invention must be useful, novel, and non-obvious. This means an invention must not have been previously described in a publication; it must have some real-world use; it cannot be something found in nature or be a naturally occurring process; and in the judgment of a person of ordinary skill in the art, the invention must not be obvious when looked at in comparison to prior literature in that field.

The conditions for patentability constitute a very large body of law, and UT Southwestern retains professional and experienced patent attorneys to apply for patents on our inventions. The Office advances all legal fees and costs – the UT Southwestern inventor does not have to provide any such funding.

Note that inventions comprised of known elements, whose combination is non-obvious, may be patentable, as are new uses for known compositions or devices.

How does UT Southwestern decide to patent inventions?

Filing a patent application is an expensive process. Thus, before UT Southwestern files any patent application on behalf of the Board, it considers the following with respect to the invention:

• Needs of a patient population
• Commercial utility
• Obligations to the sponsors of the research
• Competitive superiority
• Necessity for extensive development work
• Licensee interest

How is inventorship determined?

Inventorship is determined in accordance with U.S. patent law. Inventorship is limited to those individuals who have made an intellectual contribution to the conception of the invention which is embodied by one or more claims described in the patent application. The Office for Technology Development does not determine who should be named as an inventor. This is the responsibility of outside counsel assigned to the file. Inventorship may be amended during the course of patent prosecution. No individual at UT Southwestern can decide inventorship, although it is important to identify any individuals connected with the project.

Sometimes, patent prosecution may require dividing the claims into separate applications, which may require amendment of the inventors on each case. In rare circumstances, an inventor may be named in the case in error or an inventor may have been omitted. Provided there was no intent to deceive the USPTO, these errors can be fixed. In fact, it is important to fix any such errors. If inventors are intentionally named incorrectly, any resulting patent may be invalidated.

Can software be patented?

Yes, software can be patented, but in many cases, copyrighting the software provides adequate protection much more efficiently. Under Board policy, software created by faculty, staff, and students for educational or training purposes is not owned by the Board of Regents.

Where the creator or author may own the copyright, educational uses are still reserved to UT Southwestern. For this reason, the OTD encourages the disclosure of the software to the Office by submitting an Intellectual Property Questionnaire (IPQ). Any media intended to be protected should carry a notation on the title or cover page (e.g. "Copyright, UT Southwestern Medical Center, [year]").

How can I preserve UT Southwestern's ability to claim patent rights?

To preserve U.S. patent rights, a patent application must be filed within one year of an enabling public disclosure of the invention. To preserve foreign patent rights, a patent application must be filed before enabling public disclosure of the invention. To preserve foreign patent rights, a patent application must be filed before any enabling public disclosure of the invention. An inventor should complete an Intellectual Property Questionnaire (IPQ) describing an invention to facilitate the filing of a patent application before disclosing it to the public.

An enabling public disclosure may occur when a poster, abstract, or manuscript appears in public. Posting anything on the internet and speaking to an audience that may include individuals not employed by UT Southwestern can also be an enabling public disclosure.

Commercializing

Must inventions be patented to be commercialized?

No, inventions may be commercialized without patent protection. Common examples of such inventions include biomaterials such as cell lines, antibodies, animal strains, and software.

How does UT Southwestern commercialize technology?

UT Southwestern may commercialize patented, patent-pending, and unpatented technology. Representatives of the Office for Technology Development work together to identify parties most likely interested in the invention. Often, inventors are best able to identify potentially interested parties.

Commercial parties potentially interested in the invention are contacted and provided a non-confidential description of the invention. If these parties request additional, confidential information, a Confidential Disclosure and Limited Use Agreement (CDA) can be provided to the company to enable the transfer of such information.

Representatives from the Office for Technology Development are the only representatives authorized by law to negotiate license and option agreements on behalf of the University. The OTD is responsible for enforcing and administering all licenses and options, and distributing monies, paid by third parties, to inventors.

How will I be compensated when my invention is commercialized?

If an invention is commercialized, any cash license revenues are first used to reimburse UT Southwestern’s expenses, including patent costs. The amount remaining is subject to the following sharing formula: 50 percent to the inventors as personal income, 25 percent to the labs of the inventors, and 25 percent to the Office of the President of UT Southwestern.

If an inventor leaves UT Southwestern, their continuing share of lab disbursements is distributed to the President, but their personal income disbursements are unaffected.

What should I do if a company wants me to share unpublished information related to my invention?

If you are willing to share unpublished information with a company, contact a Licensing Associate in the Office for Technology Development, who will work with a representative of the company to draft a Confidential Disclosure and Limited Use Agreement (CDA). Once the agreement is executed you will be free to share the information with the company. However, you are under no obligation to share all available information with the company. The investigator must be able to judge what information may be shared and what information might be best not to share at this stage. If a license is entered into, then you will be expected to share all information with the company that is needed to practice the invention.

How can I send research reagents to my colleague at another university?

Research reagents sent outside UT Southwestern should only be shared after completion of an appropriate Material Transfer Agreement (MTA). The Office for Technology Development’s Cooperative Research group is responsible for negotiating such agreements. In some cases, it may be appropriate to seek reimbursement of the cost associated with production and delivery of such materials.

Material Transfer Agreements only provide for non-commercial research use of materials, so when companies request access to materials, a license agreement is the more appropriate instrument to enable the transfer of materials to commercial entities.

Startups

If my invention is licensed to a startup company formed through the Office for Technology Development at UT Southwestern, how can I expect to be compensated?

After paying legal expenses, 50 percent of license revenues that the Office receives are distributed to the co-inventors and 25 percent are distributed to the co-inventors' laboratory sub ledger. If the OTD receives shares of stock as part of the license, the shares are held by the University of Texas Investment Management Company (UTIMCO) until such time that they can be sold on a public exchange. UT Southwestern then sells the shares, and the resulting proceeds are distributed under the same 50/25/25 percent formula.

It may be the case that the co-inventors directly negotiate with the investors and management of the startup company to receive shares of stock. This is a separate negotiation and transaction from the license. Any shares obtained this way are:

• The sole property of the co-inventors.
• Held by the co-inventors themselves.
• Able to be sold whenever the company allows their sale.
• Not subject to any monetary split with UT Southwestern.

The existence of any equity shares obtained in such a transfer from the startup company does not alter the sharing formula of proceeds that UT Southwestern may realize from the sale of UT Southwestern's shares in the manner described above.

Note that UT Southwestern may enter into agreements with startup companies to receive shares of stock that are not connected to an individual license or not connected to sales of a product covered by a given license. In such circumstances, proceeds from share sales are not distributed, since they are not license revenues.

If my invention is licensed to a UT Southwestern startup company, can I perform sponsored research for the company?

Yes, you may perform sponsored research under a UT Southwestern approved sponsored research agreement. A conflict of interest management plan must also be established to be certain that the research follows University and System guidelines.

If my invention is licensed to a UT Southwestern startup company, what role will I play in the company?

The Office for Technology Development recognizes that your involvement may be integral to the success of the startup. However, such activities may not interfere with your basic research and primary employment obligation to UT Southwestern. You may enter into a consulting agreement with the company or participate on their Scientific Advisory Board, provided this is approved by UT Southwestern. Compensation for such activity is agreed upon between you and the company – the OTD does not determine or negotiate it.

However, in instances where a company is founded (in whole or in part) based on your intellectual property, UT Southwestern policy does not allow you to hold a Board of Directors position or act as an officer in the company.

How are conflicts of interest managed by UT Southwestern?

Conflicts of interest are managed by the Conflict of Interest Office and the Conflict of Interest Committee. In some cases, a conflict of interest management plan must be finalized concurrently with completion of a license agreement. More information may be obtained at the Conflict of Interest Office website.

If my invention is licensed to a UT Southwestern startup company, will I have to leave my position at UT Southwestern?

No, you only need to leave your employment at UT Southwestern if you decide to become an employee of the startup company. UT Southwestern policy does not permit you to be an employee or director of the startup. However, you are allowed to serve as a member of a scientific or medical advisory board, or as a compensated consultant to the startup. With department chair approval, faculty may spend up to a total of 20 percent of their time on all of their outside activities, consistent with UT Southwestern policies. The Office for Technology Development maintains a neutral position in instances where a faculty member might choose to change careers by joining a startup company. This decision is yours and not determined by the OTD.