Responsible Conduct of Research

Research AdministrationTechnology Management

July 9, 2015

Intellectual Property

Prior to 1980 The title (ownership) to any invention

created using federal funding was owned by the U.S. Government

No uniform policy among federal agencies for the transfer of the invention into private sector commercialization

Government controlled the patents◦ Wouldn’t grant exclusive licenses ◦ Separation of inventor from invention

Prior to 1980 con’t In 1978 Government owned over 28,000

patents but had licensed less than 4%

Little incentive to develop any technology

Inventions reported to the Government began to decline even though there was a boom in funding

The Bayh-Dole Act - 1980

• Created uniform federal intellectual property policy

• Nonprofits and small business could elect title to inventions that were created in whole or in part with federal funding

• However, universities would have to agree to a set of due-diligence requirements

The Bayh-Dole Act

• Provides ownership and title to any invention made in whole or in part with federal funds to universities.

• The government receives a royalty-free license to practice any invention for governmental purposes.

• Provides the first statutory authority for the government to obtain, own and license patents (before its passage, nearly 30,000 technologies were sitting on government shelves with no plan for development).

• Resulting university licensing income is invested in more research, rewarding university scientists and supporting the cycle of invention.

• Operation under the Act keeps the inventors actively engaged in the technology transfer process which is critical for companies to enable products for public use.

The Bayh-Dole Act

• Since passage of the Bayh-Dole Act, American universities have spun off more than 4,000 companies.

• 153 new FDA approved vaccines, drugs and/or new indications for existing drugs have been discovered through research carried out in public sector research institutions since implementation of the Bayh-Dole Act.

• In 2012 alone, 591 new products originating from university research were introduced to the marketplace by companies.

Royalty Income to US Academic Institutions

$0

$200

$400

$600

$800

$1,000

$1,200

$1,400

$1,600

1980 1985 1990 1995 2000

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Source: A. Stevens, les Nouvelles, 38, 133-140, September 2003; AUTM Annual Survey

Innovations Resulting from Research

• University research is critical, not only for advancing science, but also for helping the US maintain its competitive edge.

• Research performed at US universities produces important innovations, or intellectual property, that provide value to the university in many ways• It draws attention to the university and its faculty• It provides revenue to the university, in the form of

additional research dollars, licensing fees and/or royalties

• Much of the research performed at US universities is funded by US government agencies.

UT System Policy

• The Board of Regents automatically owns the intellectual property created by full and part-time faculty and staff and visiting faculty members and researchers, and anyone using the facilities or resources of the UT System or any UT System institution

• Before intellectual property owned by the Board of Regents is publicly disclosed, the creator shall submit a reasonably complete and detailed disclosure of such intellectual property to the creator’s institution for determination of the UT System’s interest

• All licensing income received by the institution is divided as follows (after reimbursement of the costs of licensing):

• 50% to creator(s)• 50% to UT System

What is Intellectual Property?

• Creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce

• Protection of intellectual property in the US is provided for in the US Constitution (Art. 1, Sec. 8, Clause 8), Laws (35 USC § 100 et seq.), Regulations (37 CFR Chapter I), and Guidance (US PTO Manual of Patent Examining Procedure)

• For physical property, the courts will enforce rights against “trespassers” – in the case of IP, the “trespass” is unauthorized use, generally for commercial gain

What is Intellectual Property?

Type of IP Description Term

Patent an exclusive right granted for an invention ~20 years from earliest filing

Trademark marks that identify the source of goods or services

As long as the mark is used in commerce

Copyright

rights that creators have over their literary and artistic works, including books, music, paintings, sculpture, films, computer programs, databases, advertisements, maps, technical drawings, etc.

(normally) life of the author + 70 years

Trade Secret commercially valuable, protected information

As long as it remains secret and valuable in fact

Know-how Knowledge of how to do something smoothly and efficiently; expertise N/A

Requirements for Patentability• Patentable subject matter• Utility• Novelty• Non-obviousness• Disclosure

Patentable Subject Matter• Process – process, act, or method; primarily includes

industrial or technical processes; includes a new use of a previously known process, machine, manufacture, composition of matter, or material

• Machine/apparatus

• Manufacture – articles that are made; includes all manufactured articles

• Composition of matter – chemical compositions; includes mixtures of ingredients as well as new chemical compounds

• Plants

• Designs

Patents: Novelty• A person shall be entitled to a patent unless

• the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention …

• EXCEPTIONS:• A disclosure made one (1) year or less before the

effective filing date of a claimed invention shall not be prior art to the claimed invention … if –• The disclosure was made by the inventor or joint

inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or

• The subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor

What is a public disclosure?

• Publications in journals, books, etc.

• Presentation to anyone not employed by UTA without a Confidentiality Agreement in place.

• Posting on a publicly available website.

• Sending information or materials to another university without obligations of confidentiality in place.

• Publicly displaying (e.g., a poster) detailed information about the technology

• A public disclosure that can affect patentability contains an “enabling” (detailed) disclosure of the unique elements of the invention

When might a public disclosure affect patentability?

• When it contains details about what makes the technology unique or how it’s put together

• When it contains a suggestion about what the technology could be used for

• When it contains enough information to enable someone skilled in the art to make and use the invention

Confidentiality• Maintaining confidentiality is important – if disclosures are

made to parties outside of the University without a Confidentiality Agreement in place, it can be considered a public disclosure

• Public disclosure of an invention prior to filing a patent application absolutely destroys the ability to obtain a patent outside of the US and can destroy the ability to obtain a patent in the US

• Avoid premature disclosure of potentially patentable intellectual property• e.g., “These data suggest that …..”• Submit intellectual property disclosure to OTM before

public communication of new technology (a good time to submit to OTM is at the same time a manuscript is submitted to a journal or an abstract is submitted to a conference)

Lab Notebooks• Why keep detailed information regarding your research?

• You’ll have a complete record of why experiments were performed and how

• Your data is recorded in a central and physical place for future reference

• It provides information to a person who is interested in continuing your research project

• The data, ideas, processes, etc. can be vitally important for supporting patent claims, particularly if you have to enforce a patent or prove that you invented it first

• How to keep a notebook• Never remove a page• Draw a thin line through mistakes; don’t use correction

fluid• Record the full date whenever you make an entry• Write in pen

Disclosing your invention

• Disclose your invention to the OTM before you present or publish

• IP Disclosure form (IPD) is on OTM website (web version coming soon)

Email to: otm@uta.edu

• Disclose “ideas,” whether or not you think they are patentable; it may still be marketable

• Disclosing to OTM does not protect patentability of the technology – only filing a patent application will protect patentability

• Keep OTM informed of upcoming publication or presentation dates

OTM ProcessInvention

(or manuscript preparation)

Intellectual Property

Disclosure

IP Committee (VPR, AVPR, OTM, UTARI, TechFW, & ad hoc: TMAC & other advisors

Patent application

filed

Preliminary Review

Comprehensive Review

Patent(s)

Issue(s)

Research & Development Publish

Patent Prosecution

Active & Passive Marketing Activities;Development Activities (Incubation,

Acceleration)

Inventor

IP Review

& assessm

ent

IP Protecti

on Process

Licensing &

Business Developm

ent

IP Committee• Who

• VP Research• AVP Research• OTM• UTARI• TechFW• Ad hoc attendees: TMAC, other advisors

• Decisions• Makes disposition decisions with respect to:

• New disclosures• Conversion of Provisional applications• Payment of Issue/Maintenance fees• Continuing prosecution

• Discusses License Agreement terms

Receipt & Review of IP Disclosure IP Protection Process (Patent Prosecution) Assess Technology Readiness Level (TRL) &

Manufacturing Readiness Level (MRL) Market Analysis (Application & Opportunity) Licensing – negotiation & management Teaching/Coaching/Mentoring

Entrepreneurs/Inventors Business Development Pursue Funding Opportunities

Functions for the Protection & Commercialization of Technology

Type of FilingEstimated Attorney

Fees

Patent Office Fees

US Provisional applicationIn-house filing $0 $130

Law firm filing $4K-$8K $130

US Non-provisional application

In-house provisional $6K-$8K $800

Law firm provisional $1.5K-$4K $800

PCT ApplicationIn-house provisional $6K-$8K*

Law firm provisional $1.5K-$4K*

US Patent Prosecution

Respond to Restriction Requirement $1K-$2K

Within 3 months* $0

1 mo. Ext. $100Respond to Office Action $2K-$3.5K 2 mo. Ext. $300

File Request for Continuing Examination

$600-$8503 mo. Ext. $700

4 mo. Ext.* $1100

Pay issue fee$150-$500 5 mo.

Ext.* $1500

Nationalization $2.5K-$20K* $25K-$200K*

IP Protection Process & Cost

58 Invention Disclosures Received FY15 (so far)

52 Invention Disclosures Received FY14 ~55 Provisional, Non-Provisional or PCT

applications filed in FY15 (so far) ~19 US Patents issued or allowed FY15 (so

far) (21 US Patents issued FY14) ~200+ technologies available for licensing

UTA’s Patent Portfolio

Contact Information

• Jeremy Forsberg, Assistant Vice President for Research• Center for Innovation (202 E. Border St.), Suite 211• j.forsberg@uta.edu• x2-3657

• Teri Schultz, Director of Technology Management• Center for Innovation, Suite 116• tschultz@uta.edu• x2-1140