LSU School of Medicine-New Orleans (LSUSOM-NO) is the provider of Continuing Medical Education for this activity. The planning and presentation of all LSUSOM-NO activities ensure balance, independence, objectivity and scientific rigor. The LSU School of Medicine-New Orleans designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credit(s) ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure I do not have any relationship(s) with commercial interests. A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

TECHNOLOGY MANAGEMENT Processes and IP Primer -Patrick E. Reed, MS, RTTP Director, Office of Technology Management

BAYH-DOLE ACT Patent and Trademark Law Amendment Act, adopted in 1980 (codified in 35 USC § )

Federal patent policies inconsistent and ineffective No uniform policy among agencies No statutory authority that gave agencies a right to hold patents or license technology Colleges and universities rarely given exclusive control except through lengthy greater rights determinations Result: inventions not commercialized WHY BAYH- DOLE?

Gives nonprofit organizations and small business firms rights to inventions under government grants, contracts, and cooperative agreements Promotes commercialization and public availability Encourages researchers to disclose inventions WHAT DOES BAYH-DOLE DO?

Grant the government a nonexclusive license for government purposes Report on the utilization of the subject invention Make reasonable efforts to license to small business Agree that exclusive licensee will manufacture invention substantially within the U.S. Institution has responsibility to make timely filings of patent applications INSTITUTIONAL OBLIGATIONS UNDER BAYH- DOLE

INTELLECTUAL PROPERTY The tools of Tech Transfer

Patents protect machines, articles of manufacture, compositions of matter, processes or methods Trademarks and Service Marks protect identity Copyrights protect expression Trade Secrets protect secret information TYPES OF INTELLECTUAL PROPERTY

The legal right to exclude others from making, using, selling, offering to sell, or importing, or offering to import, a patented item A patent does not grant an affirmative right. Patent rights are exclusionary. WHAT IS A PATENT

Utility (aka usefulness)- 35 USC § 101 Novelty- 35 USC § 102 Non-obviousness- 35 USC § 103 Statutory CONDITIONS OF PATENTABILITY

A patent is a “contract” between the inventor and the Government (Patent Office). Consideration for the contract: Inventor agrees to disclose fully the invention to the public- “fully” is the operative word, meaning nothing can be held back. PATENT THEORY

Pursuant to Part II, Chapter VII of the Bylaws and Regulations of LSU, an LSU Invention is defined as: “an invention or discovery that is either conceived or first reduced to practice, in whole or in part, during activities that are: (1) carried on by, or under the direction of, LSU personnel, regardless of when or where conception or reduction to practice occurs; or (2) supported by funds under the control of LSU; or (3) conceived, created, designed, developed, or conducted with the use of LSU facilities, equipment, or supplies.” WHO OWNS PATENTABLE SUBJECT MATTER I CREATE AT LSUHSC?

Defined as, “all LSU Supervisors, Officers, Faculty, Staff, Research Associates, Postdoctoral Fellows, Instructors, Graduate Students, and other employees of LSU, whether part- time or full-time.” Includes: Visiting faculty Adjunct faculty Emeritus faculty LSU undergraduate and professional students employed by LSU when those persons act within the course and scope of their employment with LSU “LSU PERSONNEL”

An invention or discovery that is wholly conceived and wholly first reduced to practice during activities that satisfy each of the following four conditions: The activities occur during the personal, off-duty time of all involved LSU personnel; and The activities are not supported by funds under the control of LSU; and The activities are not performed with the use of LSU facilities, equipment, or supplies; and The activities are unrelated to any current or past field or area of expertise, responsibility, or employment of any involved LSU personnel. WHAT’S NOT AN LSU INVENTION?

SO….UNLESS YOU’RE A BIOCHEMIST AND INVENT A MORE EFFICIENT ICE CUBE MAKER ON A SATURDAY IN YOUR GARAGE, IT’S LIKELY AN LSU INVENTION

COPYRIGHT Protects the expression of an idea, not the idea itself Protects against copying, not against independent development of an identical work Copyright protection occurs automatically once the original work is fixed in a tangible medium Registration of the copyright is NOT required for protection (but it may be required to sue for infringement).

© 2014 Board of Supervisors of Louisiana State University and Agricultural and Mechanical College through its LSU Health Sciences Center New Orleans ALL RIGHTS RESERVED COPYRIGHT NOTICE

Pursuant to Part II, Chapter VII of the Bylaws and Regulations of LSU: “LSU releases to the respective author(s) of all LSU’s interest in any copyright to a book, article, lecture, thesis, dissertation…, Course Material, or musical composition that would otherwise be an LSU Work.” “Course Material” is defined as “educational materials or course content used in the bona fide teaching or instruction of a regularly scheduled course for credit offered by LSU…” WHO OWNS COPYRIGHTABLE MATERIAL I CREATE AT LSUHSC?

Word, name, symbol, or device that identifies the source of goods or services Protects against likelihood of confusion Rights are based on use or registration TRADEMARKS

Before using a word, name, or slogan, ask for a trademark search Identify the risk associated with using the word, name, or slogan Before adopting a new mark for a product or service, get protection Make sure you are not infringing another entity’s mark Protect your mark before publicizing it by filing an intent-to-use federal trademark application TRADEMARK TIPS

TRADEMARKS MUST BE DEFENDED

Part II, Chapter VII of the Bylaws have been revised – PM-16 and PM-64 have been rescinded and incorporated into the Bylaws Patentable subject matter: – Recent Supreme Court cases have put some life sciences inventions’ patentability in question. Biomarkers Genes – Stay tuned… UPDATES

TECHNOLOGY TRANSFER From the bench to the bedside

HOW IS TECHNOLOGY TRANSFERRED? Research Publications, reports, theses, and dissertations Students Continuing education and professional development Consulting, service on government panels Licensing Student employment

Ensure public benefit from LSU Health Sciences Center research Provide inventor satisfaction and motivation Meet LSU Health Sciences Center’s obligations to sponsors and compliance with Intellectual Property Policy Researchers are required, as a condition of employment, to disclose inventions Generate revenue to support research and research infrastructure TECHNOLOGY TRANSFER: WHY DO WE DO IT?

The sooner the better! As soon as you recognize that you have a new discovery or invention that might be useful to others and could be turned into a commercial product or service, you should contact the Office of Technology Management, especially if you intend to publicly disclose the invention. WHEN SHOULD I CONTACT OTM?

Written publications: manuscript, book chapter, journal article, proceedings, thesis, white paper Oral presentations Prototypes and samples Meetings and other communications such as or postings on websites PUBLIC DISCLOSURE

CREATE ACT The Act amended the patent statutes so that an invention may not be precluded from patent protection when there is not common ownership as long as certain provisions are met. Patents granted on or after 12/10/04. Inventions that result from activities undertaken within the field of a “written joint research agreement.” The Act expands the concept of “the same person” to include certain collaborators under a written joint research agreement.

BENEFITS OF THE CREATE ACT Can allow for a patent that would otherwise be precluded due to prior art. Encourages the exchange of information between the JRA parties. Can provide significant patent benefits to collaborators through incremental improvements.

WHAT ARE THE RISKS OF INVOKING THE ACT? The Act can be relied upon unilaterally. One party may never know that the Act and the JRA are being used as a defense to support the issuance of the other party’s patent. One party may be blocked by the other JRA party from practicing its own patent. Effect on future research?

SUGGESTED CLAUSE FOR JRAS “No party shall invoke 35 U.S.C. §102(c) without the consent of the other party. In the event that a party invokes 35 U.S.C. §102(c) without such prior written consent, any patent issued arising out of such invention will be jointly owned by the parties.”

The more detailed the better! Title Inventor details Description of the technology Sponsorship mic/otm/Disclose.aspx NOTE: A Technology Disclosure Form does not protect the invention; it is simply a record of your invention. DISCLOSURE FORM- INVENTION

Likely not patentable, but still valuable! Animal Models Cell Lines Antibodies Plasmids demic/otm/research_material.aspx DISCLOSURE FORM- RESEARCH MATERIAL

WHAT IS THE TECHNOLOGY REVIEW PROCESS? Review for possible public disclosure Review research sponsorship Perform reference search Perform technology market assessment Determine best route to commercialization Discuss with inventors

Grant of rights to a company allowing them to make, use, and sell the licensed technology – Exclusive vs. nonexclusive – Startup vs. BigCo – Diligence provisions: Performance milestones and financial requirements to insure licensee does not shelve the technology – LSU reserves the right to use the invention for education and research with other non-profits LICENSING

Most licenses will include: Upfront license fee Industry standard royalty rates Minimum annual royalty Sublicense fees Milestone payments A percentage of equity Reimbursement of patent expenses WHAT ARE THE FINANCIAL TERMS?

40%- Inventors/Developers 15%- Inventors’/Developers’ Department 35%- Chancellor’s Office 5%- Office of the President 5%- LIFT 2 Fund (Proof of Concept fund) ROYALTY DISTRIBUTION

Proof-of-Concept Fund available to any LSU investigator Biannual awards up to $50,000 First round of funding awarded over $500,000 to 15 LSU investigator teams (3 to LSUHSC-NO) No overhead No salaries Must have a Technology Disclosure Form on record with OTM LIFT 2 GRANT

Inventor’s Guide (“How to” manual and FAQ) Explanation of the Patenting Process Tips for searching for prior art Forms and Template agreements Links to relevant policies ADDITIONAL RESOURCES

CONTACT US Office of Technology Management 433 Bolivar St., Suite