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.

OFFICE OF TECHNOLOGY MANAGEMENT Refresher and Policies & Procedures Update -Patrick E. Reed, MS, RTTP Director, Office of Technology Management

NEW STUFF! LIFT 2, Material Transfer Process, and Faculty Startups

Proof-of-Concept Fund available to any LSU Employee Biannual awards up to $50,000 No overhead Must have a Technology Disclosure Form on record with OTM Technology cannot be encumbered LSUHSC-NO investigators have received seven awards over two rounds representing 25% of the total awards made to date. LIFT 2 GRANT

Focus on the product and the market, not the exciting research and experiments Avoid use of overly technical jargon Do not include salary support if at all possible Propose projects where the main endpoints are achievable with the funds requested and within the time allotted (12 months) If a technology does not fit into a lucrative market, if it meets an unmet societal need, it will be looked upon favorably. LIFT 2 GRANT PROPOSAL TIPS

August 17- inform OTM of your decision to apply so that we may assist with the “Commercial Opportunity” section of the application September 1- route application packet through ORS September 8- OTM will provide the Letter of Support September 15- deadline for online submission LIFT 2 DEADLINES

The administrative process for transferring materials is not fun MATERIAL TRANSFER PROCESS

Responsibility for this process has moved from ORS to OTM. Instructions and forms may be found under “Material Transfer Process” under the “For Inventors” tab on OTM’s website. The investigator need only complete the relevant material transfer initiation form; OTM will take care of the rest! – Contacting the company – Negotiation – Execution MATERIAL TRANSFER REQUESTS

Why is OTM taking over this process? – MTAs are similar to license agreements – Grows our company contact list and helps build relationships – Allows us to identify frequently requested material that may be better served being licensed to a research material provider OK, CAPTAIN OBVIOUS…

When sending any research material (plasmid, cell line, antibody, animal model, etc.). When receiving a research material from any outside organization (whether or not that party requires an MTA). – Ensure appropriate research controls and approvals are in place (IRB, IACUC, IBC) Ideally, contact us at least a week prior to when you want to take receipt of material or make the transfer. – Allow us to negotiate any necessary agreements. WHEN TO CONTACT OTM ABOUT A MATERIAL TRANSFER?

Uniform Biological Material Transfer Agreement (UBMTA) – No negotiation agreement – Limited to signatories of the model Simple Letter Agreement/Notification Letter – Simply disclaim any warranties and limit our institutional liability MTA for proprietary material or material with 3 rd party restrictions – May require extensive negotiation No agreement possible – Deal term agreement is not possible or 3 rd party restrictions prohibit transfer MTA VARIETY

Startup Manual to be published soon – Covers COI issues – Lists available resources – An all-inclusive guide on the how’s and why’s of startup formation CM-35 Addendum to publish soon…. – Will allow faculty startups to sponsor pre-clinical research back to their lab LSUHSC EMPLOYEE STARTUP COMPANIES

There is no potential conflicts of interest, there are real conflicts of interest. IMPORTANT! Disclosure and Transparency Limit student involvement Pre-clinical work only! LSUHSC EMPLOYEE STARTUP COMPANIES

If this activity is so rife with conflict, why allow it? GOOD QUESTION! Early stage technologies are inherently difficult to license Allows LSUHSC to capture more research dollars The faculty entrepreneur is likely the best one to conduct the research LSUHSC EMPLOYEE STARTUP COMPANIES

Part II, Chapter VII of the Bylaws have been revised – PM-16 and PM-64 have been rescinded and incorporated into the Bylaws – No substantive changes Patentable subject matter: – Recent Supreme Court cases have put some life sciences inventions’ patentability in question. – Invited Speaker will provide additional information in Fall OTHER UPDATES

Fiscal Year Invention Disclosures Licenses/Options Executed Startup Companies Formed New Patents Filed US Patents Issued Patent Expenses$296,993$332,451$227,933$180,236$224,204$211,215 Patent Expenses Reimbursement $46,080 $80,778$39,281$109,566$108,281 Reimbursement Rate15%14%35%22%49%51% Licensing Revenue$114,097$159,651$96,124$81,618$97,755$69,527

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 invention Give preference to small business manufacture invention substantially within the U.S. Institution required 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, and improvements thereof 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

Statutory- 35 USC § 101 Utility (aka usefulness)- 35 USC § 101 and 112 Novelty- 35 USC § 102 Non-obviousness- 35 USC § 103 CONDITIONS OF PATENTABILITY User-Operated Amusement Apparatus for Kicking the User’s Buttocks. Patent No. 6,293,874. (2001)

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 MY INVENTION?

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 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?

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 (JRA).” The Act expands the concept of “the same person” to include certain collaborators under a written joint research agreement.

BENEFITS OF CREATE 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. Could diminish the worth of our translational research

SUGGESTED CLAUSE FOR JRAS “Neither party may invoke the Act with respect to any invention that is developed pursuant to this Agreement without the prior written consent of the other party, such consent to include specific reference to the invention for which the benefits of the Act are claimed.”

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).

© 2015 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?

TECHNOLOGY TRANSFER From the bench to the bedside

HOW IS TECHNOLOGY TRANSFERRED? Research publications, reports, dissertations, etc. Graduating students Continuing education and professional development Consulting, service on external panels Licensing Startup companies Existing industry

Ensure public benefit Provide inventor satisfaction/motivation Meet our obligations to sponsors and compliance with IP Policy Invention disclosure is an employment requirement 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 as a commercial product or service, you should contact OTM, especially if you intend to publicly disclose the invention. WHEN SHOULD I TELL YOU ABOUT MY INVENTION?

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

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

Likely not patentable, but still valuable! Animal Models Cell Lines Antibodies Plasmids Forms may be found under the “For Inventors” tab on OTM’s site. DISCLOSURE FORM- RESEARCH MATERIAL

WHAT IS THE TECHNOLOGY REVIEW PROCESS? Review for public disclosure Review obligations to 3 rd parties Prior art search Market assessment Determine best route to commercialization Discuss with inventors

Grant of rights to a company allowing it to make, use, and sell the licensed technology – Exclusive vs. nonexclusive – Startup vs. BigCo – Diligence provisions – 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

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