# Presentation: 496838

## Technology Transfer Branch

- Kevin Brand
- NCI Technology Transfer Branch

## Introduction

- The Services of NCI Tech Transfer Branch:

- Consulting and assistance on issues of inventions, of patents, and tech-transfer policies and procedures
- Negotiation of agreements with the               private sector for collaborations and      cooperative research
- Trademark registrations, copyright            questions, and consulting

## Concepts to Keep in Mind

- Inventor(s)
- The person who has a definite and fixed idea of the complete and operative invention (joint inventorship is not the same as co-authorship)
- Assignment
- Transfer of ownership
- License
- Permission to make, use, sell, and/or import invention (waiver of suit)

## Employee Invention Report (EIR)

- Are used to memorialize inventions made by PHS employees
- Should be signed by all inventors and witnessed
- When there are outside co-inventors, they need not fill out an EIR, but they might need to complete similar paperwork with their respective institution
- EIRs are also used to document inventions which were made years ago, in order to track that invention for licensing to outside parties

## When are EIRs submitted?

- Ideally, as soon as you believe you have an invention!!
- The invention review process takes 3 months to complete.
- An oral or written disclosure of the novel discovery to a party outside of PHS can have negative impact on the patentability of the discovery, and, in turn, the marketability of the technology.
- As an example, a good time to perhaps submit an EIR would be once you have completed an abstract describing the discovery, which you plan to submit for publication.

## Inventions: Action Timeline

- Inventor completes
- EIR, attaches info,
-  submits it to:

-  Technology
- Transfer Branch

- Patentability Report
- NIH Office of Technology Transfer

- Patent application filed in the US Patent Office (OTT)

- Patent is issued

- Technology is licensed
- and royalties flow back

## Why patent government inventions?

- One viewpoint:
*	**If they arose from taxpayer-funded research, shouldn’t they be dedicated to the public?*
**But...**
- They provide an incentive for commercial development
- They are a stimulus for economic growth
- They are an incentive to PHS inventors (royalties up to $150K per year to each inventor)

## Negotiating Agreements With The Private Sector

- Agreements Available:
- Confidential Disclosure Agreement (CDA)
- Material Transfer Agreement (MTA)
- Clinical Trial Agreement (CTA)
- Cooperative Research And Development Agreement (CRADA)
- Materials-CRADA

## Confidential Disclosure Agreement

- When:  scientist wants to discuss a pending publication, invention, or confidential information with someone *outside* scientist’s Institution

**Catch**: If **YOU** sign a CDA, the Institution is not bound -- and you may breach agreement by telling other people in your own Institution, *even to colleagues in your own lab!*

## Transfers of Research Materials

- MTA:  Transfer of research materials (no funds) for *basic research* purposes only
- If the Agreement is for the exchange of “research tools” with non-profit or academic entities, the NIH strongly encourages use of the “Simple Letter Agreement” (**SLA**)
- Commercial use and clinical use prohibited
- CTA:  Transfer of research materials for ***clinical trials***
- Essentially a modified MTA, except it includes terms on who has rights to own and to use data
- The MTA and CTA are both flexible agreements

## Cooperative Research And Development Agreement (“CRADA”)

- A CRADA is appropriate:
- To formalize ongoing collaborative work
- To provide a collaborator with present rights to some of your future inventions
- To permit a collaborator to provide PHS with funds to do collaborative research
- To facilitate the exchange of significant material and/or FTE-ceiling-exempt personnel in support of collaborative research
- The cornerstone of any NIH CRADA is *actual collaboration*

## CRADAs - Process

-  PI approaches TTB with a specific Collaborator, or TTB advertises for Collaborator
-  PI completes Conflict of Interest form
- PI and Company scientists develop research plan, while TTB negotiates legal and funding terms with Company lawyers
- Review of CRADA by PHS’s “CRADA Subcommittee”
- Execution of CRADA by parties
- Estimated time:  4-8 months

## Materials-CRADA

- When:  Company transfers its proprietary or sole-source material in exchange for IP rights
- No personnel or other material will be exchanged
- Company does not “collaborate” in the research
- One-year term; company can fund up to $20,000
- If Company agrees to use unmodified form, PHS approval is highly streamlined
- If Company wants minor modifications, PHS approval is partially streamlined
- Estimated time:  4-8 weeks

## Who else does TTB work with?

- TTB also works with...
- Office of Technology and Industrial Relations (OTIR)
- Office of General Counsel
- NCI Ethics Office
- NIH Office of Technology Transfer
- On occasion, any group that has their hand in procurement and grants

## Summary

- TTB can provide information                          and assistance on issues of                                 patents and inventions
- TTB can assist in interactions                        with the private sector through              negotiation of an appropriate                agreement
- TTB can process trademark registrations, as well as consult and assist on copyrights, other intellectual property issues, and related matters

## Contact Information

**ROCKVILLE OFFICE**
**NCI Technology Transfer Branch**
**6120 Executive Blvd., EPS Suite 450, Rockville**
**Phone: (301) 496-0477**
**Fax:      (301) 402-2117**
**FCRDC OFFICE**
**NCI Technology Transfer Branch**
**1003 W. Seventh Street, suite 500**
**Frederick, MD  21701**
**Phone:    (301) 846-5465**
**Fax:  (301) 846-6820**
**Web address:  http://ttb.nci.nih.gov/**