II. Definitions

Cooperative R&D Agreement (CRADA) An agreement between a particular local Federal Laboratory and one or more private companies, universities, or individuals under which money to support R&D can be accepted by the Federal Laboratory in exchange for the right to manufacture and market any patentable devices that may be developed during the agreement. These agreements were authorized under the Technology Transfer Act of 1986 (Public Law 99-502) and also provide for royalties flowing into the agency (i.e.,VA Central Office) to then be distributed among VA laboratories, after first paying at least 15% of the total to the individual employee/inventors (see Appendix A). The distribution of such royalties has since been modified by the National Technology Transfer and Advancement Act of 1995 (See Appendix N.).

Copyright The right to reproduce, distribute, and sell original intellectual property that may or may not be patentable; e.g., literary works, music, software, motion pictures, videotapes, etc. This right can be simply asserted by the author or originator by affixing to the work the inscription of the circled letter "c", followed by the year and the originators last name. If the work was developed over a period of years, there may be multiple years listed. However, such materials developed by a government employee while performing his/her official duties are not copyrightable by anyone (See Section XV).

Disclosure The act of disclosing the details of a new idea or invention. Disclosures are assumed to be made without compensation and without any restriction on the receiving party in the absence of a non-disclosure or confidential disclosure agreement. An "enabling" disclosure is one which would be sufficient for a person knowledgeable in the field to replicate the product or process which is disclosed. A "non-enabling" disclosure is not. The patentability of a device or process is dependent on the date of the first non-confidential enabling disclosure (See Section XIV).

Federal Laboratory (as used in the TT Act of 1986) A laboratory owned by the Federal Government and authorized to negotiate and enter into CRADA's. In the VA, this means your VA Medical Center, not your individual group or laboratory.

Infringement The act of manufacturing and marketing a product for which another person or entity holds a valid issued patent that has not expired in the country in which those activities occur. (The question of whether a certain patent is actually valid and includes a particular product is a legal decision, often leading to prolonged and expensive litigation.)

Invention A new and useful process, machine, manufacture or composition of matter, or any new and useful improvement, finding, or product which clearly advances the state of the art or practice and may be patentable.

Inventor The originator of, or a principal contributor to the concept(s) contained in a specific invention. The legal definition requires that this individual be personally responsible for at least one of the claims listed in the patent.

Investigator A scientist or engineer who is a member of a research or development team, either on the laboratory staff or the staff of a contractor, and who plays a key role (other than as a consultant) in a given project.

Know-how The specialized knowledge required tointerpret and apply a finding, perform a process, or develop or manufacture or market a product.

License An agreement under which one party (the licensor) permits another party (the licensee) to make, use, offer for sale, sell, import and distribute the product in question in return for a specified schedule of royalties, fees, or other forms of compensation.

Nondisclosure Agreement An agreement between the developer of an invention (either the RR&D Center or the inventor) and the party to which the idea is to be disclosed on a confidential basis. It provides conditions under which the receiving party may or may not disclose to a third party (see Appendix B).

Patent A document issued by the U.S. Patent and Trademark Office (or corresponding office of any other government) which prohibits any other person or entity within its jurisdiction from making, using, offering for sale, selling or importing the patented product without payment of royalties to the inventor(s) named on the patent, or to the owner(s) if assigned.

Patent application A document filed with the U.S. Patent and Trademark office (or a corresponding office in some other country), usually filed by a registered patent attorney or agent, which requests the issuance by that office of a patent on a specific product or process which is considered to be patentable.

Patentability A process or product which satisfies certain specific criteria is said to be patentable. The criteria for patentability are: Novelty, utility, non-obviousness, and non-disclosure (See Section XIV).

Principal Investigator The lead investigator with primary responsibility for the project. This role may be shared by two investigators, in which case they are co-Principal Investigators.

Technology Products, processes, or related findings that are tangible, reproducible, and scientific or technical in nature.

Technology transfer as used herein (a) for products, the transfer from the laboratory to a private company for manufacture, marketing, and sales; and (b) for research, the transfer of information in the form of a paper or publication which is then used by another laboratory, researcher or clinician.