What is a license?
The USDA has the authority to grant an agreement that permits commercialization of patented and unpatented technologies as well as plant varieties developed at the USDA.
How do I obtain a license with USDA?
To obtain a license to an unpatented biological material, a patent pending or patented invention for commercial use, or a plant variety developed at USDA, the first step is to complete a license application. The application should contain a description of the licensee, USDA technology desired, type of license sought, and a commercial development plan that describes how the licensee intends to develop and market the technology for practical application. This information will be helpful in selecting the most appropriate license agreement for transfer of the USDA technology.
Who do I contact to negotiate a license for a USDA invention?
A completed license application should be submitted to the Business Licensing Officer at the Office of Technology Transfer who will then docket and assign the application to a Technology Licensing Specialist (TLS). The TLS will review the application and may request additional information prior to negotiation of the license agreement. Please note that confidential financial and business information provided in a license application is exempt from disclosure under the Freedom of Information Act (FOIA) (5 USC 552(b) ).
What types of licenses are available?
USDA offers nonexclusive and exclusive license agreements for issued and pending utility and plant patents, and issued and pending certificates for plant varieties. USDA offers nonexclusive license agreements for unpatented biological materials. In addition, USDA offers a nonexclusive commercial evaluation license agreement for the aforementioned patents, plant varieties and biological materials.
What does it cost to obtain a license?
Determination of financial terms for each license can vary depending on the type of license and other market considerations as each technology and development path may be distinct. Typically, financial terms considered in the structure of a license include but are not limited to an execution fee, minimum annual royalties, earned royalties on sales, milestone or benchmark payments, as well as reimbursement of patent expenses.
Do I still have to license a biological material even if the material is unpatented?
A non-exclusive biological material license is required to grant the right to make and sell tangible biological materials developed at the USDA for the commercial use. The company may first need to coordinate with USDA ARS scientists as well as the Scientific Technology Transfer Coordinator to determine whether a material can be licensed for commercial purposes.
Can I obtain an exclusive license?
Exclusive licenses may be granted for federally owned inventions, when necessary, to encourage the commercial development of USDA inventions.
What criteria are needed to obtain an exclusive license?
The criteria used to evaluate whether an exclusive license is warranted is outlined in (37 CFR §404.7 ). Upon determination that an exclusive license is warranted and the application is complete, a Notice of Intent to grant an exclusive license to the invention must be published on the Federal Laboratory Consortium website, by law for a minimum of 15 days, for public comment. If an exclusive license application is submitted for an invention developed under a CRADA, public notice is not required.
What information do I need to include in my commercial development plan?
During the evaluation of a license application directed to commercialization of a USDA invention, a commercial development plan should be submitted that includes, but not limited to, the following information:
- Description of Company Financial Resources and Facilities
- Description of Product Envisioned
- Regulatory Requirements (if appropriate)
- Pre-launch R&D or Field-Testing Requirements
- Manufacturing and Distribution
- Marketing and Sales Strategy
- Timeline of Development to First Commercial Sale
- Financial Sales Projections (at least 5 years)
How long does it take to obtain a license?
The length of time to obtain a license varies depending on the type of license selected and complexity of terms negotiated. Licenses such as non-exclusive commercial evaluation and biological materials licenses may be completed quicker than long term exclusive commercial licenses which typically require additional statutory requirements for evaluation and completion.
How do I submit a license payment?
Payments due to USDA can be submitted by check or electronically using Pay.gov at https://pay.gov/public/form/start/76123725.
How does USDA monitor compliance under the license?
Licenses typically contain performance or benchmark requirements based on the commercial development plan submitted as part of the company license application. These benchmark requirements ensure that the USDA inventions are commercialized, and the practical application realized for public benefit.
What happens if a license benchmark is not attained or delayed?
USDA understands that development and commercialization of technologies is a dynamic process and as such recognizes that challenges can arise. Under circumstances where such problems are encountered, USDA and the licensee work together to amend the license agreement.
Where do I send reports (i.e. sales reports, progress reports, etc.)?
Send sales, earned royalty, and progress reports to:
|Technology Licensing Compliance Specialist|
|5601 Sunnyside Avenue|
|Beltsville, MD 20705-5131|
What happens if my royalty payment is not paid by the due date or past due?
A late payment of a license fee or royalty shall automatically raise said fee or royalty by an amount equal to one percent (1%) of the amount due for each month beyond the due date of such late payment.
Can I contact the inventor(s) before and/or after the licensing process is completed?
USDA encourages discussions between inventors and potential licensees on the scientific merits and technical feasibility of the invention. However, to minimize potential conflicts of interest, USDA inventors must not be involved in financial business discussions or participate in the actual negotiation of license agreements with potential licensees.