Below are some general, frequently asked questions regarding technology transfer. If you don’t find the answer to your question, please contact us at TTO@cdc.gov.
- How do I disclose an invention?
- What is intellectual property (IP)?
- What is a patent?
- Why is it important to disclose my invention, as early as possible to the TTO?
- What is a public disclosure of an invention?
- What is the process of filing a patent application at the CDC?
- What happens after a patent is filed?
- How are royalty payments determined?
- How does the enactment of AIA impact CDC researchers?
- I’m an outside party and interested in an invention, who do I contact?
- How do I obtain a trademark?
- What is the purpose of research agreements?
- How do I initiate an agreement review?
- What is the process of agreement review?
- What are material transfer agreements (MTAs)?
- What are confidential disclosure agreements (CDAs)?
- What are research collaboration agreements (RCAs)?
- What are cooperative research and development agreements (CRADAs)?
- What are license agreements?
Technology transfer is the process of transferring knowledge or technologies developed at the CDC to non-federal organizations, including industry, academia, and state and local governments. In order to benefit public health, CDC innovations must become useful products that the public can use. The CDC technology transfer mission is to partner with entities that can develop CDC inventions so that they become viable products.
There are many reasons to transfer technology, including:
- Ensuring your intellectual property is protected to continue research and ability to publish
- Benefit to the public good
- Compliance with federal regulations
- Economic development
- Foster collaborations among scientists
- Obtain licensing revenue to support further research
The first step on reporting a discovery is to contact our office at TTO@cdc.gov. TTO will help researchers work through the process of formally reporting a technology.
IP refers to creations of the mind: inventions, know-how, literary and artistic works, symbols, names, images, and designs. IP protection occurs through patents, copyrights, trademarks, or trade secrets.
A patent is a publically available document issued by the government that establishes certain rights to inventions, including limited rights to stop others from making, using or selling your invention. To be eligible for patent protection, an invention must be useful, novel, and non-obvious. The patent application must also show that the inventor has enabled the invention and include a sufficient description of the invention.
As of March 16, 2013, U.S. patent law has shifted from a “first to invent” to a “first to file” system. This means the first inventor can lose to a second inventor who filed a patent application first. Therefore, to ensure a patent can be obtained, it is important to disclose the invention to TTO soon after its conception so a patent application can be filed in a timely manner.
A public disclosure can include scientific presentations, publications, public use, or offers of sale. There are strict rules for public disclosure that may negatively impact the ability to obtain patent rights, therefore it is important to contact TTO before any form of public disclosure.
The TTO relies on an experienced group of patent attorneys, both internal and external, to oversee this complex, lengthy, and costly process. Put simply, a patent defines the scope of the rights to inventions using sentences called "claims." To get claims issued, a patent application with proposed claims is submitted to the patent office for review of patentability in each country a patent is desired. Patent examiners will review the proposed claims in light of, literature and public disclosures, and then negotiate the exact language. A "provisional" patent application can be utilized to preserve the ability to file a future application within certain timelines since it is not reviewed for patentability.
Although there are many different ways to manage patent filings, a typical process includes:
- Filing a "provisional" patent application at the USPTO that includes a complete description of the invention;
- Filing an international patent application under the Patent Cooperation Treaty (PCT) often referred to as a "PCT application" (an international search is performed on these applications, and these also preserve the ability to file future applications within certain timelines) – a PCT application is filed within one year after filing the provisional application;
- Filing a patent application in each country in which a patent is desired – this occurs 30 months after filing the provisional application; and
- Issuance of patents after negotiating claim language with examiners – although this timeline varies, it is typically between about 2 to 4 years.
A fully detailed U.S. patent application must be filed prior to any public disclosure of an invention to preserve international patent rights. It also must be filed within one year of public disclosure by the inventor to preserve U.S. patent rights. After TTO reviews of patentability and commercial marketability, a patent application is filed with the U.S. Patent and Trademark Office by a contract attorney. The TTO is responsible for the supervision of patent prosecution and for ensuring that all information and material are forwarded to the PTO to assure that a patent may be awarded. Once the U.S. patent application is filed, TTO will update its preliminary marketability and patentability analysis and will provide, within 12 months, a recommendation regarding international filing.
TTO reviews the invention and its commercial potential, develops a licensing approach, and identifies potential companies to commercialize the invention. After formally advertising for potential licensees and promoting the technology to companies, the CDC unit of the NIH OTT receives an application for a license. The CDC unit of the NIH OTT then negotiates the terms of the license, and administers the license.
Royalty payments to inventors are processed two times in the calendar year. The first payment is made from late May to mid-June. The second payment is made from late October to early November. Inventors receive the first $2,000 received from a licensee. Next, they receive 15 percent of royalties received above $2,000 up to $50,000. Finally, they receive 25 percent of royalties in excess of the first $50,000 received each year. Each inventor cannot receive more than $150,000 in royalty payments for a calendar year.
- The new “first to file” system ensures that whoever files the patent application first gets the patent. CDC investigators will need to disclose the invention after conception so their ability to patent the technology is not lost.
- Filing of a provisional application can no longer secure an earlier priority date unless it is fully detailed. CDC researchers must fully disclose the invention to TTO to ensure that all aspects of the invention are described in the application. If the invention is not fully described in the provisional, inventors will lose the benefit of the early filing date and possibly an opportunity to patent the invention.
- The one year grace period to file a patent after public disclosure only protects inventions that were publically disclosed by the inventor. Public disclosure can destroy the patentability of an invention. CDC researchers need to contact TTO before any form of public disclosure and also exercise caution when working with collaborators.
- AIA created two procedures for challenging granted patents. It is highly recommended that CDC researchers keep detailed records of their lab activities, discussions, and ideas that can be instrumental in proving inventorship should it be challenged.
A company that desires a license to develop a CDC invention must complete and submit to the CDC unit of the NIH OTT an Application For License To Public Health Service Inventions.
For assistance with trademarks, please contact the TTO at TTO@cdc.gov.
Research agreements promote collaboration and sharing of materials among colleagues. Research agreements are formal contracts that define the role of each party during a collaboration or limit the use of reagents. Establishing research agreements ensures clear intellectual property ownership and supports paperwork required for patent filing.
For CDC researchers, go to the forms page of the website to find the initiation form and instructions. The initiation form describes the materials to be exchanged or the collaborative research project. Once the initiation form is complete, please contact the TTO at TTD@cdc.gov.
For outside parties, please correspond directly with CDC researchers who will then fill out an initiation form and contact our office.
TTO will receive an initiation form completed by CDC researchers and assign a technology transfer specialist to each agreement. The technology transfer specialist will review the agreement and negotiate with the outside party. Once both parties agree on the terms of the agreement, the technology transfer specialist will obtain clearance from the branch and division to ultimately obtain a signature from the authorized official who is the director of the center. Upon full execution of the agreement, the CDC researcher and outside party will notified.
A Material Transfer Agreement (MTA) generally is utilized when any proprietary material is exchanged andwhen the receiving party intends to use it for his/her own research purposes.
A CDA defines what information is confidential, how that information can be shared, and what information is restricted from sharing with other parties.
RCAs are a collaborative exchange of materials and/or confidential information to support a mutual research project. These agreements outline specific goals, how the parties will interact with each other and may also define IP ownership, patent filing responsibilities and other issues related to technology transfer.
CRADAs are agreements for collaborators who will make significant intellectual contributions to the research project undertaken or will contribute essential research materials or technical resources not otherwise reasonably available to CDC.
A license is a legal agreement, subject to Federal, state, and local regulatory authorities, by which a patent owner promises not to take action to exclude the licensed party from making, using, or selling a potential invention.