The general NCI patent process is described below.
The first step in the NIH patent process is to report a discovery through filling an EIR form and submitting it to TTC for handling and processing. An EIR review will be scheduled to conduct a comprehensive evaluation of the reported EIR and make a decision on patent filing strategy. Should the NIH Institute/Center (IC) agree to file a patent application, TTC will send the EIR to a contract law firm for patent application preparation and filing with USPTO. At different stages of patenting, the inventors will work closely with the patent attorney at the contract law firm on the preparation and prosecution of the patent application to seek the issuance of a patent.
It is NIH general practice that a U.S. provisional patent application will be filed first, to establish the priority date of invention. The provisional patent protects the intellectual property for 365 days, allowing the inventor and the TTC to discuss the invention publically and to futher develop the invention and supporting data, and add new details and information, in further support of the drafted claims of the patent application. Prior to the one year anniversary, as the provisional patent application is expiring, a checkpoint will be reached for TTC to make a recommendation and the lead NIH institute to make a determination whether or not to continue the application, and file a preliminary filing under the Patent Cooperation Treaty (PCT international patent application), usually designating all contracting countries/regions. If prosecution of a PCT patent application is continued, the patent application will enter the National Stage of foreign filing at thirty months from the priority date set by the provisional patent application. At this decision point, NIH will designate which countries it wishes to continue to seek patent protection in.
A U.S. patent application must be filed prior to any public disclosure of an invention to preserve international patent rights and must be filed within one year of the official publication date or public use to preserve U.S. patent rights. After a patent application is filed with USPTO, patent attorneys at a contract law firm will work on patent prosecution seeking the issuance of patent. The general patent process may take averagely 3~5 years. At different stages of this process, there are several checkpoints where TTC staff will obtain invention update from NCI inventors for new rounds of review and analysis to justify the continued filing/prosecution for pursuing a patent. Patent applications may be abandoned due to variable reasons or considerations.
Once a U.S. patent application is filed, TTC will update its preliminary marketability and patentability analysis and prior to 12-month filing deadline, a recommendation regarding international filing is made. In general, where international filing is possible and one can reasonably anticipate commercial interest, TTC recommends at least a preliminary filing under the Patent Cooperation Treaty (PCT), 12 months after the U.S. filing date, to preserve international rights for an additional 18 months at modest cost. Upon agency determination to exercise international patent rights, the contract attorney arranges for international patent prosecution. In parallel with the filing of a patent application, TTC reviews the invention and its commercial potential, develops a licensing approach, and identifies potential companies to commercialize the invention. This is coordinated by the TTC Specialist and TTC Licensing and Patenting Managers under whose case dockets the invention lies, and is a collaborative process requiring input from the inventors, and the TDC. After a patent application is filed, a formal advertising campaign for potential licensees and co-developers is developed to promote the technology to companies and other collaborative partners.
TTC Staff reviews all new inventions submitted, and facilitates the whole patent process. If you need any assistance in this process, please contact your Technology Transfer Specialist.