An invention is any new and useful discovery. Inventions are protected through the United States patent system as a property right established by the U.S. Constitution. Other countries also have their own version of our U.S. patent system. The patent system allows an inventor to obtain protection for their invention, which gives the inventor the right to prevent others from making, using or selling their invention for a period of time. The patent system grants this protective right to any invention that is a new and useful process, machine, manufacture, or composition of matter. Therefore, patent protection can be obtained for inventions covering, but not limited to: methods of making or doing a thing (e.g., method of treating a disease or conducting a surgical technique); the thing being made (e.g., a medical device, chemical or biological composition, a modified organism or plant); and improvements to already existing processes, machines, manufactures, or compositions of matter.
It is the policy and objective of Congress to use the patent system to promote the utilization of inventions arising from federally supported research or development (35 U.S.C. §200). Therefore, obtaining patent protection for NIH inventions facilitates commercial development of new, novel products and services that benefit public health. Further, commercial partners who license NIH inventions also acquire the patent system's protections (i.e., the right to exclude other from making, using or selling), allowing the investment of capital and resources into development and commercialization with lower risk.
All NIH scientists are required to promptly report their inventions by completing and submitting an EIR to their Institute's technology transfer office, before any public disclosure of the invention (i.e. manuscript/abstract publication, oral meeting presentation). The EIR allows the inventor(s) to document the invention in sufficient detail so that their technology transfer office can evaluate whether patent protection can or should be obtained.
NCI's Technology Transfer Center (TTC) has a formal EIR review process, wherein TTC staff review the invention description for patentability and commercial marketability. TTC then makes a recommendation (supported by evidence and documentation) to the NIH Institute providing the EIR on whether patent protection should be pursued based on the invention's patentability and commercial viability. Using this recommendation, the NIH Institute makes a decision on whether to file a patent application.
Upon receiving the NIH Institute's decision to pursue patent protection, TTC will instruct one of our contract law firms to prepare and file a patent application with the U.S. Patent and Trademark Office (USPTO). The TTC is responsible for the supervision of both the patent prosecution process and our contract law firms to ensure that our applications have the best chance of being issued. The TTC works closely with the NIH Intramural Research Program (IRP) to ensure that its scientific discoveries are either transferred to the marketplace through patenting, co-development and/or out-licensing, or published to facilitate public access.
Wednesday, September 14, 2016