Abstract
Patents can give a medical device company a key advantage over competitors. If the right patent protection can be obtained, it can keep your competitors out of the market space, while you develop and solidify your products and your brand. A patent may be granted for the invention of any new and useful process, machine, manufacture or composition of matter or any new useful improvement thereof. A patent gives a patent owner a bundle of property rights that grants the inventor the right to exclude others from making, using or selling the medical device invention as defined by the patent’s claims in the United States for a limited period of time.
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Notes
- 1.
A Request for Continued Examination (RCE) under 37 C.F.R. § 1.114 can be filed upon payment of the requisite fee to present new arguments or claims in an application after a final rejection as an alternative to filing a continuation application.
- 2.
As a reminder, the secondary considerations include: long-felt but unsolved need for the invention, failure of others to create the invention, commercial success of the invention, unexpected results and copying by others.
- 3.
A terminal disclaimer is an official statement by a patent owner that the term of the patent in question is disclaimed, i.e., shortened, to less than the twenty (20) year grant. The patent owner effectively forfeits a portion of the patent’s term and allows the patent to enter the public domain.
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Halt, G.B., Donch, J.C., Stiles, A.R., VanLuvanee, L.J., Theiss, B.R., Blue, D.L. (2019). Patents. In: FDA and Intellectual Property Strategies for Medical Device Technologies. Springer, Cham. https://doi.org/10.1007/978-3-030-04462-6_6
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