The FDA approval process oftentimes runs concurrently with the patent application procurement process before the United States Patent and Trademark Office (USPTO). 2 The FDA approval process requires compliance with rigorous testing programs (clinical trials) and compliance with a lengthy administrative approval process, and is most times very costly. The FDA is responsible for assuring that a new drug or new product is safe and effective. ![]() The Food and Drug Administration (FDA), upon approval of a New Drug Application (NDA), provides medical product applicants perhaps the most important element needed to bring the product to the public. However, critics of this system argue that the extraordinarily high prices of new drugs/new medical products protected by a patent seriously limit access of the best forms of health care to poorer populations, and are therefore unethical. Financial rewards are available to patentees who create new products in the form of higher product sale prices. 1 Sophisticated patent and/or technology licensing strategies and other arrangements (e.g., collaborative research agreements), with one or more other parties, are vehicles that the patentee may use to generate revenue. The present article will focus on medical “utility” patents.īiotech companies, universities and physicians use patents to protect their patented inventions against competition for a finite number of years. ![]() ![]() In the United States, the main categories of patents are utility patents (machines, processes/methods and manufactured objects), design patents (ornamentation), and plant patents (under the Plant Variety Protection (PVP) Act, not to be confused with a plant utility patent). Thus, a patentee may effectively preclude potential competitors from making, using or selling the patented item or process, while providing the patentee a mechanism (e.g., licensing) for capturing the value of the invention and incurred development costs. A patent is a legal instrument that conveys to the patentee (the patent holder) the right to exclude others from making, using, selling, or offering to sell the subject matter of the patent “claims.” Medical patents, for purposes of the present article, will be defined broadly to include patents that relate to pharmaceuticals methods of making and using them medical treatment regimens surgical procedures medical devices health care information technology for hospital and health care management systems (including software for managing hospital bed utilization, care distribution, medical staff allocation, and cost containment), and combinations of these (e.g., an “app” that includes the use of a “medical device” like an attachment that interacts with an iPhone for preforming a medically related function/measurement, such as blood pressure measurement, insulin level monitoring, etc.).Ī patent provides the patentee a unique marketing advantage for his/her invention, as others may be prevented from utilizing any aspect of the patented subject matter unless a license, or other “right to use” is conveyed.
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