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Part I: Patents 101 for the Healthcare Industry

on Monday, 28 April 2014 in Health Law Advisory: Zachary J. Buxton, Editor

A patent is a property right granted by the United States Patent and Trademark Office. An owner of a U.S. patent (e.g., an inventor of the invention covered by the patent) may exclude others from making or selling the invention in the United States for a limited period of time. For most patents, this limited period of time is 20 years from the date on which the patent was first applied for. Thus, a patent creates a temporary monopoly on the invention for the patent owner. This temporary monopoly is intended to serve as an incentive for promoting innovation. Development of a new drug requires a large investment of time, money and effort in developing the drug and obtaining regulatory approval. By providing a mechanism allowing an inventor to have a temporary monopoly on his or her invention, patents offer a significant time window within which inventors may recoup those development costs and profit from their innovations. If such a mechanism did not exist, and a generic manufacturer was allowed to immediately reverse engineer drugs as soon as they hit the market and undercut the inventor by producing the same drug at lower cost, there would be little incentive for inventors to spend the time and money developing new drugs. In exchange for the temporary monopoly provided to the patent owner, the granted patent discloses to the public the details regarding the invention. The motivation for this public disclosure is to drive innovation forward by providing the public (e.g., other prospective inventors) with a state-of-the-art template for developing further technological advances.

 

What types of innovations may be patented? A first type of innovation that can be patented is a composition of matter (e.g., a pharmaceutical drug). A further type of innovation that can be patented is an article of manufacture (e.g., a surgical instrument). Another type of innovation that can be patented is a process. For instance, a process for synthesizing a pharmaceutical drug or a process for manufacturing a surgical instrument may be patentable. Examples of medical-related processes that have been patented include: a process for carrying out a medical procedure using a 3-D tracking and imaging system (U.S. Patent No. 6,246,898); a process for performing a navigated freehand computer-assisted surgical procedure on a knee of a patient (U.S. Patent No. 8,560,457); and a process for automated medical records processing (U.S. Patent No. 8.606,594). In addition to protecting the processes themselves, patent protection may also extend to software programs and devices used in carrying out such processes. Machines may also be patented. An example of a medical-related machine that has been patented is an intravenous drip feed monitor (US Patent No. 4,383,252). Further, design patents can be used to protect the unique ornamental features of devices, such as a uniquely-shaped stethoscope or uniquely-shaped blood pressure monitoring cuff housing. Finally, certain types of plants may also be patented.

 

What are some of the requirements for patentability? Aside from falling within one of the general subject matter areas discussed above, an innovation, in order to be patentable, must be new. That is, some differences must exist between the innovation and pre-existing technologies. Further, those differences must be non-obvious. For example, merely changing the dimensions of a pre-existing device may be an obvious change. Still further, in order to be patentable, an innovation must be useful. For instance, if the innovation is a device or machine, it must serve a useful purpose and must be able to actually perform its intended purpose. Finally, in order to have a patentable invention, the inventor must be able to describe the invention in a patent application in such a way that a person in a similar field of technology as the inventor could make and use the inventor’s innovation. For example, the inventor’s application doesn’t have to provide an exact blue print of how to make and use the invention, but it has to provide enough information so that someone in the inventor’s field of technology, upon reading the application, could make and use the invention without undue trial and error.

 

Next month, Part II: Licensing of Patents, will describe ways that patent owners can leverage the temporary monopoly to their benefit, such as through licensing.

Grayson J. Derrick

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