By Ravish Patel

Based on ‘Biodesign: The Process of Innovating Medical Technologies

The world of medical devices is often intertwined with intellectual property and the protection of such intellectual property. One such form of protection is the patent. A patent is a grant of exclusive rights from the government to make, use, sell, or import an invention. This protection generally lasts for about 20 years. The main type of patent used in medical devices is the utility patent which covers the device itself, the methods of how it is used and how it is manufactured. These are considered design patents which cover the shape and design elements of the invention. 

    Although utility patents are the mainstay of intellectual property protection, they are very detailed and expensive. Hence, provisional patents are often written and used by innovators to record their ideas and intention to follow-up with a utility patent. Provisional patents are preliminary filings that can be submitted to establish a priority date for subsequent utility patents. These are generally much less intensive to write and significantly cheaper to obtain as well. For this reason, it is much more feasible for an individual inventor to start off by writing a provisional patent. The price of filing a provisional patent is about $100 whereas a utility patent should be written by an attorney expert and can cost significantly more. It is important to note that this provisional patent can never become an enforced patent. There must be a non-provisional (utility) patent filed within 12 months of the filing of a provisional patent. While there is no required format for the provisional patent application, it should include at least the following: (1) the need or problem that the invention addresses, (2) the problems with current solutions, (3) why a new invention is needed, (4) the details of the invention itself, and (5) advantages of this invention as a solution to the problem. It is highly recommended to include drawings and schematics, if applicable, with the application as well. 

In order for a patent to be awarded, at least one feature of the invention must be novel and non-obvious compared to any patents, publications, presentations, or other public disclosures dating back over all time. There are three basic parameters for judging the patentability of an invention.

  1. Usefulness. The invention must do something useful.
  2. New. It must be new relative to all known patents, products, or descriptions for all time.
  3. Non-obvious. It must not be obvious for someone of average skill and knowledge working in the given field.

    Only if an invention objectively meets all three of the above criteria is it considered patentable. Another requirement is that the innovator must be able to demonstrate that he or she has made a good faith effort to bring an invention into practice. Typically, this means building a prototype and performing some sort of preliminary testing. These steps can occur after the patent filing as there are no strict guidelines about the timeline of this “reduction to practice” other than what is reasonable for the technology. If constructing a working model will be difficult (eg, extremely expensive, time intensive), one can include a carefully written and very detailed description of how to build and use the invention so that someone with knowledge in the field could do so. This description can serve as an alternative to making and testing a model. Importantly, constructive reduction to practice via a patent application has the same legal value as actual reduction to practice. 

    Currently, in the United States, the first person to invent an innovation is given the patent assuming the inventor was reasonably diligent in reducing the invention to practice. It is important to note that internationally, this is different and the first person to file a patent application is awarded the patent.

    A patent application can be filed via mail or electronically. More information about the entire process can be found at the USPTO website below.

 

https://www.uspto.gov/patents/basics/patent-process-overview#step1

 

There are a lot more details regarding patents and their filing process, and it is recommended to read more about the process from other more detailed sources as well. This article is meant to serve as an introduction to patents and what they should consist of. We hope you learned about the basics of patents and wish you luck in your future ventures.