By Jackie Hutter, founder, The Hutter Group IP strategists spend considerable time "Monday Morning Quarterbacking" patent strategy for medical device inventions for the purposes of valuation and commercialization. We are often asked to review medical device patents to provide opinions on commercial potential. For some of these reviews, we are forced to conclude that the medical device patent fails to create a scope of protection to justify the investment. Let's start with an example: A medical device investor recently had me conduct a preliminary review of a patent for a device invented by a medical specialist – let's say she's an ENT who is a recognized expert on sinus surgery. Like many experienced practitioners, the doctor was frustrated with the tools available and, after many surgeries she experienced a key insight about improving a particularly tricky aspect of treating a condition of the sinuses. This "ah ha" moment made her realize that patient outcomes could be significantly improved if the design of an instrument was tweaked to allow better contact with a part of the sinus cavity that was hard to reach in a significant subset of patients.
The filler was a known material, but the medical technique was new. It was decided that the therapeutic effect was achieved by physical displacement of the sensitive tissue and not due to the chemical composition of the filler. The spacing effects were present for any filler material, which further underlined that the effect was physical and independent of the filler's particular chemistry. It was thus concluded that the filler was a device and not a substance or composition, and the patent was denied. As "substance or composition" can be summarized as a product that achieves a direct therapeutic effect by a chemical, as opposed to physical, interaction with the body, it is still possible to protect non-pharmaceutical devices and substances which are effective by nature of their chemistry, for example a surgical dye for use in eye lenses. Furthermore, protecting the new use of a pharmaceutical, where the new use requires a particular device, may be possible. Supplementary protection certificates SPCs are not available for standalone medical devices, but could potentially be available for device-drug combinations.