Why are medical device patents important? New medical devices are both expensive and risky to produce. Without patent protection, few new medical devices would ever reach the market.
The number of filed and granted medical device patents has substantially increased over the last few years, with certain US states (California, Minnesota, and Massachusetts) leading the way. Certain countries, in particular, Japan and Germany, are also heavily active in this area.
Write carefully: In contrast to some high tech areas, such as computers and software, which often rely on a larger number of lower impact patents, the medical device industry tends to rely on a smaller number of higher impact patents. What this means is that any given medical device patent is more likely than average to be subjected to a high level of competitor scrutiny. Remember also that in the medical device field, both the patent office and the courts may view the “person having ordinary skill in the art” (PHOSITA) as being highly skilled, such as a PhD or MD. Thus care should be given to write accordingly. It is helpful to include a lot of detail and discuss alternative approaches. Research and disclose prior art, and of course try to write claims in a manner that distinguishes over prior art.
Remember Europe: Medical devices are an international market, and often due to slower FDA review times, US firms first introduce new products in Europe. Many US medical device patent applications end up being filed as international patent applications in Europe. Thus European patent rules are often important.
Although there are a few glaring exceptions, US medical device patent eligibility rules generally tend to be expansive. The USPTO typically reviews these patents in its 3700’s art unit. In recent years, this art unit has continued to grant medical device patents according to its historical percentages.
European patent eligibility rules are also generally quite permissive with regard to “gadgets” and in-vitro devices, as well as technical aspects of in-vivo devices. However, Europe (See G-II 4.2.1) doesn’t allow “methods of treatment of the [living] human or animal body by surgery or therapy and diagnostic methods practiced on [usually interpreted as “in”] the human or animal body “ (the US has a similar carve-out for medical procedures). Fortunately, the Europeans tend to read this exclusion narrowly, so this isn’t actually quite as restrictive as it sounds.
However, from a claim writing perspective, be careful of method claims with limitations that read on the patient’s body. Try to focus more on the details of how the gadget (device) itself works. Watch out for methods that remove a tissue, treat it, and then return it to the body, as these could run into trouble.