Intellectual property considerations need to be made at every stage of a medical device product lifecycyle to ensure strong protection and increases chances of commercial success.
The demands placed on medical devices companies – strong regulatory control requiring high quality products with close to perfect reliability – often lead to high product development costs and long lead times to market, creating a commercial need for long product lifetimes.
In such an arena, the management of intellectual property (IP) matters to protect innovative products from competitive action, is central to commercial success. This is demonstrated by the high and growing level of patent filings in this area. Medical technology is the largest technology area for patent applications filed at the European Patent Office.
At each stage of the product lifecycle for a medical device understanding IP matters and reacting accordingly is vital. Design patents and other means of IP protection such as copyright for software and trademarks to protect the brand all play their role in the successful commercialization of a medical device.
However, most companies involved in device innovation are necessarily small and medium-sized entities (SMEs) that are almost always constrained by resources in general, and budgets in particular. This places stress on the IP budget.
Still, many SMEs appreciate IP's importance. In our recent report on the patent landscape for point-of-care diagnostic assays and devices, Microbial Infection: Point-of-care diagnostics we found that SMEs are very active in patenting point-of-care diagnostic inventions: over half (51%) of patent applications worldwide over the last five years in this field were filed by private companies and of these, 71% were filed by SMEs.
So, where does IP fit into the product life cycle? Different considerations need to be made in depending on the phase:
At the conception or research phase, an initial idea leading to the product is formed and several IP questions loom large: Is the product, or some aspects of it, new? Where does it sit with the prior art? Do third parties have IP rights that could prevent progress to a marketable product? If so, when will those rights expire?
Freedom to operate is a key question. Spending time and effort on good quality searches and analysis of the results pays dividends here. Spending money at this stage can avoid costly revisions at the product development phase, or even shuttering of the project.
Even if the field seems clear for the new product, good searches build a valuable database of relevant technology that helps inform the research group. Old technology that has been “forgotten” can be surprising, even to specialists.
If there are relevant third-party IP rights those implications must be considered. Can developers of new devices license those rights in? Do they have to contemplate dealing with a third party, which has controlling IP for the proposed product being developed?
Answers to such questions will determine whether or not the project is worth pursuing, assuming the concept has met the threshold in other non-IP related considerations. Developers may choose to file patent applications for their invention at this time, and they can prove essential to secure investment for product development.
Product Development Phase
As the project progresses through to more concrete development, testing, and then production phases, preserving confidentiality and ensuring that IP protection is in place as far as possible is imperative.
The timing of filing of further patent applications (and/or design registrations) is important. For many types of medical devices, there is a risk that confidentiality may be lost during the product development phase. This is because development of a device requires testing, eventually in a real life situation, with clinical trials required for many types of devices. Care has to be taken to ensure that any patent applications are filed before a device goes public.
Filing patent applications as the product evolves and with regular review of the situation as the project continues are always a good idea.
Does a change in the product materially affect the relevance of already filed patent applications? If so, should a new filing be made and if so when?
Design registrations are normally made around the time when the finished form of the product is decided, but late changes to the design can happen. This can lead to the requirement for new filings that show the modification, especially for devices where how the product looks is a selling point.
In the production phase, where the product is approved and on sale, understanding the IP rights that makers of new devices have, and having a realistic view of their strength is important. Can they defend the product against competitor activity? Is there a strategy in place for this?
Monitoring competitor activity, both in the marketplace and their filings for patent applications is necessary intelligence.
Where product modifications are made, the associated IP should be reviewed. Even minor changes, made in the light of practical experience, can be valuable innovations protectable by patents.
--Dr Mike McPherson is an European Patent Attorney with Marks & Clerk