Ian Grey is a partner at intellectual property firm Venner Shipley (exhibiting on stand 83). Here, he discusses some of the key IP considerations for medical devices.
In addition to meeting regulatory requirements, intellectual property should always be a primary consideration from the initial concept to the commercial use of a new medical device.
As any prior disclosure can undermine subsequent attempts to seek intellectual property protection, it is important to ensure that that everyone involved in the development of a new medical device understands the need for secrecy from the initial concept stage. Although IP rights created by employees in the normal course of their work are owned by the employer, if you are collaborating with others, then the ownership of any IP generated as a result of that collaboration should be established in writing and steps take to ensure that non-disclosure agreements are in place.
Existing intellectual property can provide a valuable source of information and so a search and analysis of previously published patents should be carried out to gain an understanding of what has already been developed. It is also necessary to establish whether any third parties have rights which they could rely on to stop you from marketing your product by carrying out freedom to operate searches.
You also need to consider how best to protect your own intellectual property, including the filing of patents to protect the inventive concept, trade marks to protect the brand and trading name and registered designs to protect the shape and appearance of the device.
A patent is usually the most valuable form of protection for a new medical device. A granted patent can provide an owner with a monopoly in the invention covered by the patent for a maximum period of 20 years. This means that you can take legal action against third parties who use the same inventive concept without authorisation. Patents are also licensable and assignable and if you are seeking investment or eventually hope to sell your business, then the existence of a patent portfolio can help to increase the value of your company to investors. The UK, as well as a number of other countries, also offers favourable tax incentives to companies that derive income from patented inventions.