The IEEE 11073 suite of standards relating to medical device communication was completed last year with the adoption of CEN ISO/IEEE 11073:20701. Where there are standards in communication systems, we expect standard essential patents (SEPs). How does this environment compare to other areas where standards are in play, and how may this new area develop over time?
When the joint photographic expert committee formed to establish the JPEG standard, it was a coalition between the overarching ISO/IEC and an industry study group formed from key players in the emerging photography and electronics industries. This meant that the industry itself was setting the standards, and had the effect of accelerating the development of standards and creating a market between the key players to licence and cross licence portions of the standards which they individually owned. This format has extended into MPEG and 4K.
However medical device standards are set only by the International Standards Organisation and the IEEE. Whilst there is specialisation within the ISO divisions, and these divisions are no doubt formed in part by members of the medical device profession, their involvement is almost covert and thus appears to result in almost no associated intellectual property.
For example, a cursory search shows that about 300 patents in the digital healthcare realm mention this suite of standards since its first publication in 2003, but none of these appear to relate to the development of the standards; they merely note that their interfaces are compliant.
In the light of this, in my view, it cannot be long before the industry starts to develop its own standards. Currently there appear to be no published formats, but there also appears to be no requirement to conform to the IEEE 11073 suite of standards and precious few patentees who require such compliance. Compared to the 300 patents referring to the IEEE 11073 suite of standards, approximately 70,000 electronic medical device patent applications have been filed globally. Of course, not all of these devices will require a communication protocol, but many will, and presumably many of these will communicate according to their own protocols. It is unclear whether any of these protocols are collaborative, locally adopted, manufacturer specific or competing with the IEEE 11073 suite of standards. What is clear is that, in my view, the medical device industry is on a course similar to JPEG, and the industry will no doubt have to embrace SEPs sooner or later. I believe it will be sooner.
If you or your client have any questions about IP for digital healthcare and especially SEPs, please do let us know.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.