Medical device innovators often rely on patent protection, but they should not forget the importance of other rights. Registered designs are mainly thought of in relation to protecting the visual appeal of products like fashion and furniture. But they can also provide important protection to a technical product.
Leeds-based company Arc Medical Design did just that and succeeded both in relation to patents and designs.
The colonoscope market and the Endocuff
Colonoscope supply to the European market is dominated by three Japanese manufacturers of optical equipment, Olympus, Pentax and Fujifilm. Arc's innovative design was the Endocuff, to be used in combination with a colonoscope. This is a 2cm plastic cuff with radial projections. When fixed to the end of the colonoscope, it helps the clinician to see behind folds on the inside of the colon, and keeps the tip of the colonoscope in position in the central part of the colon. This addresses the two main difficulties that physicians faced in trying to detect lesions or polyps that could lead to cancer.
Arc registered European and UK patents, and also EU-level Community designs, to protect its new product.
The relationship with Cantel Medical
Arc originally signed up with Cantel Medical Corporation for distribution of the Endocuff in the US. This arrangement came to an end in 2016, after a change in ownership. The US distribution rights passed to an Olympus group company.
Cantel Medical prepared itself for the change by developing their own design, the AmplifEYE. To clear the way for launch in the UK, Cantel Medical applied for revocation and/or declarations of non-infringement of Arc's proprietary rights. Arc responded with an infringement claim.
If obvious, why had this not been done before?
Cantel Medical’s arguments for invalidity of the patents were unsuccessful. Earlier described devices were not close enough to Arc's innovation. Of interest here is Arc's use of arguments that the device could not be obvious, because if so, it would have been done before. This type of argument has often been raised in patent cases, with mixed results. Here evidence supplied as to the reaction of experts to the new product, and the commercial success it enjoys found favour. The judge concluded that the patents were valid and infringed.
Do looks matter?
Arc's registered designs showed images of two versions of the Endocuff, viewed both from the side and the end. Arc had to overcome the exclusion of features that are “solely dictated by its technical function”. But if aesthetic considerations play any part, this does not bite. Design freedom is also important. If there are design constraints on the product, minor differences can be enough to produce a different overall impression. And there was evidence from clinicians that the look of the product was important to both doctors and patients.
Both of Arc's registered designs were valid, the judge concluded, and the AmplifEYE infringed the later version.
Arc also succeeded with a claim for unregistered design right.
Don't forget design registrations
In this case both patent and registered design arguments were successful. But it highlights the merits of having both forms of protection. If Arc's application to amend its patent claims had failed, or an obscure piece of prior art had made the patents invalid, then that side of the case could have collapsed. Having registered design protection in place alongside the patents meant that Arc had another line of attack.