Appleyard Lees

Global medical devices

Appleyard Lees have successfully defended a medical bandaging patent for a global medical device company. After the European patent was granted, it was opposed by a competitor looking to clear the path in Europe. The opposition was refused at first instance. The decision was confirmed at an appeal hearing for all the main claims. The patent therefore remains in force blocking the path for competitor products in the EU.

In 2003, Appleyard Lees were instructed by BSN Medical Inc., based in the US, to enter the European regional phase of WO02054983. BSN Medical are a global medical device company and one of the world’s leading suppliers of casting products, bandages, traditional wound care and compression therapy. The patent application was filed to protect an improved medical bandaging product used to form a cast for the immobilisation of a body member during the treatment of a fractured bone.

Traditional plaster-of-Paris casts are being superseded by synthetic roll form products that comprise a flexible fabric impregnated with a moisture-curing resin that can be applied to the body member in a flexible state which then hardens due to activation with moisture. Such products avoid the mess of plaster-of-Paris casts and, in comparison, can be applied quickly and provide a cast that is extremely light-weight, has a very high strength-to-weight ratio and permits a flow of air to the body member. Synthetic splint systems were known that allowed desired lengths of material to be dispensed from a hermetic sleeve so that the bandage was kept away from moisture prior to being dispensed.

The client had improved their known ORTHO-GLASS® synthetic splint system to become more adaptable. The improved system allows physicians to use less padding or to use padding in different densities or thicknesses form one point on the splint to another without the need to increase its stock line. Appleyard Lees were responsible for prosecuting the patent through the European Patent Office and a European patent was granted in 2007 to the inventive feature of a synthetic splint system having a removable padding liner attached to the bandage. The granted patent included two independent product claims and a method claim. The two independent product claims protected the system with and without the resealing means. The independent method claim covered the method of application with the optional step of removing the liner.

 

Grant of the patent was opposed by a part of the Hartmann Group based in Germany. It was claimed the patent should be refused because it was not inventive over prior art synthetic splint systems. The main argument was that the padding permanently attached to a bandage could be removed for instance by cutting through the bond between the layers. However, it was successfully argued that the term “optionally removable” in the granted patent claims had an inherent meaning that implied a structural aspect requiring the padding layer to be specifically intended to be removed. In the prior art, the padding layer was not so specifically intended. Consequently, at both opposition and appeal, the product claims were upheld as being new and inventive over the prior art arguments. Although the Opposition Division applied the same reasoning to the method claim, the method claim was lost at the appeal hearing because the optional feature was held non-limiting, meaning the method claim covered the prior art of not removing the padding.

As the appeal decision is final, the product claims were maintained in force in the validated European states without amendment. BSN medical’s granted patent therefore remains as a barrier to market entry for competitor synthetic splint systems.

Appleyard Lees regularly handles opposition and appeal cases on behalf of clients. For more information please contact a member of the Appleyard Lees Medical Device team.