- Alert: Heart valve patent held valid and infringed (Edwards Lifesciences LLC v Boston Scientific Scimed, Inc.)
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IP & IT analysis: This judgment concerned a claim by Edwards Lifesciences LLC (Edwards) for revocation of two European patents owned by Boston Scientific Scimed, Inc .(Boston) and a counterclaim by Boston for infringement of those patents. Both of the patents claimed inventions entitled ‘repositionable heart valve’, which prevented or limited the passage of blood around the valve, known as paravalvular leakage (PVL). Edwards alleged that both patents were invalid for lack of novelty, inventive step, insufficiency and added matter. The product said to infringe the patents (Sapien 3) featured an ‘outer skirt’, which covered part of the outer surface of the frame and had been designed to minimise PVL. Among other things, the court held that Sapien 3 infringed claim 1 of the first patent (254 patent) due to the positioning of its valve. Claims 2 and 6 were also infringed due to the way in which the fabric seal of Sapien 3 bunched up. Claim 1 of the second patent (766 patent) was also infringed. The attacks on validity of the 766 patent failed, meaning that the patent was held valid and infringed. However, the 254 patent was held invalid on the ground that it lacked inventive step.
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