EWHC 6 (Pat)
Edwards Lifesciences, the world leader in replacement heart valves, succeeded in upholding the validity of their patent for a transcatheter valve. The patent (EP 0 592 410) claimed a collapsible and reexpandable stent, a metallic slotted tube previously used in the coronary arteries to help prevent atherosclerosis, in which a valve was mounted within the stent, the whole of which was delivered via catheter. CoreValve, having recently introduced their own percutaneous heart valve to the market, challenged the patent on the grounds of (i) novelty; (ii) lack of inventive step; and (iii) insufficiency. At the heart of the allegations was the insufficiency plea, CoreValve alleging that the patent did not teach the skilled person to make the device small enough for percutaneous delivery, nor to place the device accurately within the heart with the techniques available to the interventional cardiologist by the priority date of 1990. Deputy Judge Prescott held that the patent did not purport to monopolise the operational procedure, nor is that allowed under Article 53(c) EPC 2000, but only the making of the transcatheter valve. The patent was sufficient in its teaching of how to make the valve.
The CoreValve product was found not to infringe the term “cylindrical” within claim 1. Deputy Judge Prescott interpreted cylindrical within the claim to be “substantially cylindrical but not mathematically so”. The “bulbous” portion of the CoreValve stent was sufficient to escape infringement. Had CoreValve’s product infringed, the experimental use defence would have failed. Section 60(5)(b) of the Patents Act 1977 provides that an act which would otherwise infringe a patent shall not do so if “it is done for experimental purposes relating to the subject-matter of the invention.” The CoreValve product was granted CE Mark approval in May 2007 and patients were being treated throughout Europe as part of a “formidable clinical programme”, an important feature of which was the training of interventional cardiologists in the use of the product. CoreValve further invoiced “a very substantial amount for each unit.” Although “a defendant could always say, and with some truth, that by putting his product on the market…he was gaining valuable information that might even prompt him to modify his device” this did not outweigh the purpose of establishing confidence in the product within the relevant market and generating immediate revenue.