Two recent hearty judgments

In the past few days two substantial, and clearly commerically important, judgments have issued from the Patents Court, one relating to a way of stopping heart attacks before they happen, the other relating to a way of fixing hearts when they go wrong.  

The first one, Corevalve v Edwards Lifesciences [2009] EWHC 6 (Pat), related to a type of valve covered by EP0592410, owned by Edwards. Corevalve, a competitor to Edwards in the field of artificial heart valves, applied to revoke the patent on the grounds of anticipation, obviousness and insufficiency. In return, Edwards counter-claimed that Corevalve were infringing the patent.

The claimed valve was in the form of a collapsible stent, enclosing a flexible membrane-type of valve, developed by its Danish inventor back in 1990 using heart valves retrieved from pigs. The patent claimed that the stent was deliverable by catheter, i.e. was able to be collapsed to a small enough diameter that it could be inserted via an artery (usually the femoral artery), put in place at the right position next to the patient's heart and allowed to expand to its normal diameter.  The patent said very little, however, about how this would be done in practice.  

Mr Peter Prescott QC, sitting as deputy judge of the High Court, heard much expert testimony relating to how difficult such a procedure actually was in practice, but determined that the validity of the patent was not really affected by the fact that it was clearly insufficient in this regard, particularly because it did not claim the method of installing the valve (which would, of course, be unpatentable anyway).  It was enough that the patent described the valve in terms sufficient for the skilled person to go ahead and make it.  As for Corevalve's claims for the patent being anticipated and obvious, these claims were dismissed because there were apparently no enabling disclosures around at the time the invention was made that disclosed or suggested to the skilled person a stent-type artificial valve that could be implanted by catheterisation.  The patent was held to be valid, but not infringed. 

The other judgment, Actavis v Novartis [2009] EWHC 41 (Ch), related to another European patent, EP0948320, which claimed a formulation for a drug intended to prevent heart attacks caused by high cholesterol.  The drug, fluvastatin, was one of a family of drugs together known as statins, used to lower levels of LDL cholesterol in the body by affecting its synthesis in the liver.  One alleged problem at the time the patent was applied for was that of maintaining the correct level of drug in the body, for which the patent provided a solution in the form of a 'sustained release' composition, i.e. a formulation that allowed the drug to be slowly released over time through being bound together with a material that slowed its dissolution when passing through the body.  

A huge amount of expert testimony was heard by the judge, Mr Justice Warren (presumably a result of there being a huge amount of money at stake), but in the end the judgment was one that could probably be predicted from a quick look at the claims and from two facts: i) fluvastatin was known for a long time before the patent was applied for; and ii) sustained release formulations were well known at the time.  Since the skilled person, in the form of a research team, would know of these facts, it would be an obvious step to combine them.  The patent was consequently found to be invalid for being obvious.  

More about heart valves here, here and here. 

How to spot evergreening here.