Sofosbuvir - a $2.54bn infringement in the US, but not in Europe

It is a common misconception among inexperienced (typically would-be) patentees that getting a patent for their invention will give them the right to commercialise it. As I have had to explain quite often to new clients, there is a big difference between these two things. A patent only gives you the right to stop others from doing what the claims cover, while being free to put your invention into practice is dependent on not being found to infringe anyone else's patent.

A good recent example of this difference is the verdict from the case of Idenix Pharmaceuticals LLC v Gilead Sciences Inc, as reported here and many places elsewhere. Gilead were found to have infringed US 7,608,597, and have been ordered to pay $2.54 billion in damages. Gilead have their own patent on the infringing drug, known as Sovaldi and Harvoni and with the generic name sofosbuvir, which I have written about here and here in relation to the European patent. Gilead do, of course, have a corresponding US patent for the drug, but this did not help them in their case against Idenix.

What is also interesting about this case though is the contrast that it shows between what can be achieved in the US and what can be done with the same starting material in Europe. Claim 1 of the US patent is very brief, and reads as follows:

1. A method for the treatment of a hepatitis C virus infection, comprising administering an effective amount of a purine or pyrimidine 𝛽-D-2'-methyl-ribofuranosyl nucleoside or a phosphate thereof, or a pharmaceutically acceptable salt or ester thereof.

Claim 1 of the only corresponding granted European patent EP2319856B1, however, is very very long indeed, much too long to be reproduced in full here. It starts off in a similar vein, defining a pharmaceutical composition for use in a method for the treatment or prophylaxis of a Hepatitis C virus infection in a host, but then goes on for a further two pages with various structural features and alternatives. What was possible in the US therefore seems to be impossible in Europe in this case. Not only would sofosbuvir alone not be an infringement of the European patent (I am fairly sure about this, but happy to be proven wrong), but also European courts do not go for such huge damages as are found in the US (although the headline $2.5 billion figure is very likely to be whittled down on appeal).

Another interesting feature of this long-running story is that an infringement action has already been tried by Idenix against Gilead in Europe, but this ran aground when Mr Justice Arnold at the England & Wales High Court found that Idenix's patent EP1523489B1 was invalid (see the IPKat post here), and this was upheld on appeal. So, at the moment at least, it looks like Gilead have done very well in Europe to keep their patent on sofosbuvir and also avoid it infringing anyone else's, but the story is very different in the US. This seems to be largely down to more thorough examination in Europe, both at the EPO and the courts (although this does not always apply: see my recent post here), compared with the generally far more lenient USPTO and more patent friendly court system in the US.