A LEGAL battle that could have big consequences for the biotech industry began on Monday.
The case, the latest round in a long-running patent war, is about the human blood protein erythropoietin, which stimulates the production of red blood cells. EPO is used to treat anaemia (and by cheating athletes), and is the top-selling biotech drug, earning an estimated $4 billion last year.
The protein is currently made by Amgen of Thousand Oaks, California, using animal cells genetically engineered to make human EPO. But another company, Transkaryotic Therapies (TKT) of Cambridge, Massachusetts, wants to sell a rival version called Dynepo that is made in human cells by turning on the EPO gene.
Advertisement
Amgen argues that TKT is infringing its patent on producing EPO. TKT says there is no infringement because it has not manipulated the EPO gene itself. The companies have been slugging it out in courts around the world since 1997.
Over the next two weeks, the UK鈥檚 highest court, the House of Lords, will decide whether to uphold an earlier verdict by the court of appeal in favour of TKT. If it does so, it could open the way for rival versions of other blockbuster human proteins, such as growth hormone. A UK decision could also set a precedent for decisions in other European countries.