The OncoMouse patent is one of several whose scope is limited by the European Patent Office. Credit: Oak Ridge National Laboratory

Researchers in Europe are benefiting from the European Patent Office's (EPO) decision to prune several high-profile patents, a result of key differences between US and European policy. The EPO's rulings broaden avenues of research that would otherwise be choked off by licensing fees, but some scientists and citizen groups say the decisions are still not enough.

On 6 July, the EPO restricted a patent on the OncoMouse model for cancer research from including all rodents to just mice. In May, the agency revoked one of three patents Salt Lake City–based Myriad Genetics has on the breast cancer gene BRCA1. Months earlier, the EPO had granted a patent similar to Myriad's on another breast cancer gene, BRCA2, to Cancer Research UK. The charity announced in August that it would allow free access to academic researchers, undermining Myriad's position.

Unlike the US, Europe forbids patents that threaten ''ordre public' or morality.' The EPO invoked this clause against the OncoMouse patent and, in July 2002, the Edinburgh patent on stem cells.

The agency is also less flexible in allowing corrections to patents, says Siobhan Yeats, EPO's director of Examination and Opposition in Biotechnology. Corrections to Myriad's initial BRCA1 patent, which was found to have gene sequencing errors, would not be allowed in Europe, says Yeats.

Those sequencing errors might be enough to overturn the other two BRCA1 patents in Myriad's portfolio, says Gert Matthijs, a geneticist at the University of Leuven, Belgium. But scientists cannot rely on such technicalities to battle patents, he notes. “What will happen with other major patents that don't have errors?”

Matthijs says he is worried about patents on BRCA2, against which he and others filed an opposition earlier this year, and on a gene related to the disease hemochromatosis, for which a European patent is expected next year. Those patents lack an “inventive step,” he says. Isolating and sequencing a mapped gene “is a major breakthrough but not a major invention.”

[Sequencing a mapped gene] is a major breakthrough but not a major invention. Gert Matthijs, University of Leuven, Belgium

Fortunately for Matthijs, the EPO allows 'routine' questioning of patents, and about 80% end up being limited. One reason for this is that the cost for opposition is in the tens of thousands of dollars, compared with hundreds of thousands in the US, giving even citizen and animal rights groups the opportunity to contest patents.

Still, the road ahead for these patents is unclear. Patent opponents argue that the OncoMouse patent, which had already been restricted in 2001 from covering all mammals, should be overturned completely. “It just solves a small controversy on the broad scope of the patent,” says Marcos Malumbres, a researcher at the Spanish National Cancer Centre.

The OncoMouse patent can no longer be challenged except at the level of EPO member-states. The BRCA1 and Edinburgh decisions are awaiting appeals. In the case of BRCA2, the existence of two conflicting patents on the same gene has led to confusion among researchers—and at the EPO itself. Asked what a researcher should do in the BRCA2 case, says EPO's Yeats, “Consult a lawyer.”