Commercial laboratories can’t patent naturally occurring genes after all, according a court ruling issued Monday.
Patents are supposed to cover inventions, so it would seem that the DNA of a naturally occurring living organism shouldn’t be able to be patented. The U.S. patent office, though, has been granting an exception to that based on a court ruling that allows “isolated” gene sequences to be patented. The new court ruling suggests that the patent office has misinterpreted the earlier ruling, which is meant to apply only an active product made from a physically isolated gene sequence. The routine laboratory activity of looking at, or testing, specific gene sequences is not what is meant by “isolating” them.
If this ruling stands up on appeal, as I expect it ultimately will, it will invalidate all patents on naturally occurring genes. This means scientists who discover important gene sequences will not be able to gain a copyright-like protection of those gene sequences by using the patent process. It also means that a new genetic test must involve a novel, non-obvious testing procedure to be patentable. You can’t patent a gene test you design if it uses industry-standard techniques and the only thing that is “novel” about it is the specific genes you are testing.
If genes are not “novel” in the legal sense and cannot be patented, it will open the door for more vigorous research into medical conditions. Many diseases have genetic components, but gene patents have prevented scientists from looking into these connections. Now, it appears, scientists will be free to investigate the genetic components of any disease they might be studying.