Should Genes be Patentable?

In a ruling that shocked most patent lawyers, a federal court has ruled that human genes may not be patented. The case involved seven patents on genes are thought to be related to breast and ovarian cancer. The plaintiffs — women who have cancer along with genetic researchers and medical associations — argued that the patents are not legal for DNA, which is something that occurs naturally and is not invented, The plaintiffs also objected to how the patents inhibited their access to tests for breast cancer, because the patent precludes the development of competitive tests.

The ruling by Judge Robert W. Sweet sent shock waves through the biotech world because it threatens to invalidate thousands of other patents on genes and human tissue. On the other hand, the case is almost certain to be appealed, and any resolution could take years. Moreover, the U.S. Supreme Court ruled in 1980 — in a case that opened the door to gene patents in the first place — that living things can be patented. Overcoming that precedent could be a formidable challenge.

Investors and biotech companies claim that the patents are essential for providing the financial incentive to researchers to develop new medical diagnostic tests and treatments. But others argue that that claim in unsupported. Other diseases, such as Huntington’s Disease, have genes that remain unpatented, and yet there is robust competition in the development of diagnostic tests. Indeed, the case can also be made that allowing patents for a given set of genes can deter researchers from investigating further, lest they get sued for patent infringement.

This case, Association for Molecular Pathology v. U.S. Patent and Trademark Office, was clearly aimed at challenging the broad patents on living things that have emerged over the past thirty years. Judge Sweet showed considerable courage in finding that DNA as a chemical isolated from nature (which can therefore be patented) is essentially the same as DNA as found in nature (which cannot be patented).

The plaintiffs had written that “many scientists in the fields of molecular biology and genomics, have considered this practice [isolating DNA from nature] a 'lawyer’s trick’ that circumvents the prohibitions on the direct patenting of DNA in our bodies but which, in practice, reaches the same result." (The plaintiff were represented by the ACLU and the Public Patent Foundation at the Cardozo School of Law.)

In light of the established legal doctrine and the Supreme Court’s 1980 ruling, it is difficult to imagine the federal courts forcing a wholesale retreat from the patenting of genes and other lifeforms. Still, this ruling is a welcome opening and an appropriate time to re-visit the accumulated abuses of the patent system.

Too, the Supreme Court is considering another major patent case at the moment, the "Bilski case," which also involves overly broad patents — in this case, for a business method for hedging risk in the commodities market. So perhaps, just perhaps, there will be a wider, more vigorous debate about the proper scope of patents. It’s about time.

You can read the federal district court decision by Judge Sweet here.