The U.S. Supreme Court agreed to hear, for a second time, a lawsuit challenging patents held by Myriad Genetics on human genes implicated in breast cancer.
The court, in an order today, said it would consider only the question of whether human genes can be patented, meaning it plans to dive straight into one of the most contentious — and elusive — questions in patent law, which is the difference between an invention and a natural phenomena. Opponents of the patents say they prevent researchers from even examining naturally occurring genetic material that companies have patented. Supporters say the law allows patents on any process that isolates a valuable substance, even if it’s naturally occurring, citing industrial processes to create useful products out of hydrocarbons and plant material.
This will be the second trip to the Supreme Court for the Myriad case, which the high court sent back to the Court of Appeals for the Federal Circuit in Washington in March for reconsideration after it issued a decision narrowing the scope of allowable patents. The D.C. Circuit upheld the patent again in August, in what might be seen as a direct challenge to the high court’s interpretation of patent law. In its order accepting the case again, the court said it would limit both sides to the simple, but confounding, question of whether human genes can be patented.
The case pits Salt Lake City-based Myriad against researchers and critics who said Myriad’s patented on the BRCA genes found in breast tumors hindered research into the deadly disease. Myriad lawyers have sent threatening letters to the University of Pennsylvania and others, urging researchers isolating those genes to desist or pay royalties. The ACLU joined with the Association for Molecular Pathology and other groups in urging the court to declare such purified snippets of DNA as unpatentable.
Some patent lawyers — and two of the three judges on the D.C. Circuit — believe the case presents nothing more than an old dispute over whether “laws of nature” can be patented. Given the amount of work involved in actually isolating genes from the much larger DNA molecule transforms them into something useful, the majority said, just like any other industrial process based on naturally occurring compounds. The refining industry has thousands of patents on processes that revolve around extracting naturally occurring hydrocarbon molecules, for example; it’s the difficulty of creating hydrocarbons any other way that makes crude oil so valuable.
Opponents of human genes say such patents hinder research. They seem to have support on the Supreme Court, which has taken a skeptical view of overbroad patents in recent decisions.