The business of diagnostic treatments and personalized medicine got a boost Tuesday after an appeals court made it harder to invalidate certain patents by claiming they simply cover laws of nature.
Patents can be obtained for processes relating to laws of nature if they go at least one step further, the U.S. Court of Appeals for the Federal Circuit said. The Washington court, which specializes in patent law, overturned a ruling that a patent owned by closely held Rapid Litigation Management Ltd. was invalid, and revived an infringement suit against a unit of Thermo Fisher Scientific Inc.
The ruling could make it easier to obtain patent protection for a fast-growing area of medicine where doctors are increasingly using a patient’s DNA or other individual information to create customized treatment plans without having to use trial and error.
Tuesday’s decision was one urged by the trade group representing biotechnology companies and the National Venture Capital Association. Court rulings involving isolated DNA and diagnostic tests have resulted in “ mounting uncertainty” over what is eligible for legal protection, according to the Biotechnology Innovation Organization. Along with the rest of health care, service companies are hurting — the S&P 500 Health Care Services Select Industry Index has fallen 12 percent in the past 12 months through Friday. George Goodno, a BIO spokesman, had no immediate comment.
The dispute is over a way to preserve a type of liver cell known as hepatocytes, used for things like testing the toxicity of a new drug. There’s a limited supply for researchers and the cells have a short lifespan in labs, and it was earlier believed they could only be frozen once and then had to be discarded.
The inventors on the patent discovered that some hepatocytes could survive multiple freezings and thawings, and created a process to weed out the cells that were most likely to still be viable after the second freezing.
Were this not be eligible for a patent, “no one could ever get a patent on cryopreservation, or on any other innovative method that acts on something that is naturally occurring,” Chief Judge Sharon Prost wrote for the three-member panel.
The Supreme Court of the United States has been clamping down on what can be patented, putting limits on isolated DNA, some diagnostic tests and software. Some Federal Circuit judges have warned that the cases together have endangered the ability to obtain patents on medical diagnostics.
As a result of those rulings, courts and patent examiners have struggled to find the line between something that happens in nature and the “inventive application” of it. In this case, it was between the natural ability of hepatocytes to survive being frozen multiple times, with the technological process of figuring out which ones would remain viable.
The case is Rapid Litigation Management Ltd v. CellzDirect Inc., 15-1570, U.S. Court of Appeals for the Federal Circuit (Washington).