Expert Challenges Validity of Genetic Test Patents

In a letter published in the Feb. 15 issue of the New England Journal of Medicine, molecular pathologist and attorney Roger Klein of the Yale University School of Medicine questioned the validity of patents used to prevent clinical laboratories from performing certain genetic tests.

Such patents cover relationships between individual genetic variations and inherited predisposition to particular diseases, or likely drug benefits and side effects in certain patient populations. “These patents claim ownership over mere biological correlations in violation of the longstanding prohibition against patenting natural phenomena,” Klein said.

“Molecular genetic testing is rapidly increasing in importance,” Klein said. “Yet correlation patents are already restricting its availability, resulting in increased costs, diminished access, decreased innovation and an inability to confirm results.”

In June 2006, the Supreme Court declined to decide the case of LabCorp v. Metabolite Laboratories, which posed questions about the patentability of analogous correlations between bodily chemicals. “The most important implications of the LabCorp case are for patents that claim analogous correlations between genetic variants and predisposition to disease, therapeutic drug response and susceptibility to pharmacologic side effects,” Klein said.

If the disputed claim in the LabCorp case is invalid, such patents may also be invalid, Klein added, noting that the dissenting opinion of Justices Stephen Breyer, David Souter and John Stevens “is cause for optimism that in a future case the court will rule in the best interests of our patients.” — Anne Cook