EXPERT CHALLENGES VALIDITY OF GENETIC TEST PATENTS

In a letter published the most recent issue of the New England Journal of Medicine, molecular pathologist and attorney Roger Klein of the Yale University School of Medicine questions 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, citing a recent Supreme Court case.

"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."