Expert questions validity of genetic testing patents

Molecular Pathologist-Attorney Roger D. Klein in a letter published in the February 15, 2007 issue of the New England Journal of Medicine questioned the validity of patents often used to prevent clinical laboratories from performing certain genetic tests.

Such patents cover relationships between individual genetic variations and inherited predisposition to diseases like cancer, or the likely benefits and side effects of medicines in given patients.

Argues the Yale affiliated and educated doctor-lawyer, "These patents claim ownership over mere biological correlations in violation of the longstanding prohibition against patenting natural phenomena."

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. "Although procedural constraints appeared to persuade the Court not to rule in LabCorp," Klein asserts, "by sua sponte raising the natural phenomenon issue the Court made it clear that the 'natural phenomenon doctrine' is still very much alive." While addressing the Association for Molecular Pathology in November 2006, Klein elaborated on these statements.

"Unlike the recombinant production of drugs and vaccines, which requires extensive mechanical alteration of underlying genes, genetic testing involves straightforward applications of legitimately patented techniques and instruments. When performing genetic testing," Klein explains, "DNA is solely used for its informational, as opposed to its chemical, content.

This places patents on genetic testing squarely within the natural phenomenon doctrine." Klein concludes, "Patent holders claim that they can prevent any individual from looking at information contained in his or her DNA. Under United States' law, this just isn't the case."

Roger D. Klein, MD, JD