Outcome of Metabolite case could revolutionize what can and cannot be patented

By Julia Spalding

Published on March 21, 2006

The potentially blockbuster case involves Patent No. 4,940,658, a two-step method that describes how homocysteine levels can be measured in a blood or urine sample, and how high levels of this amino acid can mean a deficiency in folic acid or B12, a condition that signals serious health problems.

The method, which costs a couple of dollars to perform, was patented by three medical school doctors in 1990. It is used tens of millions of times a year by medical labs such as Laboratory Corp. of America Holdings.

LabCorp stopped paying some royalties on the patent in 1998 and was sued by the patent's holders, including Metabolite Laboratories Inc. and Competitive Technologies Inc. LabCorp lost the case and was ordered to pay about $5 million. They subsequently lost an appeal where they argued that the patent was too vague and gave its owners a monopoly over a natural phenomenon. Metabolite countered that the patent covers a practical application of a scientific discovery that is used as part of a specific diagnostic step.

The outcome of Laboratory Corporation of America Holdings v. Metabolite Laboratories Inc., et al., could lead to restrictions on new patents -- and challenge tens of thousands of existing patents on drugs, medical devices, computer software and other inventions.

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