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Biotech Patents Under Fire

What Supreme Court decisions say about threats to the progress of personalized medicine.

Ronald I. Eisenstein and David S. Resnick

On the face of it, the recent decision by the US Supreme Court in Laboratory Corp. of America v. Metabolite Laboratories seems like a footnote. LabCorp was sued for patent infringement and lost. Upon appeal, the Supreme Court dismissed the case, saying that it should not have granted review. Open and shut, except that the dissent justices opened a can of worms that will be wiggling their way through the field of personalized medicine for years to come.

The case stems from US Patent No. 4,940,658, which is based on the discovery that there is a relationship between elevated levels of total homocysteine and a deficiency in either cobalamin (vitamin B12) or folate (folic acid). The claim focused on a method of detecting the deficiency of B12 or folic acid in warm-blooded animals, and using this in an assay for B12 or folic acid deficiency. The patent was assigned to...

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