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Invalid! The Supreme Court Questions the Basis for Diagnostic Patents

 
• By Roger Longman

The Supreme Court has decided to hear a case--LabCorp. vs Metabolite--that could invalidate patents based on the correlation between natural biological markers, like proteins or genes, and a disease. The case strikes at the heart of the new diagnostics start-ups-and could also invalidate a host of pharmaceutical IP strategies.

"I don't like to be alarmist," says Vern Norveil, a partner at Wilson Sonsini Goodrich & Rosati, "but this case could be a disaster for the industry if the [Supreme Court] goes too far." The industry is diagnostics—and specifically the burgeoning world of diagnostic start-ups. The case—due to be heard in March—goes to the very heart of the new biomarker-based diagnostics industry: whether a patent on the correlation between natural biological markers, like proteins or genes, and a disease is valid.

The story's beginnings didn't appear portentous. A predecessor company of Competitive Technologies Inc. , a firm which buys and...

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