“Precision Medicine” Initiative Leaves Patents “Lost in Space”

On January 30th, the White House released a press release expanding upon President Obama’s mention of “precision medicine” in his State of the Union Address. Not surprisingly, the details are pretty much what we who are involved in various aspects of “personalized medicine” would expect – an emphasis on the use of genomic diagnostics to improve treatment selection – especially for cancer patients. The largest of the “Key Investments” listed would be to the NIH to develop what looks like the creation of a reference data base “through engaged participants and open, responsible data sharing.” The NCI would get $70 million to “identify genomic drivers in cancer” and develop more effective approaches to treatment.

While one of the stated goals of the Initiative is to “accelerate biomedical discoveries” via “managing and analyzing large data sets,” the need for adequate patent protection for these advances is nowhere mentioned. Of course, as we all know by now, the Federal Circuit has twice held that claims to comparing a patient’s DNA sequence with a reference DNA sequence are patent ineligible “abstract ideas” and one other time, held that a diagnostic “If A, then B” diagnostic test was patent-ineligible as an attempt to patent a natural phenomenon – an opinion apparently shared by Justice Breyer.

President Obama has put forth big ideas before that have gone nowhere in Congress. But the area of personalized medicine, particularly companion diagnostics, is the new “It Girl” of life sciences, and it doesn’t even require disassembling zygotes to function. Too bad the White House missed a chance to support better—or any– patent policies in this area, but if one thing hasn’t changed, it is that no politician wants to be in favor of “patenting genes.”

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