In Gene Patent Case, Judge Tells Myriad: "You Don't Know Funk"
Myriad Genetics (MYGN) may have lost its gene patents -- and potentially cost the pharma and biotech industries theirs -- based on a subtle, but ultimately colossal, misunderstanding of a 62-year-old court case called Funk Brothers.
A New York federal court yesterday invalidated a series of Myriad patents on sections of human DNA that relate to breast cancer, because DNA exists in a naturally occurring form and is thus beyond patent protection. The ruling will make it more difficult for any drug company to get patents on a pharmaceutical that's merely a refined version of something occurring in nature.
In his ruling, Judge Robert Sweet leaned heavily on Funk Brothers, a 1948 case in which the Funk Brothers Seed Co. sought a patent for a mixture of bacteria that were good at fixing nitrogen in the soil and, crucially, did not inhibit other bacteria from doing so. The U.S. Supreme Court ruled -- and Sweet agreed -- that even though the Funk Brothers' idea was ingenious, it was not patentable because the bacteria already existed in nature and weren't invented.
Sweet, in a footnote on page 108 of his ruling, suggested that Myriad misunderstood the Funk case. Indeed, in Myriad's brief, the company mentions Funk only once and describes it as a case that illustrates how "obvious" inventions aren't patentable. Sweet wrote:
Myriad suggests that the Supreme Court's holding in Funk Brothers was premised on an obviousness determination, rather than patentable subject matter. Subsequent Supreme Court opinions, however, have treated the holding in Funk Brothers as a statement of patentable subject matter.Myriad may not be the only company -- or court -- that misunderstands Funk. At least two other cases have held that chunks of DNA can be patented, one involving Amgen (AMGN). So if Myriad has this right and Sweet has it wrong, we'll be revisiting Funk-town again on appeal.
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