Last week, the US Supreme Court issued a long-awaited decision in Myriad Genetics, which sent shockwaves through the very foundation of the biotech industry. The decision invalidated one of Myriad’s patents on mutated BRCA-gene sequences associated with increased risk of breast cancer. Though widely referred to as “a gene patent,” Myriad’s patent, in fact, did not claim genes per se, but instead claimed the sequences in their “isolated” form. Such claims –“isolated XYZ substance”–have long been widely accepted as a valid approach for claiming purified or isolated substances extracted from nature (e.g., insulin, antibiotics, blood coagulation factors, to name a few). The Federal Circuit has twice considered these claims and upheld them both times. Nevertheless, the Supreme Court held that for genomic sequences “isolation” does not go far enough in distinguishing them from the genomic DNA. According to the Court, such claims are merely trying to protect “natural phenomena.”
The article presents the six most salient points that every biotech executive should bear in mind in the post-Myriad world.
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