The discussion that started with a federal court overturning two gene patents continues as the biotech industry, researchers and lawyers debate the merits of the decision, the chances of an appeal, and the future of genetic research. As the debate continues, some say it's not really a big deal, and the emerging consensus is that this ruling may actually be a good thing if it forces companies to think outside the patent box and start innovating again.
The idea that researchers and investors will lack incentive to invest time and money into research such as what led to Myriad's breast cancer susceptibility tests without gene patents is coming under increased scrutiny, according to the New York Times' Andrew Pollack. And Genomics Law Report's Dan Vorhaus agrees, saying it's likely that the biotech patent landscape will have to change, perhaps transitioning from single gene testing to multiplex testing and whole-genome sequencing, adding that by the time the decision has gone through the appeal process, several of Myriad's core patents will be near expiration. "There are good reasons to believe that the coming collision between single gene patents and multiplex genetic testing will demand material change in advance of organic patent expirations," Vorhaus writes.
Michael White at Adaptive Complexity calls gene patents "an obsolete and ineffective model for intellectual property protection that maybe made more business sense in the 1990s, but not now." Gene patents have been inhibiting both research and diagnostics based on genome-wide genotyping, he adds. At the Cross-Border Biotech Blog, Jeremy Grushcow says no matter what people's opinions on the decision are, it has people thinking about DNA, genomics and innovation, "and that’s never a bad thing."
As everyone starts thinking more about the case, some say that Myriad's patents were granted based on a faulty understanding of what constitutes an invention. Bnet blog's Jim Edwards says a "subtle, but ultimately colossal misunderstanding" of a 62 year-old court case may have cost Myriad their patents. In 1948, the Funk Brothers Seed Co. wanted a patent for a mixture of bacteria that were good at fixing nitrogen in soil and didn't inhibit other bacteria from doing the same thing. At the time, the Supreme Court ruled that this wasn't patentable because it occurred in nature and wasn't invented. Judge Robert Sweet relied heavily on the case, Edwards says, and suggests that Myriad misunderstood the ruling. In Myriad's brief, the company mentions Funk and describes it as a case that illustrates how "obvious" inventions aren't patentable, Edwards writes. But in his ruling, 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." This point could be revisited on appeal, Edwards says.