More Myriad: Moving Beyond Single Gene Patents

Unless you have been living under a rock – or, if you hail from the Northeast, living under water – Monday’s decision in Association for Molecular Pathology v. USPTO is no longer new news. Previous coverage from the Genomics Law Report (here and here) reviews Judge Sweet’s opinion and its implications.

Moving Beyond Single Gene Patents. Much of the discussion following the decision has centered on what effect the invalidation of Myriad’s gene patents – should that decision be affirmed by a higher court and extended to other similar patents – will have on scientific and commercial innovation.

In many ways, that issue is at the center of the policy debate surrounding Sweet’s opinion and, more generally, the appropriateness of certain biotechnology patents. It’s a question that’s difficult to answer prospectively, but Andrew Pollack’s piece in The New York Times succinctly makes an important point about an emerging reality in the biotechnology industry.

…[T]he [biotechnology] industry is already moving to a period of somewhat less dependence on DNA patents for its sustenance. Diagnostic laboratories, for instance, are shifting from testing individual genes to testing multiple genes or even a person’s entire genome. When hundreds or thousands of genes are being tested at once, patents on each individual gene can become a hindrance to innovation rather than a spur.

The standard story that links gene patents to innovation says that, without strong biotechnology patents, including gene patents, researchers and investors will lack the incentive needed to invest time and money into the research and companies that ultimately produce valuable health care services, such as Myriad’s breast cancer susceptibility test.

As Pollack points out, that thesis is coming under increasing scrutiny. While this is not a new issue – the recent SACGHS report includes an extended discussion – Judge Sweet’s opinion is helping to focus the public’s attention in a way that the SACGHS report did not. It seems increasingly likely that the biotechnology patent landscape will need to be reshaped, in some fashion, if it is to promote true scientific and clinical innovation, such as the transition from single gene testing to multiplex testing and whole-genome sequencing.

Misha Angrist identifies this issue as well, and points to research he performed with Duke colleagues – which also appears in the SACGHS report on gene patents – that suggests patent “monopolies are not necessary incentives for innovation in DNA diagnostics.” Angrist also points out that patents do not persist forever – by the time AMP v. USPTO reaches a final decision, several of Myriad’s core patents may have only a few years of life left – but 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. As has been said many times previously, the AMP v. USPTO decision is an important step in that direction, but it is only a step.

Share Your Own Thoughts. While the commenting feature here at the Genomics Law Report was broken (it is now fixed), a good discussion about the implications and the wisdom of Judge Sweet’s ruling has broken out over at Genetic Future. Please share your own perspective on these issues there, as well as here.

Meanwhile, in a bit of fortuitous timing, there is a long-scheduled Genetic Alliance webinar tomorrow at noon on the topic of “How and Why Genes are Patentable.” The webinar will feature the GLR’s own John Conley. John will review the law surrounding gene patents, as well as share his thoughts on AMP v. USPTO and how the Federal Circuit – which gets to hear the case next – might react to Judge Sweet’s surprising decision.

Filed under: Badges, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation
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