Gene Patenting Decision: Undesirable Result or Pointless Ban?
The gene patenting case by the ACLU and patient groups against biotech company Myriad Genetics is motivated in large part by a desire to have knowledge and use of discoveries free and open to all rather than owned and locked up by single patent holders. While this attractive aspiration has caught favor with most of the public, it conflicts with market realities of biomedical assays and therapies. The reality is that most new biomedical assays and therapies would not be developed unless the developer has some assurance that their (usually large) investment in development can be compensated by profits down the line. While the facts around development of any given assay or drug are complicated and will differ, two likely scenarios illustrate why the ACLU’s anti-gene patent position will either be counterproductive to development of biomedical assays and therapies (the Undesirable Result Scenario) or will be ineffective at producing free and open use of gene discoveries (the Pointless Ban Scenario).
In the Undesirable Result Scenario, assume that patent protection on a gene is essential for an assay developer to recoup development costs. In this scenario, the developer could spend millions of dollars developing and gaining approval of an assay, but without patent protection, could not prevent competitors from swooping in and simply implementing the developer’s assay with little development costs. Undercutting the developer’s price (due to lower investment), the competitors can capture the market and keep the developer from making back their development costs. In the real world, developers that see this scenario before them will simply refrain from developing an assay when they do not have effective patent protection. This effect, repeated many times over many years will ultimately limit the development of many new assays and therapies that depend on gene patents. This is the undesirable result.
In the Pointless Ban Scenario, assume that an assay can be protected by patenting some aspect other than the gene involved. In this scenario, the developer would spend millions of dollars developing and gaining approval of an assay safe in the knowledge that it could prevent competitors from copying the developer’s assay. The developer’s assay would be protected by a non-gene patent. But then a prime goal of the gene patent ban would not be realized, since the assay would still be controlled by the patent-holding developer. Although the first scenario shows that this is a desirable result in order to promote assay development, it renders a ban on gene patenting pointless.
The gene patenting case by the ACLU and patient groups against biotech company Myriad Genetics is motivated in large part by a desire to have knowledge and use of discoveries free and open to all rather than owned and locked up by single patent holders. While this attractive aspiration has caught favor with most of the public, it conflicts with market realities of biomedical assays and therapies. The reality is that most new biomedical assays and therapies would not be developed unless the developer has some assurance that their (usually large) investment in development can be compensated by profits down the line. While the facts around development of any given assay or drug are complicated and will differ, two likely scenarios illustrate why the ACLU’s anti-gene patent position will either be counterproductive to development of biomedical assays and therapies (the Undesirable Result Scenario) or will be ineffective at producing free and open use of gene discoveries (the Pointless Ban Scenario).
In the Undesirable Result Scenario, assume that patent protection on a gene is essential for an assay developer to recoup development costs. In this scenario, the developer could spend millions of dollars developing and gaining approval of an assay, but without patent protection, could not prevent competitors from swooping in and simply implementing the developer’s assay with little development costs. Undercutting the developer’s price (due to lower investment), the competitors can capture the market and keep the developer from making back their development costs. In the real world, developers that see this scenario before them will simply refrain from developing an assay when they do not have effective patent protection. This effect, repeated many times over many years will ultimately limit the development of many new assays and therapies that depend on gene patents. This is the undesirable result.
In the Pointless Ban Scenario, assume that an assay can be protected by patenting some aspect other than the gene involved. In this scenario, the developer would spend millions of dollars developing and gaining approval of an assay safe in the knowledge that it could prevent competitors from copying the developer’s assay. The developer’s assay would be protected by a non-gene patent. But then a prime goal of the gene patent ban would not be realized, since the assay would still be controlled by the patent-holding developer. Although the first scenario shows that this is a desirable result in order to promote assay development, it renders a ban on gene patenting pointless.
