A Near-Miss on Gene Patents in Congress
In March 2010, U.S. District Court Judge Robert Sweet ruled to invalidate patents held by Myriad Genetics on the BRCA1 and BRCA2 genes, mutations of which are associated with heritable forms of breast and ovarian cancer. The ruling was a huge boost to a lawsuit that challenges the patents on the grounds that human genes, 20% of which are currently "patent-protected," are naturally occurring materials and thus should not be patentable. The American Civil Liberties Union (ACLU), along with several women's health, patient advocacy, and molecular pathology groups, also argue that gene patents stifle medical research in general and that Myriad's monopoly over testing for BRCA mutations poses serious threats to women's health.
This April, the case was brought before the U.S. Court of Appeals and a decision is expected sometime in late July. Although May and June have been somewhat of a waiting period before the litigation moves forward (many believe to the U.S. Supreme Court), much has been astir on the legislative end of the gene patenting issue. Until recently, Congress has been wary of weighing in on gene patents due to lingering questions and concerns, which it hopes the courts will clarify.
One such concern is whether or not the public health and access issues posed by gene patents might be addressed by allowing patients to seek second opinion testing for genetic conditions involving patented genes. As it stands, when a company or research institution holds a patent on a human gene, as does Myriad on the BRCA genes, it has exclusive control over who can develop tests for that gene. A second opinion allowance would create a "safe harbor" for third-party (non-patent holding) companies to offer confirmation tests, without fear of being sued for infringement.
Last week, Florida Congresswoman and Chair of the Democratic National Committee Debbie Wasserman Shultz introduced an amendment to the U.S. patent reform bill (Section 27 of H.R. 1249-America Invents Act) that would grant such an allowance.
The proposal drew quick and fierce opposition from a coalition of activist and civil society groups spearheaded by the ACLU, Friends of the Earth (FOE), International Center for Technology Assessment (ICTA), and American Medical Association. While they recognize that Wasserman Shultz's amendment seeks to address some of the harms to patients posed by gene patents, they worry that an isolated and relatively weak legislative work-around like this one would threaten the more important goals of the ongoing case: a broad ban on gene patents. They worry that if Congress were to adopt the amendment, Myriad and other biotech interests will argue in court that Congress has provided implicit consent to the patentability of genetic material.
These and other concerns were laid out in a coalition letter [pdf] to Congress. In addition to ACLU, FOE, and ICTA, signatories included the Center for Genetics and Society, Our Bodies Ourselves, and Breast Cancer Action. As the letter explains,
The harms created by gene patents extend far beyond the barriers presented to second opinion testing, and any legislative proposal should address these as a whole. Gene patents limit the availability of and access to testing in the first instance, impede the development of new and different types of tests, and chill genetic research because scientists fear accusations of patent infringement and liability.
Rep. Wasserman Shultz responded to these objections by submitting a revised amendment excluding the second opinion allowance, but calling instead for the U.S. Patent and Trademark Office to "conduct a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist."
While this new amendment language could possibly still be construed by gene patent proponents as implicit Congressional consent to the patentability of genes, the record shows that this is far from the intent of Congress in requesting this study. Even so, gene patent proponents will likely try any legal argument they can think of to support their IP portfolio and profits (remember - this is the same industry that argued elements such as lithium should be patentable!).
This experience shows the need for constant vigilance from the advocacy community that is working to bring an end to the patenting of all genetic material. Well-intentioned legislative language can sometimes undermine advocacy efforts, ultimately causing more harm than good. Even if the ACLU and plaintiffs win the appellate court case, proactive legislation to ban the patenting of all genes and DNA sequences will be needed - either to correct a bad ruling or to defend a victory.
Special thanks to Eric Hoffman of Friends of the Earth for consulting on this post.
Previously on Biopolitical Times: