PACEOMICS joins with Duke University’s Sanford School of Public Policy to examine gene patenting after the Supreme Court’s ruling in Association of Molecular Pathologists (AMP) v. Myriad Genetics.
March 13-14, 2014
PACEOMICS researchers from the University of Alberta and McGill University joined with Duke University’s Sanford School of Public Policy and the Office of US representative Debbie Wasserman Schultz to host a Congressional Briefing and two workshops in Washington D.C. on the implications of two Supreme Court of the United States (SCOTUS) decisions for personalized medicine that help define what can be patented in the genetic and diagnostic fields.
Background:
Researchers, policy-makers and patients have raised concern over the effects of human gene and diagnostic patents over patient access to diagnostic tests, the development of next generation genetic testing and the sharing of genetic information. On June 13 2013 the SCOTUS delivered its much-anticipated ruling on whether human genes can be patented in Association of Molecular Pathologists (AMP) v. Myriad Genetics. At issue was the right to control two of the most publicized human genes – breast and ovarian cancer-associated BRCA1 and BRCA2. Since the late 1990s, Myriad has held multiple patents on these genes and tests, allowing them to, in principle, exclude others from offering or using genetic tests in breast cancer research, diagnostics and treatment. In 2009, a group of clinicians, researchers and patients were so concerned over these effects that they launched litigation to overturn Myriad’s patents. The Court ruled that isolated genes or parts of genes – because they are essentially unchanged from nature – constitute non-patentable subject matter, while artificial molecules, including cDNA, remain patentable.
The 2012 SCOTUS decision in Mayo v. Prometheus concerned a patent directed to a method for determining optimum drug dosage – in other words personalizing drug treatment – by administering a medicine to a patient, measuring blood metabolite levels of that drug, and, in accordance with the results, increasing or decreasing that dosage. As the Court concluded that this process constituted nothing more than a correlation fixed by nature, it was not eligible for patent protection.
The two rulings prompted speculation that investment in the field of personalized medicine will dry up and incited the United States Patent Office (USPTO) to issue new – and controversial – guidelines on patent eligibility.
Congressional Briefing: The Future of Gene Patents – making sense of the Supreme Court’s decision in the Myriad case.
The briefing reviewed the holding and implications of the AMP v. Myriad ruling for US genetic testing and innovation. US Representative Debbie Wasserman Schultz launched this lively session by not only relating her own experience in battling cancer, but her attempts to give patients to access to genetic testing. International leaders in genomics, medicine, law and ‘gene’ patenting, as well as patient advocate Lisa Schlager of Facing our Risk of Cancer Empowered (FORCE), suggested that while the decisions seem to provide more patient access and openness to innovation, lack of clarity and inconsistency may undermine these goals.
Workshop One: Examining broader implications of Myriad v. AMP and Mayo v. Prometheus.
The workshop focused on three issues relating to the Myriad and Mayo decisions.
The first session examined whether and how other jurisdictions – Canada, Australia and Europe – would draw on these decisions in elaborating their own case law. In both Australia and Europe, the two decisions have had no formal effect. Not so in Canada where the decisions are viewed as causing uncertainty over Canadian patent law which is modeled, in significant part, on the US patent statute.
A second panel reviewed the anticipated effects of the two decisions on the fields of agriculture, regenerative medicine and synthetic biology. Again, the immediate impact of the decisions seems to be minimal. In the case of agriculture, this has more to do with the structure of the industry where reliance on the same type of natural gene patents is less. In the cases of regenerative medicine and synthetic biology, which are both at an early stage of development, neither decision is likely to affect the core patentability of induced pluripotent stem cells or of synthetic parts.
The third session drew on the Myriad and Mayo decisions to examine the intersection of science and law, particularly given the quickly evolving, forward, nature of scientific knowledge with the backward looking and slow processes of the law. Not only do the scientific and clinical communities look upon the questions of gene patenting differently, but the understanding of what is at stake differs significantly with the perspective of patent experts. The day closed with an eloquent address on science and the judicial system by Judge Pauline Newman of the United States Court of Appeals for the Federal Circuit.
Workshop Two: Analyzing Policy Impacts on Biotechnology Innovation Using Patent Data
Patent data alone or in combination with other kinds of data provide a rich foundation on which to examine how policy and laws influence innovation. The goal of this more technical workshop was to investigate data sources and analytical methods that can better facilitate policy development and academic inquiry.
Prof. Stuart Graham, the former Chief Economist at the US Patent and Trademark Office (USTPO), kicked off with a candid overview of the challenges involved in collecting and using patent-related data. This was followed by five in-depth sessions in which participants examined different types of data and analysis. Investigators from the US, Canada, Australia and Europe presented cross-disciplinary perspectives on the collection and use of patent data including Profs Loet Leydesdorff, a pioneer of innovation analysis and Osmat Jefferson, Principle Scientist on the open source patent database PatentLens, a key resource for both industry and academia in this field.
Many analyses of patent data rely on stratification of gene patents by type of invention claimed or by the way specific types of claims are made. Algorithms that categorize claims can be time and cost-effective for analysis of the large volumes of data. However, challenges arise because claims language and formulation vary, and patent law is heterogeneous across jurisdictions. Thus, generic reference to ‘gene patents’ without a careful reading of the claims may lead to mistaken observations of trends in the field. While hand-analysis of claims helps limit these problems, it is expensive and, especially in large data sets, unworkable. Workshop participants thus highlighted the need for new and creative approaches to analyze claims, better ways of tracking the people involved in the creation and flow of knowledge through innovation pathways, and access to rich data sets held privately or subject to high proprietary barriers (for example, licensing data).
These events were supported by Office of US representative Debbie Wasserman Schultz, PACEOMICS, Alberta Innovates, the Canadian Institutes of Health Research (CIHR), the Canadian Stem Cell Network, and Genome Canada.