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• Introduction to Our Research (ALL USED)
  • The field of Biotechnology including Genomics and Proteomics is a critical US industry, by some estimates approaching 2% of the US GPD and growing 15% per year. The emerging research in the genetic diagnostic kits presents unique challenges in intellectual property (IP). Changes in laboratory research due to actual or anticipated patent or license enforcement could signal the failure of intellectual property to spur the innovation these protections are intended to promote. It is these issues that are at the centre of our research under the Industrial Cooperation Project at the Berkman Centre at Harvard University. This research is part of a broader project being led by Prof. Yochai Benkler. In the research, we are seeking to understand the approaches to innovation with genetic diagnostic kits looking specifically at barriers to use and innovation.
• Genetic Diagnostics(ALL USED)
  • Our research is focused primarily on genetic diagnostics. In a 2008 report, The Secretary’s Advisory Committee on Genetics, Health, and Society (pg. 17) defined this class of tests as those that involve the analysis of human DNA, RNA, genes, or gene products to detect mutations, genotypes, and phenotypes related to disease and health. As of 10/22/2009, http://genetests.org lists 1557 disease conditions for which clinical genetic tests are commercially available, and the number is growing by at least 7% per year. However, despite this growth, fewer tests and therapeutics are reaching the market than would be expected based on major scientific achievement and investment in the field. This phenomenon is termed the "pipeline problem" in the literature.
  • As with therapeutics, bringing a diagnostic test to market is a complicated process. The development pipeline for genetic diagnostics involves several key steps: Basic research, intellectual property protection and subsequent licensing, pre-clinical development & trials, and obtaining FDA and CMS approval. (Post-market steps continue with negotiations with payers such as public and private health insurance companies, with further trials to demonstrate clinical utility, and with marketing for physicians and patients.)
    • The process begins with basic research, in which new genetic targets are identified and correlated with disease or healthy conditions, or in the case of pharmacogenomics, with drug response. New analysis techniques may also be developed. Most of this research is publicly funded.
    • The research is often published in an academic journal in the following year. In parallel, the hosting university usually pursues intellectual property rights on the discovery per the Bayh-Dole act. This IP may then be licensed, sometimes exclusively, to companies wishing to commercialize the discovery and to build a new diagnostic product.
    • Licensees conduct preclinical feasibility studies on the diagnostic target and build prototypes of new hardware (if necessary - many genetic tests can be conducted with existing tools and techniques). To reach market, the new diagnostic must pass through state and federal regulatory systems, which requires a demonstration of the new test's analytical & clinical validity, possibly its clinical utility, and quality control processes associated with its manufacture and use. In the US, there are two regulatory pathways for bringing genetic tests into clinical practice: developing the technology into a In-Vitro Diagnostic (IVD) Kit, to be sold to many laboratories as a complete testing system, or developing the key foundation of the discovery into an Analyte Specific Reagent (ASR), to be sold to CLIA-certified laboratories for internal development of a test that will solely be used within that laboratory. SACGHS Oversight pg.65. In general, ASRs are less burdensome to develop from a regulatory perspective than IVDs.
  • Demonstrating analytical & clinical validity is a significant challenge during the development of genetic diagnostics, both to meet regulatory requirements and to demonstrate to payers and to physicians that the diagnostic is effective and useful. Hence, the development of calibration and validity standards has been identified important to the future of genetic diagnostics, both by the government and academics. These would be used before and during FDA review and could be important community platforms for commons-based production and collaboration.
• The market and the commons
  • One of the dangers present in the patent protections surrounding genetic diagnostic tests is that basic scientific knowledge is being protected. This is part of a larger misled belief that public support of open science is less necessary as science becomes a task of the private sector and focused on addressing specific society needs (see Nelson, 2003). This use-inspired basic research has its benefits but science is a largely unpredictable enterprise and it's evolution requires the work of many people. This view of science requires widespread access to basic research. An influential discussion regarding the concerns about the affects of patents and licensing on diagnostic test has been the article titled Diagnostic testing fails the test: The pitfalls of patents are illustrated by the case of hemochromatosis published in Nature in 2002. The primary concerns highlighted by this study were the possible delays in publication and the affect on cost and availability of clinical diagnostic testing.
• Relevent Caselaw
  • The most important legal protections of genetic diagnostic kits are trade secret and patents. Trade secret protection of diagnostic kits often covers details of production and material choices. If efforts are made to keep the secret, and the information cannot be reverse engineered, the information is only available through contractual arrangement or independent discovery. Even when patents are used, the information often does not fully enable practice so trade secret information (knowhow) is licensed along with the patent. While trade secret plays a large role, studying it is difficult because most of the information is not public. Patents are public information and they have been the focus of our current research. The gene-disease associations that researchers study can be developed into a genetic diagnostic kit and these tests are often covered by patents. Our research aims to discover the role patents play in genetic diagnostic kit development and commercialization. The Bilski case “machine-or-transformation” test provides patent protection for genetic diagnostic kits if the machine or transformation used in the claimed process would "not merely be insignificant extra-solution activity." In re Bilski, 545 F.3d 943, 962 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (2009). The recent Prometheus Labs case investigate the bounds of the Bilski case by looking specifically at a transformation that takes place within the human body. Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 2008-1403, slip op. at 8 (Fed. Cir. Sept. 16, 2009).[[1]] This broad interpretation of a transformation has important implications about the scope of protection that genetic diagnostic kits will receive. The finality of this analysis will be determined when the Supreme Court reviews Bilski.
• The Role of Universities
  • Research universities are active in DNA patenting and licensing so technology transfer is central to how important developments in diagnostic tests are licensed. Patenting of research is encouraged by the Bayh-Dole Act which deals specifically with federal government-funded research but has more widely effected the patenting procedure of all university research. The act aims "to promote the commercialization and public availability of inventions made in the United States" and "protect the public against nonuse or unreasonable use of inventions" (35 U.S.C. § 200). If a university elects to hold title to the federally funded invention it is obligated to attempt to commercialize the invention and this often has been carried out through a policy of patent protection. A theoretical limit on this patenting policy are "march in rights" held by the funding agency which allow it to grant further licenses. March in rights are constrained by a necessity analysis under the statute and until now the rights have only been requested or threatened but never used. Another source of licensing restriction can come from the source of the funds. For instance, the National Institutes of Health is a major source of funding and their funding power has allowed them to create guidelines on how to license research resources arising from the funded research.
• Possible Solutions
  • One solution to potential patent problem developing is the use of patent pools or patent clearinghouses (see Verbeure, B. et al., 2006). One important limitation to this approach is antitrust law due to susceptibility to anti-competitive behavior. An additional challenge is that the biotechnology industry lacks standard-driven incentives found in other industries that benefit from patent pools. The scope of patent protection is currently being questioned by the Bilski case but a more limited interpretation of patentable subject matter would allow more basic research to remain available for all scientists to build upon without restriction. Altering the scope of patent protection is only a partial solution but requiring more substantial transformations and the expanding the meaning of what is natural could be key to limiting the possible creation of a patent thicket surrounding the basic research relied on in genetic diagnostic kit development. Lastly, licensing behavior that gives preference to reasonable pricing and non-exclusive rights could have a significant impact. The march in rights under Bayh-Dole have never been carried out but federal agencies funding genetic diagnostic kit research should provide licensing guidelines and resort to utilizing march in rights if they promote the goals of the statute and are required to reduce barriers to use and innovation.

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