The Patentability of Genetic Diagnostics in U.S. Law and Policy
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Description
In the US, a confluence of developments has drawn attention to the issue of patents on diagnostics, particularly to patents involving genetic information used in the diagnosis of familial conditions. Foremost is the movement of patents into ‘upstream’ research. Arguably fueled, in part, by universities’ attempts to derive economic value from their faculty’s research efforts, the notion of patenting fundamental technologies initially enjoyed a warm reception in (not surprisingly) the court that was established specifically to hear patent appeals and stabilize patent law—the United States Court of Appeals for the Federal Circuit. As a result of Federal Circuit decisions—in particular its decision in State Street Bank & Trust Co. v. Signature Financial Group, Inc.—patenting proliferated, including in the medical field. Thus, there are now patent rights covering around 20 percent of the genes said to comprise the human genome. There is, of course, ample precedent for using patents as a mechanism for spurring research and commercialization. However, because rights in this sphere can cover advances fundamental to the biological sciences, they could very well frustrate society’s ability to fully benefit from genomics’ considerable promise to revolutionize healthcare and transform pharmaceutical research. Patents on genes and on associations between genes and hereditary conditions can raise the cost of, and interpose other obstacles to, accessing diagnostic services. These patents also create an ‘anticommons’ that could undermine the development and implementation of more efficient diagnostic and research technologies. These techniques, including multiplex testing (which permits simultaneous analysis of large arrays of genes) and whole genome sequencing (the analysis of each person’s entire genetic endowment), would enhance research efforts and permit doctors to engage in ‘personalized medicine’ and tailor care to each individual patient’s predispositions. Indeed, concerns about patents on products (such as genes) that have informational content, and on processes (such as diagnostics) that exploit basic biology have surfaced in both the courts and in policy circles. In Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., a case about patent rights over a diagnostic process (in that case, associating an elevated level of a particular amino acid with a vitamin B12 deficiency), Supreme Court Justice Stephen Breyer dissented from the dismissal of review, suggesting that ‘sometimes too much patent protection can impede rather than “promote the Progress of Science and useful Arts.”’ In Bilski v. Kappos, the Court soundly repudiated State Street and confirmed that laws of nature, physical phenomena, and abstract ideas cannot be patented. And most recently, in Mayo Collaborative Services v. Prometheus Laboratories, the Court invalidated a patent on a different diagnostic process, warning of the ‘danger’ of ‘inhibit[ing] future innovation.’ Unfortunately, the Supreme Court’s decision in Mayo left many open questions. The case concerned a particularly straightforward association diagnostic test: it determined whether a patient was receiving the right amount of medication by looking at whether a metabolic product of that medication was within a specified range. The Court did not consider more complicated diagnostics, such as the effect of a genetic endowment on the potential contraction of a disease. Furthermore, Mayo (like Bilski) concerned only process claims; it did not deal with product patents, such as patents on isolated genes. Another case, Association for Molecular Pathology v. Myriad Genetics, Inc., is, however, waiting in the wings. Often called the ‘Myriad’ case, after the patent holder, Myriad Genetics, Inc., AMP involves (among other things) claims on associations between certain genetic mutations (the so-called ‘BRCA’ mutations) and breast cancer as well as claims on isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequences (that is, DNA molecules containing the sequences of nucleotides which, when mutated, cause an increased risk of breast cancer). In the trial court, Judge Robert Sweet held all these patents invalid. On appeal, the Federal Circuit reversed on the diagnostic claim and the Supreme Court sent the case back to the Federal Circuit to reconsider in light of Mayo. After the Federal Circuit reinstated its position, the Supreme Court granted review on the product claim.
Source Publication
Pharmaceutical Innovation, Competition, and Patent Law: A Trilateral Perspective
Source Editors/Authors
Josef Drexl, Nari Lee
Publication Date
2013
Recommended Citation
Dreyfuss, Rochelle C., "The Patentability of Genetic Diagnostics in U.S. Law and Policy" (2013). Faculty Chapters. 1182.
https://gretchen.law.nyu.edu/fac-chapt/1182
