Racial disparities in genetic testing of breast cancer patients.

10591 Background: TNBC is disproportionately prevalent in African American (AA) populations and in women with BRCA-1 germline mutations. BRCA mutation carriers are candidates for targeted therapy with PARP-inhibitors, and testing results may influence risk-reducing surgery choice. Methods: We evaluated genetic testing patterns and outcomes for TNBC patients treated in the prospectively maintained databases of academic cancer programs in two metropolitan cities in the Northeast (New York City, NYC) and Midwest (Detroit, Det), 1998-2018. Median follow up was 3.73 years. Testing patterns were also analyzed by time, comparing pts diagnosed before versus after the mid-2013 Supreme Court ruling that expanded testing availability by banning gene patenting. Results: Of 810 pts, 600 were from NYC and 200 from Det; 202 were AA and 488 WA. Pts undergoing genetic testing were younger (median age 50 vs 62; p < 0.0001). Compared to WA, AA pts were less likely to undergo genetic testing overall (23.8% vs 42.0%; p < 0.0001) and within site (NYC: 25.6% vs 42.8%, p = 0.008; Det: 22.3% vs 38.6%, p = 0.025). No significant differences were seen in frequency of pathogenic BRCA mutations (AA-14.6%; WA-29.3%) or VUSs (AA-6.3%; WA- 4.9%); p = 0.20. Genetic testing disparities were reduced among pts diagnosed after mid-2013 (AA-31.4% vs WA-44.0%; p = 0.01) compared to pre-mid-2013 (AA-18.3% vs WA-40.7%; p < 0.0001). No differences were seen in local or distant recurrence free survival between patients with BRCA, BRCA variants of uncertain significance, non-BRCA mutations, and patients without genetic mutations (local recurrence p = 0.827; distant recurrence p = 0.574). This outcome equivalence was consistent when stratified by WA vs AA identity. Conclusions: Genetic testing has increased for TNBC pts following the mid-2013 Supreme Court ban on gene patenting, but race-associated disparities persist. Pts undergoing genetic testing are more likely to undergo risk-reducing mastectomy, but testing results do not affect survival outcomes, regardless of race. Addressing genetic testing disparities will become increasingly important as mutation-associated targeted therapies are identified through advances in precision medicine.

The Gene Patenting Controversy

Genes are found in every living thing. They make us who we are. In the modern age of rapid technological advances, it is common for new discoveries to be patented for profit. A question arises. Does finding and isolating a human gene make it patentable by a company? This question has spurred much controversy over the last few years. Last year, a medical company called Myriad Genetics tried to patent the human gene that is responsible for breast cancer. To further understand the opinions of the public with regards to the issue of gene patenting, we conducted a study in one high school in Mississauga. Our results showed that the majority of teenagers are against gene patenting. However, we learned that teens knew very little about this issue. This motivated us to take action by making two informational videos on gene patenting to spread awareness among our peers and the wider community. In addition, we reached out to a group called Breast Cancer Association (BCA) by writing a letter to express our solidarity. We received a ‘thank you’ reply for BCA shortly after the U.S. Supreme

Patenting of Human Genes: The United States, Canada and Australia Case Law

The paper is a review of the case law of the United States of America, Canada and Australia, in which an attempt is made to answer the question on possibility of human gene patenting. The paper substantiates the relevance of this issue, examines the ethical aspects of gene patenting. The author analyzes the landmark and most significant cases from the point of view of the development of patent law of foreign countries: Diamond v. Chakrabarty (USA), Association for Molecular Pathology v. Myriad Genetics (USA), Myriad v. Cancer Voices (Australia), The Children’s Hospital of Eastern Ontario (CHEO) v. Transgenomic (Canada). In the analysis, the author gives special attention to the arguments and conclusions of judicial institutions regarding the patentability of human genes. A conclusion is drawn regarding the continuity and possible harmonization of legislation and judicial practices of both the states mentioned in the paper and countries that have just embarked on the development of biomedical technologies.

International Divergence in Gene Patenting

This review explores the recent divergence in international patent law relating to genes and associated subject matter. This divergence stems primarily from decisions of the highest courts in the United States and Australia on the eligibility of patent claims relating to the BRCA gene sequences. Patent offices, courts, and policy makers have struggled for many years to clearly articulate the bounds of patent claims on isolated and synthetic DNA and related products and processes, including methods for their use in genetic diagnostics. This review provides context to the current divergence by mapping key events in the gene patent journey from the early 1980s onward in five key jurisdictions: the United States, the member states of the European Patent Convention, Australia, Canada, and China. Early approaches to gene patenting had some commonalities across jurisdictions, which makes exploration of the recent divergence all the more interesting.There is insufficient empirical evidence to date to confidently predict the consequences of this recent divergence. However, it could potentially have a significant effect on local industry and on consumer access.

Edifying Thoughts of a Patent Watcher: The Nature of DNA

In the pending case Myriad Genetics v. Association for Molecular Pathology, the United States Supreme Court will consider the patentability of human genes under the "product of nature" doctrine. Patentable subject matter is generally held to encompass materials and artifacts created by humans, and not that which exists independently in nature. However, it is not clear that this is a meaningful or helpful distinction. Given on one hand that the concept of a gene is a human construct, and on the other hand that all human creations are drawn from the material environment, the question of gene patenting is better addressed as a matter of innovation policy than of imponderable labeling.

Anticipating Patentable Subject Matter

By the summer of 2013, the United States Supreme Court should issue an opinion in Myriad v. AMP, a case dealing with the patentability of human genes, including "cDNA" molecules that are created in the laboratory. Opponents of gene patenting have argued that such molecules should be deemed unpatentable "products of nature" because, statistically, such molecules might sometimes be fortuitously created in human cells. But this argument improperly imports into patent law's section 101 subject matter analysis the doctrine of inherency from section 102's provisions on novelty. And, if inherency is to be imported into section 101, the proper standard for patentability would be the "public benefit" criteria that has been developed in section 102 consideration of inherency. Under the "public benefit" standard, Myriad's cDNAs would constitute patentable subject matter.

Healthcare in Australia

No single issue has dominated health practitioners’ ethical debates in 2014 in Australia, but a controversial decision on gene patenting and the media focus on “Dr. Death,” euthanasia campaigner Dr. Philip Nitschke, have given new life to these two familiar (and global) debates. Currently a dying with dignity bill, drafted by the Australian Green Party, is under examination. The Senate inquiry into the bill received more than 663 submissions, with 57% opposed and 43% in support of the bill, which has now been referred to a Senate committee. Will this be another of Australia’s failed attempts to legalize euthanasia? The trial of Dr. Nitschke begins on November 10, 2014.