{"id":18168,"date":"2012-09-09T22:14:23","date_gmt":"2012-09-10T02:14:23","guid":{"rendered":"http:\/\/www.iposgoode.ca\/?p=18168"},"modified":"2012-09-09T22:14:23","modified_gmt":"2012-09-10T02:14:23","slug":"genetic-testing-patents-uspto-presents-the-generic-comments","status":"publish","type":"post","link":"https:\/\/www.yorku.ca\/osgoode\/iposgoode\/2012\/09\/09\/genetic-testing-patents-uspto-presents-the-generic-comments\/","title":{"rendered":"Genetic Testing Patents: USPTO Presents the 'Generic' Comments"},"content":{"rendered":"<p><span style=\"font-family: Calibri;font-size: small\">The current system for genetic testing in America functions by having the patent holder of a particular genetic test control the testing process and results interpretation of that test. There\u00a0is <a href=\"http:\/\/www.uspto.gov\/aia_implementation\/gene-comment-aba.pdf\">concern<\/a> that, inherent in that current system, there is a lack of independent second opinion testing available - testing which has the potential to make the results more accurate.<\/span><\/p>\n<p><span style=\"font-family: Calibri;font-size: small\"><!--more-->On January 25, 2012 the USPTO invited the public to <\/span><a href=\"http:\/\/www.uspto.gov\/news\/pr\/2012\/12-06.jsp\"><span style=\"color: #0000ff;font-family: Calibri;font-size: small\">comment<\/span><\/a><span style=\"font-family: Calibri;font-size: small\"> on the availability of independent second opinion genetic diagnostic testing and its relationship to the medical field.\u00a0 More <\/span><a href=\"http:\/\/www.uspto.gov\/aia_implementation\/2012-1481_genetic-testing-hearing-notice.pdf\"><span style=\"color: #0000ff;font-family: Calibri;font-size: small\">specifically<\/span><\/a><span style=\"font-family: Calibri;font-size: small\">, the U.S. government is looking for information on the medical detriment of the patent system controlling genetic testing and whether changing the law would stifle innovation in the area.\u00a0<\/span><\/p>\n<p><span style=\"font-family: Calibri;font-size: small\">The information was to be used in accordance with section 27 of the America Invents Act (hereafter \u201cAIA\u201d) to assist the director of the USPTO in delivering his recommendations on the subject to congress no later than June 15, 2012.\u00a0 Along with two public hearings set up at American colleges, the USPTO also received written comments from intellectual property organizations, academic research institutions, companies, and individuals (all are posted on the USPTO <\/span><span style=\"color: #0000ff;font-family: Calibri;font-size: small\"><a href=\"http:\/\/www.uspto.gov\/aia_implementation\/genetic-testing-comments.jsp\">website<\/a>)<\/span><span style=\"font-size: small\"><span style=\"font-family: Calibri\">.<\/span><\/span><\/p>\n<p><span style=\"font-family: Calibri;font-size: small\">The positions of many of the intellectual property organizations followed closely with the interests that they represent.\u00a0 For example, the <\/span><a href=\"http:\/\/www.uspto.gov\/aia_implementation\/gene-comment-prma.pdf\"><span style=\"color: #0000ff;font-family: Calibri;font-size: small\">Pharmaceutical Research and Manufacturers of America<\/span><\/a><span style=\"font-family: Calibri;font-size: small\"> (\"PhRMA\") has taken the position that the current patent system is essential to support innovation. They also assert that there is not enough information to support a conclusion that independent second opinion testing, done by relaxing patent law, is even medically necessary. \u00a0The <\/span><span style=\"color: #0000ff;font-family: Calibri;font-size: small\"><a href=\"http:\/\/www.uspto.gov\/aia_implementation\/gene-comment-digsp.pdf\">Duke Institute for Genome Sciences and Policy<\/a>\u00a0<\/span><span style=\"font-family: Calibri;font-size: small\">offered only anecdotal evidence from patients and researchers they have talked to about the desire for independent second opinion genetic testing.\u00a0 Indeed one of the only groups that appeared to offer a full analysis of the current issue was one made by the <\/span><a href=\"http:\/\/www.uspto.gov\/aia_implementation\/gene-comment-aba.pdf\"><span style=\"color: #0000ff;font-family: Calibri;font-size: small\">American Bar Association<\/span><\/a><span style=\"font-size: small\"><span style=\"font-family: Calibri\"> (hereafter \u201cABA\u201d).\u00a0 <\/span><\/span> <span style=\"font-family: Calibri\"><span style=\"font-size: small\">Their comment begins by outlining the history of genetic testing and the role that it can play in modern diagnostics.\u00a0 Starting with the discovery of the structure the DNA in 1953, the comment discusses the initial costs of mapping the human genome and what the current costs are to sequence DNA.\u00a0 The focus then moves to the intellectual property issues, where the cost of these new innovations is identified and where the strongest argument for where intellectual property protection comes from.\u00a0 They state that the research is funded largely by third-parties and, without protection of intellectual property, investors will likely not fund medical research.<\/span><\/span><\/p>\n<p><span style=\"font-family: Calibri\"><span style=\"font-size: small\">Most importantly, the ABA comment also evaluates the goal of public access to the newest and best diagnostic tests.\u00a0 In the medical field, more than in any other field of innovation, there is a goal of using knowledge gained for the good of the public.\u00a0 The ABA identifies that patented tests are often much more expensive than the generic ones that are created after the patents expire.\u00a0 They also identify the cost of initial innovation as the main reason for why the price of a patented product might be higher than that of a generic. \u00a0They conclude that while competition would undoubtedly decrease prices, the resulting cost to new innovation would be to the overall detriment of the medical field.<\/span><\/span> <span style=\"font-family: Calibri;font-size: small\">These issues are understandably complex.\u00a0 Medical patents come under a great deal of scrutiny because promoting access to healthcare is a primary goal of most governments.\u00a0 <\/span><\/p>\n<p><span style=\"font-family: Calibri;font-size: small\">The USPTO no doubt acknowledges this complexity because the final report and recommendations that their director was to make before congress were\u00a0<\/span><a href=\"http:\/\/www.uspto.gov\/blog\/aia\/category\/Studies+and+Reports\"><span style=\"color: #0000ff;font-family: Calibri;font-size: small\">delayed<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"font-size: small\">. \u00a0When he did appear before congress to discuss the AIA on June 20<\/span><sup><span style=\"font-size: x-small\">th<\/span><\/sup><span style=\"font-size: small\">, 2012, Mr. Kappos (the director of the USPTO) could only state that the USPTO \u201csolicited comments and held two public hearings on the issue of genetic testing and are finalizing our report to Congress\u201d.\u00a0\u00a0It is worth noting that the AIA doesn't propose to change the law on second opinion genetic testing; <a href=\"http:\/\/www.iposgoode.ca\/wp-admin\/post.php?post=18168&amp;action=edit\"><span style=\"color: #0000ff\">section 27<\/span><\/a>\u00a0of the act\u00a0only calls for a study to be compiled on the subject.\u00a0Therefore any information the USPTO has obtained\u00a0does not necessarily need to be available\u00a0before\u00a0the AIA comes into <\/span><\/span><a href=\"http:\/\/www.uspto.gov\/aia_implementation\/aia-effective-dates.pdf\"><span style=\"color: #0000ff;font-family: Calibri;font-size: small\">effect<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"font-size: small\"> on September 16, 2012. <\/span><\/span><\/p>\n<p><em><span style=\"font-size: small\"><span style=\"font-family: Calibri\">Adam Stevenson is a JD Candidate at Western University, Faculty of Law.<\/span><\/span><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The current system for genetic testing in America functions by having the patent holder of a particular genetic test control the testing process and results interpretation of that test. There\u00a0is concern that, inherent in that current system, there is a lack of independent second opinion testing available - testing which has the potential to make [&hellip;]<\/p>\n","protected":false},"author":2140,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","footnotes":""},"categories":[60,138,10,1001,143],"tags":[1546,1149,1344,1684,48,144],"class_list":["post-18168","post","type-post","status-publish","format-standard","hentry","category-ip","category-jurisdiction","category-patents","category-regulatory-policy","category-us","tag-adam-stevenson-ipilogue-editor","tag-aia","tag-america-invents-act","tag-genetic-testing","tag-patent","tag-uspto"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Genetic Testing Patents: USPTO Presents the &#039;Generic&#039; Comments - IPOsgoode<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.yorku.ca\/osgoode\/iposgoode\/2012\/09\/09\/genetic-testing-patents-uspto-presents-the-generic-comments\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Genetic Testing Patents: USPTO Presents the &#039;Generic&#039; Comments - IPOsgoode\" \/>\n<meta property=\"og:description\" content=\"The current system for genetic testing in America functions by having the patent holder of a particular genetic test control the testing process and results interpretation of that test. 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