{"id":1550,"date":"2017-08-13T12:09:09","date_gmt":"2017-08-13T00:09:09","guid":{"rendered":"https:\/\/www.jamesandwells.com\/?p=1550"},"modified":"2022-02-03T12:12:18","modified_gmt":"2022-02-02T23:12:18","slug":"diagnostics-inventions-in-the-us-the-situation-worsens","status":"publish","type":"post","link":"https:\/\/www.jamesandwells.com\/nz\/diagnostics-inventions-in-the-us-the-situation-worsens\/","title":{"rendered":"Diagnostics inventions in the US: the situation worsens\u2026"},"content":{"rendered":"<div class=\"column1\">\n<div class=\"column_inner\">\n<div class=\"blog_single blog_holder\">\n<div class=\"itp_post_text\">\n<div class=\"post_text_inner\">\n<h6>Athena Diagnostics, Inc. v Mayo Collaborative Services, et al [2017]<\/h6>\n<p>&nbsp;<\/p>\n<h6>On 4 August 2017, the United States District Court handed down another decision to dishearten the biomedical sector. The U.S. judiciary are sending a constant message that diagnostic methods based on a natural law or principle are not to be considered as patent eligible subject matter.<\/h6>\n<p>&nbsp;<\/p>\n<h6>Introducing the parties and their arguments<\/h6>\n<p>&nbsp;<\/p>\n<p>The Plaintiffs (the patent owners) in this case are\u00a0Athena Diagnostics, Inc, Isis Innovation Limited (rebranded as\u00a0Oxford University Innovation), and\u00a0Max-Plank-Gesellschaft zur Forderung de Wissenschaften e.V., and are collectively referred to herein as \u201cAthena\u201d. \u00a0The Defendants (the alleged infringers) are Mayo Collaborative Services, LLC (doing business as \u201cMayo Medical Laboratories\u201c), and\u00a0Mayo Clinic\u00a0\u2013 which for the purposes of this article, are collectively referred to as \u201cMayo\u201d.<\/p>\n<p>&nbsp;<\/p>\n<p>Specifically, Athena were alleging that Mayo had developed two diagnostic tests that infringe on the Athena patent \u2013\u00a0U.S. Patent No. 7,267,820\u00a0(\u201cthe \u2018820 patent\u201d). Mayo\u2019s defence:\u00a0<strong>the \u2018820 patent is invalid under the famous 35 U.S.C. section 101<\/strong>, because the claimed method merely applies routine and conventional techniques to a law of nature. Accordingly, the present case specifically considered a Motion to Dismiss the pending infringement case on the basis that the patent is not valid.<\/p>\n<p>&nbsp;<\/p>\n<h6>The \u2018820 patent<\/h6>\n<p>&nbsp;<\/p>\n<p>The\u00a0patent-in-suit\u00a0is directed to the diagnosis of Myasthenia Gravis, a chronic autoimmune disorder. Symptoms include waning muscle strength throughout the day, eye weakness (e.g., drooping eyelids), leg weakness, dysphagia, and slurred or nasal speech.<\/p>\n<p>&nbsp;<\/p>\n<p>The inventors of the \u2018820 patent found that 20% of Myasthenia Gravis patients lack acetyle choline receptor (AChR) autoantibodies, and instead have IgG antibodies that bind to the N-terminal domains of muscle specific tyrosine kinase (MuSK), a receptor that is located on the surface of neuromuscular junctions. Advantageously, the methods disclosed in the patent specification provide a more accurate and speedy diagnosis of these 20% of Myasthenia Gravis patients.<\/p>\n<p>&nbsp;<\/p>\n<p>The \u2018820 patent is therefore directed to a method for diagnosing Myasthenia Gravis using a radioactive label attached to MuSK (or a fragment of MuSK) \u2013 which is then introduced into a sample of bodily fluid. In particular,\u00a0<sup>125<\/sup>I-MuSK is introduced into the bodily fluid, the MuSK autoantibodies, if present, attach to the labeled fragment. Once precipitating the bodily fluid, the presence of radioactive label on any antibody indicates that the person is suffering from Myasthenia Gravis.<\/p>\n<p>&nbsp;<\/p>\n<h6>Mayo\u2019s Motion to Dismiss<\/h6>\n<p>&nbsp;<\/p>\n<p>Although Athena put forward the case that Mayo was infringing their patent \u2013 this isn\u2019t the subject of this article (or really, this decision) and accordingly is not discussed here. More interestingly \u2013 Mayo opines that the infringement complaint should be dismissed\u00a0<strong>\u201c<em>on the ground that the patent seeks to patent a law of nature, and it uses techniques standard in the art.<\/em>\u201d<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>As one might expect, Athena disagrees with the assertions of Mayo \u2013 responding that the patent requires the production and use of a fluorescently labelled protein,\u00a0<sup>125<\/sup>I-MuSK (which, of course, is not naturally occurring). In addition, Athena comments that various procedures are applied to the non-naturally occurring protein which are sufficient to \u201c<em>transform the claim<\/em>\u201d and thus make it patent eligible.<\/p>\n<p>&nbsp;<\/p>\n<h6>The Test For Patent Eligibility<\/h6>\n<p>&nbsp;<\/p>\n<p>In the U.S., it is well established that a threshold standard for patent protection is that the subject matter of a patent must be patentable under Section 101. Otherwise, the patent is invalid. The highly discussed\u00a0<em>Alice Corp v CLS Bank<\/em>,\u00a0and\u00a0<em>Assoc. Mol. Pathology v Myriad Genetics<\/em>\u00a0Supreme Court decisions have determined that Section 101 contains implicit exceptions to:<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Laws of nature;<\/li>\n<li>Natural phenomena; and<\/li>\n<li>Abstract ideas;<\/li>\n<\/ul>\n<p>which are all patent ineligible.<\/p>\n<p>&nbsp;<\/p>\n<p>The U.S. Patent and Trademark Office are currently applying a two-step method for assessing patent eligibility, as set out in the controversial\u00a0<em>Mayo v Prometheus<\/em>\u00a0decision.<\/p>\n<p>&nbsp;<\/p>\n<h6>Step 1: Are Claims Directed to a Patent Ineligible Concept?<\/h6>\n<p>&nbsp;<\/p>\n<p>Although the \u2018820 patent describes the formation of of a complex between a man-made chemically-modified version of MuSK, with the patient\u2019s own autoantibodies \u2013 resulting in the creation of a specific complex that\u00a0<strong>does not occur in nature<\/strong>, the Court have determined this to be insufficient to render the subject matter eligible.<\/p>\n<p>&nbsp;<\/p>\n<p>In arriving at this finding, the Court highlights that the \u2018820 patent claims only define a method for diagnosing a disease \u2013 and not the man-made chemical entity\u00a0<em>per se<\/em>. Allegedly, the focus of the claims of the invention is the\u00a0<strong>interaction<\/strong>\u00a0between the\u00a0<sup>125<\/sup>I-MuSK and the antibodies within the bodily fluid, and this interaction is naturally occurring. Because the claims focus on the natural occurrence, it is directed to a\u00a0<strong>patent-ineligible<\/strong>\u00a0concept.<\/p>\n<p>&nbsp;<\/p>\n<h6>Step 2: Does the inventiveness of the claim make it patent eligible?<\/h6>\n<p>&nbsp;<\/p>\n<p>Should a patent fail part one of the Section 101 analysis \u2013 it proceeds to step two. That is, the patent can be upheld if the method contains an \u201c<em>inventive concept\u201d<\/em>.<\/p>\n<p>&nbsp;<\/p>\n<p>In this case, Mayo argued that the \u2018820 patent should also fail step two, because merely identifying the presence of autoantibodies to MuSK is not an inventive concept, as the techniques for doing so are well established in the art. The Federal Circuit have previously advised that \u201c<em>more is required than well-understood, routine, conventional activity already engaged in by the scientific community<\/em>\u201d\u00a0(see,\u00a0<em>CellzDirect<\/em>,\u00a0827 F.3d at 1047).<\/p>\n<p>&nbsp;<\/p>\n<p>Mayo draws support from the \u2018820 patent itself, which teaches that: \u201c<em>iondination and immunoprecipitation are standard techniques in the art, the details of which can be found in references (4 and 6)\u201d<\/em>. References 4 and 6 were published in are dated 1976 and 1985, respectively.<\/p>\n<p>&nbsp;<\/p>\n<p>Athena disputed Mayo\u2019s allegations on the basis the the step of detecting autoantibodies was neither well understood nor routine. Additionally, the step of contacting MuSK or a MuSK epitope with a suitable label was highlighted as being novel. Athena further opined that in light of the complexity of protein molecules, getting known iodination methods to work specifically with proteins, is not routine.<\/p>\n<p>&nbsp;<\/p>\n<p>Unfortunately for Athena, the Court did not accept their arguments \u2013 because the specification appeared wholly silent on any of the complexity of the steps that Athena alleged were neither well-known nor standard. It is well established that a patent specification must contain a written description of the invention, and the manner and process of making and using it, \u201c<em>in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains<\/em>\u201d could make or use it. Therefore, in the absence of the features that allegedly make the invention \u2013 the specification clearly fails to meet this requirement.<\/p>\n<p>&nbsp;<\/p>\n<h6>Mayo, Ariosa and now Athena: the trend continues\u2026<\/h6>\n<p>&nbsp;<\/p>\n<p>The Supreme Court started the wrecking ball on diagnostic inventions back in 2012 in the\u00a0<em>Mayo v Prometheus<\/em>\u00a0decision. As discussed in intricate detail elsewhere, the Prometheus patent was directed to a diagnostic test which measured how well a person metabolized thiopurine drugs. Despite the test involving a patient being administered with the drug 6-thioguanine before measuring the level of the drug in the patient\u2019s blood stream \u2013 the Court held that claimed method was no more than the observation of a law of nature!<\/p>\n<p>&nbsp;<\/p>\n<p>Simply put, the Court asserted that the necessitation of human action (i.e., the administration of a thiopurine drug) to trigger the reaction \u2013 the reaction itself was not a human action \u2013 and accordingly not patent eligible. The methods merely measured how effectively a person metabolizes the drug \u2013 an \u201c<em>entirely natural process\u201d<\/em>.<\/p>\n<p>&nbsp;<\/p>\n<p>The Decision of the US Court of Appears for the Federal Circuit in\u00a0<em>Ariosa v Sequenom<\/em>\u00a0added fuel to the fire. There was no doubt that the innovative technology solved a huge market need \u2013 the patent was directed to a method of using fetal DNA to diagnose certain conditions. Quite amazingly, the inventors found that cell-free fetal DNA was present in maternal plasma and serum \u2013 a portion of the maternal blood sample that other researchers had previously discarded as medical waste \u2013 and from the tiny fraction of paternal cell-free fetal DNA the inventors could determine certain inherited characteristics. The claimed method encompassed methods of isolating and amplifying the DNA to provide a greater efficiency in diagnosis of genetic defects.<\/p>\n<p>&nbsp;<\/p>\n<p>However, it was the view of the Court that \u201c<em>the only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum\u201d<\/em>. This statement appears flawed \u2013 at least in part because the patent claims were not directed to the cffDNA\u00a0<em>per se<\/em>\u00a0\u2013 but to a new and incredibly inventive diagnostic method that only became possible after the discovery of the cffDNA. It\u2019s difficult to agree with the decision that such methods, requiring significant human intervention, are based on a natural law or phenomenon \u2013 and it sets a terrifying trend as to how far this concept could be extrapolated? If you dig deep enough, could an argument be made that every possible method in the world relates, at some level, to a natural law?<\/p>\n<p>&nbsp;<\/p>\n<h6>Is there a glimpse of relief?<\/h6>\n<p>&nbsp;<\/p>\n<p>Moving forward, there appear to be fewer and fewer pegs to hang your hat on with respect to diagnostic method patents. The most prevalent glimmer of hope is vested in the recent\u00a0<em>Rapid Litigation Management v CellzDirect<\/em>. The patent considered in this case claimed a method for preserving primary liver cells by re-freezing. This technology was hugely valuable \u2013 because hepatocytes naturally have a very short life span (thus could only be frozen once using previous technologies), and can only be harvested from a limited number of donors.<\/p>\n<p>&nbsp;<\/p>\n<p>Although in the first instance the District Court believed the claims to be directed to ineligible subject matter, on Appeal the Federal Appeals Court more sensibly found that the claims were not directed to the natural law, but instead to a new and useful method for preserving hepatocytes. Specifically, the Appeals Court found that the invention was not the mere observation or detection of the ability of hepatocytes to survive multiple freeze-thaw cycles, but instead directed to a new and useful method of preserving the cells. Thus \u2013 the outcome was a method to produce something useful, and the claims were considered to define patent-eligible subject matter.<\/p>\n<p>&nbsp;<\/p>\n<p>This result appears to distinguish over the conclusion arrived at in respect of the \u2018820 patent \u2013 because the \u201c<em>desired outcome<\/em>\u201d of the \u2018820 patent is the mere detection of MuSK autoantibodies. Allegedly, it does not \u201c<em>produce something useful beyond that diagnosis\u201d<\/em>.\u00a0Of course, the counter argument is that the diagnosis itself is hugely useful \u2013 as it allows for a more effective treatment regimen to be prescribed to a patient in need. However, it appears that a stance has been set in the \u00a0U.S. that they are looking for a biomedical method to result in a material and tangible product (which is certainly a new, and in our view misplaced, consideration with respect to traditional patent law).<\/p>\n<p>&nbsp;<\/p>\n<p>Although the future is far from certain, it looks like owners of technology involving diagnostic methods are in for a rough few years with respect to obtaining their U.S. patents. Exceptional care and creativity must be taken when drafting claims directed to diagnostic method technology. For example, one option likely to be positively viewed appears to be to formulate a product that is integral to the working of the diagnostic method.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Athena Diagnostics, Inc. v Mayo Collaborative Services, et al [2017] &nbsp; On 4 August 2017, the United States District Court handed down another decision to dishearten the biomedical sector. The U.S. judiciary are sending a constant message that diagnostic methods based on a natural law or principle are not to be considered as patent eligible&#8230;<\/p>\n","protected":false},"author":8,"featured_media":577,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[99,62],"class_list":["post-1550","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-sciences","category-patents","insight-resource-articles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Diagnostics inventions in the US: the situation worsens\u2026 - James &amp; Wells<\/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.jamesandwells.com\/nz\/diagnostics-inventions-in-the-us-the-situation-worsens\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Diagnostics inventions in the US: the situation worsens\u2026 - James &amp; Wells\" \/>\n<meta property=\"og:description\" content=\"Athena Diagnostics, Inc. v Mayo Collaborative Services, et al [2017] &nbsp; On 4 August 2017, the United States District Court handed down another decision to dishearten the biomedical sector. 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