{"id":4501,"date":"2024-05-02T18:44:36","date_gmt":"2024-05-02T18:44:36","guid":{"rendered":"https:\/\/blogs.luc.edu\/ipbytes\/?p=4501"},"modified":"2024-08-11T20:33:42","modified_gmt":"2024-08-11T20:33:42","slug":"patent-enablement-for-the-greater-good-of-the-general-public","status":"publish","type":"post","link":"https:\/\/blogs.luc.edu\/ipbytes\/patent-enablement-for-the-greater-good-of-the-general-public\/","title":{"rendered":"Patent Enablement \u2013 For the Greater Good of the General Public"},"content":{"rendered":"<p>Patent law is often thought to incentivize and benefit inventors. Patent holders have exclusive rights restricting others from making, using, selling, offering to sell, and importing into the U.S. their patented invention. However, the <a href=\"https:\/\/www.law.cornell.edu\/wex\/intellectual_property_clause\">constitutional clause<\/a> founding patent law aims to benefit the greater public by promoting the progress of science and useful arts. One of the ways patent law helps promote the progress of science is through the <a href=\"https:\/\/www.uspto.gov\/web\/offices\/pac\/mpep\/s2164.html\">Enablement Requirement<\/a>.<\/p>\n<p><!--more--><\/p>\n<p>After a patent applicant satisfies the first four patentability requirements (patentable subject matter, novelty, utility, and nonobviousness), the applicant is still faced with satisfying the enablement requirement. Therefore, it is an important hurdle for an applicant to consider during their application. Before diving into the enablement requirement, let\u2019s first quickly review the other patent requirements.<\/p>\n<p><!--more--><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-4505 aligncenter\" src=\"https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture1-214x300.png\" alt=\"\" width=\"214\" height=\"300\" srcset=\"https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture1-214x300.png 214w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture1-732x1024.png 732w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture1-768x1074.png 768w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture1-64x90.png 64w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture1.png 797w\" sizes=\"auto, (max-width: 214px) 100vw, 214px\" \/><\/p>\n<p style=\"text-align: center;\"><em>Photo by Jaron Nix on <u>Unsplash.<\/u><\/em><\/p>\n<p><!--more--><\/p>\n<p><u>The Basic Patent Requirements<\/u><\/p>\n<p>If you\u2019ve ever looked at a patent, you\u2019ll notice there are several <a href=\"https:\/\/henry.law\/blog\/the-anatomy-of-a-patent\/\">parts<\/a> to a patent. Even if you\u2019ve never looked at one before, we can do that now.\u00a0 Check out this <a href=\"https:\/\/patents.google.com\/patent\/US6871616B2\/en?oq=6871616\">one<\/a> about a pet leash that serves as an umbrella for the pet. As you can see, a patent includes a front page, drawings, specification, and at the very end, patent \u201cclaims\u201d (I\u2019ll explain that later). The front page provides general background information such as the title, patent number inventors, an abstract, etc. Most patents also include drawings of the patented invention to help readers better understand the invention. The specification is the written part of the patent describing the invention details and providing context for the claims. Finally, every patent has claims which define what the patent legally covers.<\/p>\n<p>There are key differences between a patent\u2019s specifications and claims. Specifications describe the invention and enable a person having ordinary skill in the art (<a href=\"https:\/\/www.upcounsel.com\/phosita\">PHOSITA<\/a>) to understand and reproduce the invention. Patent claims legally define what the patent covers for the invention.<\/p>\n<p>For a patent to be granted, an invention must be <a href=\"https:\/\/www.law.cornell.edu\/uscode\/text\/35\/101\">patent eligible subject matter and useful<\/a>.\u00a0 Essentially \u201c<a href=\"https:\/\/caselaw.findlaw.com\/court\/us-supreme-court\/447\/303.html\">anything under the sun<\/a>\u201d can be patentable except common law exclusions such as <a href=\"https:\/\/www.law.cornell.edu\/supreme_court_of_the_united_states_2013%E2%80%932014_term_in_review\/patentability_of_abstract_ideas#:~:text=The%20Court%20has%20long%20held,building%20blocks%20of%20human%20ingenuity%2C%E2%80%9D\">abstract ideas<\/a>, <a href=\"https:\/\/www.bitlaw.com\/source\/mpep\/2106-04-b.html\">laws of nature, and natural or physical phenomena<\/a>. So, patents on, for example, mathematical formulas are excluded as laws of nature; for more on this you check out Johnny Jansky\u2019s recent post \u201c<a href=\"https:\/\/blogs.luc.edu\/ipbytes\/2024\/04\/14\/can-i-patent-that-a-wade-into-the-patentable-subject-matter-thicket\/\">Can I Patent That? A Wade Into the Patentable Subject Matter Thicket<\/a>.\u201d\u00a0 And so long as the invention works and does what it claims to do, the invention satisfies the utility requirement.<\/p>\n<p>The <a href=\"https:\/\/www.law.cornell.edu\/uscode\/text\/35\/102\">novelty requirement<\/a> requires there is no \u201c<a href=\"https:\/\/www.epo.org\/en\/learning\/learning-resources-profile\/business-and-ip-managers\/inventors-handbook\/novelty-and-prior-art\/what-prior-art\">prior art<\/a>\u201d (any evidence the invention is already known through prior products, publications, uses, etc.) that discloses all of the claimed invention.<\/p>\n<p>The invention must also be <a href=\"https:\/\/www.law.cornell.edu\/uscode\/text\/35\/103\">nonobvious<\/a>.\u00a0 If the differences between the claimed invention and the prior art are such that the claimed invention would have been an obvious variation of the prior art to a PHOSITA, the invention is deemed obvious and non-patentable.<\/p>\n<p>Finally, the patent application itself must satisfy certain requirements. It must provide an adequate written description of the invention and it must also satisfy the enablement requirement.<\/p>\n<p><!--more--><\/p>\n<p><u>The Enablement Requirement \u2013 Background<\/u><\/p>\n<p>What is the enablement requirement?<\/p>\n<p>Codified in <a href=\"https:\/\/www.law.cornell.edu\/uscode\/text\/35\/112\">35 U.S.C. \u00a7 112(a)<\/a>, the <a href=\"https:\/\/ipwatchdog.com\/2017\/10\/28\/patentability-drafting-enablement-requirement\/id=89721\/\">enablement requirement means<\/a> a patent specification must \u00a0\u201cenable any person skilled in the art\u2026 to make and use [the invention].\u201d\u00a0 The <a href=\"https:\/\/www.uspto.gov\/web\/offices\/pac\/mpep\/s2164.html\">test<\/a> for enablement is whether the PHOSITA could make or use the invention disclosed in the patent with general knowledge known in the particular field without undue experimentation.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-4504 aligncenter\" src=\"https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture2-300x188.png\" alt=\"\" width=\"300\" height=\"188\" srcset=\"https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture2-300x188.png 300w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture2-1024x643.png 1024w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture2-768x482.png 768w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture2-143x90.png 143w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture2.png 1109w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p style=\"text-align: center;\"><em>Photo by Julia Koblitz on <u>Unsplash.<\/u><\/em><\/p>\n<p>The Supreme Court has discussed the enablement requirement multiple times since the 19th century. For example, the case of <a href=\"https:\/\/tile.loc.gov\/storage-services\/service\/ll\/usrep\/usrep159\/usrep159465\/usrep159465.pdf\"><em>The Incandescent Lamp Patent<\/em><\/a> involved Thomas Edison and incandescent lighting. Edison sought to use bamboo material in his lamp. Edison was sued for <a href=\"https:\/\/www.law.cornell.edu\/wex\/patent_infringement\">infringement<\/a> by the patentees for an \u201celectric lamp\u201d with an \u201cincandescing conductor\u201d made of \u201cmineral or gas carbon.\u201d However, the Court rejected the patentees\u2019 infringement allegation because it found the patent claim too broad. The claim at issue covered \u201cevery fibrous and textile material,\u201d which would include bamboo. The broadness of the claim failed to enable a PHOSITA to make or use the claimed invention. The Court specifically noted that Edison underwent \u201cpainstaking experimentation\u201d to discover bamboo would be an effective material for his lamp.<\/p>\n<p><!--more--><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-4503 aligncenter\" src=\"https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture3-169x300.png\" alt=\"\" width=\"169\" height=\"300\" srcset=\"https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture3-169x300.png 169w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture3-576x1024.png 576w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture3-51x90.png 51w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture3.png 660w\" sizes=\"auto, (max-width: 169px) 100vw, 169px\" \/><\/p>\n<p style=\"text-align: center;\"><em>Photo by Franco Mariuzza on Unsplash.<\/em><\/p>\n<p><!--more--><\/p>\n<p><u>The Enablement Requirement Remains the Same<\/u><\/p>\n<p>On to 2023. The only patent law case that the Court decided on last year was <em>Amgen v. Sanofi<\/em>.\u00a0 Both Amgen and Sanofi are pharmaceutical companies. Amgen alleged Sanofi\u2019s product, <a href=\"https:\/\/www.praluent.com\/s\/\">Praluent<\/a>, infringed Amgen\u2019s patented cholesterol drug, <a href=\"https:\/\/www.repatha.com\/what-is-repatha\">Repatha<\/a>. The drug functions by having antibodies bind to receptors in the body. In its patent covering Repatha, Amgen provided 26 target antibodies as preferred embodiments. However, the claims at issue were broader, i.e. disclosed more, than these 26 antibodies. Amgen claimed all antibodies that \u201cbind to specific amino acid residues on PCSK9 [(a protein)]\u201d and block that protein from binding to bad cholesterol.<\/p>\n<p>Though a bit more complicated invention than a lamp, the Court maintained its stance regarding enablement. The Court noted the resemblance to many of the past cases it had decided upon, including <em>The Incandescent Lamp<\/em>. Like the patentees in <em>Incandescent Lamp<\/em>, the Court found that Amgen sought to \u201cmonopolize an entire class of things defined by their function.\u201d Within that class, there are many antibodies not shown in the embodiments that can achieve this function.<\/p>\n<p>The Court explained that the broader a claim is, the more it must enable a PHOSITA. The methods claimed in the patent required undue experimentation to make or use the invention, and thus failed the enablement requirement.<\/p>\n<p>The Court concluded that the enablement requirement is meant to ensure that not only the inventor benefit from obtaining patents, but also that the public does. In this way, the Court continues to solidify its position that patents should benefit the general public via enabling disclosures.<\/p>\n<p><!--more--><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-4502\" src=\"https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture4.png\" alt=\"\" width=\"210\" height=\"250\" srcset=\"https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture4.png 210w, https:\/\/blogs.luc.edu\/ipbytes\/wp-content\/uploads\/2024\/08\/Picture4-76x90.png 76w\" sizes=\"auto, (max-width: 210px) 100vw, 210px\" \/><\/p>\n<p><em>Matt O\u2019Boyle<\/em><br \/>\n<em>Assistant Blogger<\/em><br \/>\n<em>Loyola University Chicago School of Law, J.D. 2025<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Patent law is often thought to incentivize and benefit inventors. Patent holders have exclusive rights restricting others from making, using, selling, offering to sell, and importing into the U.S. their patented invention. However, the constitutional clause founding patent law aims to benefit the greater public by promoting the progress of science and useful arts. One of the ways patent law helps promote the progress of &hellip; <a href=\"https:\/\/blogs.luc.edu\/ipbytes\/patent-enablement-for-the-greater-good-of-the-general-public\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Patent Enablement \u2013 For the Greater Good of the General Public<\/span><\/a><\/p>\n","protected":false},"author":56,"featured_media":4504,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"class_list":["post-4501","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-patents"],"_links":{"self":[{"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/posts\/4501","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/users\/56"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/comments?post=4501"}],"version-history":[{"count":5,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/posts\/4501\/revisions"}],"predecessor-version":[{"id":4512,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/posts\/4501\/revisions\/4512"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/media\/4504"}],"wp:attachment":[{"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/media?parent=4501"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/categories?post=4501"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/tags?post=4501"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}