The laws of nature exclusion is one of the fundamental exceptions to patent eligibility in many jurisdictions. While its precise scope varies from country to country, it is a recognised element of subject matter analysis for biology-based inventions. The exclusion covers products of nature, natural relationships, and natural phenomena, among others. The standard test for determining whether an invention falls within the scope of the exclusion is the “hand of man” test, which precludes anything obtained by human intervention from the scope of the exclusion.<\/p>\n
Since its recognition, the laws of nature exclusion has been understood to cover anything that exists in nature but not a practical application of that law. This principle was reaffirmed in the 2011 decision of the United States Supreme Court in the Mayo case. The invention in question was based on the relationship between thiopurine drugs and metabolite levels in the body, and involved a process of determining the correct dose of the drugs based on those metabolite levels. The Supreme Court held the claims to be non-patentable subject matter because the conventional methods employed in the process did not amount to a practical application of the natural relationship. The steps of administering the drug, determining metabolite levels, and defining the correct dosage for a patient were all known in the art and therefore did not constitute a practical application of the relationship between the drugs and the metabolite levels.<\/p>\n
One inference that may be drawn from the Mayo decision is that the use of conventional methods to apply a natural relationship does not render an invention patent eligible, even if the natural relationship itself was not previously known. To put it differently, if a series of steps already forms part of the prior art, applying those steps to a natural relationship does not confer patent eligibility. Taking this reasoning further, the scope of the laws of nature doctrine expands in proportion to the progress of the state of the art, the increase in the size of the prior art, and the enhancement of predictability within the relevant field.<\/p>\n
This conclusion was affirmed by the United States Court of Appeals for the Federal Circuit in the Myriad Genetics case, in the context of a diagnostic process claim. The claim, which appears in U.S. Patent 5,710,001, reads:<\/p>\n
1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises [] comparing a first sequence selected from the group consisting of a BRCA1 gene from said tu-mor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.<\/p><\/blockquote>\n
The claim recites three steps to screen for breast cancer gene expression in somatic cells: first, selecting the gene sequence from a tumour sample and a non-tumour sample; second, comparing the gene sequences in the two samples; and third, determining the existence of the tumour sequence in the non-tumour sample. The claim was rejected on the ground that it involves mental steps and does not amount to a practical application of the natural relationship between breast cancer susceptibility and the presence of the gene sequence, since the method of assessment formed part of the state of the art. The Federal Circuit concluded that applying conventional and well-known methods to the natural relationship between the gene sequence and susceptibility to breast cancer could not constitute a practical application of that relationship.<\/p>\n
Doctrinal Implications<\/h2>\n
The laws of nature doctrine, at least as applied in the United States, now requires an assessment of the state of the art. A practical application of a law of nature will be patent eligible only if at least one of the steps or elements of the invention is novel. It is a logical corollary that the scope of the laws of nature exception is inversely proportional to the state of the art, and that laws of nature analysis necessarily overlaps at some level with novelty analysis.<\/p>\n
Authored by Dr. Kalyan.<\/em><\/p>\n
Disclaimer: This article is for general information and does not constitute legal advice. Readers should consult a qualified attorney before acting on any matter discussed here.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"
This post explores how the laws of nature exclusion shapes patent eligibility, especially in biotechnology. It discusses key judicial decisions and the impact of state of the art on the scope of this legal doctrine.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"iawp_total_views":37,"footnotes":""},"categories":[6,14],"tags":[6589,12774,6817,12772,12773,3607,12775,6815],"class_list":["post-9515","post","type-post","status-publish","format-standard","hentry","category-intellectual-property","category-patents","tag-biotechnology-patents","tag-brca1-patent","tag-diagnostic-process-claims","tag-laws-of-nature-patent-eligibility","tag-mayo-decision","tag-myriad-genetics","tag-natural-phenomena-exclusion","tag-state-of-the-art"],"_links":{"self":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/9515","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/comments?post=9515"}],"version-history":[{"count":4,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/9515\/revisions"}],"predecessor-version":[{"id":149680,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/9515\/revisions\/149680"}],"wp:attachment":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media?parent=9515"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/categories?post=9515"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/tags?post=9515"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}