On June 16, 1980, The U.S. Supreme Court case decided Diamond v. Chakrabarty, 447 U.S. 303 (1980), a case dealing with whether genetically modified organisms constituted patentable subject matter.
Genetic engineer Ananda Mohan Chakrabarty, working for General Electric, had developed a bacterium (derived from the Pseudomonas genus) capable of breaking down crude oil, which he proposed to use in treating oil spills. Chakrabarty filed and prosecuted a patent application for the bacterium in The U.S. Patent and Trademark Office ("USPTO"), which was denied, because the law dictated that "living things" were not patentable.
The Board of Patent Appeals and Interferences agreed with the original decision; however, the United States Court of Customs and Patent Appeals overturned the case in Chakrabarty's favor, writing that "the fact that micro-organisms are alive is without legal significance for purposes of the patent law," which prompted Sidney A. Diamond, Commissioner of Patents and Trademarks, to appeal to the U.S. Supreme Court.
In a 5–4 ruling, the court ruled in favor of Chakrabarty, and upheld the patent, holding that:
A live, human-made micro-organism is patentable subject matter under [Title 35 U.S.C.] 101. Respondent's micro-organism constitutes a "manufacture" or "composition of matter" within that statute.
Some years later, the USPTO published what would ultimately become Sections §§1.821-825 of 37 C.F.R., at 55 FR 18245, on May 1, 1990. This notice now required that every sequence disclosed in the specification, claims, abstract and figures, consisting of four (4) or more specifically defined amino acids or ten (10) or more nucleotides, four or more of which must be specifically defined, even if disclosed for example purposes, illustrative purposes, and/or not claimed, must appear in a document called a "Sequence Listing."
Eight years later, on June 1, 1998, the USPTO published is Final Sequence Rule entitled "Requirements for Patent Application Containing Nucleotide Sequence and/or Amino Acid Disclosures" (see Federal Register 63:104, 29620-29643, June 1, 1998). Furthermore, WIPO published its final version of WIPO Standard ST.25, November 1, 1998, entitled "Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings in Patent Applications." The amended U.S. rules under 37 C.F.R. §§1.821-825, as well as the corresponding foreign equivalents, were marshaled forward for the purpose of simplifying the sequence rules and creating an international, language neutral, standard for Sequence Listings. While this is the last time the sequence rules were "substantively" and "formally" amended, many authoring offices have made their own "internal" interpretation of the rules in recent years, and thus, all Sequence Listings are not completely uniform.