Abstract
We now turn to the idea of patenting biological process and structure. American law has no inherent limitation in considering patents related to transhuman innovation. As such we might look for legislation to ban patenting these types of products. We look at current intellectual property policy, and where U.S. courts and international legislation appears to be drawing lines. Actual cases are discussed, as are current patent regulations regarding patenting genes, embryos, stem cells, and chimeric animals.
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Notes
- 1.
35 U.S.C. §101 sets out the subject matter that is patent-eligible. Section 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. The U.S. patent office publishes its administration of the patentability of inventions through the Manual of Patent Examining Procedure (MPEP). MPEP 2106.04 deals with whether a subject is patent eligible under the U.S. statute: 35 USC 101. Determining that a claim falls within patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter) does not end the eligibility analysis, because claims directed to nothing more than abstract ideas (such as mathematical algorithms), natural phenomena, and laws of nature are not eligible for patent protection. Diamond v. Diehr, 450 U.S. 175, 185, 209 USPQ 1, 7 (1981). Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, 106 USPQ2d 1972, 1979 (2013)); Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978). Supreme Court’s decisions, regarding isolated DNA for example in Myriad, were deemed novel or newly discovered, but nonetheless were considered by the Court to be judicial exceptions because they were “‘basic tools of scientific and technological work’ that lie beyond the domain of patent protection.” Myriad, 133 S. Ct. at 2112, 2116, 106 USPQ2d at 1976, 1978 (noting that Myriad discovered the BRCA1 and BRCA1 genes).
- 2.
In October 2011, the European Court of Justice issued a landmark decision on the patentability of biotech inventions in the case “Oliver Brüstle vs Greenpeace.” In a nutshell, the issue was whether a patent should be granted for the neural precursor cells (stem cells) and the processes for their production from embryonic stem cells and their use for therapy in diseases such as Parkinson’s, Huntington’s, and Alzheimer’s. Europe’s top court decision effectively banned patenting any stem cell process that involved destroying a human embryo.
- 3.
See, Congress Bans Patents on Human Embryos, Washington (February 4, 2004). https://www.nrlc.org/archive/news/2004/NRL02/congress_bans_patents_on_human_e.htm.
- 4.
In the U.S. once a patent is issued, it protects the invention in the U.S. and its possessions for a term of 20 years from the date of filing. Anyone can make, use or sell the invention in countries where it’s not patented.
- 5.
Martin P. Golding referring to H.L.A. Hart notes: “…Hart points our various facts about human nature that make necessary some of the rules of social morality and law: men are vulnerable and liable to harm; they are approximately equal in intelligence and physical abilities; they are not completely selfish but have limited good will toward others; and they are limited in their powers of foresight and self control…” Golding, M.P. (1975). Philosophy of Law. Prentice-Hall.
- 6.
The identification, alteration and cloning of genes that produce proteins has led to new medicines and genetic mutations that cause disease has been employed for instruments and diagnostic. Patents that assert property rights over DNA sequences have been granted in both these areas.
- 7.
In 1996, removing a nucleus of an unmatured sheep egg, and then using a second sheep nucleus having a genetic blueprint, was fused that into the enucleated egg cell, which developed into an embryo, implanted into a surrogate producing a clone. See, Dolly the Sheep is Cloned, BBC (February 22, 1997). http://news.bbc.co.uk/onthisday/hi/dates/stories/february/22/newsid_4245000/4245877.stm[http://perma.cc/2RTX-RYG6].
- 8.
Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), Court held that microorganisms produced by genetic engineering are not excluded from patent protection in a case involving the creation of an organism not found in nature.
- 9.
U.S. Patent Nos. 5,843,780 (1998), 6,200,806 (2001), and 7,029,913 (2006). The ‘780 patent claimed: 1. A replicating in vitro cell culture of human embryonic stem cells comprising cells which (i) are capable of proliferation in in vitro culture for over one year without the application of exogenous leukemia inhibitory factor, (ii) maintain a karyotype in which the chromosomes are euploid through prolonged culture, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are inhibited from differentiation when cultured on a fibroblast feeder layer.
- 10.
The first stem cell patents were directed to hematopoietic stem cells (e.g., U.S. Patent Nos. 5,436,151 [1995] and 5,670,147), fetal/neonatal cells (e.g., U.S. Pat. 5,004,681), and mesenchymal cells (e.g., U.S. Pat. 5,827,740). Embryonic stem cells were first patented from animals (e.g., birds [U.S. Pat. 5,340,740 and U.S. Pat. 5,656,479] and mice [U.S. Pat. 5,453,357 and]).
- 11.
In genetics, complementary DNA (cDNA) is DNA synthesized from a single-stranded RNA (e.g., mRNA) template in a reaction catalyzed by the enzyme reverse transcriptase. cDNA may be used to clone eukaryotic genes in prokaryotes.
- 12.
35 U.S.C. §101 refers to the section of the patent statute that states the subject matter eligible for patenting: any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.
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Carvalko Jr., J.R. (2020). Patenting the Transhuman. In: Conserving Humanity at the Dawn of Posthuman Technology. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-030-26407-9_52
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