Patenting Oranisms

 INTRODUCTION

Nowadays, scientists have isolated genes that cause particular diseases and modified genes that alter organisms for particular reasons. The technology has been manipulated to allow scientists to alter DNA by adding to or changing targeted sections. By doing so, scientists hope to eliminate genetic diseases. The mention of gene editing may invoke up images of rampaging dinosaurs in the film, Jurassic World, but this image is far from the truth. The closest to the truth about the rampaging dinosaurs is watching the endless Jurassic Park franchise. In general, the predominating opinion is that it is almost impossible to patent a living being. This pre-conceived notion is often based on grounds such as the lack of novelty, how can you patent something that already exists in nature, or unsurprisingly, the ethical impediments. However, whether it is possible to patent a living being, depends on the type of living being and the territory in which protection is to be obtained. Putting the ethical quagmire of human gene editing to one side, the realities of animal gene editing through the CRISPR technology is debated in terms of de-extinction and conservation. On October 18, 2016, a biopharmaceutical company called CRISPR Therapeutics AG that focused on translating CRISPR/Cas9 gene-editing technology into transformative medicines, announced the pricing of its IPO. It is a type of technology based on the natural functioning of bacteria called Clustered Regularly Interspaced Short Palindromic Repeats, abbreviation as CRISPR. the CRISPR/Cas9 edits genes by precisely cutting DNA and then letting natural DNA repair processes to take over. The system consists of two parts: the Cas9 enzyme and a guide RNA. The technology applied in modified bacteria to defend against invading viruses by remembering the genetic codes of previous invaders. If attacked again, the remembered code allows the bacteria to target the viruses’ DNA and disable the virus. Ethically sensitive and scientifically thrilling, CRISPR technology is sparking international debates that aren’t likely to be readily resolved. Whether the answer is to bring back extinct species or focus on those currently under threat, scientists are delving into gene editing as a way of repairing a damaged world. 

The CRISPR PATENT DISPUTE

As we learned above, much has been written about the power of CRISPR, the genetic-editing system first elucidated in 2012. But there has also been extensive interest in the variety of intellectual property issues surrounding CRISPR. While the intellectual property disputes concerning CRISPR are far from over, new characters central to the dispute continue to materialize five years of hindsight has given some perspective on their ethical, legal, and social implications. Since the first U.S. patent applications were filed for an engineerable CRISPR system in 2012, the IP landscape has become significantly more crowded, with several researchers controlling a few significant battlements. 

However, most of the commentary on the CRISPR patents has been negative. But, aside from money, there are some significant social positives as well. Patents are not the only means of private governance to reign in ethically unruly technology. At their core, patents are rights to exclude others from practicing the claimed invention. The corollary to this axiom is that patents, therefore, allow their owners to dictate to the rest of the world how to use the inventors’ technology. Although the claimed technology raises ethical or social concerns, patent holders have the right to tell their technologies’ users to behave ethically and to provide access to downstream inventions. The patents, when used well, can function as a powerful form of private governance. Those scientists have proposed patenting the use of CRISPR-based gene drives to prevent others from using the technology without rigorous scientific and ethical controls. Rather than using patents to ethically restrict access to controversial technologies, patents can be used to ethically promote access to the same. That is, patent holders can demand licensees promise that they make their technology available to broad segments of society and on fair terms. And, patents could also be used to ensure research access to a variety of technologies. Patent holders can publicly commit to refuse to execute their patents against researchers or academic institutions. In addition, patent holders can also use open licensing systems to researchers interesting in developing and sharing the technology for the public good. 

One potentially inappropriate use of CRISPR is its use in gene drives, a daisy chain of genetic editing that essentially forces future generations to inherit and subsequently pass on only a single variant of a particular gene. The concern is that gene drives, because they are forcibly heritable, become difficult to control once put in place. If later research finds negative, unintended effects of the particular genetic variant driven through the population, it may be too late. The legal mechanics of enforcing patent protection in this manner leave some gaps that likely need to be addressed. Moreover, the overreliance on patents as vehicles promoting the ethical uses of technology may crowd out other equally effective and less restrictive forms of control. 

IN CONCLUSION

Despite claims that the CRISPR patent dispute is a unique event, there are some greater lessons to be learned about the ethical, legal, and social implications of intellectual property in research science. The CRISPR patent controversies teach us that patents, like kitchen knives, are simply tools, without a moral valence separate from their users. Patents, like the CRISPR patents, can be used in ways that impede further research, or they can be used to promote, if not demand, their ethical application. The patents themselves do not do these things. The outcomes depend entirely on who's wielding them. To that end, the CRISPR patent controversies should encourage researchers to think about how, and by whom, their inventions will ultimately be used.

CASE IN POINT - Diamond v. Chakrabarty, 447 U.S. 303 (1980)

Diamond v. Chakrabarty, 447 U.S. 303 (1980), was a United States Supreme Court case dealing with whether living organisms can be patented. Chief Justice Warren E. Burger held that human-made bacterium could be patented under the patent laws of the United States because such an invention constituted a kind of manufacture or composition of matter. However, other Justices argued that because Congress had not expressly authorized the patenting of biological organisms, the Court should not extend patent law to cover them. Diamond v. Chakrabarty was a significant legal case, particularly with respect to the patent laws and the biotechnology industry. 

The story began with a genetic engineer Ananda Mohan Chakrabarty who works for General Electric for developing a bacterium capable of breaking down crude oil, which he proposed to use in treating oil spills. General Electric filed a patent application for the bacterium in the United States, but it was rejected by a patent examiner. Because, under patent law at that time, living things were generally understood to not be a patentable subject matter. And, of course, they appealed.

The Congress intended for the patent laws to be given a broad scope that was not unlimited and laws of nature, physical phenomena, and abstract ideas were not patentable. However, the GE was not trying to patent a kind of natural phenomenon but rather a human-made bacterium he developed. But, the Supreme Court here held that Chakrabarty had not merely discovered the bacteria's existence, he created it by himself and adapted it to a particular purpose. 

To summarize the case, a live, human-made micro-organism is a patentable subject matter under the organism that constitutes a manufacture or composition of matter within that statute. While laws of nature, physical phenomena, and abstract ideas are not patentable, the respondent's claim is not to an unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter, a product of human ingenuity. Moreover, the passage of the 1930 Plant Patent Act, which afforded patent protection to certain asexually reproduced plants, and the 1970 Plant Variety Protection Act, which authorized protection for certain sexually reproduced plants but excluded bacteria from its protection does not evidence congressional understanding that the terms manufacture or composition of matter. The U.S. Supreme Court reads the term manufacture in 35 U.S.C.S. § 101 in accordance with its dictionary definition to mean the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery. Eventually, the court found that the respondent had produced a new bacterium with markedly different characteristics from any found in nature and which had the potential for significant utility. The court held that the language of 35 U.S.C.S. § 101 embraced Chakrabarty's invention.

Reference

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Diamond v. Chakrabarty, 447 U.S. 303 (1980). Justia Law. (n.d.). Retrieved December 13, 2021, from https://supreme.justia.com/cases/federal/us/447/303/. 

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ScienceDaily. (2018, October 8). Genetic disease healed using genome editing. ScienceDaily. Retrieved December 12, 2021, from https://www.sciencedaily.com/releases/2018/10/181008183347.htm.