Patents on life-forms

SIGNIFICANCE: In 1980, the US Supreme Court upheld the right to patent a live, genetically altered organism. The decision was opposed by many scientists and theologians who believed that such organisms would pose a threat to the future of humanity. Although "legally" settled, the debate has continued, with opponents arguing that patenting life-forms and DNA sequences imposes too great a cost and greatly inconveniences genetic research. Another major development came in 2013, when the Supreme Court ruled that naturally occurring gene sequences could not be patented, though complementary DNA (cDNA) could be. The issue of biological patents has also been confronted in other countries, with Canada notably banning patents on higher life forms.

Patent on Life-Form Upheld

On June 16, 1980, the US Supreme Court voted 5 to 4 in the case Diamond v. Chakrabarty that living organisms could be patented under federal law. The case involved Ananda M. Chakrabarty, a scientist who, while working for General Electric in 1972, had created a new form of bacteria, Pseudomona originosa, which could break down crude oil, and, therefore, could be used to clean up oil spills. Chakrabarty filed for a patent, but an examiner for the Patent Office rejected the application on the ground that living things were not patentable subject matter under existing patent law. Commissioner of Patents and Trademarks Sidney A. Diamond supported this view.

Federal patent law provided that a patent could be issued only to a person who invented or discovered any new and useful "manufacture" or "composition of matter." The US Court of Customs and Patent Appeals reversed that decision in 1979, concluding that the fact that microorganisms are alive has no legal significance. It held that a live, human-made bacterium is a patentable item since the microorganism was manufactured by crossbreeding existing strains of bacteria and had never existed in nature.

Writing for the majority, Supreme Court Chief Justice Warren E. Burger upheld the patent appeals court judgment, making a distinction between the new bacterium and "laws of nature, physical phenomena and abstract ideas," which are not patentable. In the Court majority's view, Chakrabarty had invented a form of life that did not exist in the natural world, so it could not be considered part of nature. Instead, it was a product of human "ingenuity and research" that deserved patent protection.

Items not patentable include new minerals that are discovered in the earth or a new species of plant found in a distant forest. These things occur naturally and are not created by humans. Burger also stressed that physicist Albert Einstein could not have patented his formula E = mc², since it is a law of nature, nor could Sir Isaac Newton have received a patent for the law of gravity. Discoveries such as these are part of the natural world and cannot be owned by a single individual.

Chakrabarty, on the other hand, had not found an unknown, natural species, nor had he discovered a law of nature. His new bacterium had a distinctive name and was developed in the laboratory for a specific purpose. None of the characteristics of the new organism could be found in nature. His discovery, Burger reemphasized, was patentable because he had created it.

Opposition to the Ruling

The court majority refused to consider arguments made in friend-of-the-court briefs filed by opponents of genetic engineering. The briefs were presented by groups representing scientists, including several Nobel Prize winners, and religious organizations. One brief suggested that genetic research posed a dangerous and serious threat to the future of humanity and should therefore be prohibited. Possible dangers included the spread of pollution and disease by newly created bacteria, none of which would have any natural enemies. Other threats involved the possible loss of genetic diversity, if, for instance, only the "best" form of laboratory-created plant seeds were grown. It was also argued that research into human genetics could lead to newly designed gene material that could be used to build a "master race," thereby devaluing other human lives.

Chief Justice Burger concluded, however, that humans could be trusted not to create such horrible things. Quoting William Shakespeare's Hamlet, the chief justice asserted that it is sometimes better "to bear those ills we have than to fly to others that we know not of." People can try to guess what genetic manipulation could lead to, but it would also be a good idea to expect good things from science rather than "a gruesome parade of horribles." Besides, he then said, it did not matter whether a patent was granted in this case; in either case, scientific research would continue into the nature of genes.

The People's Business Commission, a nonprofit educational foundation, had argued that granting General Electric and Chakrabarty a patent would give corporations the right "to own the processes of life in the centuries to come" through genetic manipulation. Chief Justice Burger wrote that the Court was "without competence to entertain these arguments." They did not have enough information available to determine whether to ignore such fears "as fantasies generated by fear of the unknown" or accept them. Such a determination was not the responsibility of the Court, however. Questions of the morality of genetic research and manipulation were better left to Congress and the political process. How to proceed in these matters could only be resolved "after the kind of investigation, examination, and study that legislative bodies can provide and courts cannot."

Supreme Court Justice William J. Brennan presented a brief dissenting opinion. He noted that Congress had twice, in 1930 and 1970, permitted new types of plants to be patented. However, those laws made no mention of bacteria. Thus, Brennan argued, Congress had indicated that only plants could receive patents and that the legislators had thus clearly indicated that other life-forms were excluded from the patent process. The Court majority rejected this view, arguing that Congress had not specifically excluded other life-forms.

The US Patent and Trademark Office (USPTO)

Those opposed to patents on DNA sequences continued to hold a wide variety of contentions, ranging from the concern that sole privileges will impede research to the notion that genes represent the very basis of life and thus no one should have exclusive rights to them.

In 2001, the USPTO thoughtfully considered whether genetic discoveries were patentable by evaluating opposition comments from thirty-five individuals and seventeen organizations. Their decisions were published in the Federal Register. To address the contention that a gene is not a new invention because it exists in nature, the USPTO emphasized that only DNA in an unnatural form, excised and purified from its chromosome or synthesized in a laboratory, is patentable. To tackle the notion that no one person or company should own a human gene sequence because it inherently belongs to all humans, the USPTO asserted that progress is promoted and secrecy reduced when a patent gives an inventor purely the legal right to exclude others from making, using, selling, or importing the gene for twenty years, not ownership. To avoid reckless patenting of any gene sequence found, the USPTO stipulated that the utility of a gene or expressed sequence tag (EST), not just its sequence, must be known when filing for sole rights. Examples of a gene's utility include being involved in the cell regulation, coding for a useful protein, or flagging a disease.

The USPTO established these four criteria when considering a patent grant on a gene, gene fragment, single nucleotide polymorphism (SNP), gene test, protein, or stem cell: novelty, usefulness, nonobviousness, and enablement, whereby the life-form could be reproduced by someone skilled in the biochemistry field. Patentees must deposit a sample of the unique life-form in one of twenty-six worldwide culture depositories.

Sharing Knowledge, Licensing, and Commercializing Life-Forms

Measures have been taken by key institutions to even the genomics playing field for all researchers. In April 1999, the UK Wellcome Trust vowed unrestricted access to the 1.5 million SNPs they identified and patented in order to prevent others from gaining exclusive rights to them first. The Human Genome Project publicly lists the genome for free on the internet.

As one of the United States' primary financial supporters of scientific research, the National Institutes of Health (NIH) weighed in on the patenting debate in 2004 by developing its "Best Practices for the Licensing of Genomic Inventions." These guidelines leave room for researchers to protect their work with patents, especially when there is potential to commercialize their product through the private sector for society's health benefit, but the NIH also strongly encourages investigators to propagate information by granting nonexclusive licenses to other universities receiving NIH funding.

In 1980, Congress passed the Bahy-Dole Act, which permits universities to commercialize via private industry their federally funded discoveries. This prompted colleges to establish a campus Technology Transfer Office and implement a material transfer agreement (MTA). Academic researchers now need to obtain an MTA before they disclose information to other investigators, adding another potential hurdle to the flow of knowledge. A 2005 survey of ninety-three agricultural biology departments found that MTAs had taken the lead over patents as the hindrance of conveying scientific information. This study and others found that patents are not aggressively enforced and did not truly encumber academic research.

After the human genome was sequenced in 2003, the genomics industry increased in prominence, to the point that many questioned the ethical nature of genes patents. In 2013, in a unanimous decision, the Supreme Court ruled that naturally occurring genes could not be patented (though those produced synthetically could). The case in question—Association for Molecular Pathology v. Myriad Genetics, Inc.— involved a lawsuit supported by the American Civil Liberties Union and the Public Patent Foundation against molecular diagnostics company Myriad Genetics, which owned the patents to several genes, including BRCA1 and BRCA2, linked to breast and ovarian cancers. The decision was seen as an landmark in the protection of individual rights and in the development of personalized and inclusive medical care.

Despite the additional legal precedent set by the Supreme Court in 2013, the issue of patenting life forms remained highly controversial. The debate continued to surface with various incidents that captured public attention, such as the efforts by the agrochemical corporation Monsanto to enforce its patents on various genetically modified crops. Opponents of biological patents often connected their arguments to the backlash against genetically modified foods in general. Other ongoing concerns regarding life-form patents included the power of corporations and the wealthy, potential threats to biodiversity, and the complexity of international regulation. One attempt to address some of these concerns on a global scale was the Nagoya Protocol, an agreement signed by over one hundred nations—but not the United States—in 2010 and entered into effect in 2014. The protocol sought equal international benefit from exploitation of genetic resources.

Key term

• patenta grant made by the government that gives the creator or inventor the sole right to make, use, or sell that invention for a specific period of time, usually twenty years in the United States

Bibliography

Barfield, Claude, and John E. Calfee. Biotechnology and the Patent System: Balancing Innovation and Property Rights. Washington, DC: AEI Press, 2007. Print.

Baran, George R., Mohammad F. Kiani, and Solomon Praveen Samuel. Healthcare and Biomedical Technology in the Twenty-First Century: An Introduction for Non-Science Majors. New York: Springer, 2014. Digital file.

Berg, Thomas C. "Playing God? Moral Arguments on Patents on Life." University of St. Thomas, 25 Jan. 2016, news.stthomas.edu/playing-god-moral-arguments-patents-life/. Accessed 5 Sept. 2024.

Chapman, Audrey R., ed. Perspectives on Genetic Patenting: Religion, Science, and Industry in Dialogue. Washington, DC: American Assn. for the Advancement of Science, 1999. Print.

Diamond, Commissioner of Patents and Trademarks v. Chakrabarty. 447 U.S. 303. Supreme Court of the US. 1980. Print.

Doll, John. "Talking Gene Patents." Scientific American Aug. 2001. Print.

Ghosh, Shubha. Identity, Invention, and the Culture of Personalized Medicine Patenting. New York: Cambridge UP, 2013. Print.

Hanson, Mark J. "Religious Voices in Biotechnology: The Case of Gene Patenting." Hastings Center Law Report Nov.-Dec. 1997. Print.

Hope, Janet. Biobazaar, the Open Source Revolution and Biotechnology. Cambridge: Harvard UP, 2008. Print.

Resnick, David B. Owning the Genome: A Moral Analysis of DNA Patenting. Albany: State U of New York P, 2004. Print.

Smith, Ryan P. "Nearly Half the Patents on Marine Genes Belong to Just One Company." Smithsonian.com, 13 June. 2018,www.smithsonianmag.com/science-nature/nearly-half-all-patents-marine-genes-belong-just-one-company-180969325/. Accessed 5 Sept. 2024.

Specter, Michael. Can We Patent Life? New Yorker. Condé Nast, 1 Apr. 2013. Web. 6 Aug. 2014.

"Supreme Court Issues Compromise Ruling on Landmark BRCA Gene Patenting Case." New York Daily News. NYDailyNews.com, 14 June 2013. Web. 6 Aug. 2014.

US Patent and Trademark Office. Federal Register 66.4 (2001): 1092–99. Print.

Vogel, Fredrich, and Reinhard Grunwald, eds. Patenting of Human Genes and Living Organisms. New York: Springer, 1994. Print.