Introduction
Inventions and discoveries are intellectual property, which emanate from creative and innovative minds. The US constitution recognizes these inventions and discoveries because it has provisions for them. Title 35 and section 101 of the US constitution provides that “whoever invents or discovers any new and useful process, or any new manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof, subject to the conditions and requirements of this title” (Schaffer, Agusti, & Dhooge, 2014, p. 467). The provision forms the basis of the decision that led to the acceptance of the patent regarding genetically engineered bacterium, which Ananda Chakrabarty wanted to patent. Diamond v. Chakrabarty is an appeal case, which affirmed that genetically engineered organisms are patentable because they constitute inventions and discoveries, which emanate from human process. Although the decision of Diamond v. Chakrabarty is a precedent that allows researchers to patent organisms, the research paper argues that the patent protections should not involve or include human organisms such as stem cells, fetuses, and embryos.
Diamond v. Chakrabarty
As the US constitution recognizes intellectual property, it allows researchers to patent their inventions and discoveries. In 1972, a creative microbiologist, Ananda Chakrabarty, genetically engineered bacterium called Pseudomonas. The microbiologist engineered the bacterium by creating two plasmids and inserting them into the bacterium to change its biochemical pathways. The two plasmids enhance degradative capacity of the bacterium in breaking down crude oil, which often cause pollution in the seas owing to oil spills. As the bacterium gained the capacity to break down crude oil, the microbiologist decided to patent the organism through the General Electric Company. Before Chakrabarty managed to patent the bacterium, he went through legal tussle, which threatened to prevent him from patenting and owning the intellectual property, as envisioned by the US constitution.
Understanding his rights, Chakrabarty decided to patent his creation as per the provision in the US constitution, Title 35, section 101. The provision states that anyone may patent any invention or discovery and make it an intellectual property so long as it entails a creation of a new or improvement of pre-existing invention through a process of manufacturing. Although the creation of a bacterium entailed a discovery, the US Patent and Trademark Office (PTO) declined the application of patent by highlighting that the bacterium is not a patentable organism because it is a product of nature, according to the provisions of Title 35, section 101 (Schaffer et al., 2014). Such a decision denied Chakrabarty the right to patent his creation and own intellectual property, as stipulated by the US constitution.
However, the Court of Customs and Patent Appeals decided to overturn the decision of the PTO by holding that the bacterium is a patentable organism because it is not a product of nature, but the handiwork of Chakrabarty. Following the decision to overturn, Diamond appealed and the case went to the Supreme Court, where the jury decided if genetically engineered organism could be considered as intellectual property and patentable as other inventions and discoveries. As the US constitution recognizes discoveries or inventions as products of the manufacturing process of machinery or handiwork, the Supreme Court holds that the creation of a unique bacterium constitutes manufacturing. Moreover, the Supreme Court holds that creation of the bacterium meets the requirement of a new composition of matter because the bacterium has two plasmids inserted, which gives unique properties to the native strain of bacterium. Therefore, the Supreme Court made the decision that the creation of the bacterium through the process of genetic engineering constitutes discovery because it entails a manufacturing process that changes the composition of the natural matter, and thus, the bacterium is a patentable product (Schaffer et al., 2014). The decision of the Supreme Court, therefore, made a precedent that allows scientists to patent genetically engineered microorganisms.
Stakeholder Identification
In the case of Diamond v. Chakrabarty, the stakeholders are the United States government, Congress, General Electric Company, Ananda Chakrabarty, microbiologists, the US Patent and Trademark Office, and the Court of Customs and Patent Appeals. To argue that the law should not allow patent claims that involve human organisms, the research paper presents two arguments, which offer objective analysis.
Argument one: Sanctity of Human Life
One of the arguments that prevent biotechnologists and other scientists from patenting human organisms is the sanctity of life. The US Patent and Trademark Office holds that human organisms are not patentable because human life is sacred and enjoys inalienable rights. If the law allows patentability of human organisms, it would lead to degradation of human dignity and violation of rights that preserve the sanctity of human life. According to Gunderman and Hammond (2014), patent allows discoverers to own their inventions, and thus, subjecting human organisms to ownership of other parties, a situation that constitutes slavery and violates the 13th Amendment to the US constitution because it encourages slavery of humans. The owners of inventions would create human organisms and enslave them because patents gives them rights to own and manipulate them. Patents that claim human organisms are unethical because commodify and commercialize humans and their body parts leading to the degradation of rights and ethics that guard the dignity of humanity. In this view, human organisms are not patentable because the patent allows degradation of human dignity and sanctity of life.
Second Argument: Monopoly of Health
Biotechnology is a promising field of health, which appear to be the panacea of chronic diseases that have perplexed humanity for centuries. In health, biotechnology aids in the production of therapies that are not only safe and effective, but also specific to the treatment of chronic diseases, such as diabetes, cancer, and immunological disorders. Patenting discoveries such as stem cells, fetuses, embryos, and clones, which are important to the health, open avenues that lead to the monopoly of medical treatments. Caffarini (2013) argues that patenting medical treatments would lead to inaccessibility and unaffordability of healthcare services because doctors would be struggling to comply with patent rights rather than providing quality healthcare services. If the law allows patenting of human organisms, it would mean that discoverers would monopolize medical treatments, create new hurdles that increase inaccessibility to healthcare services, and increase the cost of acquiring patented treatments. Parsons, Teng, Moore, and Snyder (2011) state that the technologies involved in the regeneration of cells, tissues, and organs from stem cells are expensive, and thus, they make healthcare services expensive. Thus, patenting of human organisms would complicate accessibility and affordability of healthcare services owing to the monopoly of inventions and discoveries.
Patenting Human Organisms
The analysis of the case study shows that the ambiguity of the provisions in the US constitution has contributed to the controversy regarding patent eligibility of inventions and discoveries related to human organisms. The US Patent and Trademark Office dismissed the request of Ananda Chakrabarty to patent the genetically engineered bacterium citing that the bacterium is a natural product and organisms are not patentable, subject to section 101 of Title 35 of the US constitution (Schaffer et al., 2014). The provisions in this section does not explicitly mention human organisms, but they emphasize that the discoverers have the privilege of patenting their inventions and discoveries so long as they constitute a new matter, which is a product of the manufacturing process. Such a provision gave the US Patent and Trademark Office the leeway to reject organisms as unpatentable products of nature. Moreover, legal precedents, such as the Plant Patent Act (1990) and the Plant Variety Protection Act (1970), excluded bacteria from the patent protection (Schaffer et al., 2014). In this view, there is no explicit provision, which supports or invalidates patenting of bacteria.
Regarding the patenting of human organisms, the US constitution is also not clear because its provisions do not specify the nature of human organisms. Caffarini (2013) argues that section 33 of the US constitution is vague because the words used, namely, ‘directed to’ and ‘encompassing human organisms’ are very subjective in that they have the potential of curtailing biotechnology discoveries. The words ‘directed to’ have a wide meaning in that they may mean that anything related to the human organism is unpatentable. Moreover, the words ‘encompassing human organism’ are vague because they may mean any invention that associates with human organisms. The broadness and vagueness of the terms used in restricting patentability of organisms have the potential of invalidating intellectual property in the realm of biotechnology, as evidenced in the case of Diamond v. Chakrabarty.
Conclusion
Patenting of human organisms has been subject to religious, ethical, and legal provisions. Evidently, the research paper holds that human organisms are unpatentable because they are sacred. Patenting of human organisms degrades the sanctity of life and dignity of humans as rational agents, who have the capacity to make informed decisions. Moreover, patenting of human organisms leads to monopoly of medical treatments, which result in reduced accessibility and affordability of healthcare. However, alternative arguments hold that human organisms are patentable because they are novel products, which are creatures of the human mind. In this view, humans have the right to own property of their minds and manipulate their own creatures with a view of reaping optimum benefits. Since human organisms have the potential of generating safe, effective, and specific therapies, their protection as intellectual property using patent is essential to promote research in biotechnology and health. Thus, the alternative argument supports intellectual property rights and promotion of biotechnology.
My personal opinion is that human organisms are unpatentable because they are sacred organisms. Religious, ethical, and legal provisions regard humans as unique creatures, with inalienable rights, which cannot be subject to laboratory experiments or other humans. The 13th amendment to the US constitution upholds dignity and sanctity of human life by outlawing slavery.
Given that the provisions that determine patentability of inventions and discoveries are ambiguous, vague, and broad, the provisions related to patents should be clear enough to indicate the nature of the organisms that qualify for patents and the ones that do not qualify. In this view, section 33 and section 105 should explicitly indicate unpatentable organisms and patentable organisms respectively. In this case, the research paper recommends amendment of the aforementioned sections and provisions to improve clarity and specificity of words used to prevent haphazard invalidation or validation of the inventions.
References
Caffarini, A. (2013). Directed to or encompassing human organism: How section 33 the America invents act may threaten the future of biotechnology. The John Marshall Review of Intellectual Property Law, 12(1), 768-786.
Gunderman, R., & Hammond, J. (2014). Patent claims directed to or encompassing a human organism: Where law, morality, ethics, and religion meet. The Rochester Engineer, 1(1), 10-11.
Parsons, X., Teng, Y., Moore, D., & Snyder, E. (2011). Patents on technologies of human tissue and organ regeneration from pluripotent human embryonic stem cells. Recent Patents on Regenerative Medicine, 1(2), 142-163.
Schaffer, R., Agusti, F., & Dhooge, L. (2014). International Business Law and Its Environment (9th ed.). Stamford, CT: Cengage Learning.
