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Alienation from the Objectives of the Patent System: How to Remedy the Situation of Biotechnology Patent

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Abstract

Some fundamental biotechnologies hold unprecedented potential to eradicate many incurable diseases. However, in absence of regulations, the power of patent makes the future use of some important biotechnology in few institution’s hands. The excessive patents restrict researcher access to the fundamental technologies. It generates concerns and complaints of deteriorating the public health and social welfare. Furthermore, intellectual curiosities, funding, respect among colleagues etc., rather than patents, are the real motivations driving a major ground-breaking discoveries in biotechnology. These phenomena reveal that some biotechnology patents are alienated from the purpose of patent system. Therefore, it is necessary to take some approaches to stop over-patenting these fundamental biotechnology inventions. This article proposes a model regulatory framework for controlling biotechnology patent alienating from the purpose of patent system.

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Notes

  1. Special obviousness requirements for software patent.

  2. The purpose of the patent is to give to the exploiter of the patent a monopoly on the profitable use of the patent for a limited period of time. However, the phenomena like patent thicket-requiring innovators to reach licensing deals for multiple patents from multiple source and patent ever greening-tweaking expiring patents to apply for new patents which artificially extend their patent life smother innovation.

  3. The patent system allows inventors to sell all of their right in a patent or patent application.

  4. Hardin writes: therein is the tragedy. Each man is locked into a system that compels him to increase this heard without limit-in a world that is limited. Ruin is the destination toward which all men rush, each pursuing his own best interest in a society that believes in the freedom of the commons. Freedom in a commons brings ruin to all.

  5. The Lockean theory of property allows a laboured resource to become one’s property if it complies with the two provisos: the first is the non-spoilage proviso, which means as much as anyone can make use of to any advantage of life before it spoils; so much he may by his labour fix a property in; the second is the enough and as good proviso, which means at least where there is enough and as good left in common for others.

  6. In Locke’s terms: “whatsoever then he removes out of the state that nature hath provided, and left it in, he hath mixed his labour with, and joined to it something that is his own, and thereby makes it his property”.

  7. Although regulatory agencies have the responsibilities to provide the money for medicines for pool people, not all government can afford the expensive medicine. For example, in the developing countries, the high cost patented medicine reduces the people’s access to much needed essential drugs which further worsen their health and economic status.

  8. Article 8 of the agreement states that “members may in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socioeconomic and technological development”.

  9. There is strong tension between pharmaceutical patent holders, often supported by powerful countries like the United States, and countries that want to use compulsory licensing to gain access to medication. In February 2001, the tension led the United States to seek sanctions against Brazil and sent strong messages to countries seeking to use compulsory licensing.

  10. US patent 5,843,780, US patent 6,200,806 and US patent 7, 029,913.

  11. It is observed by Jacob S. Sherkow that the CRISPR patent battle demonstrates how overzealous efforts to commercialize technology can damage science. One obvious danger of increasing the focus on commercialization is that “educational institutions will view scientific research as a path to profit, above all else”. It is not hard to imagine that “patent disputes might lead to university administrators pushing certain views on their scientists, denigrating collaboration with researchers from competing institutions and tasking tenure committees with valuing patents over publication”.

  12. National Institute of Health Care Management on Pharmaceutical Innovation in US investigated and found over 75% of the patent drugs are new forms of known substances, eliminate competition, extend monopolies, make drugs unaffordable and adversely affect the right to health.

  13. Genetic diagnostics for BRCA1 and BRCA2 can be very important for cancer prevention. The lifetime risk for breast cancer can be up to 80%, which is considerably higher than the 10% risk for women who do not carry a mutation.

  14. Myriad Genetics Inc. is a molecular diagnostic company founded in 1991 by a group of scientists from the University of Utah’s Centre for genetic epidemiology, whose purpose is to identify cancer susceptibility genes as well as to provide genetic tests for high-risk individuals. Myriad filed patents on the coding sequences, amino acid sequences and associated primers for BRCA1 and for BRCA2.

  15. In 1980, the landmark case Diamond versus Chakrabarty open the door to patent some forms of life. After that, there are broad categories that are eligible for patents in US, including a composition of matter. Gene patent include both a composition of matter and the gene itself are allowed. However, in June 2013, the US Supreme Court ruled that naturally occurring genes were unpatentable in case Myriad.

  16. 13% respondents in Walsh, Cohen and Cho investigation and 18% respondents in Nicol and Nielsen investigation.

  17. The CRISPR patent holder, Eric Lander, the director of the Broad Institute, said: “Consistent with the Broad’s mission to accelerate the understanding and treatment of disease, we are committed to empowering the global research community by making this technology broadly available to scientists for research around the world”. The stem cell patent holder WARF allow academic researchers to use HESC for noncommercial research purposes.

  18. The governmental organisations range from the Ministry of Science and Technology, the National Natural Science Foundation to the Chinese Academy of Sciences.

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Acknowledgements

The work of the first author has been funded by the Ministry of Justice Research Foundation of People Republic of China (17SFB3028), the Jiangsu Philosophy and Social Science Foundation (17ZXC003), and the project “the alienation of biotechnology patent” approved by Philosophy and Social Science Research Fund of Colleges and Universities in Jiang Su Province (2017SJB1330). I would also like to thank the editorial team of Science and Engineering Ethics and the two anonymous reviewers of this paper for their constructive and very helpful comments.

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  1. Kenneth Wang School of Law, Soochow University, Suzhou, People’s Republic of China

    Li Jiang

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Jiang, L. Alienation from the Objectives of the Patent System: How to Remedy the Situation of Biotechnology Patent. Sci Eng Ethics 25, 791–811 (2019). https://doi.org/10.1007/s11948-018-0043-3

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