Whether Patent Law Protects Biotechnological Inventions
The relationship of law and morality is particularly fraught in the sphere of patent law.
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When Louis Pasteur in 1873 received US Patent 141,072, claiming ‘yeast, free from organic germs of disease, as an article of manufacture’, first patent concerning a micro-organism was granted.
In essence, the India Patents Act gives only very limited protection to research-based pharmaceutical companies. Patenting of human material in the form of gene sequences is considered to be wrong as it amounts to commercialization of life. Failure of the basic patent principles to cater to the needs of genetic inventions has given rise to ambiguities for companies concerned with bio-technology.
Characteristics of Patents in Bio-Technology
Biotechnology is special and it is based on living organisms. Indeed, biotechnological inventions can be self-reproducing and self disseminating.
The Biotechnology Industry Association (BIA), the representative body of international biotech product makers in a representation to the office of the US Trade Representative (USTR) on February 2008 contented that each patent applicant is responsible for tracing the history of all naturally-derived biological materials contributing to the invention, even if the applicant obtained the material from a commercial supplier and the material has been available from secondary sources for decades. The failure to identify the geographical source of a biological material used in the invention may be the basis for opposition or revocation proceedings. Such requirements pose unacceptable risks for patent applicants and would undermine the incentives of the patent system to promote innovation in biotechnological inventions.
Foreign Courts’ Views
In Diamond v. Chakrabarty , US Supreme Court noted that the laws of nature, physical phenomena and abstract ideas were not patentable. The claimed invention, however, was not directed to an existing natural phenomenon but to new bacteria with markedly different characteristics from any found in nature. The invention therefore resulted from the inventor’s ingenuity and effort and could be the subject of a patent. It further observed that microorganisms produced by genetic engineering are not excluded from patent protection
Supreme Court of Canada in Monsanto Canada Inc. v. Schmeiser has laid down that higher life forms were not patentable because they were not a manufacture or composition of matter within the meaning of invention of the Patent Act.
Factors determining the question of patentability
Protection of intellectual property is at the core of the business for biotechnology firms. When considering these issues, one also needs to recognize that legal regimes other than patent systems are typically relied upon to address other public interests, such as the environmental or medical safety of products, efficacy of products, and unfair competition that may occur in the assertion of patent rights. The transparency of the patent system supports ethical scrutiny of biotechnology and can help inform the bioethics debate.
Oliver Mills has suggested that in order to protect adequately biological invention, effectively harmonizing legislation regarding patentability criteria is necessary.
Han Somsen has differentiated between pre-grant and post-grant concerns. He is of the view that pre-grant objections relate to subject-matter, requirements and disclosure whereas post-grant objections revolve around blocking effects of patents on research as well as health-care. Prof Gardner has put: “Our experience with animals suggests that there would be a very real danger of creating seriously handicapped individuals if anybody tries to implant cloned human embryos into the womb.”
Biological inventions possess properties that pose unique challenges to the patent system. We always hear that morals or ethics are impeding bio-tech progress, but in reality these ethics have ensured a check whether small over biotechnological inventions. Patenting human genes amounts to a form of modern slavery since it involves the dismemberment of women and their piecemeal sale to commercial enterprises.
William Heseltine (President, Human Genome Science) has interestingly noted that trying to patent a human gene is like trying to patent a tree. You can patent a table that you build from a tree, but you cannot patent the tree itself.
By signing “Budapest Treaty on the International Recognition of the Deposit of Micro organisms for the Purposes of Patent Procedure”, India can assist in the standardization process of biotechnology pate in the country. Since patent system cannot survive in a moral vacuum, so we must not let any conflict continue between bio-technology and patents regarding it.
1.Carsten Fink, How Stronger Patent Protection in India Might Affect the Behavior or Transnational Pharmaceutical Industries, Development Research Group The World Bank.
2.Oliver Mills, Biotechnological Inventions: Moral Restraints and Patent Law, Ashgate Publishing, Ltd, (2005) at 170.
3.447 U.S. 303, 206 USPQ 193 (1980).
4.2004 SCC 34.
5.Swiss Federal Institute of Intellectual Property, Research and Patenting in Biotechnology - a Survey in Switzerland
6.WIPO Academy notes.
7. Intellectual Property and Bioethics- An Overview , Consultation Draft WIPO.
8.Margaret Sampson, The Evolution of the Enablement and Written Description Requirements under 35 U.S.C. §112 in the area of Biotechnology, 15 Berkeley Tech. L. J. 1233, 1234 (2000).
9.Bioethics and Patent law – The Relaxin case, WIPO Magazine, April 2006.
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