Genetic engineering which provides ways of changing the genetic structure of organisms in order to produce desired characteristics is seen as a new tool of medicine, agriculture and biotechnology. However, together with the scientific opportunities that can be provided by CRISPR, there are numerous legal and ethical questions, based primarily on the question of ownership of the results achieved and the subsequent considerations of possible misuse for creating ‘designer babies’, as well as attempts to patent the technology. The legal protection of GMOs, synthetic genes, and paradigmatic gene-editing tools has produced ownership, accessibility, and the propriety of tweaking life at its subbasal level.
This article examines the legal and ethical issues related to intellectual property rights in genetic engineering with emphasis on specific questions concerning the patenting of genetically engineered organisms or technologies, and the entire social effects of the foregoing.
1. There are several reasons why the subject matters of the Genetics and Intellectual Property have been in the limelight.
This is true because the law of intellectual property especially patents has an important function to encourage innovation in genetic engineering. Organizations and researchers spend a lot of time and capital on the creation of genetic engineered organisms and tools, and through patents they are able to protect their exclusive ability to market these products for a period of time. This protection is considered as necessary to revenues and more development of these new technologies.
Patents in genetic engineering typically fall into two categories:
Patents on Genetically Modified Organisms (GMOs): These patents involve unique organisms, plants and other genetically altered animals wherein new characteristics have been incorporated. For instance, Monsanto that is now a Bayer’s subsidiary patented such products as Roundup Ready soybeans which are genetically modified crops capable of surviving herbicides.
Patents on Genetic Engineering Tools: Technologies also involve patenting in genetic engineering; for instance, the CRISPR-Cas9 technology, a gene-editing tool that greatly enhanced the ability of humans as compared with hereditary material. Legal battles over CRISPR have been going on with universities and companies struggling to gain exclusive rights on how it is going to be used commercially.
Legal Challenges and Controversies
High interest in patenting genetic engineering innovations is pegged on some of the legal issues it poses regarding the qualification of ownership of such innovations, and the extent to which it is protected through patent laws.
a. Patenting Life
Perhaps one of the most contentious legal issues relates to the possibility of using Living organisms as items of Patent protection. Diamond v. Chakrabarty, 447 U.S. 303 (1980) of the United States Supreme Court provided the great foundation that permitted the issuance of patents on genetically modified organisms by saying anything under the sun made by man. The above decision paved way for patents on GMO and other forms of genetic engineering arena.
Still, this principle is under a constant pressure in terms of its ethical and legal permissiveness. For instance, in the case of patenting of genetically modified animals for instance, Aqua Bounty genetically salmon engineered salmon there has been apprehension about the ownership of patents in higher life forms. The opponents of the patents on animals claim that such patents turn living organisms into objects and thus raise concerns with the animals’ rights and the conservation of diverse species.
b. Gene-Editing Tools and Ownerships
The recent bio technology advancement in the area of gene editing has resulted in a protracted legal war over patents. In the United States the University of California Berkeley and the Broad Institute MIT and Harvard University have been locked in a major controversy between them as each claim they have the rights, to the CRISPR-Cas9 patent. The result of these disputes is significant because this technology has the possibility of transforming medicine, agriculture and many more fields.
The Ownership issue also has further implications on the usage as well as the costs associated with it With regard to the question of who owns rights to use CRISPR technology, the impacts are drawn from aspects such as access and affordability. If one entity owns exclusive rights then this considerably restricts competition and directs the evolution and operational cost of other therapies that are develop using gene editing technology.
Copyright concerns such as the ownership of living organisms and genetic resources may warrant reviewing the patent laws. Legal mechanisms may also include provisions for research exemptions, compulsory license provisions in respect of key technologies, and benefit sharing of the profits derived from the use of such resources with the source communities among others. Biotechnology is a strategic tool for the advancement of agriculture and medicine as it combines genetic engineering with the acquisition and management of intellectual property. Patents encourage innovation, however, they present interesting challenges that must be dealt with. We must argue for equal and ethical distribution of the benefits of genetic engineering through genetic engineering as a dialogue between the lawyers, scientists and ethical intellectuals. As progress continues in the field, it is important to strike an optimum equilibrium between safeguarding intellectual property rights and the defense of the public interests in the biotechnology industry.
Author : Pillai Syamily, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at IIPRD