User:Emma2244/GeneticallyModifiedMouse

Regulation
The regulation of genetically modified organisms addresses the novelty in managing animals used in research. Welfare and containment guidelines vary between different countries. Genetically modified mice do not generally face the same regulation as other genetically altered animals, such as fish or cattle.

The development of genetically altered animals has led to concerns of containment. Mice as disease models, for instance, raise concerns of genetically modified mice spreading pathogens to humans if not properly contained. Another issue revolves around the possibility of genetically altered mice with recombinant DNA escaping from their enclosures and breeding with wild mice populations. However, genetically modified animals are expected to follow BL1-N conditions of biological safety from the National Institute of Health to avoid these issues.

Welfare Concerns
The overall expansion of mice and other animals in genetic modification research has led to welfare concerns and subsequent regulations regarding animal treatment. Due to the advancement of mice as human disease and treatment models, the implementation of mice in genetic engineering has increased beyond the use of other animals. This decreases the overall number of animals with higher sentience used in laboratories. However, certain widespread welfare laws enacted in the U.S do not include the protection of rats, mice, or birds.

Under the U.S Congress, mice are not protected by the Animal Welfare Act (AWA). Due to the high volume of mice used in research, the USDA is unable to monitor the abundance of genetically modified mice. Research mice, including genetically altered mice, are instead protected under the Public Health Service Policy (PHS Policy). The PHS Policy protects animals used in federally funded research. The PHS Policy enforces regulations from the Guide for the Care and Use of Laboratory Animals as well as the implementation of an Institutional Animal Care and Use Committee (IACUC). An IACUC is tasked with the responsibility of reviewing and approving animal research studies. The National Institute of Health's Office of Laboratory Animal Welfare inspect any reports that allege the misuse of mice in research.

The United Kingdom protects laboratory mice through the Animals Scientific Procedures Act of 1986 (ASPA). This act covers all vertebrate animals used in invasive research, including genetic modification.

Patenting
Main Article: OncoMouse

The OncoMouse, developed by Philip Leder and Timothy Stewart of Harvard University, was the first patented animal in history. The OncoMouse is engineered to be predisposed to develop cancer as a model for humans. The Myc gene is isolated from an organism and injected into fertilized mouse eggs. The eggs are implanted within a female mouse, with nearly half of the subsequent offspring carrying the active oncogene. The mice are used as models to understand and treat human cancer.

In U.S Supreme Court case Diamond v. Chakrabarty, the court decided that genetically modified organisms may be patented on the basis that the subject of the patent is not a direct product of nature. The success of the OncoMouse as patentable subject matter in the U.S was largely due to the precedent set by the Diamond v. Chakrabarty case. The OncoMouse was considered a new "composition of matter" under Title 35 U.S.C §101. DuPont de Nemours, Inc, who provided funding for Leder and Stewert's research, was given exclusive licensing to the patent.

The OncoMouse patent application faced further examination over the course of nineteen years in Europe. Examiners of the European Patent Office considered Directive 98/44/EC, which determines plant and animal varieties as patent ineligible. However, the EPO Patent Examining Division marked the OncoMouse as a classification above the category of species, differentiating it from being considered a "variety". In contrast to the original patent presented to the EPO in 1992, the final approved patent is limited to mice rather than all transgenic mammals.

The patent raises questions among researchers into how intellectual property rights affect developments in genetic engineering. The Bayh-Dole Act of 1980 inclines government-funded institutions to develop relations between scientific innovation and commercialization. Supporters of the OncoMouse patent deem intellectual property rights in biotechnology as protections against competitors gaining unlawful revenue from the invention. Critics to the OncoMouse patent point to issues of the morality in patenting life and to the potential restriction of legal access to materials for further advancement.