Complex Genetic Disorders and Intellectual Property Rights
During the initial development of the ethical and legal frameworks for
dealing with genetics research and clinical practice, the focus was on
single gene disorders. But now attention is being paid to complex genetic
diseases where multiple genes or interactions between genes and the environment
contribute to the manifestation of a disease. Yet there is emerging evidence
that the intellectual property scheme developed in the context of single
gene disorders may be counterproductive to innovation with respect to
complex genetic disorders.
Working with a grant award from the Department of Energy, a team of researchers
designed this project to assess the potential impact of gene patents on
research and the development of testing and treatment technologies for
complex genetic disorders; analyze current developments in legislation,
litigation, patent office policy, and international trade negotiations
about gene patents to determine their impact in the realm of complex genetic
diseases; and propose intellectual property policy alternatives in order
to solve any problems created by the current scheme.
This is a pivotal moment for gene patents, which are currently being challenged in numerous
ways. The challenges to human gene patents come from a variety of interested
parties -- people from whom the patented genes were isolated, researchers
who wish to undertake genetic epidemiology or develop gene therapies,
clinicians and health plan operators who allege that they cannot afford
the licensing fees for genetic tests, and policymakers who want to ensure
that the patent system actually meets its goal by encouraging invention.
Evidence is mounting that gene patents are inhibiting biomedical research,
interfering with patient care, and causing criticisms from international
trading partners. As a result, various policy alternatives are being considered,
including banning gene patents, exempting researchers and diagnosticians
from the reach of the patents, encouraging patent pools, compulsory licensing,
recognizing the rights of third parties to oppose the granting of a particular
gene patent, and allowing the people who are the sources of the patented
genes to have a greater say in their use. A major focus of this project
will be to analyze the implications of these developments for research,
diagnosis, and treatment for complex genetic disorders.
In this project, the researchers will collect and analyze evidence
about whether, in the context of complex genetic disorders, gene
patents are creating barriers to research and the development
of technologies and are impeding health care. They will collect
information about and analyze proposed policy solutions such as
1) giving greater rights to the source of genes, 2) encouraging
patent pools or compulsory licensing, 3) giving third parties
a right to initiate re-examinations of gene patents, and 4) narrowing
the scope of gene patents. In addition, they will analyze patents
that have been granted for genes related to complex genetic disorders
to determine whether the claims granted are excessively broad
and could be narrowed within existing patent law.
Read
resulting article on human gene patenting
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