The genetics community is increasingly concerned that patents might lead to restricted access to research and health care. We explore various measures that are designed to render patented genetic inventions accessible to further use in research, and to diagnosis and/or treatment. They include the often-recited research or experimental-use exemption, conventional one-to-one licensing and compulsory licensing, as well as patent pools and clearing-house mechanisms. The last two alternatives deserve special attention in the area of human genetics.
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This research was supported by the Fund for Scientific Research (FWO-Flanders), the Sixth Framework Programme of the European Union (Eurogentest) and the Vancraesbeeck Fund. Special thanks go to P. Vancraesbeeck for interesting discussions.
The authors declare no competing financial interests.
- Blocking patents
Patents that block further development and commercialization of a product because they might be infringed when the product is used, manufactured or sold.
- Community Patent Convention
A convention that was signed in Luxemburg on 15 December 1975, with the aim of creating a community patent: a single patent that is legally valid throughout the European Community. The expected advantages of this system include a substantial reduction in patenting costs (particularly those relating to translation and filing), simplification of application procedure (one single application procedure) and harmonization of interpretation (thanks to the establishment of a single centralized system of litigation). The convention has never entered into force. The discussions were resumed in 1989, but the convention is still not in place.
- Complementary patents
Two patents are complementary when they are both required to produce the product or carry out the methods to which they relate.
- Cross licence
A cross licence is a bilateral mutual exchange of licences between unrelated parties.
- Hatch–Waxman act
This is the Drug Price Competition and Patent Term Restoration Act of 1984, which provides incentives to support the development of generic versions of off-patent drugs and allows patent owners to recover time that is lost during the FDA procedure for approval.
- Patent thicket
An overlapping set of patent rights, which requires those who seek to commercialize new technology to obtain licences from multiple patentees.
- Royalty stacking
The accumulation of royalties that have to be paid when confronted with a patent thicket.
A norm or a measure that might be the result of a formal consensus-building procedure that is managed by a standardization body (de jure standards) or arise spontaneously owing to the degree of market penetration of a particular technical solution (de facto standards).
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Van Overwalle, G., van Zimmeren, E., Verbeure, B. et al. Models for facilitating access to patents on genetic inventions. Nat Rev Genet 7, 143–148 (2006) doi:10.1038/nrg1765
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