Diagnostic Kits/Models for facilitating access to patents on genetic inventions
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Geertrui Van Overwalle et al., 2005. Models for facilitating access to patents on genetic inventions. Available at: http://www.nature.com/nrg/journal/v7/n2/full/nrg1765.html [Accessed August 10, 2009].
- Geertrui Van Overwalle et al., 2005 - This article addresses restricted access to research and health care caused by patenting. The article explores various methods of improving access including: "research or experimental-use exemption, conventional one-to-one licensing and compulsory licensing, as well as patent pools and clearing-house mechanisms."
- Exemptions are activities using the patent that do not qualify as infringement. It is unclear if diagnostic testing falls with in the research exemption. Because this is a judicially created theory, rather than a statutory exception, more litigation may be required to solidify the applicability of this exception to diagnostic testing.
- Licensing is a contractual negotiated right to use. Four licensing approaches are considered by this article:
- Free access to the genetic sequences but royalty payments for the commercial test kits
- Licensing to laboratories at a rate that makes the commercial test kit more ecnomical
- Exclusively licensing to a limited number of laboratories
- Biological Innovation for Open Society license that makes improvements to the patent shared as a way to facilitate cooperative invention.
- Patent Pools
- "An agreement between two or more patent holders to license one or more of their patents to one another, or to license them as a package to third parties who are willing to pay the royalties that are associated with the license." Patent Pools provide a reduction in transaction costs but they also risk anti competitive effects and the shielding of weak patents.
- Clearing House
- A "mechanism by which providers and users of goods services and/or information are matched." Types of clearing house models discussed include: information clearing houses, technology exchange clearing houses, royalty collection clearinghouse, and the open source clearing house.
- Compulsory Licensing
- A compulsory license occurs when the government or court compels a patent owner to license their rights. There is no general provision for compulsory licensing under the patent statute, only very specific instances where it will be applicable. This has not been applied to licensees in genetics so far.