The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation
67 Pages Posted: 11 Feb 2008 Last revised: 26 Mar 2013
In 2005, an article in the highly influential journal Science reported that roughly 20% of human genes are patented. This figure has been widely cited and at times over-interpreted. For example, a popular science fiction author warns the public that their bodies are "owned" by someone else. A bill was introduced in Congress in 2007 that would essentially seek to ban the patenting of DNA. The bill appears motivated in part by a perception that one-fifth of our genes are owned by somebody else, that these owners can do whatever they want with these genes, and that there is "nothing that we can do to stop them" (presumably short of banning the patenting of DNA).
While clearly many US patents have issued that reference human genetic sequences, the actual scope of exclusivity varies dramatically from claim-to-claim as dictated by the actual claim language. Many patents restrict only some very narrow use of the genetic sequence, others are much broader - none cover actual human genes as they exist in their native state. And it should go without saying that none confer actual ownership of human beings, or allow a patent owner to do "whatever it wants" with another person's genes.
In light of the hyperbole and high interest currently surrounding human gene patents, and in an attempt to assess the true impact of these patents, I conducted a search to identify and analyze all instances where a patent relating to a human gene was asserted in a lawsuit. The results suggest that the impact of human gene patents has been felt primarily in the context of biotechnology-derived protein therapeutics, i.e., biologics, the most important fruit of the biotechnology revolution. The impact on genetic testing and assess to research tools has been relatively modest, with some notable exceptions. Furthermore, lawsuits are being filed at a decreasing frequency over time, and it appears that only three human gene patent litigations are currently pending. Two involve patents relating to the production of recombinant erythropoietin, an important biologic drug; these patents claim priority to applications filed in the early 1980s. The third is best characterized as a contract dispute, wherein the licensor of a research tool patent alleges that a licensee has exceeded the scope of its license; this case has been stayed pending the outcome of a court-ordered arbitration of the underlying contractual dispute.
The article concludes with a discussion of some policy implications to be drawn from the results of this survey.
Keywords: patents, gene, DNA, biologics, biotechnology, genetic testing, forensics, diagnostic testing, biomedical research, research tool, patent litigation, patent infringement
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