On April 28, 2010, the Board of Appeals and Interference (BPAI) of the U.S. Patent and Trademark Office (USPTO) reversed an earlier decision that upheld the claims of U.S. Patent Number 7,029,913, one of the trio of patents commonly known as WARF or Thomson patents. The patents cover the first isolation of non-human primate and human embryonic stem cells (hESCs) by James Thomson. Thomson successfully patented these cell lines and assigned the patents to the Wisconsin Alumni Research Foundation (WARF).
The WARF patents have a history of controversy and legal challenges. In April 2007, the USPTO revoked the patents on the grounds that Thomson’s work was obvious in the light of previous scientific work and thus unpatentable. In 2008, the Patent Examiner reversed the revocation order and upheld the patent claims. The April 28 BPAI decision is the latest episode in the patents’ controversial history.
The issue at the heart of the WARF patents legal dispute is somewhat of a red herring; the real trigger stems from objections to the patents on the basis that they are overly broad and restrictive, and inhibit researchers’ access to stem cell lines due to high licensing costs. Some critics also feel that hESC lines are products of nature, and as such, no one has an ethical right to own them. While these objections have little or no import in the world of patent law and litigation, they have fueled critics’ successful efforts to overturn the patents.
Much like the WARF patents dispute, the recent Myriad Genetics case highlights a now familiar trend in the world of biotechnology patents, whereby social controversy acts as the main driver for legal regulation. On March 29, 2010, a U.S. District Court held that isolated human DNA sequences and the methods for comparing or analyzing their sequences are not patentable. These famously controversial patents, owned by Myriad Genetics and the University of Utah Research Foundation, relate to two genes (BRCA 1 & 2) and a test developed by Myriad to assess susceptibility to hereditary breast and ovarian cancer. While Myriad plans to appeal the ruling, the court’s decision is significant to legal trends relating to biotechnology patents on “products of nature”, a class that includes stem cell patents.
The question of whether or not patents can be granted on products of nature in an altered or unaltered form is one of the most vexing and controversial issues facing biomedical research today. Patents on biotechnology products and applications, such as transgenic mice, higher life forms, stem cell lines, and human DNA have been the focus of legal / regulatory disputes and policy action in many jurisdictions around the world. The specific triggers for controversy vary, but have mainly focused on claims that such patents could result in inappropriate commodification of life, impede research, and frustrate public access to biomedical products, procedures and applications.
Nonetheless, social controversies associated with the above-noted claims have resulted in successful legal challenges against biotechnology patents, as the Myriad case illustrates. Much like the WARF patents situation, the Myriad challenge appears to have been triggered by reactions to the company’s approach to marketing the genetic tests, which involved a monopoly on the sequencing and commercial exploitation of the genes. Indeed, several of the plaintiffs and amici curiae in the case were motivated to join either because Myriad had sent them a cease-and-desist letter, or because they could not afford Myriad’s exclusive testing services.
In Canada, the legal scope of biotechnology patents is somewhat uncertain. Although stem cell patents have been granted in Canada, none pertains to hESCs. The patentability of higher life forms is also an open question; although the Supreme Court of Canada held in 2002 that a transgenic mouse with cells genetically altered by a cancer-promoting gene was not patentable under Canadian law, the decision did not settle the question of whether higher life forms are patentable. However, given that many scientists consider the U.S. to be perhaps the most important market to protect their inventions, the fact that hESC patents are less controversial in Canada offers no solace – Canadian stem cell researchers have as much reason to be interested in and concerned about legal developments in the WARF and Myriad Genetics cases.
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