The Department of Justice (DOJ) [official website] on Friday filed an amicus curiae brief [text, PDF] in the US Court of Appeals for the Federal Circuit [official website] revising the government's stance on patenting isolated genetic material, including human genes. The position represents a significant departure from established policy, which has permitted the Patent and Trademark Office [official website] to grant patents for isolated genes. The government argues that DNA is a product of nature and thus unpatentable "because it is not the inventive work of humankind." The DOJ is urging the Federal Circuit to affirm a March ruling that invalidated [JURIST report] two such patents. Opponents to the new stance contend that isolated genes are chemicals that differ from their natural state in the body and are thus protectable, and that a decision to the contrary would inhibit research due to limited profitability. According to the government's brief, however, adopting the policy would not significantly impair biotechnology researchers as artificial modifications to DNA would still be eligible for patents. Opponents to the new stance, however, argue that isolated genes are chemicals that differ from their natural state in the body and are thus protectable.
The US District Court for the Southern District of New York's [official website] March ruling [opinion, PDF] nullified patents held on two genes linked to hereditary ovarian and breast cancer "[b]ecause the claimed isolated DNA is not markedly different from native DNA as it exists in nature." If the decision is upheld, it could invalidate patents covering nearly 2,000 human genes. The District Court's decision stands in contrast to the stance taken in the EU [Nature report], which allows such patents. Genetic research companies currently hold patents to approximately 20 percent of the human genetic code, many of which are associated with diseases such as Alzheimer's and cancer. The holder of a gene patent can prevent others from studying the gene and can also develop testing for specific genetic mutations, which they can then market without direct competition.