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In a ruling with potentially far-reaching implications for the patenting of human genes, a judge struck down a company’s patents on two genes linked to an increased risk of breast and ovarian cancer.
The decision by US District Judge Robert Sweet challenging whether anyone can hold patents on human genes was expected to have broad implications for the biotechnology industry and genetics-based medical research.
On May 12, 2009, the ACLU and the Public Patent Foundation at Benjamin N. Cardozo School of Law (PUBPAT) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.
The U.S. Patent and Trademark Office has granted thousands of patents on human genetic sequences.
While the purpose of the patent system is to encourage innovation, increasingly human gene patents appear to be inhibiting biomedical research and interfering with patient care. For example, the Utah-based company Myriad Genetics has patented two genes - BRCA1 and BRCA2 - and certain mutations along these genes that have been associated with an increased risk of certain forms of breast and ovarian cancer.
The high licensing and diagnostic testing fees charged by Myriad have forced some researchers to discontinue research on breast cancer and have prevented women from having access to screening for mutations.
In addition to inhibiting freedom of research, patents on human genes raise troubling questions about the right of patients to access information about themselves and whether parts of human beings should be patentable at all.
Gene patenting refers to the grant of patents for identified sequences of human DNA forming part or all of a gene.(14) The gene patenting controversy arises from an international tension between legal and ethical norms in the genetic science context. More specifically, a significant obstacle to gene patenting exists at the threshold inquiry level of patent law. Genes are considered by some to be an object inappropriate for patenting, particularly from an ethical standpoint. Arguably, genes are a common, universal possession, representative of humankind's collective heritage, and thus perhaps not a subject matter for which individual intellectual property rights should be granted. Patents, however, are granted in virtually every other field of research and serve to reward the considerable human effort expended in the invention process. Such effort is not absent from genome research. Thus, an ethical tension underlies the gene patenting controversy.