U.S. Federal Judge Robert Sweet (Manhattan) has agreed to hear a lawsuit challenging patents on two human genes associated with hereditary breast and ovarian cancer.
The lawsuit has been brought by the American Civil Liberties Union challenged patents held by Myriad Genetics and the University of Utah Research Foundation on grounds that genes are “products of nature” and cannot be patented.”
The lawsuit was filed in federal court in May on behalf of women’s health groups, geneticists and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals, and concerns patents for the BRCA1 and BRCA2 genes. The wider issues are patents for genes in general. Note, the issue is not genetic engineering, but rather patenting scientific discoveries.
The same issue is being considered in Australia, see Gene Patents Under Attack and the European Court of Justice has also been asked to clarify through interpretation of Directive 98/44 whether a DNA sequence is entitled to patent protection as a compound as such, or only under circumstances where the DNA performs its function.
Back in October 2008, the Israel Commissioner of Patents in Circular M.N. 64 – ruled that gene sequences can be patented in Israel. See Gene Sequences are now patentable in Israel, but that ruling ignored the fundamental issue of whether such things are fairly described as being inventions. If challenged in Court, I would not be surprised if a judge finds the ruling of the Patent Commissioner as being ultra vires, since the Israel law does relate to patentable material and excludes scientific discoveries and natural products.
We note that in the interim to the US Supreme Court hearing re Bilski, the USPTO has issued guidelines on patentable subject matter. See https://blog.ipfactor.co.il/2009/08/27/uspto-issues-guidelines-about-patentable-subject-matter/ which themselves seem to indicate that genes are no longer patentable.