By Dr. Joanne Elliott

US authorities have been granting gene patents to researchers in both Academia and Industry for almost 30 years. By isolating genes relevant to disease, scientists hoped that these discoveries could be applied to genetic screening and potential gene related therapies. It is estimated that current gene patents cover approximately 40% of the human genome. A biological patent provides the patent holder with the exclusive right to use or sell the protected invention for a limited time (usually 20 years) and to exclude others from doing so.

Gene patents might be considered essential to allow companies time to research genes without competition while simultaneously encouraging investment in research and development. However, on June 13, the US Supreme Court made a ruling that as a product of nature, human genes cannot be patented. This decision is a culmination of efforts by the American Civil Liberties Union and the Public Patent Foundation, who originally filed a lawsuit in 2009 to challenge gene patents.
They filed a lawsuit claiming that gene patents were unconstitutional and hindered cancer research. Specifically, the lawsuit was aimed at Myriad Genetics, a Utah based company, who had the monopoly to perform diagnostic tests on BRCA1 and BRCA2. Myriad was granted these patents in 1994 and 1995. Mutations in these human tumor suppressor genes are associated with hereditary breast and ovarian cancer. As patent holders, Myriad had the exclusive right to screen patient samples for these genes. Samples of hundreds of patients had to be shipped to Myriad in Salt Lake City for screening at a cost of over $3,000 each. Moreover, other companies were forced to exclude BRCA1 and BRAC2 in their genetic screens in order to prevent patent infringement.

While Myriad argued that BRAC1 and BRAC2 were both isolated by the company as a result of human ingenuity and were therefore patentable, the Justice’s final decision that isolated genes are non-patentable, will have repercussions throughout the biotech industry. For example, companies may now expand their clinical care and research focus. More companies can offer multi-gene testing, leading to greater competition and competitive pricing. Likewise, more open research on these previously patented genes may advance our understanding of disease and aid the development of relevant therapies. Current and future plans for whole genome sequencing projects such as those aimed at sequencing DNA of cancer patients and those with rare genetic diseases can also proceed without the fear of infringing gene patents.

Finally, although the US Supreme Court concluded that naturally occurring genes can not be patented, they agreed that artificially copied DNA can. These include complementary DNA (cDNA) or synthetic DNA. The Justice ruled these can be patented as it involves making something that does not naturally occur. However, cDNA is nothing more than an edited copy of the same information that already exists within a gene. Is it necessary to introduce deletions, insertions or other modifications into the cDNA sequence to make it patent eligible? In addition, some viruses make their own cDNA from mRNA suggesting that cDNA can be a natural product. Likewise, is a synthetic gene product patentable if a single base change is incorporated into the sequence? Although certain doubts and questions remain regarding the US Supreme Court decision, the ruling will obviously alter the road map for biotech companies. It is envisaged that cDNA patents may become more valuable to allow exclusive research protection for pharmaceutical companies.