U.S. Supreme Court will decide if the human genome should be patented

Medical researchers and private companies across the world spend years mapping the human genome in an effort to discover the root causes – and cures – for gene-related diseases and illnesses that kill people every day. The research involves isolating and testing individual genes in order to determine how to manipulate them.

For nearly 30 years, the U.S. has been allowing private companies to obtain patents for genes – human DNA molecules – they have isolated. Approvals of gene patents are frequently opposed by the American Civil Liberties Union (ACLU) and other organizations on the basis that human DNA cannot belong to a company as it is a natural substance like water or air.

The value in these patents is that they give the patent owners exclusive rights to create and use diagnostic tests. For example, Myriad Genetics successfully isolated a number of genes that are known to cause ovarian and breast cancers, two of which are becoming household names – the BRCA1 and BRCA2 genes. Last year, despite opposition by the ACLU, the Federal Circuit Court of Appeals confirmed Myriad’s patents for the BRCA1 and BRCA2 genes. Diagnostic testing for these genes has become quite common in the U.S., providing a steady stream of income for the company. The ACLU appealed that decision.

In April, the U.S. Supreme Court heard arguments from both sides of the case and will render an opinion later this year, hopefully answering the fundamental question of whether isolated genes can be claimed as intellectual property. Some argue that the high court’s decision will have a significant impact on future gene research and have far-reaching, negative effects on the medical and scientific research arenas.

However, researchers from Colorado State University, University of Minnesota and Pennsylvania State University are conducting a study by analyzing what the actual impact might be. The study is revealing that the case may not affect the biotech industry as much as some fear because there are just not that many human gene patents out there. However, it may affect patents for genes from non-human species.

A reversal by the Supreme Court may invalidate patents for all types of organisms because of the legal language used in the patent being challenged. The study points out that the patent language and language of genetics may fail to maintain a distinction between human and non-human gene sequences. Thus, parties on both sides of the fence are anxiously awaiting the court’s decision. How a decision will play out in the intellectual property and patent law arenas may take a long time to determine.

If you or your company is seeking the protection a patent or license can offer, seek the counsel of an intellectual property lawyer. An attorney experienced with patents, trademarks, copyrights and other areas of patent law can help guide you.