Inventors pursuing medical patents involving genes should listen to this...
On October 29th, the federal government reversed a longstanding policy by saying that human genes are part of nature and therefore cannot be patented. While the U.S. Patent and Trademark Office is not changing its rules for the time being, this decision may reverse the nearly 30 year old legal precedent of patenting parts of nature.
It all started with a March 29th decision by a Judge Robert W. Sweet that invalidated seven patents related to the genes BRCA1 and BRCA2, whose mutations have been associated with cancer.
The patents were held by Myriad Genetics and the University of Utah Research Foundation, who charged $3,000 to perform tests on women to determine whether or not BRCA1 or BRCA2 genes would lead to mutations which could lead to breast and ovarian cancers.
You Can't Patent "Natural"
The main argument in this medical patent case is what is natural and what is not. The government claims that since genes are natural, you can patent them any more than you could patent an apple. A government brief from this case states:
"the chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated' from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth."
Government critics are singing a different tune...
Long Term Innovation Hampered by No Patent Ruling?
Critics claim the government's anti-patent view of genes will put people in danger. Denying patents – they say – will hamper experimentation and development of diagnostic tests and drugs to treat specific genes. The long term implications being less treatment options for people with rare diseases.
The government insists prohibiting patents on parts of nature would not adversely affect the medical or biotechnology industry. And patents for man-made manipulations to DNA could still be approved.
Who is right? Only time will tell.
Sources for this article:
NY Times - Judge Invalidates Human Gene Patent