New Rules Proposed on Gene Patenting
The US Justice Department filed an Amicus Brief with the US Court of Appeals for the Federal Circuit that surprised many of the people that have been closely following the case (link to full brief here). What surprised people was not that the brief was filed, but that it supported the party challenging the patents and goes against the policies of the US Patent and Trademark Office (USPTO) as well as decades of case law on the subject.
The Justice Department made the claim that human genes in their natural isolated state are unacceptable for patent protection because the genes are not human-made and thus are more akin to a discovery than an invention. This brief has received its fair share of criticism. While this will certainly have far-reaching effects on the bio-medical industry, it is not as far reaching as it may at first seem. While the brief states that the Justice Department feels that patents shouldn’t be granted for isolated genes, many of the valuable patents dealing with genes actually refer to scientific processes or altered genes, which the Justice Department states should be able to receive patent protection.
Many of those who oppose the patenting of genes say that it will stifle the ability of new medical techniques, such as the ability of a person to have their personal genome read and reviewed for various diseases. Proponents of gene patents claim that the ability to patent genes fosters innovation in the field by ensuring that those who do research will be compensated for their work.
Currently the USPTO is not following the opinion of the Justice Department as stated in their Amicus Brief, but with such a respected authority coming down on this side of the argument the industry is on very uncertain ground in their ability to receive patent protection in the coming years.
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