R.I.P. -- Gene Patents and the Biotech Industry

  By Lori Andrews
 
Last Sunday's 60 Minutes explained the logic behind a federal court decision invalidating patent claims related to the breast cancer genes.  A proponent of gene patents told 60 Minutes that patents were necessary to encourage people to find genes.  Elsewhere, interviewees have implied that invalidating gene patents will be the death knell of the biotech industry.

But wait a minute!  Patent law says you can only patent inventions, not products of nature.  No one invented a breast cancer gene; it exists in each of our bodies. So why do we have to pay a royalty fee for our doctor to look at any of our own genes?  It's as if someone stole my car and then tried to lease it back to me.  If a court stopped car thieves, no one would shed a tear about the death knell of the car theft industry. 

So I can't get worked up about companies losing their gene patents.  Those companies have unjustly enriched themselves for years by claiming ownership over products of nature.  It's as if a company patented air and charged a royalty each time we breathed. 

                                                                                                  Click here to watch the 60 Minutes interview with Lori.

Scientists were searching for and finding genes long before patents were available and there is no evidence that the grant of gene patents (as opposed to the patent on the gene sequencing machine) sped this search up. Researchers try to discover genes for a number of reasons –- to help mankind, to win a Nobel Prize, for academic advancement, and for professional status.  The fact that patents are not necessary for gene discovery and actually interfere with discovery is underscored by the fact that the professional organizations of geneticists -- the people who discover genes—are the plaintiffs and amici who are urging that genes should not be patentable! In fact, in a study of American Society of Human Genetics members, 61% of those in industry, 78% of those in government, and 77% of academic scientists stated that they disapproved of patenting DNA. 

Further, patents on genes actually stifle innovation. Once a gene sequence is patented, the holder of the patent can stop research by anyone else.   If a researcher wanted to study asthma, he or she would have to get permission from the holders of the patents on nine genes related to asthma.  If even one of them decided to exert exclusive control of the gene, research on cures and treatments would be stymied.  When a non-profit foundation and the American Neurological Association wanted to finance research to find a cure for a particular genetic disease, researchers were unwilling to undertake the work because of the potential for legal action against them by the holder of the patent. 

Many scientists in the US ignore gene patents and do research anyway.  But they are in for a rude awakening.  Unlike in most European countries and Japan, there is no general research exception in the U.S.  So they can later be sued by the patent holder for past royalties in their use of the gene in research.  Or, more importantly, the patent holder can wait until the subsequent researcher discovers something useful, such as a gene therapy using the gene and then assert ownership over it.  Researchers who are aware of the scope of gene patents thus have no incentive to develop a true invention, such as a therapy which makes use of the gene. 

The barriers to research caused by patents are even greater in genetics than in other areas of science.  In a study by the American Association for the Advancement of Science, 35% of scientific researchers had difficulty related to being allowed to use a patented invention.  The number was even higher - 76% – for bioscience researchers.  As a result, 58% of scientific researchers responded that they delayed their research, 50% responded that they changed their research, and 28% reported abandoning their research. 

One study found that 53% of genetics labs have stopped doing research due to concerns about gene patents.  Another found that 49% of American Society of Human Genetics members have had to limit their research due to gene patents.  Moreover, once a patent is granted in the area of biotechnology, there is a chill on future research using the patented information, including a statistically significant decline in scientific publications using the patented information.

The invalidation of gene patents will be an overall boon to the biotech industry.  While it might threaten companies whose sole asset is an improperly-granted patent on a gene, the liberation of genes will help biotech companies who provide chip technology to test multiple genes at the same time.  The widespread availability of gene sequence information will also reward biotech companies who use that information to create better diagnostic technologies and treatments. 

Justice Breyer of the U.S. Supreme Court discussed the reason why it is important not to have patents on products of nature or laws of nature.  He said:

The justification for the principle does not lie in any claim that "laws of nature" are obvious, or that their discovery is easy, or that they are not useful. To the contrary, research into such matters may be costly and time-consuming; monetary incentives may matter; and the fruits of those incentives and that research may prove of great benefit to the human race. Rather, the reason for the exclusion is that sometimes too much patent protection can impede rather than "promote the Progress of Science and useful Arts," the constitutional objective of patent and copyright protection.

Gene patents are dead.  May they rest in peace. 
 

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