Patent Law and Children with Genetic Mutations
by Edward Fennell and Haley Hilt

As parents of children with genetic mutations, we strive every day to provide the best for our children, and we pray for solutions.  Too often we are impatient about the manner in which politics, finance, law and the practice of medicine interfere or inhibit our ability to care for our children.  I am as guilty as the next guy; when my irritation rises to anger, I lose sight of the best way to fight for my granddaughter.  She is my precious grandchild.  I care for her every day and she and her welfare are on my mind 24/7.  Given that, I must be mindful that my priorities are not those of others, and in fact there are others whose priorities are extremely adverse to my granddaughter's interests.  Are these adverse interests intentionally malicious?  Frankly, most of the time, they are not.  Nevertheless, there are cultural mores that are adverse to her interests.



Let me illustrate a point.  Let's say I am a genetic specialist and a researcher who owns and operates my own lab.  A few years ago, my wife and I had a grandchild that we subsequently learned had a CDKL5 mutation, which is what my granddaughter actually has.  Let's say we become obsessed with this CDKL5 cure.  After a few years, I isolate all known genetic sequences contributing to the disability, and develop processes that reverse some of the more damaging effects.  Do I file patents that are exclusive and commercialize my findings, issue stock and become rich, or share the knowledge?

Your reaction may be you can't patent such things as genes.  Well, according to some sources, twenty percent of the human genome has been patented.  And as you might imagine, the lawyers are busy.


A Case in Point

One of the biggest cases involves breast cancer.  If you go to myriad.com, you will enter the site of Myriad Genetics, a company whose resources are invested in the role of genes and human disease.  Featured prominently on that page is a link for BRACAnalysis.  This DNA test answers the question of whether breast or ovarian cancer runs in your family.  The test may cost $3,000 or more.  No one else can offer it because they own the patent rights on the genes known to predict these cancer risks.  Because of litigation, their ownership and exclusivity is in question.

Myriad just lost a very big case this year.  The federal judge in the case handed down a summary judgment that certain patents related to such tests are invalid.1  He ruled that the patents were improperly granted, as they are directed to a law of nature.  To understand the importance of this decision, one must take a look at patent law and what is not patentable.

Myriad argued that it had isolated DNA, in this case the BRAC1/2 DNA, and those isolated genes were markedly different from native DNA as it exists in nature and therefore deserving of a patent.  The judge thought differently and stated that because the, "isolated DNA is not markedly different from native DNA as it exists in nature," it cannot be patented under current US codes.

Myriad will, of course, appeal.  And interestingly enough, one of the sitting judges at the U.S. Court of Appeals where their case will be heard recently dissented in a related genetics case.  His views help us understand the patentability issue of DNA:

Thus, it appears that in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with "markedly different characteristics from any found in nature."  It is far from clear that an "isolated" DNA sequence is qualitatively different from the product occurring in nature....The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question.  It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.2 


Patents and Children with Genetic Mutations

These issues are very much our issues.  We raise funds and seek appropriations for funds, and quite often these funds are directed to scientists at major university research centers.  In fact, in the Myriad breast cancer case, not only was Myriad the defendant, but the University of Utah was as well.  They are both based in Salt Lake City and the University had given Myriad the exclusive rights to the technology.

The influence of major university research centers is considerable.  In a recent brief filed in a Supreme Court case, MIT disclosed it received:

$718.2 million in research funding in its 2009 fiscal year.  The United States government provided almost 73% of that total ($522.6 million).  In addition, the federal government provided $746 million to MIT Lincoln Laboratory.3

Our national policy regarding research and development, how we fund it, and who retains exclusive rights can cut a number of ways.  We need to be aware that it--and particularly patents--can make few rich at the expense of the many children with genetic mutations who could get better.


I write and Haley inspires.  Haley is four, my granddaughter, my companion in Poppy Day Care for four years and a child who has been diagnosed with a CDKL5 genetic defect.  Our relationship is spelled out in our blog, HaleyandPoppy.com.  We started that blog in October 2010 and actually introduced ourselves on October 18, 2010. 

I began my career in the 60's as a certified social worker, specializing in child abuse.  I spent the early 70's resettling developmentally disabled people from institutional settings back to community settings.  A foray into local hometown politics launched a career in labor relations and local government finance.  From 1976 to 2005 I ran a national consulting practice, consulting to and testifying for large police unions in matters related to their collective bargaining agreements.  Along the way, I wrote hundreds of reports and served as an editorial writer. 

My time now is dedicated to assisting my daughter care for Haley and my new grandchild, Emily Lynne (DOB 11/20/10), who has short bowel syndrome and is under the care of a great team at Boston Children's Hospital.  She will join the editorial team at Poppy Day care soon, and will receive proper credits in our blog.


For more information on CDKL5, see The International Foundation for CDKL5 Research.



1See http://www.genomicslawreport.com/wp-content/uploads/2010/03/Myriad-SJ-Opinion.pdf for a copy of the opinion.
2See http://www.genomicslawreport.com/wp-content/uploads/2010/08/Intervet-Merial-opinion.pdf for a copy of the opinion.
3See http://web.mit.edu/ogc/pdf/MIT-AMICUS.pdf for a copy of this brief.


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 Author:  Edward Fennell and Haley Hilt Date Uploaded:  12/8/2010