Patent Genes? That is the Question

       To patent or not to patent, that is the question.  More accurately, is patenting specific human genenic material something that should be legal? 

       The Supreme Court of the United States is hearing just such a case right now.  Just a couple of weeks ago oral arguments began for a very unusual court case.  And the resulting ruling by the Supreme Court could have an impact on the future of medicine.

       For the previous few decades the practice of patenting human genes has been legal in the United States.  In fact, according to this Fiscal Times article roughly 20% of all human genes already have existing patents.

       But now that practice is being challenged in court.  The case involves Myriad Genetics and their patented diagnostic test BRACAnalysis.  That diagnostic test checks for a pair of mutated genes that are excellent markers for predicting breast and ovarian cancers in women. 

       Myriad owns the patent on the two genes involved in that diagnostic test.  And this means no other company can develop and market products that would similarly screen for those mutated genes. 

       The problem is that the diagnostic test Myriad has available sells for thousands of dollars.  And some groups including the American Civil Liberties Union (ACLU) are not happy about that fact or the fact that Myriad has those exclusive rights. 

       The arguments for and against patenting genes are familiar to those of us who work in pharmacy.  They are very similar to the arguments for and against the patenting of prescription drugs. 

       On the one hand, patent protection encourages exploration and development because of the potential profits involved.  While on the other hand, restricting who can develop tests or manipulate a certain gene may result in higher costs for any and all resulting medical breakthroughs.

       I’ll refrain from trying to predict what the Supreme Court will do in this case.  But I will say that the reason the case made it to the highest court is the fact that a US Federal Court of Appeals ruled in favor of patenting genes late last year. 

       The potential impact of a court case such as this is quite large.  I fully believe that the future of medicine lies in gene therapy.  And removing patent protection on genes could slow down advancements in this area of medicine.

       On the other hand, cost effective care is the current buzz phrase of choice for the healthcare system.  And removing patent protection on genes could lead to lower cost treatments and diagnostic tests in the near future. 

       So what do you think?  Should the genetic makeup of a human be something that can be patented?  Should we only allow alterations of genes or other manipulations to be patentable?  What happens to all the existing patents if genes are ruled unable to be patented by the Supreme Court? 

       I don’t know the answers to any of those questions.  But what I do know is that one of the most promising area of medicine could be impacted by this ruling. 

       What will that mean for the future of medicine?  How will the outcome of this court case potentially impact what we see on the shelves of pharmacies years down the road?  Is this area of medicine too important to restrict with patents or is it too important not to have patent protections available?

        I don’t know.  But I do know that the big question right now seems like a simple one- to patent or not to patent.  But it is anything but a simple question to answer. 

The Redheaded Pharmacist

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