SCOTUS to Rule on Patentability of Human Genes

| December 9 2012

The Supreme Court announced it will hear a legal challenge to a patent held on a breast cancer gene.  Myriad Genetics holds the patent.  The tech boom of the 90′s threw a duffle bag full of monkey wrenches into patent law, and advances in computational bioinformatics have begun to do so much as the same.  Does ownership reside in the hands of the entity (i.e., a company) that performed the work to develop the genetic mapping, or does ownership reside within the entity (i.e., a person) where the genes reside?  That question captures the essence of the debate.  To affirm the former recognizes the fruits of labor.  To affirm the latter respects personal privacy.

I have studied bioinformatics within a computer science context in my educational pursuits, so I understand the labor and expertise required to produce knowledge of the human genome.  But I also have unease about not having complete control over information about my body.  I can only imagine readers of Western Free Press have similar concerns.

The mapping of the human genes gives researchers the ability to experiment and computationally simulate for the purposes of determining how drug leads (candidate drugs, in a sense) may impact the human body.  As research becomes more agile, they can determine how a specific drug may affect you in particular based on your genetic profile.  The drug discovery pipeline (the process of brining a molecular compound all the way to market) costs lots of dollars and consumes years of time.  Many leads fail some stage of the pipeline, meaning those funding the research effectively must hope to recover costs through the success of another drug passing through the entire pipeline.

If our legal system fails to award patents to those performing the labor, doing so puts revenue at risk for companies spearheading much of the research.  On the other hand, if our legal system awards patents too liberally, we may see a patent war within the medical research community similar to the one ongoing within the tech sector, e.g., Apple vs. Samsung.  And what happens to patient privacy if the legal system permits the patenting of your and my genes.

Thinking outside the scope of this particular  court case, other battlegrounds on this front exist.  For example, some heart patients have a defibrillator implant, and the company who produces them also collects routine information from them.  The patients have wireless monitors installed in their homes that collect the data from the implant and upload them to servers that any employee of the manufacturer can access whenever they choose.  They archive that information, and regulations only permit them to share the data with a patient’s doctor or a hospital, but not the patient.  The companies haven’t complained about those regulations, not surprisingly.  The patient only has access to the data in the form of summaries provided by the doctor in response to requests.  Further complicating the legal matters, the companies who produce such devices use them in money making endeavors of new forms of treatment.  The patient can make the claim that he or she should have access to that data whenever they so desire.  On the other hand, giving access to the patient may lead to less incentive for innovation within the industry, because at that point anyone can access it should the patient choose to share it.  If the company who produces the technology cannot envision reliable ways to finance the means to enhance and improve their technology, they may scale back their efforts or even discontinue working within the domain entirely.  Privacy issues also come into play.  A 2010 research project at MIT used defibrillator implant data to predict health.  The researchers correlated behavior with colds, stress, and even mild depression.  In a world where public policy wonks have made great strides in moving health from a personal concern to a public one, insurance companies and health policy officials will want access to this data.  (Related: See article Here Comes the War on Fun.)  Declaring the patient the owner puts some leverage against this.  My larger point, this SCOTUS decision will have ramifications far beyond DNA patentability, also patents applying to many other areas of medical technology.

A court decision  going either way comes with benefits and undesirable concessions.  Much like the NAFTA debates of the mid 90′s, I think we will see this issue divide supporters on both sides of the aisle.  As this debate unfolds, I encourage you to stay engaged in it.  Don’t allow the science to overwhelm or discourage you.  Besides, once you sink your teeth into it, Science is fun!  On whichever side you come down on this issue and issues like it, this debate needs the voices of people who respect personal liberty.

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