News

With all the focus this past week on health care reform with a capital “H” (and a really boring official name, The Patient Protection and Affordable Care Act), a very important development relating to the public’s health could easily have been missed: a seminal ruling by New York federal court judge Robert Sweet. Judge Sweet’s March 29, 2010 ruling invalidates gene patents held by Myriad Genetics on the BRAC1 and BRAC2 genes. While the front pages of newspapers (and whole sections, in fact) were focused on the details of health reform, the gene patent story was, for the most part, found in the business pages or buried somewhere in the middle (except, of course, for journals catering to the biotech industry where headlines like “Pigs Can Fly” abounded). And, yet, this ruling is one the public should really pay attention to because it could have a profound impact on our health: now and into the future.

U.S. law prohibits patents from being issued for “products of nature.” Whether human genes and gene sequencing fit that definition or not has been an ongoing legal and public policy controversy. There is much legal debate about how to deal with the evolving field of genomics (indeed, health reform seems to give a nod to the biotech industry by giving 12 years of patent protection to new biologics). There is no question that Judge Sweet’s ruling will be appealed and that this issue could even go to the Supreme Court. Nevertheless, the biotech blogosphere is full of articles on the short and long term impact this ruling will have on the field and the industry – whether it is upheld or not.

I wouldn’t presume to comment on the legal merits or industry impacts of the case but I do want to take a moment to look at related public health issues. Myriad licensed the genes from the University of Utah. An important question to understand is why the University of Utah licensed the genes to Myriad in the first place. The general issues involved here are of great interest to all universities today – especially public universities – as they deal with struggling state budgets and cuts in funding to public universities as a way to help balance those budgets.

The issue of patenting genes is a good case example of the kind of dilemma universities face. Universities have to balance issues related to their scholarship, teaching, and public mission with fiscal realities. I don’t know the thinking of those at the University of Utah on this issue, but I do know that these issues are being debated around the country. The University of Michigan (U-M) has brilliant researchers who work in genetics and gene mapping. Researchers I have heard speak on this issue here are committed to having their work be open source to help advance the science. While that doesn’t mean some application of their work couldn’t be commercialized down the road, they are scientists first and foremost, most interested in expanding public knowledge, and clearly hoping that patients will have cheap and easy access to a full interpretation of their genetic code – without clinicians or labs having to run a gauntlet of approvals from patent holders, which would surely increase cost and lengthen the time it would take to get this information to patients.

Dean Warner of the U-M School of Public Health speaks eloquently to the importance of schools of public health engaging in teaching, research and service that ultimately benefits the public. And, he notes, commercialization of products is not necessarily inconsistent with that mission: indeed, there are times when using the force of the market can significantly enhance the speed and reach of products to the benefit of the public. The development of vaccines is a case in point: there would have been little value in the basic research to develop vaccines had the vaccine developers not partnered with business entities that could produce and distribute the vaccine – and who had sufficient incentives to do so. Millions of lives have been saved as a result.

But there is a difference between the ideas of commercializing/patenting a product as a means to benefit people and limiting/ patenting findings that are building blocks of basic science. While the definition of “building block of science” is increasingly blurred and legal eagles will have lots of time for debate (not to mention, careers) around this issue, Judge Sweet’s ruling invalidating the patents on the BRAC1 and BRAC2 genes is a stand for public health – and for that, we should all be grateful.

(Read the NEJM article, which comes to the same conclusion from a different perspective: http://content.nejm.org/cgi/content/full/NEJMp1004026v1)