(link to Reuters article) (link to ACLU article)

A victory in the courts!  Finally the law is catching up with reality on gene patents.

A basic fact about patenting is that naturally occurring substances cannot be patented.  I cannot patent water, gold or air and charge you a royalty if you use them.  There has to be an "invention" involved where you have created something new as a prerequisite for patenting.

At the center of this current debate is Myriad Genetics and their patents of BRCA1 and BRCA2.  Having mutant alleles at BRCA1 or 2 elevates a woman's lifetime risk of breast cancer.  The patent allowed Myriad to legally prevent people from testing if they had these alleles unless they bought a $3,000+ testing kit from Myriad.  These are alleles that are a biological part of the people seeking to be tested.  Myriad does not own these people, how can they have a patent on part of their genome that the people naturally inherited from their parents?

I am fine with patenting genetic constructs that are novel and involve creativity in their design--constructs that do not already exist in nature.  I am also involved in a gene patent application based on our work to engineer underdominance via haploinsufficiency (M 10021/RN Max-Plank-Society for the Advancement of Science).  These kinds of patents can be potentially valuable to the institutes that own them and help drive research into new areas.

However, patents on naturally occurring substances can seriously inhibit medicine and research (see Paradise et al. 2005 and references therin).  Also, not having humanitarian and research exemptions can be a problem.  Imagine that you are developing a new line of research in the lab and then the university grants an exclusive license to a company from a patent based on your research.  Suddenly you are not allowed to continue your own research without permission from the company...  (see Andrews et al. 2006).

Incidentally, I am listed as an "inventor" on a human gene patent application (USPTO App. #20080220429) that stemmed from my postdoc work on lactase persistence in East Africa. I did not initiate patenting of the alleles; I was unaware a patent application had been drafted when the work was published; and transferring ownership of the patent to the University of Maryland was a term of my previous employment.  However, there is often confusion by the public that research scientists are responsible for gene patents rather than the companies and people that employ them.  After it was published I found out about an article in South Africa (Jordan 2009) criticizing me personally for this patent application.  (It also contained a number of other misconceptions, for example, I have never been affiliated with the University of Pennsylvania and I have no record of the author ever attempting to contact me for comment.)

When I first heard about the ACLU's challenge to human gene patents in early 2010 I contacted them and offered to help in any way I could--if my unique position as an "inventor" of gene patents and personal opposition to the granting of gene patents was useful.  They wrote back to me and we had a brief correspondence but in the end they did not take me up on my offer.  However, clearly they did not need any help and in the end were successful with today's court ruling.