Patently Absurd?

Last May, the American Civil Liberties Union and the Public Patent Foundation filed suit against Myriad Genetics, charging that their patent on the BRCA genes was unconstitutional. Also last May (not knowing that I do, in fact, carry the gene), I asked Clark to write a little bit about his thoughts on the case. I'll sum it up for you- patents are good, money from patents make the discovery of genes like BRCA possible and cancer is bad. Oh and this case will probably go away.

Well, it turns out the case didn't go away and yesterday a federal court nullified Myriad's patents. The whole 156-page ruling can be found here and here are some links to the analysis of the decision written by people who know more about it than me. If Clark weren't busy at trial in Washington, I'd probably bug him to write another guest post. This will have to do for now:

New York Times: Judge Invalidates Human Gene Patent

NPR: Federal Judge Rules Against Patents on Human Genes

Newsweek: In Surprise Ruling, Court Declares Two Gene Patents Invalid

Los Angeles Times: Breast Cancer Gene Can't be Patented, Federal Court Rules

I'm not going to pretend to have any understanding of the legal implications of this ruling, but I do have a few concerns as a BRCA carrier.

If the ruling stands, a lot can change. It's likely that the test will be more readily available and perhaps cheaper. Right now, Myriad holds a monopoly on testing for the deleterious mutations in these genes. If you test positive and want a second opinion, tough luck. Also, in the absence of competition, Myriad charges $3000 for the screening tests. What these articles don't mention is that insurance will often cover the cost of the test (if you have a family member who carries the gene) and often research facilities such as the Huntsman Institute in Salt Lake City and the Arizona Cancer Center will test you for free or for a much smaller fee. I haven't come across anyone who has actually paid $3000 to have the test.

I'm all for bringing the cost of the test down- it's the readily available part that scares me. Will the quality of the test go down? Will the test be made available to people who don't need it? Will women demand to be tested so "they can have insurance pay for their boob job?" (Yeah, someone actually approached me about that one. I told her I would personally pay for her boob job if it meant I didn't have to have this gene.)

Are Primary Care Providers (who might start performing the test out of their offices) qualified to prepare you for the impact of a positive result? My answer is a resounding NO. Genetic counseling is essential and ought to be required for anyone seeking to understand their genetic predisposition to a disease. I shudder to think of unqualified doctors testing women and sending them off to make important life and boob altering decisions without really knowing the facts.

It's not clear yet what effects this ruling will have on the future of genetic testing. I'm really hoping that it might open the avenues for further research on the BRCA gene and spur advancement in the prevention of hereditary cancers. One thing I repeatedly hear from my doctors is that science is always moving forward and things will be different in ten years. Whichever way the ruling eventually falls (I'm assuming that Myriad is going to appeal the decision), I really hope that's true.

**I ended up bugging Clark anyways and here are his two cents**

I would only add this link to a patent blog that I follow. It cites the most interesting language in the opinion and notes that this thing is likely to be reversed by the Federal Circuit (the appeals court for patent issues). None of the patent people I know can imagine the Federal Circuit invalidating gene patents - especially not under this kind of rationale. I can't really see the Supreme Court upholding it either. In my opinion, this is the kind of crap that gets churned out when English majors issue patent decisions. A lot of the judges on the Supreme Court are English majors, though, so we'll see what happens.