Monopolies, Rulings and Controversies on BRCA1 and BRCA2 Patents

Last November I was contacted by a journalism student attending Emory University in Atlanta, Georgia. She was working on a paper about BRCA gene mutation testing, the monopolies held by two genetic testing companies and the recent controversial rulings on patents. She also wanted to include some thoughts and insights from a person directly influenced by both breast cancer and a positive BRCA2 test outcome. That would be me!

I was impressed with the fact this young woman even knew about BRCA testing and the recent controversial US Department of Justice ruling. I see this as real progress! Sadly, I think there are still some, even in the medical profession, who are not “up” on this topic. I want to thank her for getting me to think once again about this topic. Also, I’d like to thank her for caring enough to write about such a thing. I was delighted to talk with her because it meant some of what we are all working toward is working.

Number one, awareness about the availability of BRCA gene mutation testing has grown tremendously since my family first became acutely aware of this DNA mystery about four years ago. When my mother decided to get the BRCA test, I was not supportive I reluctantly must admit. My reasoning was we already knew our family was at a greater risk than the normal population, so why add to our sense of doom and gloom? We could simply stay on top of our health and monitor things, surely that would be enough. Obviously, that theory didn’t work out too well for me.

In addition to there being more awareness about the existence of this available test, many women are now proceeding to not only have the testing done, but also are taking proactive preventative measures such as choosing to undergo prophylactic mastectomies and oophorectomies. These women are taking their test results and acting upon them. They are deciding to take action before cancer strikes. They are making bold, personal and difficult decisions about their lives and bodies, sometimes even being chastised as a result, with some critics even going as far as calling these women self-mutilators.

Why do people so often feel they have the right to judge the decisions of others anyway?? (Ah, a topic for another day’s post!)

Now that more women are aware of the test and are also willing to act upon the results, we need to get past the next hurdle. It seems to me that hurdle is the cost, due in large part, because of the monopolies two companies have. Something about this seems wrong to me. I am not opposed to any company making money on a test or technique they have perfected. I am opposed to women (and men) being denied access to information about their own genes because of prohibitive cost, limited availability of testing and restrictive insurance coverage. There must be some kind of middle ground.

I am certainly no legal expert, but I believe the main issue surrounding this controversy is the dispute over whether any company has the right to patent human genes. This controversy came to the forefront in 2009 when Myriad Genetics tried to patent the BRCA1 and BRCA2 genes. This resulted in a lawsuit brought by various individuals, medical researchers and others represented by the American Civil Liberties Union and the Public Patent Foundation whose basic challenge stated that patents on BRCA1 and BRCA2 genes impeded access to testing and information about oneself.

The main premise was a person’s genes remain part of nature and are therefore ineligible to be patented.

In March of 2010, Judge Robert W. Sweet of the U.S. District Court in Manhattan, ruled the patents invalid in his 152 page document basically agreeing with that premise. Simply stated, the human gene was discovered, not created and hence should not have been patented.

Naturally, Myriad appealed and asked the US Department of Justice to offer an opinion. Perhaps to everyone’s surprise, late in October of 2010, the DOJ agreed with Judge Sweet’s ruling that human genes should not be eligible for patents because they are part of nature, things discovered not created. They belong to mankind, not any one company.

Proponents of the right to patent say similar gene patents have been granted for decades (this is true) and genes isolated from the body are considered to be chemicals, and therefore eligible to be patented. Both sides of the debate admit these are major developments. Clearly the lines have been drawn in the sand. This debate is not going away anytime soon. There will be no surrendering, not when millions of dollars in profits are at stake. Also, no changes are expected in the near future on granting or rescinding patents until all litigation ends. Who knows how long that will take?

I say what about the lives at stake?

A woman with a BRCA gene mutation is at greater risk for breast cancer in her lifetime. She is at greater risk for recurrence. She is at greater risk for ovarian cancer and possibly other cancers as well. In addition, once a carrier develops cancer, (like me), more drastic treatment options also must be considered. In addition, as genetic science advances, surely more yet unknown gene mutations will offer valuable information for future patients with varying diseases. This matter does need to be resolved.

Do only men and women who can afford the cost of testing deserve to know the information their genes hold? I don’t think so. I, for one, will be keeping an eye on this unfolding story.

I hope those in the legal community can figure out a resolution that benefits everyone. Is that too much to hope for?

If you are interested in learning more, here are a few links to articles dealing further with this controversial topic:

“Gene Patent Ruling Raises Questions for Industry”

“Judge Invalidates Human Gene Patent”

“DOJ Responds to BRCA Gene Patent Dispute with Proposed Rule Change”

Also, the following link is an excellent audio clip from NPR (“Gene Ruling Could Have Wide Implication”), well worth the three minutes or so it takes to listen: 20100330_atc_02

Do you think human genes should be eligible for a patent? I welcome all viewpoints (yes, really!)