Friday, July 12, 2013

The Gene Patent War: SCOTUS Decision

Original interview by BEI Young Professionals member James Muller

On Friday June 21st, I had the pleasure of interviewing Ellen Matloff, the Director of Cancer Genetic Counseling at the Yale Cancer Center.  Matloff was a petitioner in the patent law case regarding genetic testing that came before the Supreme Court on April 15th, 2013 (Association for Molecular Pathology, et al. v. Myriad Genetics, Inc. et al.).  This case considered the legality of Myriad Genetics, Inc. patents on the breast cancer genes BRCA 1 + 2.  BRCA1 and BRCA2 are human genes that belong to a class of genes known as tumor suppressors. Mutation of these genes has been linked to hereditary breast and ovarian cancer[i].  On June 13th, 2013 the Supreme Court ruled in favor of the petitioners, with the holding that “naturally occurring human DNA is not patentable” (  Matloff’s story regarding how she became a petitioner in this case is quite fascinating.  Throughout our conversation the circumstances leading up to this case are discussed, and some common misconceptions surrounding the legal dispute are resolved.

The responses in the interview below are in Matloff’s own words, and she has approved of this interview being published on the Bioethics International’s online forum.

I suppose the best way to begin our conversation is to first ask “how did you become a petitioner in this case?”
Well, my interest in Myriad Genetics Inc.’s (hereinafter “Myriad”) patents on BRCA 1 + 2 arose long before any legal suits against Myriad were ever filed.  Since Myriad began enforcing their patents in ~1998 and shut down all laboratories – including the one at Yale – I watched how gene patents could lead to corporate monopoly and a wide variety of problems for patients and providers. In fact, I contacted several large law firms to see if they’d be willing to take the Myriad case pro bono, but due to size of [Myriad Inc.], all of the firms willing to take the case had conflicts-of-interest (i.e. in one way or another, they were all associated with Myriad).  It was difficult for me to get others to see the problems with gene patents or to get a paper published describing the associated dangers.  A colleague suggested that I contact bioethicist Arthur Caplan to see if he’d be willing to work together on an article on patents and the ethical implications of direct-to-consumer genetic testing (a topic of shared interest). We wrote the article together, it appeared on the front cover of the American Journal of Bioethics, and it attracted the interest of many.  In 2009, when the American Civil Liberties Union (ACLU) filed a suit against Myriad Genetics, they contacted me and asked if I would like to be a petitioner in the case.

What precedent will be developed as a result of this case?  When lawyers cite “Myriad,” what will they be citing?
Not being an attorney myself, it is hard for me to say exactly what legal precedent or principle lawyers and judges will derive from this case in the future.  With that being said, I think the case’s decision underscored the importance of the Products of Nature Doctrine.  Granting patents on products of human nature can be a huge mistake, and [in this case] it was a mistake in so many directions.  I mean, this affected not only research within BRCA 1 + 2, and drug development, and protein product development, but also the costs of the test, competition in the market, advertising, etc.  It is just amazing how many things were affected by the patent and the monopoly that was created.  This company did not have to listen to the concerns of patients, clinicians or the community – and they knew it.

Under the product of nature doctrine, there can be no patents for laws of nature, physical phenomena, and abstract ideas.[ii]       

I would now like to switch gears and discuss the relevance of “cDNA” in the case.  Obviously not being a molecular biologist myself, there was a lot of scientific jargon in the oral argument revolving around the concept of cDNA that I wasn’t grasping.  Could you explain the importance of cDNA in the context of Myriad’s argument?
Well, I could go into the details of what cDNA is, but from what I’ve been told, from what our attorneys told us, the Supreme Court did not, in fact, uphold the cDNA patenting, nor did they ban it.  The court did not make a ruling either way on the cDNA patenting.  What I will say is that the cDNA issue will not impact clinical testing or research.

After reading through the oral argument, I concluded that Justices Scalia & Justice Kagan’s question of “future motives” posed the greatest challenge to the petitioner’s case.  The question they posed to Hansen (the petitioner’s counsel) was: “why would a company incur massive investment if it cannot patent?”
The Myriad patenting of BRCA 1 & 2 is significant and noteworthy due to its degree of stringency.  Myriad is the first company to ever patent a gene and enforce it this strictly; there have been patents before and patents after, but no company has done what they have done.  The point here being companies will not lose the ability to patent in the future— for example, they can patent modified genes, targeted drugs that are developed or new techniques to look at genes. The Court’s ruling is just prohibiting future patents of a particular nature, a patent directly in conflict with the product of nature doctrine.
Additionally, the incentive for many of these researchers is actually not big dollars; a profit motive is historically not the reason researchers have searched and looked for particular genes.  
I vaguely remember that when we spoke last, just days before the Court ruled on the Myriad case, you anticipated a major drop in the cost of genetic testing for breast cancer if the court ruled in favor of the petitioners, thereby ending Myriad’s patent on BRCA 1 & 2.  Can you speak of any changes you’ve noted since the decision has been rendered?

The cost of sequencing has taken a nose dive in the past 15 years, and the cost of Myriad’s BRCA testing has gone up and up. Within eight hours after the ruling, 5 companies began offering BRCA testing, and one of those companies had slashed Myriad’s price for the test in half.  Within one week of this ruling, we now have all of these companies offering BRCA testing at a fraction of the price.
When you’ve spoken in the past about direct-to-consumer genetic testing, you discussed consumers receiving test results that vary to great degrees with other companies within the same market.  You supported that fact with comparative analyses of test results from various companies (e.g. 23andMe).  With that being said, you concluded that the value of a 2nd, or 3rd opinion, cannot be stressed enough.  Do you think as other companies begin to do genetic testing with BRCA 1 and 2 we’ll see major discrepancies in the test results between Myriad and these other companies?

The ruling is only a week old, meaning that it is certainly too soon to determine the accuracy of Myriad’s testing by means of comparative analysis.  It is also important to note the difference between testing for mutations in known genes and creating disease risk estimates based on Single-nucleotide Polymorphisms (SNPs), as 23andMe and other companies do.  These are two very different things.  That being said, we will all need to move forward with caution in choosing clinical labs that offer not only cheaper and faster testing, but testing that is equal and/or better than Myriad’s BRCA testing in quality.
This concludes my interview with Ellen Matloff.  I would like to thank Ellen on behalf of the Bioethics International community for taking the time to answer these questions and describe the case from her own perspective.  More information about this case and genome advancements in general can be found on the National Institute of Health’s National Human Genome Research Institute’s Homepage (

Click here to see the original story from Bioethics International