Myriad Supreme Court ruling: What does it means to the average patient?

In a landmark decision the Supreme Court gave its ruling in the Myriad case today.  Without going into the drawn out details, let's talk about what are the practical implications to the average patient.

1.  You can't patent DNA or a naturally occurring gene variant on a piece of DNA (known as a single nucleotide polymorphism or SNP)

Previously, the USPTO had allowed so called "gene patents" to issue.  In the case of Myriad, they patented the identification of the SNPs on BRCA1 and BRCA2 that indicated an increased risk for certain breast and ovarian cancers.  Any other company who tried to sell this diagnostic test was shut out of the market as Myriad had exclusivity to sell the test by virtue of their patents.  Now those patents and any others like them are invalid.

This means that other diagnostic companies may offer the BRCA1 and BRCA2 tests.  Naturally, with more companies offering the test, the cost of the test should go down.   This is a win for consumers in that it lowers the price of the test and provides more options for purchasing the test.

What will this ruling ultimately do to the molecular diagnostics market for tests based on SNPs?  That remains to be seen.  Some argue that without the patent protection, there is no incentive to commercialize the tests because the value of selling the tests goes down dramatically.  Others point out the without worrying about patent infringement suits, scientists will be free to continue research efforts on SNPs resulting in more products to sell.   Since most molecular diagnostics currently being sold are not based on patented technology, I actually doubt there will be much effect on the sales of these tests, nor will this ruling be seen as catastrophic to most companies currently selling genetic testing.

2.  You CAN patent new methods to extract naturally occurring DNA.  The methods already used are well established and they generally work well.  I'm not sure if we will see many patents relating to this in the near future, but at least the possibility has been allowed by the Supreme Court.

3.  You CAN patent methods of treatment based on the knowledge from naturally occurring DNA.  One example that comes to mind are algorithms that take both genotypic and phenotypic information to predict your risk of developing certain types of cancer.  I think we will see many more patents in this area.  As our knowledge base grows about what SNPs affect or predict certain conditions, methods of using that information for patient treatments will grow as well.

4.  You can patent cDNA-known as complimentary DNA. I honestly don't know how this is useful, so I'm turning this blog post over to my colleague with the PhD in Human Genetics!  I do know that Myriad stock went UP today because investors focused on this partial win for cDNA patenting rather than the fact that their BRCA patents are now invalid.

Dr. M-take it away!

-Christina

cDNA, or complementary DNA, is DNA that has been reverse engineered from messenger RNA (mRNA).  Normally in the body, DNA is used as a template to make mRNA which is then used as a template to make the proteins needed in your body.  There is a significant amount of manipulation involved in the process so that the protein at the end is nothing like the DNA sequence that started it all.  Although certain viruses such as HIV are able to partially reverse this process, it doesn’t happen naturally in the body.  Scientists, however, have been able to replicate the process used by these viruses and make cDNA from mRNA sequences.  cDNA is different than normal DNA because it lacks intervening sequences called introns that normally break up the coding sequence which is used to make the mRNA.  Because of this, the Supreme Court has ruled they are not “natural” DNA sequences, and therefore CAN be patented.  

The importance of this to genetics is that often cDNA sequences are used as probes in certain diagnostic techniques such as microarrays.  Microarrays are common tools used in disease research to enable scientists to look at the differential expression of genes between, for example, cancerous and non-cancerous cells.  Additionally, if scientists want to express a certain protein in a cell that does not normally express that protein, they can introduce cDNA into that cell and the cells is subsequently able to express that protein.  This is often done in disease research to see how a cell behaves when more or less of the protein is present, or to see how the cells behave when the normal vs. variant protein is expressed. This is incredibly  useful information when looking for targets to develop a diagnostic to treat a certain disease.

As it stands now, if a scientist wants to use cDNA, they can make the cDNA sequence from scratch, or sometimes order from cDNA “libraries”.  Patents on such sequences may make using these cDNA sequences more difficult, which could hinder disease research.  On the other hand, big companies like Myriad potentially have a vested interest in developing therapeutics for disease processes if they own patents for certain cDNA sequences.  As such, more money could be funneled into big pharma research for specific diseases directly linked to these specific cDNAs.  It will be interesting to see how it all plays out.

-Dr. M