As regular readers will be aware, the Supreme Court of the United States (SCOTUS) had recently delayed any decision on a case related to the rights of Myriad Genetics to hold and enforce use patents related to the BRCA1 and BRCA2 genes associated with the diagnosis of specific subtypes of breast and ovarian cancer.
Yesterday, SCOTUS made the deferred decision. … They have referred the case back to U.S. Court of Appeals for the Federal Circuit in New York for reconsideration. Why have they done that?
They have done that because, in the interim, SCOTUS had decided another case, in which the court invalidated gene use patents held by Prometheus Laboratories, by again clearly indicating that companies may not patent observations that are based on natural phenomena. In that case it was clear that the company had sought to patent a natural phenomenon, and there was unanimous consensus within SCOTUS that the patent was therefore inappropriate.
The full implications of the decision by SCOTUS to refer the Myriad Genetics case back to the Court of Appeals are unclear. In the short term, this is certainly good for Myriad Genetics … because it may take the Court of Appeals several years before it can re-schedule this case and make a re-assessment of its prior decision. In the longer term, it remains unclear exactly what companies are going to be able to claim patents on that are specifically tied to the use of specific, naturally occurring genes, and we have no idea at all how the Court of Appeals will rule when it does get around to reconsidering the case. Nor do we have any idea whether either party to the case will re-appeal to the Supreme Court once the Court of Appeals does make a determination.
And you though only politicians kicked the can down the road!
SCOTUS appears to have implied that transformation of a law of nature into a patentable application is acceptable under certain circumstances … but that such a transformation must relay on doing more than simply stating the law of nature and adding the words “apply it.” One possibility is that the Court of Appeals could end up determining that only some parts of Myriad Genetics’ current patents related to the BRCA1 and BRCA2 genes are actually legal. It’s also possible that by the time this case is finally concluded, the current patents on the BRCA1 and BRCA2 gene may have run their course.
For other opinions on all this, see today’s Reuters report and a report on GenomeWeb on this decision by SCOTUS. As one could reasonably expect, Myriad Genetics has issued a media release that continues to argue that its patents are valid and that the company does not seek to take action against others who are researching other aspects of the role of the BRCA1 and BRCA2 genes.
The “New” Prostate Cancer InfoLink remains focused on this boring legal and technical issue because we believe it is fundamental to the potential development of tests that may actually be able to define risk for subtypes of prostate cancer with great accuracy at some point in the future.
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THE "NEW" PROSTATE CANCER INFOLINK 
This will be a difficult issue to correctly resolve. It is difficult for folks (like me) who are not steeped in patent issues to understand where lines should be drawn. I do know that patents are not about “justice,” but rather about fostering innovation. Erring on either the side of “broadness” or “narrowness” can result in stifling, rather than encouraging innovation. And even the description “patent a gene” is misleading. Myriad discovered, back in 1993, that certain mutations of these genes were associated with a much higher risk of breast and ovarian cancer. The fact that these could be hereditary was well known, but Myriad isolated the particular gene mutation responsible.
Myriad has recently brought their Prolaris test, which is supposed to predict the aggressiveness of a particular prostate cancer, to market. I’m surprised that it hasn’t met with a warmer welcome in the prostate cancer community. (You have mentioned the need for such a test many times.) This new test works on a completely different principle. It measures the expression of a set of genes in the tumor cells, and calculates a score based on that.
Dear Doug:
We have written extensively about the Prolaris test over the past 3 years. It is a very interesting test. However, every scrap of available data about this test to date is based on retrospective analysis of data from men known to have (or not have) prostate cancer. Until the Prolaris test can show its value prospectively, it is unlikely to be widely used. Click here for our most recent commentary on this test.
I think that, in a test of this kind, retrospective analysis has proven to be very predictive of the value of the test. I read a book by Dr. Francis Collins (former head of the US arm of the Human Genome project) on personalized medicine. He related many fascinating and informative incidents, two of which are relevant to this particular dilemma. (The dilemma being, should we put confidence in a molecular test based on retrospective results.) One incident involved his work with other researchers trying to isolate the gene mutation(s) responsible for hereditary breast cancer (the very same ones under patent dispute). As it happened, one of the participants in the study made an appointment with one of the oncologists working on the study. (Neither knew the other was involved.) The woman did not yet have cancer, but given her strong family history, was considering taking some extreme preemptive steps. During the course of the visit the oncologist realized the woman was a study participant, and also knew that their research team did not believe she carried the mutant form of the gene. The oncologist said nothing, but afterward quickly consulted with Dr. Collins and the rest of the team about what they should do. They decided the ethical thing to do was reveal their results for all of this woman’s family tree to those who wanted to know, and let them decide what to do with the information. The identification of this gene mutation was based solely on retrospective analysis.
A second incident he relates in the book is that of the first woman to rely on the test (now marketed by Genomic Health) for the likelihood of the recurrence of breast cancer after surgery. That test works in almost exactly the same manner as the Prolaris test, and was based entirely on retrospective analysis. The woman’s brother had heard a quick news bit about the test, and the woman then had to twist her oncologist’s arm to order the test. Saved her from a round of unnecessary chemotherapy. Since then, the test has been wildly useful.
I had a prostate cancer scare 5 years ago. Last year I had major prostate surgery after a urinary obstruction sent me to the ER. Had a catheter in for 8 weeks, and endured another 8 weeks of incontinence. So, my interest in the topic isn’t idle curiosity (Thank God I didn’t have cancer.) During my cancer scare, the one topic which popped up repeatedly was, “If only we could know the prognosis.” Based on the data from the retrospective analysis, I would want this test result along with my PSA and Gleason score to decide on active surveillance vs. something more extreme. I have got to believe most men would feel the same way.
Dear Doug:
(1) You are entirely entitled to your opinion.
(2) You might want to check to see if your insurance company is covering the cost of this test. Most of the world doesn’t have a spare $3,400 in its pocket for any test.
(3) Regardless of your opinion and the two anecdotes from Francis Collins’ book, many of us would still like to see how accurate this test is when used prospectively.
If over 65 or on Medicare, my understanding (from Stan Rosenfeld) is that Myriad is offering the test at their expense; they are willing to assume the risk that Medicare will reimburse the cost. Contact Myriad to learn more.
Rick:
That doesn’t look like much of a risk for Myriad. Medicare is pretty much legally obligated to pay for the test if it is prescribed … and it has little to no ability to negotiate price.
In fact, this looks to me like a marketing strategy to encourage use of the test by clinicians since they will have no financial risk (in terms of time to re-compensation by Medicare).