Monday, March 26, 2012

Supremes' Prometheus Ruling Has Dire Consequences for Personalized Medicine

by Michael Boss

It is astonishing when nine very smart people get it so wrong. I refer to the US Supreme Court decision in Mayo v. Prometheus.

The court’s decision was that Prometheus’ patents are not valid since they are attempting to cover a law of nature. The analogy to E=mc2 is made. All of biology follows the laws of nature!

Prometheus developed an assay to help identify the correct dose of thiopurine drugs in the treatment of autoimmune disease. If the drug is metabolized too fast the level will be too low and so not effective. Too slow a metabolism and the drug can be toxic.

Potentially lost in the supreme circus around arguments addressing the constitutionality of the Affordable Care Act, the court is going to announce today whether it will grant or deny the ACLU’s cert petition asking it to review its suit against Myriad and determine if genes are patentable. Lawyers anticipate the court will grant the petition, vacate the Federal Circuit’s decision in favor of Myriad and remand the case back to the Federal Circuit for reconsideration in light of its ruling in Prometheus.

While the specific circumstances of the Prometheus case revolve around analyte measurements, by simple analogy it seems to me that the argument can be extended to genes and any gene products. So the identification of genetic variants that, say, cause disease or resistance to treatment by a drug or potential toxic response to a drug would all fall under this Supreme Court ruling.

This is a devastating ruling at the dawn of the personalized medicine era. The Court has wiped out any incentive to figure out why certain individuals might do better on drug A rather than drug B and how much of drug B should be given. And what about all the technologies under development to define the optimal treatment of cancer? Again by analogy, finding out which drug kills the tumor cells to select the correct drug for the patient would seem remarkably similar to the Prometheus situation.

The patent laws were developed to foster innovation and development of commercial enterprises. This decision has set back a key field by as long as it takes to get the ruling reversed.

image of Jacob Jordaen's painting, Prometheus having his liver eaten by an eagle (in our version the eagle is apparently the Supreme Court), via wikimedia commons.

Michael Boss, a biotech executive with companies including Antisoma, Xanthus, Elan and Athena, is currently an independent consultant. He is also an inventor on a seminal biotech patent.


Anonymous said...

There was a pretty good discussion of this over at The In the Pipeline blog:

My feeling is that predictions of the doom of innovation are baseless and annoyingly overused. If they were true, humanity could not have reached the point where we could be raising them on blogs. Now, let's take a deep breath and focus on doing some real innovation.

Anonymous said...

Amen! The predictions of "doom" may be overstated, but I never thought I would have seen the Supreme Court rule a claim as not being eligible under 101 for being obvious, which is really what this cases says. What does "conventional activity" mean? Aren't most polymorphisms and other genetic characteristics identified with "conventional activity." Computer innovation and medical innovation is quite different. I could write code in my dorm room to create facebook, I can't sequence them there too! That costs money, money that has to be returned to the investor. If you can't protect the investment then you won't invest at all. Eventually these correlations may be discovered but won't it take that better for society? I would say no.

Anonymous said...

Michael Boss thinks he invented the Internet and is awaiting patent approval. Measuring chemical levels in blood is hardly innovation.