Thursday, December 8, 2011

Should a Molecular Test Be Treated As A Drug?

Promethus Lab's ability to patent a molecular test is at issue at the supreme court.   Mayo Clinic produced a it's own version of Nestle's Prometheus's test for auto immune diseases and wished to offer it outside its lab.  A district court sided with Mayo and invalidated the patents. Prometheus appealed to the U.S. Court of Appeals for the Federal Circuit, and that court ruled that what Prometheus patented was a "transformation" and thus could be patented.The Supreme Court will hear this case.

Fellow personalized testing company Myriad Genetic's amicus brief provides some insight into the possible industry impact of this case.  Key to the industry argument, diagnostics should be treated as drugs are.  Molecular tests are expensive to make, they involve a lot of trial and error and risk of failure, thus they should have patent protection so that the people who made the discovery of a connection can be compensated.

 Much like in the pharmaceutical industry,
personalized medicine research and development are
extremely costly and offer a very low rate of success.
The amount of time and effort required is
enormous. Additional clinical trials are required to
demonstrate the clinical utility of the discovered
correlation. Many trials are essentially equivalent to
pharmaceutical trials in both design and scope,
sometimes involving following patients for years to
determine long-term survival. Costs for research
tools such as reagents and laboratory equipment
(especially high-throughput platform equipment such
as microarray chips) can also be substantial,
especially since many of these reagents and platforms
are themselves patented products. For example,
researchers at Genomic Health reportedly spent well
over 100 million dollars and 7 years, including
numerous clinical studies involving hundreds of
patients, in bringing OncoType DX® to market.3
 In other words, if the court allows Mayo to win, they may be providing competition on this specific test, but who will be the company that will discover the next marker-drug connection?   Further the Myriad Genetics amicus disputes the contention that Prometheus is attempting to patent a natural law.

For example, while this Court has repeatedly
explained that “Einstein could not patent his
celebrated law that E = mc2; nor could Newton have
patented the law of gravity,”  the Court has explicitly upheld
a patent claiming a 
specific and practical application of the law of gravity.
Eibel Process Co. v. Minn. & Ont. Paper Co.,

The Federal Circut Court in 2010 rejected the claim that the process
Prometheus was seeking to patent was so abstract as to be non-patentable.
“[T]he claims
recite specific treatment steps, not just the
correlations themselves. And the steps involve a
particular application of the natural correlations: the
treatment of a specific disease by administering
specific drugs and measuring specific metabolite

This will be a court case to watch as it would have implications for pricing and development of molecular tests.