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July 17, 2009


Jackie Hutter

Excellent summary, Joe. You made it easy for me to get up to speed on this complicated issue.

I find it interesting that there seems to be a convergence of testing/diagnostic patent rights on the medical side and business method patents. While the subject matter of each of these types of patent rights doesn't seem similar, the basic issue on which the rights are based are virtually identical: should others be prevented from a conducting a process that has no post-solution activity?

At the core, a method for measuring a disease state is virtually identical to a process for measuring financial risk. There really is no "promotion of progress of science" from granting of exclusive rights to inventions in these areas because others cannot make improvements without also infringing the underlying "gate keeping" patent rights.

In this regard, I tell my clients that Bilski is not an issue if they can show how their invention operates on the external environment which is another way to term "post solution activity." (I think the "touching a computer" aspect is on shaky ground as a long term concept given the emergence of cloud computing.) When an inventor can show not only how her business method works, but also what it does, there will be less struggle to validate the reason why business method patents are beneficial to society. Of course, this is a subtle difference which comes down to claim drafting skill, but there are quite a number of issues in patent law that center on the skills of the attorney.

It will be interesting to see whether the Federal Circuit will move toward preferring methods of measuring disease state patents that demonstrate an effect on the environment (ie, post solution activity), as opposed to the mere identification of how one might desire to act on the disease state if there was not a patent that would be infringed. At the end of the day, there is no doubt in my mind that the arguments against measurement of disease states will increase in the future. Those developing products in those areas should be looking at ways to reduce the furor so they can avoid draconian court decisions that center on public policy arguments and not on long-standing patent law.

Tony Contento, Ph.D.

In this suit, Mayo's case sounds shaky. The researchers at Mayo did not invent a new method of measuring thiopurine metabolites, but instead chose different levels of the metabolites to use as reference points. Prometheus created the test and patented it. It might only measure the natural metabolites of the drug, but the company invested time, effort and capital into the design. Their research findings were published in good faith in the patent, and the government deemed it worthy of protection.

This differs from the case involving Myriad Genetics and the BRAC1/2 genes. It is true that mutations in the BRAC1/2 genes were identified as cancer markers, and a test based on those mutations was designed by Myriad Genetics. However, since the filing of those patents, dozens of new mutations in those same two genes have been identified by other researchers. Myriad's patent shouldn't give them rights to every new BRAC gene. They should only have rights to the gene mutations that were initially described in their patent. Patents were designed to protect intellectual property and investment in research. They were not designed to stifle new research on the same subject, be it a gene or a metabolic profile.

Myriad's patent is being used to cover all research on these genes, and this is wrong. However, labs looking for a way around Myriad's patent is equally wrong. If those labs want to test for other mutations in BRAC, that should be allowed (even patented). However, providing a cheaper alternative to Myriad's test is a circumvention of the law. The same is true for Mayo's case.

When you invent a test for something and patent it, you can give it away, you can charge $10 or $1 million. That's your choice. Patent law in the US should protect you (if you want to circumvent that law, do the illegal testing in a nation outside of US Patent Law).

If you invent a test for avarice, that doesn't give you rights to all testing and research for the other deadly six. Patents only cover the research described.


I don't think the amount of effort put forth is (or should be) a standard to which patents are held to. You can put a lot of effort into deriving the obvious, after all, but that doesn't make it somehow worthy of protection. And I have to say, inferring the level of a drug in a patient's system by measuring metabolite levels is pretty obvious to anyone skilled in the art of medicine.

Moreover, there are good public policy reasons NOT to protect simple tests like these: namely the fact that they saddle our over-burdened health care system with additional costs and liabilities, while delaying care by forcing doctors to either outsource every little test to some independent lab or to do patent searches before every test. The cost of this is measured in human lives, not just money.

Therefore, if the economics are that we truly cannot afford to protect this research, yet it is deemed valuable enough that it must be continued anyhow, the only reasonable alternative is to have the research done by the government and make it freely available to all.

Anything else simply costs too much.

patent these genes

Rep. Becerra is obviuosly way over his head with IP matters. Not patentning genes? What a joke. Based on his comments, he probably does not know the first thing about genes other than what some very leftist constituents inaccurately feed him.

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