It’s easy until it’s hard: gene patents 3

In my last article I addressed a diagnostic method from the Association appellate court decision. That method claimed contained a single step for ‘comparing’ two human breast cancer sequences to each other. The judges concluded that this method was merely a ‘mental step’ and it is well established that mental steps are never patent eligible. The majority of Association judges also concluded that breast cancer gene sequences isolated from a human chromosome are patent eligible because they are new composition of matter.

A second diagnostic method in the Association patent presents a closer question, because it contained both patent eligible and non-patent eligible elements as follows:
(1) growing human breast cancer cell in a medium in the presence or absence of a potential cancer therapeutic agent;
(2) determining the growth rate of the breast cancer cells, both with and without the potential therapeutic agent; and
(3) comparing the growth rates of the cancer cells with and without the potential therapeutic agent in their growth medium.

The court concluded that this diagnostic method was patent eligible for several reasons. First this method was more than a single abstract mental step. Growth of the cancer cells with and without the potential cancer therapeutic agent is clearly not a mental step as it requires actual tangible physical cells that are grown in specific physical environments. Secondly, there are two physical transformative steps: (i) growth of a particular patent’s breast cancer cells and (ii) measurement of the resulting growth rate and final accumulated cell growth at the end of the test.

The judges also observed that growing these particular cells with and without the potential therapeutic agent was the underlying basis of the method that with tangible manipulation by researchers. In other words, growing the cells was not an incidental step that is similar to data gathering or collection, as was the case in previous patent eligibility decisions.

The judges further concluded that the method would not become ownership of a scientific principle that would pre-empt other future diagnostic methods for therapeutic cancer agents. Instead this method applied scientific principles to implement the effect of a specific cancer therapeutic agent on specific human breast cancer cells that are artificially grown. Consequently, although there is the mental step of ‘comparing’ growth rates, the method as a whole was patent-eligible based upon the court’s previous analysis.

As one can see from this case, the determination of patent eligibility becomes significantly more difficult when there are both patent eligible and patent non-eligible elements in a method, what will the courts decide. Because this decision’s context was genetics and diagnostic testing, its significant may be discounted by those in other arts. However, there are valuable lessons and relevant principles for other technologies, and even if they are in financial or computer related industries. Business people should remember that because of the rapidly developing technologies of all varieties, the law of patent eligibility is continuously evolving. As a result the law often surprises those most likely to be affected financially by a court decision or modifications to the United States patent statute.

© 2012 Adrienne B. Naumann
Ms. Naumann does not sponsor or endorse the advertisements at or linked in sites.


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