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« Court Report - Part III | Main | AALS 2012 MidYear Meeting »

April 26, 2012

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None of which, of course, addresses the actual legal (and ontological) question involved: are patents on such genes patents of "products" or "phenomena" of nature. Also, doesn't this challenge the usefulness of getting these sorts of patents in the first place, and thus the value of such patents?

The authors have investigated the potential of genetics to predict future disease conditions. That does not seem to be the same as using genetic testing to provide the most appropriate medicines. I do not know this area very well, but it seems to me that efficacy of a drug for a condition may have a different basis from the cause of the condition, and so these results might not be directly relevant to 'personalised medicines'.

I agree, Suleman. There is quite a difference in a genetic marker predicting disease and a genetic marker predicting disease response. Pharmaceutical companies are interested in the latter, i.e., genetic markers that help identify patients that will respond (or respond better) to their drugs. As a result, I do not believe these findings are relevant to personalized medicine, which has, as its goal, maximizing the benefit and minimizing the risk of a drug in a population already afflicted with a particular disease.

Kevin:

Great post. Not sure what you're driving at with your comment cautioning against changing established patent and other policies in view of the study. Insofar as you are cryptically attacking SCOTUS for its absolute no-brainer opinion in Prometheus, I do not see the connection. I agree with David. If anything, the study suggests that some/many/most/nearly all/all genotype-phenotype associations that are sought to be patented don't have "utility" anyway. So, again, what's the harm from Prometheus?

You seem to have skipped over the best quote: "In sum, no result, including ours, can or should be used to conclude that whole-genome sequencing will be either useful or useless in an absolute sense."

I am in total agreement with Suleman, also. The difference is whether one is talking prediction versus potential treatment.

Where we seem to be right now in the use of genomics in medicine is on the edge of being able to usefully analyze the incredibly large amounts of data from sequencing and just on the verge of the hypothesis generation phase. Using any analysis right now to discount possible uses of genomic information is unwarranted and premature. Until we know what we have, we cannot make any predictions of how to use it. But we also cannot continue drug creation in the old model, where pharmaceutical research centered around possible targets of unknown root causes. The new pharma model will need to be based on the root cause of disease, which is far more complex than just genetics or just environmental factors. Unfortunately, human disease is a very personal thing, which is why individual reactions to medications and treatment can be so, well, individualized.

What I am inelegantly attempting to say is that genomics will play its role, it already is (see Kailos Genetics, a company using markers to shunt breast-cancer patients into the optimal treatment plan). In some cases, such as one-gene-one-disease, it will be THE factor (see Kalydeco being used to treat the 4% of cystic fibrosis patients carrying mutations of the CFTR gene). And in others, there will be combinations along a spectrum.

Aside of this, though, I do not understand how this affects the patent process. Under patent law, one must feasibly show that under known conditions, laws or what-have-you, the invention would theoretically work, not that it absolutely does work, works every time or even that it works well.

Dear Laurie:

Thanks for a great and informed comment. The gist of what I was driving at was that a great deal of the angst in patent law these days is directed at the possibility that IP protection will stifle innovation, particularly with regards to personalized medicine. My point was that we are sufficiently far from attaining this goal that current patents on genes (which will all expire by about 2020) will not factor into this calculus much, and that decisions based on these fears are misguided.

Thanks for reading.

Suleman and lxf001:

The kind of companion diagnostics you mention is different, since it is a way to answer a specific question, i.e. will this patient benefit (or be harmed) by this specific drug. Entirely different paradigm and incredibly valuable, when it works.

Thanks for the comments.

Dear David:

I cannot disagree. But then I don't think any patent claim reciting "an isolated nucleic acid encoding SEQ ID NO. X" is infringed when someone performs a genetic diagnostic test on the gene represented by SEQ ID NO. X.

And at this point, I think the bigger danger is not that human (or any) DNA will be deemed patent ineligible sui generis, but that some unnecessary "product of nature" exclusion will preclude patenting a great many natural products that are not DNA.

Hope you are well.

Dear Gary:

If the Prometheus opinion was limited to those claims and claims like them I would have little problem with it. I will leave it to others if they want to rehash the analytical mess the decision imposes on patent law. With luck this decision will joint the Funk Bros., Benson, Flook et al. decisions that are rightly ignored day-to-day.

Thanks for the comment.

Dear Kevin,

As you know, I support the court-made exclusion of laws of nature, products of nature, and natural phenomena from monopoly because I think they are a commons by (logical/material) necessity, and simply cannot be ethically monopolized.

But it's glad to see we have some agreement on something, more or less. :)

All is well, best to you and yours.

David

Thanks, Kevin. That cleared it up for me. And I agree with you, definitely on that point.

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