Pharmaceutically Speaking, Part 9: Prometheus Lab v Mayo Clinic

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Danie Roy

Some of you may remember when I wrote on patenting all the immunization schedules ever. Turns out that the really ridiculous patents just didn’t end there. Apparently, there is actually a patent that is broad enough to claim even thinking about the patented treatment. If you need a minute to reread that and let it sink in, go ahead. I needed a few minutes myself.

Prometheus Lab v Mayo is going all the way to the Supreme Court. Apparently, the method patent at hand involves administering the drug thiopurine, checking a patient’s blood for how much got absorbed into the body, and adjusting the dose accordingly. Someone please tell me how this didn’t get a 103 rejection and a look of disapproval.

I made this face when I read about this patent.

For those slightly less acquainted with medical issues, a lot of medications, especially those used in the treatment of autoimmune disorders (like thiopurine is), need to be closely monitored. The amount of the drug actually absorbed by and used in the body is critical for proper treatment. The problem is, everyone’s body is different, so different doses are necessary for different people.

Take a look at cyclosporine, for example. That drug has been around since the early 80′s and blood levels and adjustments are made in much the same manner. Take any other immunosuppressant, new or old, and it’s the same deal. One should conclude that it would be OBVIOUS to to use this method for any given immunosuppressant, or even a slightly unpredictable drug, for that matter.

What is killing me is that the Supreme Court is going to be deciding the issue of whether or not this is a valid method patent, and looking to Bilski. Am I missing something? The issue here shouldn’t be whether this passes the machine-or-transformation test (or any other test that can be reasonably used), but whether this should have issued as a patent in the first place. Lives actually do hang in the balance here, so I can understand Mayo’s frustration.

I can only hope the Supreme Court makes the right decision.

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