Michael Crichton wrote an excellent op-ed, “Patenting Life,” in Tuesday’s New York Times.
I find it hard to disagree with Crichton’s comments, but it might be worth mentioning that his article really deals with two separate arguments. One is that taking something that belongs to others, i.e., actual physical material, without their permission is wrong. The second issue is that innovation is the proper subject of patents, not mere discovery. In the first situation, the question is whether patients should have a right to share in patents developed using their tissue or genes. In the second, the question is whether the genes themselves – not just the products created with them – should be patentable.
Self-determination and self-ownership are essential in a free society. Actual physical material such as tissue samples or actual genes taken from a person’s body should not be acquired or used without informed consent – that includes not using a patient’s tissue to develop and market cell lines or to develop and market medical therapies without the patient’s express consent. It is dishonest to provide patients with misleading consent forms. Some give the impression a patient’s tissue is medical waste that the hospital or doctor should be free to dispose of as necessary. Other consent forms acknowledge that a patient’s tissue may be used to gain knowledge but say nothing of the potential profits to be gained either from that knowledge or from the actual use of the tissue itself.
For consent to tissue acquisition to be informed it must clearly identify a patient’s options: 1) Is the patient making a gift of the tissue and expressly relinquishing any potential profits from medical products developed with that tissue? 2) Is the patient being paid for his tissue and willingly relinquishing any claim to profits from products that may be developed using that tissue? Or, 3) Is the patient being promised a percentage of the profits, should any materialize? Patients must not only be aware of these options but also understand them for there to be true informed consent. To do otherwise is to take something from them under false pretenses.
Patents on genes themselves is a different issue. I’m not a patent lawyer, but if Crichton is correct, it seems the courts have confused the discovery of something new in nature with the creation of something new, i.e., confused pure discovery with innovation. Scientists are awarded Nobel Prizes for discovering new elements, new species, or new diseases, but they usually aren’t, and shouldn’t be, awarded patents for such discoveries. Patents should only be awarded if something new is created – a new process, a new test, a new technique, a new cure, etc. Imagine if Casey and Jacobi had been awarded patents for their 1973 discovery of the Hawaiian Po’ouli Honeycreeper. Anyone who wanted to go looking for the Po’ouli bird would have to pay Casey and Jacobi a licensing fee. Innovative processes used to test for certain genes or their mutations or special processes for recording information about genes should potentially be patentable, but, not the genes themselves – no more than it makes sense to patent the rare and hard to find Po’ouli.
One further distinction is worth making. A patent might be justified if a scientist manipulated a gene to create something new. If a patent were awarded, the patent holder should be required to share his profits with the person from whom the original gene was acquired unless, after full and complete disclosure, that person had willingly and with full understanding relinquished his rights to such profits.