We have all read, argued, listened to, supported, discouraged (you name it) arguments for and against gene patenting. We (or at least I) have endured scientific arguments attempting to discern what is natural and what is man-made. We have endured moral arguments against gene patenting stating that we have an inalienable right to ownership of our bodies and our genomes. We have endured policy arguments for gene patenting prophesizing a decrease in medicine and scientific progress if gene patents are banned.

But all that aside: what if a ban on gene patents means no ban on the cure for cancer? On its face, it seems unlikely, I know. But, enter the slippery-slope argument put forth by pro-patent enthusiasts. This summer, in Association for Molecular Pathology v. Myriad Genetics, the Supreme Court will decide the fate of human gene patenting. In the meantime, institutions are making incredible progress in the field of cancer research. The well-known St. Jude Children’s Research Hospital just received a significant patent in this field. The patent covers genetically modified human immune cells, which destroy some of the most common forms of cancer cells. In its patent, St. Jude claims “[a]n isolated host cell . . . .” If the Supreme Court decides that the isolation step of human genes is insufficient to establish patent eligibility, will that make St. Jude’s isolated host cell equally unpatentable?

This seems like a rather weak argument that provides for pretty unreasonable results. St. Jude’s invention involves genetically modifying the host cell to enable them to make a certain protein. That protein then stimulates the human immune cell to attack and kill the cancer cells. This manufacture of the protein is not natural to the host cell. The host cell is clearly changed from its natural state in that it produces a new product. With regards to human genes, the genes themselves are not modified by humans. It is not clear that the isolated DNA has changed from its natural state, hence all the fuss and litigation.

Unlike gene patenting, the patenting of genetically modified cells is an issue that can be readily resolved under the standards put forth in U.S. patent law. However, policy arguments will only further support patentability. Who is going to do all the research for cancer treatment if there is no exclusive right patent right that can be used to recoup the required investment? This burden will fall on the public (i.e. your tax money) and on philanthropic gifts, and progress will not be up to current societal standards. It is good to be aware of the patentability trends as research progresses, but let’s not get carried away in an anti-patent frenzy: if the Supreme Court bans human gene patenting, it will be because the Court doesn’t believe there is a man-made aspect to it.  That, at least, won’t be the issue for St. Jude’s patent.

–Sonal Patel

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3 Responses to Patenting the Cure for Cancer

  1. Niels says:

    Sonal, great post. I think you made an important distinction between what’s going on here and the Myriad case. While the justices look poised to hold that isolated DNA is not itself patentable, that shouldn’t limit the patent eligibility of St. Jude’s patent. Based on the oral arguments, the court seemed willing to come to a compromise position that would allow inventors to patent the USE of various isolated DNA, but not the isolated element itself. This narrow holding wouldn’t seem to exclude the patent eligibility of genetically modified cells and various method-of-use claims derived from those modified cells.

  2. Swathi says:

    On the flip side, I’d ask everyone to consider what will happen if St. Jude’s patent is upheld. Nobody can deny the positive work St. Jude’s does. But if, hypothetically speaking, the genetically modified cell St. Jude’s has isolated is the cure for all cancers, then St. Jude’s could serve as a barrier to research as well. It’s constant need for money is well known, and it can use its position to extract large royalties and licensing fees. Licensing fees can be exorbitant, particularly for exclusive licenses. Small labs that have the know how, but lack the monetary resources, to work with this material will be shut out of the research process.

    I’m not necessarily arguing against patents on genes or genetically modified cells. Instead, I’m arguing for responsibility. If patents are necessary for researchers to recoup their R&D costs, then they should be forced to be responsible and engage in non-exclusive licensing, technology transfer projects, and other mechanisms that help spread the accessibility of the technology to everyone who could conceivably use it to make a difference. St. Jude’s, with its mission to help everyone regardless of their ability to pay, should spearhead this effort.

  3. Samantha says:

    This is a very intriguing post. It will be interesting to see what the Supreme Court decides. St. Jude’s does very important work and it would be a shame if its progress was limited.