DNA, Patents and the Supreme Court

Author

Craig Klugman

Publish date

Tag(s): Legacy post
Topic(s): Genetics Health Regulation & Law

Craig Klugman, PhD

In 1994, researchers at the University of Utah discovered that mutations in the genes BRCA1 and 2 correlated with higher rates of breast and ovarian cancer. The DNA portions in question show genetic predilection for cancer including breast, colon, uterine and ovarian. Utah patented the methods for using these sequences to test for breast cancer as well as patented a test kit, the isolated gene fragment, and cloned DNA (cDNA) of the sequence. The University made an exclusive license deal with a private company, Myriad Genetics.

In a recent letter-at-large, Peter Meldrum, CEO of Myriad says that his company deserves the patents because of their work and their investment in time and money. Myriad claims that they “discovered” (according to Meldrum’s editorial) and later synthesized (cloned) the genes in a laboratory. This argument suggests that Myriad should have the patents to earn recompense for its efforts.

In 2009, a group of researchers (Association for Molecular Pathology) and patients (represented by the ACLU) sued Myriad claiming that human genes should not be patentable. Initially a federal judge invalidated the patents, a decision overruled by the appeals court and now before the U.S. Supreme Court. This coalition argues that there should be no patent because human genes come from nature and you cannot patent things that come from nature (unless they are altered). This group fears that such patents could make research more difficult and expensive requiring permission and paying fees to private companies.

The Supreme Court accepted the case to rule on the question of whether human genes are patentable. During its day of hearings on April 15, the justices talked about a difference between natural genes—those isolated from a human cell, and synthetic genes—cloned DNA segments created in a laboratory. The difference is whether nature or a scientist determines the DNR sequence.

While the legal arguments are technical and somewhat confusing, the short response is whether it is possible for a private company, or a university, to own the genes (and mutations) that occur in a human body? Can they own those genes if they have isolated them? Can they own those genes if they can cloned them in a laboratory? These distinctions are likely to be key to how this case is decided.

What about the rightness and wrongness of this situation? Ought it be that a company or university can own the segments of DNA that together comprise the blueprints for a human being? Our DNA is part of who we are and patenting a segment of ourselves is like if Freud had patented the id and then charged a patent fee anytime anyone did talk therapy, or even used their id. Certainly the company should be able to own the techniques used to isolate the genes, and even the test developed from the techniques. After all, those are innovations that are created by humans. But the raw source material, the DNA is part of nature. And similarly to no one “owning” the oceans or the air, DNA is part of the public commons and ought to remain that way. So as a society, we should reward innovation while also protecting the commons so that it remain available to future generations of innovators and so that new parents do not have to file a patent fee just to have a child.

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