Are Human Genes Patentable?–Association for Molecular Pathology v. Myriad Genetics

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C. (Robert Wagner on G+)

Yesterday, the United States Supreme Court heard oral argument on a key patent issue—are human genes patentable subject matter? In the Association for Molecular Pathology v. Myriad Genetics, Inc., (No. 12-398), the Supreme Court granted certiorari to decide this issue, which will have a profound impact on the medical research and pharmaceutical industries. (For a complete list of the issues presented, see here). This post follows up on our earlier post discussing the Court’s decision to grant cert.

In this case, Myriad Genetics identified and isolated a human gene that could be used to help predict a patient’s genetic predisposition to breast and ovarian cancers. Myriad then obtained a patent on, among other things, cDNA molecules associated with the relevant genes, as well as the use of the molecule to  probe a patient’s DNA and to prime the production of the patient’s DNA in the laboratory. (The parties’ briefs explaining the details of the patented claims can be found here). Myriad then created a test that could be used on patients to help assess whether they were more likely to be predisposed to certain kinds of breast and ovarian cancers.

After creating the tests and obtaining the patent, Myriad sent letters to various researchers, informing them of the patent rights and requesting that they refrain from infringing. As a result, numerous researchers ceased working in this area. A number of researchers and institutions filed a declaratory judgment action, seeking a determination, among other things, that the patents were invalid.

The Federal Circuit, in a split decision with each Judge writing separately, held that human genes are patentable subject matter. The Association filed a writ of certiorari challenging this decision, which the Supreme Court granted. Oral arguments were held on April 15, 2013, and a transcript can be found here.

While it is always difficult to predict how the Supreme Court will rule, there are some aspects that appeared to concern the Court more than others.  First, the Justices probed the parties for where and how lines should be drawn about what is a product of nature that should not be patented and what is the result of human intervention. This is the heart of the question presented and what they were struggling to define. Ultimately, the Court seemed more inclined to uphold the patent claims associated with the cDNA, as they involved more human intervention, but we will have to wait to see what they actually do.

Second, the Court  questioned whether striking these kinds of patents  would eliminate the incentives for inventors to invest the time and money in developing these kinds of tests and treatments. There was some concern that eliminating these kinds of patents could hinder innovation. On the other hand, counsel for the Association argued that allowing these kinds of patents actually creates a disincentive, as many researchers and companies will not invest any time and money for fear of being sued (which is what happened here).

The transcript of the oral argument makes for a fascinating read. What will be more interesting is reading the ruling. We expect a decision sometime later this summer.

For more analysis on the oral arguments, see here.