Court's Gene Patent Decision Is Good Compromise

By Craig Nard

Editor's Note: This article is paired with another that disagrees. Read that article here.

The U.S. Supreme Court, in a unanimous 9-0 decision, determined that isolated DNA is a product of nature, and therefore, not eligible for patent protection. But the Court also held that patent law could accommodate complementary DNA (or cDNA), which was characterized as a synthetic, non-naturally occurring substance. This compromise position is fair-minded, supported by current patent law doctrine and policy, and retains important incentives for biotechnology players.

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The Court viewed this case in the context of patent law’s delicate incentive dynamic. On the one hand, patent law seeks to induce innovation by holding out the prospect of a property right, and on the other hand, carve out enough space for competitors to improve on a given innovation while also guarding the public domain. And woven within this dynamic are questions relating to the proper scope and exercise of the patent right, and what types of behavior a patent owner can engage in when exploiting its patent.

Myriad Genetics, the company at the center of the case, had patented the DNA sequences of the BRCA1 and BRCA2 genes and devised a test to determine if a woman possesses versions of the genes linked to breast cancer. These patents provided Myriad with a powerful economic tool, which allowed the company to exclude others from creating their own tests using the patented BRCA genes.

But the Court determined that Myriad’s patents on the DNA sequences improperly captured “the basic tools of scientific and technological work.” This holding will allow researchers greater liberty to use isolated DNA sequences and engage in entire-genome analysis and multi-gene genetic tests. Moreover, the Court made clear that patent law is agnostic with respect to the amount of effort, societal contribution, or intellectual insight of a given claimed invention. As the Court noted, “[g]roundbreaking, innovative, or even brilliant discovery does not by itself” make the discovery eligible for patent protection. In this regard, patent law is similar to copyright law.

Yet by allowing patent protection on cDNA, the Court retained sufficient incentives for biotechnology firms to invest in creating innovative research tools and diagnostics. For example, cDNA can be used to identify polymorphisms that are indicative of particular diseases; potentially patentable diagnostics and therapeutics can then be designed to detect and treat these diseases. While the creation of cDNA and resulting treatments, of course, must satisfy additional patentability requirements such as non-obviousness, the Court at least gave firms the opportunity to make the case.

Moreover, the Court was quick to point out what is “not implicated” in its decision, and the possibility of patent protection remains for “innovative methods of manipulating genes;” “new applications of knowledge” about genes; and inventions that alter the naturally occurring nucleotide sequence of genes. Therefore, from a greater remove, the dilutive effect on incentives for the biotechnology industry are not as severe as it could have been, and in this regard, the Court reached a sound compromise.

Craig Nard is a law professor at Case Western Reserve University. He is author of the textbook The Law of Patents.

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