On June 13, the U.S. Supreme Court announced its decision in Association for Molecular Pathology v. Myriad, a closely watched case considering the patentability of human genes.
Numerous media headlines immediately after the decision's release proclaimed that the court had found human genes to be unpatentable. But such characterizations are misleading, ignoring the court's actual holding that some human genes -- specifically, those isolated from natural sources -- are unpatentable, while other versions created in the laboratory are in fact eligible for patents.
The case involved patent claims to two different types of DNA sequences. The first, dubbed genomic DNA or "gDNA" constitutes the molecule as it is extracted from human cells. The second, known as complimentary DNA or "cDNA" is created in the laboratory through a process known as reverse transcription. The question in the case was whether either or both such DNA molecules qualify as patentable subject matter.
Patents are intended to offer an incentive for investment in new technologies, by creating a legal right to exclude others from making, using, or selling the invention described in the patent. But this incentive comes at a cost: while the patent holder can charge a premium to recoup her investment in the invention, others besides the patent holder are prohibited from using the technology during the 20 year term of the patent. So patents serve simultaneously as an accelerator and as a brake on technological progress.
In order to ensure that the incentive accelerator effect wins out over the exclusivity brake, society is cautious in distributing patents -- they are only supposed to be granted to new and significant advances in technology, which we hope will be worth the cost. Among other limits, this means that technologies already accessible, such as items that are already found available in nature, should be precluded from receiving a patent.
The Myriad decision considers how that limit applies in the cases of gDNA and cDNA. In a nearly unanimous 9-0 opinion -- with only a slight quibble in concurrence by Justice Scalia, who complained that he did not fully understand the science -- the justices held that the genomic DNA sequences were not different enough from those found in human cells to warrant a patent. But they equally unanimously held that the cDNA sequences created in the laboratory differed enough to constitute patentable subject matter.
This outcome was not much of a surprise. Patent experts and Supreme Court watchers expected that the court would look for a way to issue a very narrow holding. A broad holding in the Myriad case had the potential to disrupt innovation far beyond breast cancer or any other type of medical testing. DNA sequences are important not only to genetic testing, but to a wide range of other biotechnology companies, including pharmaceutical, chemical, and even agricultural firms.
The Supreme Court was unquestionably aware that an adverse ruling on DNA patents would upset the business expectations created by 30 years of such patents granted by the Patent Office. This was certainly on the minds of judges in the lower courts who cited such expectations as a reason to leave the gDNA patents intact. Additionally, a broad limitation on patenting substances found in nature has a potentially very wide effect -- for example, potentially undermining the value of new drugs or treatments found in the rainforest, or at the bottom of the ocean, or in other unexplored areas.
Limiting its holding to the invalidation of gDNA patent claims, while upholding the claims to cDNA, was one way of narrowing the Myriad ruling. While the value of existing cDNA patents may be partially undermined by the new access to similar gDNAs, industries that rely on DNA patents can still protect the laboratory versions of the molecules. The ruling also explicitly excludes molecules that might infrequently and accidentally occur in nature from invalidating patents on laboratory synthesized molecules.
But what may be more surprising about the opinion are the numerous hints dropped by Justice Thomas, suggesting how researchers and future patent drafters might go a about writing an acceptable DNA patent. For example, the opinion suggests that a patent to gDNA that was drafted in terms of chemical structure might pass muster. The opinion also goes out of its way to point out that it does not invalidate process claims, or claims to applied uses of genomic DNA, nudging patent drafters toward those forms of claims for future inventions.
Such openings for future DNA patents may leave unanswered more questions than they answer, and indeed may create new questions about the scope and application patent law's product of nature doctrine. But they also leave open the conceptual and legal space necessary for the patent system to promote future investment in industries that are dependent on this kind of innovation.