To the Editor: We are pleased that Dr. Palombi appreciated our case study, Myriad Genetics: In the eye of the policy storm.1 However, his letter does confuse and conflate two separate types of opinion: (1) opinions on the desirability of gene patents; and (2) legal opinions on whether isolated genes and cDNA are patentable subject matter in the United States.

As for the first point, in 1996 one of us wrote extensively on the issue of patenting human genes, arguing that, for social and economic policy reasons, it would be better not to grant such patents.2 Many commentators came to similar conclusions. Many others disagreed. The opinions expressed drew on a combination of economic, social, scientific, and religious arguments to argue for or against such patents. These policy opinions influenced some legislative bodies around the world to pass legislation that either specifically prohibited the patenting of human genes (for example, in Mexico) or specifically acknowledged such patenting (for example, by Member States of the European Union). Government-sponsored commissions also discussed the wisdom or unwisdom of patenting human genes, such as the Secretary—Advisory Committee on Genetics, Health, and Society.

The discussion of human gene patenting in the passage that Dr. Palombi highlights was not of this type. Instead, it provided a legal judgment of the current status of United States law on the patent-eligibility of isolated DNA and cDNA claims. Unlike an opinion on policy, which, while often informed, can easily be disputed on many levels, a legal judgment draws on the nature of legal argumentation, building on agreed principles motivating law in general and, in this case, patent law in particular. These principles are, in the United States system, enunciated by the courts. The most important courts on matters of patent law are the United States Court of Appeals for the Federal Circuit and the Supreme Court of the United States. The Federal Circuit has exclusive jurisdiction over all appeals on patent law in the country and is largely composed of experts in the field. Although the Supreme Court sets out the principles motivating patent law, the Federal Circuit implements those principles.

Elsewhere, we have discussed the application of patent law to human genes.3 Here, we summarize the reasons why isolated human genes are “almost certainly” a patentable subject matter in the United States.

First, ever since Diamond v. Chakrabarty,4 the United States is acknowledged to have the broadest patent law in terms of what kind of inventions can be patented. Second, over the past 30 years, the Federal Circuit has ruled numerous times on the validity of gene patents, including isolated DNA and cDNA patents. Much recent jurisprudence of that court and of other district courts was not discussed in the District Court decision in Association of Molecular Pathologists et al. v. USPTO et al.5 (There have been at least 31 law suits involving gene patents between 1987 and 2008; see Ref. 6) Third, US patent law has long recognized patents over “isolated and purified chemical products that exist in nature only in an impure state, when human intervention has made them available in a new form that meets human purposes.”7 As Professor Eisenberg notes, this is exactly what the courts found with respect to isolated vitamin B12.8 Fourth, in those countries that determined, for policy reasons, not to permit patents over DNA, the legislatures passed laws to explicitly say so. For example, the Industrial Property Law of Mexico, in Article 16, states that “Inventions that are new, the result of an inventive step and susceptible of industrial application within the meaning of this Law shall be patentable, with the exception of … biological and genetic material as found in nature.” Although Mexican or other foreign law has no bearing on the interpretation of US patent law, it illustrates a global consensus among law makers and experts that, absent a specific exclusion, naturally occurring genes are eligible to be patented. Fifth, the distinction often made when discussing policy between the information and physical nature of human genes does not translate well to patent law. This is because patents are not granted over the information or physical nature of genes separately, but together. The same patent that is directed to the use of a gene for a genetic test also applies to the use of the same gene in a therapeutic context. If patent law were to create a rule that one cannot patent the “informational” nature of genes, patent agents would simply arrive at the same result by claiming the use of genes in drug discovery. On the other hand, the distinction is useful in the policy realm because it may help develop legislative exceptions such as those proposed by the Secretary's Advisory Committee on Genetics, Health, and Society.

Although this is not an exhaustive justification of the statement that the decision on gene patents by the District Court for the Southern District of New York “will almost certainly be overturned,” it provides strong reasons for believing so. The fact that no previous case has specifically addressed the issue of whether isolated DNA or cDNA is patent eligible is probably due to the strength of these arguments. Further, our opinion on the patentability of isolated DNA is supported by the vast majority of experts in United States patent law (for example, see Ref. 9), raising its confidence level to that expressed in the case study.

In the case study, we expressed no opinion on the District Court's holding that the type of diagnostic testing method set out in Myriad's patent claims were not eligible to be patented. This is because the law on this point is currently in flux, as observers await the decision of the Supreme Court in In re Bilski. Building on the Federal Circuit's decision in that case, the District Court raises a plausible argument that these method patents are not eligible for patent protection in the United States, even if new, nonobvious, and useful.