In a case that did not present the issue, Judge Dyk wrote a separate opinion to express his views that a claim directed to “[a]n isolated DNA molecule” “raises substantial issues of patentable subject matter under 35 USC § 101.” The issues on appeal in Intervet Inc. v. Merial Ltd., related to claim construction and the doctrine of equivalents. Judge Dyk concurred-in-part and dissented-in-part with the majority’s decisions on claim construction, and disagreed with the majority’s view on the doctrine of equivalents, but wrote a separate opinion “primarily to make clear” that the fact that the court addressed the claim construction issues does not mean that the court had decided that the claims are directed to patent-eligible subject matter.

The Isolated DNA Claim

Judge Dyk focused on claim 32 of U.S. Patent 6,368,601:

An isolated DNA molecule comprising a nucleotide sequence encoding an epitope which is specific to [porcine circovirus]-2 and not specific to [porcine circovirus]-1.

According to Judge Dyk:

The question is whether the isolated DNA molecule, separate from any applications associated with the isolated nucleotide sequence (for example, the production of a vaccine) is patentable subject matter.

Judge Dyk states that this is an open question that neither the Supreme Court nor the Federal Circuit has decided directly, although he acknowledges that the U.S. Patent Office has weighed in on the issue and (as we all know) come down on the side of patentability.

In a statement that strikes me as circular, Jude Dyk asserts:

Just as the patentability of abstract ideas would preempt others from using ideas that are in the public domain . . . so too would allowing the patenting of naturally occurring substances preempt the use by others of substances that should be freely available to the public.

He then cites the 1948 Supreme Court decision in Funk Bros. Seed Co. v. Kalo Inoculant Co., and the 1980 Supreme Court decision in Diamond v. Chakrabarty, but neither of these cases support the view that “isolated DNA” claims cannot be patented.

The Funky Decision in Funk Brothers

The patent at issue in Funk Bros. was directed to a composition comprising a mixture of different nitrogen-fixing strains of bacteria, used in agriculture to inoculate the seeds of leguminous plants. The case arose before the 1952 Patent Act, and the decision does not fit squarely under today’s § 101 or § 102/103 jurisprudence.

For example, the Court discussed § 101-type issues:

[The] qualities [of the bacteria] are the work of nature. Those qualities are of course not patentable. For patents cannot issue for the discovery of the phenomena of nature. . . . The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none. He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end.

This passage suggests that the Court did not believe that the combination of bacteria was patent-eligible.

On the other hand, the Court also discussed § 103-type issues:

The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee.

This passage suggests that the Court did not find that the combination achieved any unexpected effect, e.g., that it was not nonobvious. Indeed, the Court continued:

But a product must be more than new and useful to be patented; it must also satisfy the requirements of invention or discovery.

And portions of the opinion sound familiar from KSR:

But once nature’s secret of the non-inhibitive quality of certain strains of the species of Rhizobium was discovered, the state of the art made the production of a mixed inoculant a simple step. Even though it may have been the product of skill, it certainly was not the product of invention.

Under today’s standards, though, even if the individual isolated bacterium were not patent-eligible, a composition comprising a mixture of bacteria that itself did not occur in nature certainly would satisfy § 101. Thus, I am not convinced that Funk Bros. provides a sound basis for rejecting the patent-eligibility of claims to “isolated DNA.”

The Chakrabarty Case

Chakrabarty is likewise of little help to Judge Dyk’s position, and the cited passages of this case are dicta. The claims at issue in Chakrabarty were directed to a “human-made, genetically engineered bacterium [that] is capable of breaking down multiple components of crude oil.” Thus, while the Court may have found it convenient to distinguish Chakrabarty’s claims from a “discovery [of] nature’s handiwork,” it did not decide that isolated biological products cannot be patented.

Will There be a “Qualitatively Different” Test for Isolated DNA Claims?

Judge Dyk reads Funk Bros. and Chakrabarty in concert as indicating that

[I]n order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with markedly different characteristics from any found in nature.

(This is the same test applied by the district court in Association for Molecular Pathology v. USPTO—the ACLU/Myriad case.)

Judge Dyk expresses doubt that an “‘isolated’ DNA sequence is qualitatively different from the product occurring in nature,” and opines that “[t]he mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question.” Drawing an analogy understandable to those without advanced degrees in biotechnology, he concludes:

It would be difficult to argue, for instance that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.

It remains to be seen whether the Federal Circuit will adopt a “qualitatively different” test for the patent-eligibility of products isolated from a natural state. Even if it does, experts may disagree as to whether isolated DNA claims would satisfy that test, either as a general rule, or on a case-by-case basis. Either way, the Supreme Court is likely to weigh in, leaving this question unresolved for at least another year. If isolated DNA claims are determined not to be patent-eligible, or if the decision to uphold such claims garners enough public interest—or outrage—even Congress may have its say before this issue is finally resolved.