Federal appeals court rules that isolated DNA can be patented.

MX: The Myriad DNA Case—An Update

Reversing a lower court ruling, a U.S. appeals court determined in July 2011 that isolated DNA can be patented. The ruling in Myriad Genetics by the Court of Appeals for the Federal Circuit is the most recent legal decision in an ongoing case that may reach the U.S. Supreme Court.

The appeals court based its decision on the finding that isolated DNA differs chemically from DNA as it occurs in its natural state. The July 29 opinion, which contradicts an earlier ruling by the United States District Court for the Southern District of New York, points out that the U.S. Patent and Trademark Office has routinely issued isolated DNA patents for 30 years.1The landmark case touches on important scientific, business, and philosophical issues, including matters of public policy and legal standing.

Product Claims?

One of the important issues in the Myriad case is whether isolated DNA is a patentable product under 35 U.S.C. §101 of the U.S. patent laws. Certain claims of Myriad Genetics’ patents cover isolated DNA encoding BRCA1 and BRCA2, genes in which mutations have been correlated with increased risk of cancers.

In its previous ruling the district court concluded that Myriad’s claims to isolated DNA were not patentable on the basis that isolated genes are not markedly different from genes as they occur in nature. The appeals court disagreed and reversed that decision. The three-judge appeals panel split on this question, ruling by a 2-1 majority that isolated DNA is patent-eligible.
Under Supreme Court precedent the distinction between a product of nature and one made by humans depends on whether there is a change in the identity of the claimed composition of the product compared with its natural state. In the case of isolated DNA, therefore, a comparison is made between the identity of isolated DNA and the identity of comparable DNA from the same gene as it exists naturally in an organism.

According to the court of appeals opinion, the identity of isolated DNA is significantly changed in comparison with naturally occurring DNA. The court focused on DNA that naturally exists in the form of a chromosome, and it concluded that isolation of DNA from a chromosome causes a change in its chemical identity. Specifically in this context, isolated DNA has been cleaved by the breaking of covalent bonds from the “backbone” of a much larger DNA molecule.

In addition, the isolated DNA has been removed from association with other molecules where it appears as a complex in its natural environment, i.e., histone proteins. Emphasizing the difference in structure, the court focused on the identity of isolated DNA as a unique chemical entity. Viewing it in this way, the court concluded that isolated DNA was a markedly different chemical entity when compared with the same DNA sequence in its native cellular environment.  Put simply, isolated DNA as a distinct chemical entity is not found in nature. That distinction is even clearer in the case of cDNA than in the case of isolated genomic DNA, and all three judges on the panel agreed that cDNA is patent-eligible.

Different And Distinct

The appeal court also held that isolated DNA is not obtained by “purifying” a less pure natural material. Again focusing on chemical structure, the court stressed that chemical bonds are broken when DNA is isolated. Therefore, isolated DNA is not merely a purified form of a material that occurs naturally in an impure form but instead is a different and distinct chemical entity. Moreover, the isolated molecules possess important practical uses that the much larger molecules found in nature do not possess, which supports a finding of a material difference.

Finally, the opinion explained that the USPTO has been issuing patents for isolated DNA on a relatively routine basis for the last 30 years. This practice has led to an expectation by the public as well as the inventor community that isolated DNA is patentable, assuming that the other conditions for patentability, novelty, non-obviousness, and utility are met. If those settled expectations are to be disturbed, the court thus deemed it preferable that the change should be made by the U.S. Congress and not by judicial interpretation of current patent law.

The dissenting judge on the panel disagreed. Breaking chemical bonds is admittedly necessary to isolate DNA from its natural environment, according to the dissenting opinion. However, the genetic coding sequence of a gene “remains the same whether the gene is in the body or isolated,” the dissenting judge concluded. According to this view, isolating DNA is akin to snapping a leaf off a tree, or isolating elemental lithium from a salt. Since the product of such a step is not markedly different from what occurs naturally, the product is not patent-eligible. Finally, the dissenting jurist argued that isolated DNA and native DNA are functionally the same, the essential feature of each being the encoding of information.

‘Abstract Mental Process’ Claims

Also at issue in the Myriad case are patent claims that recite the use of the BRCA genes in diagnostic methods for determining the presence of the mutations. Certain claims recited simply “comparing” or “analyzing” two DNA sequences, i.e., a comparison between a test sequence and a reference sequence to determine whether the test sequences contain certain mutations. Regarding these claims, it is important to note that the step of “comparing” was not just one step of the process being claimed; it was the only step of the process being claimed. The court of appeals agreed with the district court that these claims were unpatentable, holding that the recited “comparing” step is simply an abstract mental process.
The issue of under what circumstances abstract mental steps can form a part of patent eligible subject matter is currently an area of very active interest in the U.S. courts.

In a prior decision referred to as Prometheus, the Federal Circuit held that a mental process could be patent eligible when it involved the use of a machine or when a material is transformed by the process steps. This is referred to as the “machine-or-transformation” test for patent eligibility. In a recent decision, Bilski v. Kappos, the Supreme Court explained that the machine-or-transformation test is a proper standard, but not the sole standard, for determining patent eligibility under 35 U.S.C. §101.

Myriad’s claims reciting a single comparison step—where the claim did not recite the use of a machine to make the comparison and nothing was transformed in making the comparison—failed to satisfy the machine-or-transformation test and the invalidation of these claims was affirmed. The Supreme Court has agreed to review the Prometheus case, and the court’s ruling may add some clarity to the law governing the patentability of methods that involve mental steps.

Court Favors Therapeutic Compounds

The Myriad claim that is drawn to screening for therapeutic compounds fared better in the court of appeals. This claim recited growing transformed cells in both the presence and the absence of a candidate therapeutic compound, determining the growth rates and comparing the growth rates of the cells in the presence and absence of the therapeutic compound. These claims were found to satisfy the machine-or-transformation step, because the cells are transformed by the “growing” step and because a diagnostic comparison of the type claimed does not occur naturally.

In its opinion, the Federal Circuit gave several examples of steps that would be considered sufficiently “transformative” in order to confer patent-eligibility. Specifically, patentability of a claim based on a process using isolated DNA—and one that includes a mental step such as a comparison—could be enhanced by reciting one or more of the following additional steps: isolating the DNA; extracting the DNA; sequencing the DNA; using an administration or treatment with the DNA; or measuring a cellular response.

In defense of its claim to a method of comparing, Myriad argued that certain of these steps were implicit. But the court of appeals made clear that recitation of such additional steps must be explicit to actually be part of a claimed method.
As suggested in the previous article on the Myriad case, these observations by the court confirm that the artful claim drafter can continue to validly claim important practical uses of isolated DNA, irrespective of whether isolated DNA is patent eligible as a product. The same can be said of other products that may occur naturally and of abstract mental steps as well.

Myriad Case To Supreme Court?

As of this writing, there is still the possibility of further rehearing of the Myriad case by the Federal Circuit. One issue that might be reheard is the still-lingering issue of “standing,” which concerns whether the plaintiffs have the legal right to bring the case. One of the plaintiff doctors who proposed to offer BRCA testing services, and whose involvement was critical to resolution of the standing question, moved to another university. Myriad has pointed out that the other university is not qualified to offer BRCA testing. If that argument is accepted, the court of appeals could decide that none of the plaintiffs has a real and immediate interest in the validity of Myriad’s patents, which could result in withdrawal of the prior decision and no resolution of any of the patent eligibility issues.

Regardless of whether any further action is taken by the court of appeals, the issue of most interest is whether the case will be taken up by the Supreme Court. There are several reasons to think that it will.

First, there are important public policy implications to the patentability of isolated DNA. The plaintiffs have presented substantial policy arguments against patenting isolated DNA, e.g., there should be unrestricted availability of genetic materials for diagnosing cancer, unencumbered by patent monopolies.

The Supreme Court may be attracted to address the patent eligibility of isolated DNA—a species of biological subject matter—as a question of important legal interest. The court may deem this issue timely for consideration, since it has not addressed the patent-eligibility of biological subject matter since the 1980 Chakrabarty decision. This ruling found that genetically altered bacteria, of a type which clearly do not exist in nature, were patentable subject matter.

Unique Philosophical Interest

The patent eligibility of isolated DNA also involves questions of unique philosophical interest.  As seen from the court of appeals decision, which was a split decision as to isolated DNA, the answer depends on the perspective from which the issue is approached. In particular, the outcome can hinge on whether isolated DNA is viewed as a chemical entity or as a carrier of information. Certainly it is both, but which is it most fundamentally?

The decision of the Supreme Court in Bilski v. Kappos and the Supreme Court’s agreement to hear the Prometheus case suggest a strong interest by the court in whether claims involving abstract mental steps are patent eligible. This issue is also presented in Myriad.

In sum, the Supreme Court has agreed to hear a surprising number of patent cases in the last few years. This trend further suggests that Myriad will reach the Supreme Court. We will stay tuned.

References
 1. To access the previous MX article with background on the case, please see:
http://www.mddionline.com/article/mx-myriad-case-and-future-gene-patenting

Robert G. McMorrow Jr., JD, is a partner in the intellectual property group of Connolly Bove Lodge & Hutz LLP (Wilmington, DE). He may be reached at [email protected].

Roberte M. Makowski, JD, is a partner in the intellectual property group of Connolly Bove Lodge & Hutz LLP (Wilmington, DE). He may be reached at [email protected].
 

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