[author: Courtenay C. Brinckerhoff]

Myriad and the ACLU filed their supplemental briefs in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case), addressing the Federal Circuit’s question as to the applicability of the Supreme Court’s decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. to the patent eligibility of Myriad’s isolated DNA claims and method claim 20 of Myriad’s U.S. Patent 5,747,282. While the parties’ positions are predictable, it is interesting to see how they frame the issues.

The Myriad Supplemental Brief

Myriad’s thesis is that the Supreme Court’s decision in Mayo “has no effect” on the Federal Circuit’s previous determination that its isolated DNA claims and method claim 20 are patent-eligible under 35 USC § 101.

With regard to the isolated DNA claims, Myriad emphasizes that Mayo addressed method claims, not product claims. Myriad states further that if Mayo is extrapolated to product claims, the isolated DNA claims would be found to satisfy § 101 because, just like Mayo requires method claims to do “significantly more” than recite a law of nature, the Federal Circuit already found that isolated DNA is “distinctive” in “‘name, character and use’ from anything found in nature.” Myriad also asserts that the isolated DNA claims “do not preempt or monopolize” any “‘basic tools of scientific and technological work.’”

Myriad asks history to repeat itself, analogizing the procedural posture of this case to Chakrabarty. That case was pending review at the Supreme Court when Flook was decided, and the Supreme Court issued a GVR that remanded Chakrabarty to the Federal Circuit in view of Flook. The Federal Circuit determined that its original decision upholding Chakrabarty’s product claims was not affected by the Supreme Court’s treatment of the method claims at issue in Flook, and the Supreme Court ultimately affirmed the Federal Circuit decision upholding the Chakrabarty claims.

Myriad and other amici point out that no appellate court or Supreme Court decision rendered since the enactment of the 1952 Patent Act has invalidated a product claim under the patent eligibility requirement of § 101. Myriad highlights the “human ingenuity” and “human invention” involved in the production of isolated DNA, and the significant new utility of diagnosing an increased risk of breast and ovarian cancers. Myriad emphasizes that the claimed isolated DNA “does not exist in nature” and “cannot be reproduced by nature unaided by man.”

In an attempt to use the Supreme Court’s conflation of § 101 and § 102/§ 103 to its advantage, Myriad discusses secondary considerations of non-obviousness said to further support the “inventiveness” of its claims, such as “commercial success, widespread praise, unexpected results, unsolved needs, and prior art that teaches away.”

With regard to method claim 20, Myriad notes first that it is not properly before the Federal Circuit on remand because it was not the subject of the petition for certiorari. On the merits, Myriad states that this claim “easily survives Mayo” because “it starts not with a ‘law of nature,’ but with a new and useful product of human ingenuity—a transformed cell containing an altered BRCA1 gene—and applies method steps using that invention.”

The ACLU Supplemental Brief

The ACLU brief outlines three principles said to support its position that all of Myriad’s claims are not patent-eligible under § 101:

1. Patent claims that preempt a law of nature or product of nature are not patent-eligible.
2. Patent claims that do not “add enough” to, or that are not “markedly different” from, what is found in nature are not patent-eligible.
3.  The court must decide § 101 issues without regard to the USPTO’s approval of patents or the reliance of industry on the grant of patents.

Applying these principles to Myriad’s isolated DNA claims, the ACLU argues that the isolated DNA claims impermissibly preempt laws of nature, such as the correlation between the DNA sequence and the encoded BRCA1 protein and the correlation between the BRCA1 protein and an increased risk of cancer. The ACLU characterizes the isolation of DNA as “merely mak[ing] visible a person’s inherited genetic makeup.” According to the ACLU, “[t]he point of these claims and the sole use of them by Myriad is to uncover the informational qualities, the laws of nature that they embody.”

The ACLU appears to try to distinguish Chakrabarty by drawing a line between claims directed to “the parts that result from breaking down a naturally-occurring thing” and claims directed to the results of “recombining aspects of nature,” as long as the results are markedly different and do not preempt laws of nature or products of nature.

The ACLU underscores the breadth of the product claims, both with regard to the associated right to exclude others from using the claimed isolated DNA for any purpose and with regard to the scope of claims that encompass shorter sequences. The ACLU asserts that the isolated DNA claims “inhibit the development of more refined and advanced genetic testing” and “pose a barrier to the development of targeted cancer therapies,” because of the FDA’s requirement for a companion diagnostic test.

Turning to the cDNA claims, the ACLU draws on the Justice Breyer’s hypothetical in Mayo and argues that even if human intervention is required to make cDNA, such a “transformation” would not be sufficient if “science develop[s] a method of cleaving a gene’s covalent bonds while the DNA remains in the body.” (Because “science” is working hard on this technology!)

With regard to method claim 20, the ACLU’s arguments are even more extreme:

The process in Claim 20, like those in Mayo “set forth laws of nature”—namely the effect of a drug.

(Such a benchmark would invalidate claims directed to new methods of treatment, which the Supreme Court expressly distinguished from the Prometheus claims at issue in Mayo.)

Permitting both [the Prometheus and Mayo] claims would preempt medical and scientific activity.

(Such a benchmark would invalidate claims directed any “medical” or “scientific” inventions.)

The Supreme Court has held that limited preemption is sufficient to invalidate the claim,

(Given that the fundamental patent right is a right to exclude, such a benchmark could invalidate all patents.)

Answering The Federl Circuit’s Question

It is likely that the Federal Circuit will agree in principal that the Supreme Court’s decision in Mayo does not directly impact the patent eligibility of Myriad’s isolated DNA claims or method claim 20, but still will reconsider the § 101 issues in light of the Supreme Court’s analysis. If the panel concludes that the “markedly different” test is still a valid one, the outcome on remand may depend on whether Judge Moore reads Mayo as undermining her previous consideration of the long-standing USPTO policy of granting claims to isolated DNA and the investment-back expectations of the biotechnology industry, and if, so, whether she decides that the structural and functional differences between isolated DNA and naturally occurring DNA are sufficient to support patent eligibility.