My Myriad Nightmare

23 March 2012 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

Now that the Supreme Court has issued its unanimous decision reversing the Federal Circuit decision in Prometheus, it is expected to decide the petition for certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), as early as Monday (March 26). Many are predicting that the Court will issue a “GVR” to grant certiorari only to vacate the Federal Circuit decision that upheld the patent-eligibility of Myriad’s “isolated DNA” claims, and remand the case to the Federal Circuit for rehearing in view of Prometheus. As I try to understand how the Supreme Court’s decision that Prometheus’ method claims do not satisfy 35 § USC 101 because they “effectively claim underlying laws of nature” would impact the Federal Circuit’s decision that Myriad’s isolated DNA claims satisfy 35 § USC 101 because they “cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature,” I am frightened by a line of reasoning that could undermine the patent-eligibility of a host of pharmaceutical and biological products.  

Law of Nature vs. Product of Nature

The case law surrounding the patent-eligibility requirements of 35 USC § 101 has developed different paradigms for evaluating whether a method claim impermissibly preempts a law of nature or whether a product claim impermissibly claims a product of nature. This is why the Supreme Court’s decision in Prometheus may not necessarily impact the Federal Circuit’s decision in Myriad. On the other hand, if the Supreme Court issues a GVR in Myriad, it might be signaling that it believes that the analysis is not so different after all.

Man-Made = Patent-Eligible

Until this week, I figured that even in a “worst-case-scenario,” if the Supreme Court finds that Myriad’s isolated DNA claims do not satisfy § 101 because they are too similar to a product of nature, innovators in this field could obtain claims to compositions that include isolated DNA and other components. Such a composition certainly would qualify as something that is “made by man,” and so eligible for patenting according to the Supreme Court’s 1980 decision in Diamond v. Chakrabarty

The “Unconventional” Hurdle

But what if the Court applies its Prometheus analysis to composition claims?

What if the Court requires composition claims to contain other elements that are not “well-understood, routine, [or] conventional?”

What if the Court finds that a composition comprising an isolated product of nature and a pharmaceutically acceptable carrier does not satisfy § 101 because pharmaceutically acceptable carriers are not only well-known but ubiquitous in the field?

What if the Court finds that adding water or saline or a buffer to isolated DNA claims does not “add enough” to transform the claims into patent-eligible subject matter?

The Monster Under The Bed

I might take comfort in Supreme Court precedent if this body of law did not include the 1948 Supreme Court decision in Funk Bros. Seed Co. v. Kalo Inoculant Co. The patent at issue in Funk Brothers 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 commentators have debated whether it was decided on principles analogous to today’s § 101 jurisprudence or to today’s § 102/103 jurisprudence.

Judge Dyk cited Funk Brothers in his dissenting opinion in Intervet Inc. v. Merial Ltd., where he read the case in concert with Chakrabarty 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 that the district court applied when it invalidated Myriad’s claims, and Judge Dyk cited it to question whether Merial’s isolated DNA claims satisfied § 101, because he found it doubtful that an “‘isolated’ DNA sequence is qualitatively different from the product occurring in nature.”

Will the Federal Circuit shine a flashlight to scare this monster away?

Judge Dyk is feeding this monster under the bed, so we will have to look to other judges to scare Funk Brothers away from these types of claims. Judge Bryson dissented from the decision in Myriad, and so may help Judge Dyk keep Funk Brothers comfortable. Judge Moore concurred in the Myriad decision, but did not necessarily agree with the rationale, so she might not save her flashlight batteries for this case. Chief Judge Rader, Judge Lourie, and Judge Newman are likely to want to get rid of this monster, but we have less insight into how Judge Linn, Judge Prost, Judge O’Malley, Judge Reyna, or Judge Wallach might react.

Will they shine a flashlight that dispels my fears, or will they leave Funk Brothers lurking under the bed?

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