ACLU "Gene Patenting" Case Argued at Federal Circuit

23 July 2012 Personalized Medicine Bulletin Blog

On July 20th, 2012, the parties in the Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 10-1406 (Fed. Cir. 2011)(also known as the “ACLU gene patenting” case) argued (again) before the Federal Circuit. Recall, the U.S. Supreme Court had asked the court to reconsider its prior ruling as to the patent-eligibility of claims to isolated DNA, in light of its unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct. 2012) (“Mayo”). In Mayo, the U.S. Supreme Court held that that certain diagnostic inventions cannot be patented under 35 USC Secion 101 because they effectively claim a law of nature.

Federal Circuit Judges Lourie, Bryson and Moore led the discussion regarding the relevance of Mayo to the claims at issue in this case. Myriad Genetics, Inc. (“Myriad”), The Association for Molecular Pathology (“AMP”) and the U.S. government (“government”) presented arguments which can be accessed here.

The Federal Circuit’s Prior Myriad Decision

A discussion and review of the panel’s prior decision is found in our July 29th, 2011 post. Briefly, the Federal Circuit previously held all “isolated DNA” claims were patent-eligible as well as a screening claim. Representative isolated DNA claims are as follows:

1. An isolated DNA coding for a BRCA 1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO: 1.

5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

Screening claim 20, much discussed during oral argument, provides:

20. A method for screening potential cancer therapeutics which comprises:

 a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic,

growing siad transformed eukaryotic host cell in the absence of said compound,

determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells,

wherein a slower rate of growth of said host cell in the presence of said compound in indicative of a cancer therapeutic. 

Judge Lourie, writing for the panel in 2011 noted that “isolated DNA” claims were patent-eligible because the claims do not claim a composition found in nature. In determining the question of patent-eligibility, the court noted that one must consider whether “human intervention has given ‘markedly different,’ or ‘distinctive,’ characteristics” to the composition. The court also discussed how isolated DNAs exist in a distinctive chemical form, i.e., as distinctive chemical molecules, as compared to DNA in the body. The court explained that:

“In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.”

Judges Moore and Bryson authored separate opinions regarding patent-eligibility of isolated genomic DNA composition claims, with Judge Moore concurring on additional grounds and Judge Bryson dissenting.

Although Judge Moore agreed that all isolated DNA claims recited patent-eligible subject matter, she wrote separately to express her views that prior U.S. Supreme Court precedent do not stake out the exact bounds of patentable subject matter. Instead, she opined, each applies a flexible test…” She also suggested that the fact that a claimed DNA is not a product of nature by itself does not make it so “markedly different” as to satisfy Section 101. Rather, one should consider whether chemical differences impart a new and significant utility, i.e., “markedly different” characteristics/properties.  Under this test, she found claims directed to cDNA or isolated genomic DNA short fragments to be patent-eligible, while claims encompassing the isolated full-length gene were “a much closer call.”  Ultimately, Judge Moore was persuaded by Congress’ and the U.S. Patent Office’s long-standing authorization of an expansive scope of patentable subject matter, as well as the fact that Congress has remained silent on this issue.

The Arguments

Myriad’s Argument

Myriad presented first and began by arguing that the DNA composition claims were patent-eligible even after Mayo, because of the human ingenuity required to characterize and isolate the DNA sequences found in the human body. Isolated DNA are therefore products of human ingenuity and man-made. Myriad noted that its position was consistent with the test laid out in Diamond v. Chakrabarty and Mayo did not change that. Myriad stated that the plaintiffs’ and to some extent the government’s arguments did not address the application of the Chakrabarty test, but rather focused on a “preemption test”. Myriad stated that preemption is not a separate test of patent-eligibility but rather a proxy for whether or not there has been an invention.

Surprisingly, the panel took the discussion to claim 20 which was stated to be the closest in relevance to Mayo. Myriad remarked that claim 20 was clearly patent-eligible because it utilized a man-made composition of matter – the transformed eukaryotic host cell containing an altered BRCA 1 gene causing cancer. Myriad also took the position (which Judge Bryson strongly criticized) that claim 20 was no longer in the case because it was not appealed to the Supreme Court.

AMP’s Position

Chris Hansen of the American Civil Liberties Union (“ACLU”) argued on behalf of AMP. He started with the alleged preemptive scope of the isolated DNA claims, noting that the claims cover genomic DNA, cDNA, synthetic DNA, methylated DNA and non-methylated DNA. Judge Lourie noted that breadth is a Section 112 issue, not a Section 101 issue and later asked if Mayo was relevant to the composition claims. AMP implied it was because the product of nature doctrine is to ensure that natural things and laws are available to all mankind, whether the claim is a composition or a method. Judge Moore strongly stated that this point undermines AMP’s  preemption argument, because Mayo made it clear that breadth is irrelevant for a 101 determination. She interpreted the Mayo decision as stating that premption has no relevance to patent-eligibility because there is a bright line prohibiting the patenting of claims covering laws of nature regardless whether the claim preempts future research.

With respect to screening claim 20, the claim was argued to be ineligible because there was no invention in the claim – Myriad just calls up and orders the cell used in the claim off the shelf. Judge Lourie questioned if what Myriad had done with claim 20  - wasn’t that “something more” than a law of nature? Judge Moore questioned if the cell wasn’t found in nature, how was it not patent-eligible?

The panel then focused on the patentability of a composition versus the use of the composition. AMP argued that administering a man-made drug to the human body clearly is not patent-eligible subject matter under Mayo. It also argued that under Mayo, in terms of method claims, it doesn’t matter if the drug being administered is man-made or not. Administering a drug and looking to see what happens is unpatentable under Mayo. The drug may or may not be patentable depending on the degree to which the drug is markedly different from that found in nature but administering the drug as a method is “clearly not patentable.” After probing by the judges, AMP clarified that its position was that if the drug was known, then a method that merely compared the efficacy of the drug against another agent was not patentable.

The U.S. Government’s Argument

The U.S. government, represented by the Office of the Solicitor General (and not the U.S. Patent and Trademark Office), argued that the isolated DNA claims are not patent-eligible because the changes rendered by isolation are insufficient to make it a human invention. The government acknowledged that Mayo dealt with process claims while the DNA claims are composition claims, but that nonetheless, the eligibility of the claims all come from the same exception - ”the stuff that’s supposed to be free to all mankind” covers not only laws of nature but also products of nature. The government explained that the same concerns as expressed in Mayo as to laws of nature are relevant to the composition claims and urged the application of a preemptive-type test, stating that the question is whether the claim still allows the public to get and exploit the technology. The government argued that as a general rule, when the only changes that have been made to a product are those incidental to its extraction, you will always have a preemption problem. Extraction, the government opined, is necessary to study and use the natural properties of the product. 

Judge Moore asked how to address the settled property rights of those in the biotechnology industry that have relied on these patents in the past. The government urged that such concerns should not be taken into account in deciding the issues in this case, pointing to the thousands of patents that were invalidated under the U.S. Supreme Court’s Bilski decision.

Judge Moore also asked questioned the patent-eligibility of the primers and probes. The government answered that these claims were so broad so as to preempt another from making a new primer or probe and therefore are not patent-eligible. Moreover, the additional utility of the primers and probes depend on the inherent properties of DNA to bind to complements which distinguishes these claims from those at issue in Chakrabarty. In Chakrabarty, the government explained, the microorganisms in nature did not have the ability to break down crude oil. Judge Moore disagreed, noting that DNA in the body cannot act as a primer or probe. The government countered that the question is whether you give the composition its new utility, not whether you exploit it.

Myriad’s Rebuttal

Myriad returned to screening claim 20 and pointed out that Mayo made clear that use of a drug, even an old drug in a new way is patent-eligible. This is similar to claim 20 because the BRAC 1 gene that is inserted into the eukaryotic cell is not taken off the shelf.

With respect to the composition claims, Myriad reiterated that the claims are patent-eligible because of the inventor’s contribution to select the DNA for isolation. Judge Bryson then turned the discussion to an analogy of removing a kidney from a patient, and whether the isolated kidney would be patent-eligible if the inventor had determined where best to cut for successful isolation. Myriad opined that much more is involved in isolating DNA than deciding where to cut a kidney. Judge Lourie interjected that a kidney is an organ, not a well-defined chemical composition as is isolated DNA.

With respect to the government’s argument that you need to isolate DNA to study it, Myriad countered that this argument is not supported by the science because whole genome sequencing does not rely on isolation of the DNA.

Myriad also tried to answer Judge Moore’s concerns regarding settled property rights that she raised during the government’s argument. Judge Moore instead urged Myriad to spend more time on their arguments that the isolated DNA claims are patent-eligible because the inventors “decided where to make the cuts.” Myriad replied more was required than deciding where to make the cuts. Judge Lourie questioned if this line of reasoning didn’t sound more like obviousness than patent-eligibility.

Reading Tea Leaves

I wish I had a crystal ball or tea leaves to predict how the Federal Circuit might rule in this case. Two possible outcomes would essentially maintain the status quo. The first possible scenario is for the court to merely reiterate with modified reasoning that the claims are still patent-eligible. The second scenario is to narrowly apply Mayo as relevant to claim 20 only, a claim the panel appears to agree is most similar to the issue decided by in Mayo.  Even under Mayo, claim 20 is likely patentable because the transformed cell is not a product of nature or isolated from it. 

The third scenario would remove the economic incentives and the proven business model that built the biotechnology industry. The Federal Circuit could draft a new test for patent-eligibility that follows AMP’s and the government’s preemptive test thereby holding that isolated DNA is not patent-eligible.



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