Association for Molecular Pathology v. PTO, No. 2010-1406 (Fed. Cir. July 29, 2011) (Judges Lourie, Moore, and Bryson)

Hard Questions

This case is a biggie, because the issue is whether DNA sequences isolated from the human body can be patented. (The PTO is in the caption because it intervened. Myriad Genetics, Inc., is the original defendant, so the case is commonly referred to as “Myriad.”)  Many people have strong opinions on this question.

Myriad owns patents on isolated DNA sequences for the BRCA genes. Patients who have mutations in these genes have a higher risk of breast and ovarian cancer. Myriad also holds patents on diagnostic methods of testing for those mutations using DNA sequences. Since the late 90s, Myriad has actively enforced its patents, refusing to allow any clinical BRCA testing by other companies. Myriad is the only one who provides BRCA genetic testing in the U.S.

This suit was a declaratory judgment action brought by researchers wishing to do this testing. The researchers believe that the DNA sequences and the methods of testing using them are not patentable. The district court agreed with the researchers, and Myriad appealed that decision to the Federal Circuit.

Different Answers

The court struggled with the patentability issue, and each judge had a different take on it. The three opinions are quite different in their approaches. Judges Lourie and Moore agreed that isolated DNA sequences found in nature (that is, DNA that has been extracted from a living cell) are patentable, but they did not agree on why that is the case. Judge Bryson thought it was not patentable.

The big point of contention is whether DNA should be thought of as a chemical compound or as a way of storing information.

Judge Lourie, writing for the court, believes that genes should be defined by their chemical structures, rather than their functions. The process of isolating DNA changes its chemical structure, because the isolated molecule is only a fraction of the size of the original chromosome. For Judge Lourie, the fact that isolated DNA is a new chemical entity that is created by humans means that it is patentable.

Judge Moore agreed it’s patentable, but did not agree with Judge Lourie’s reasoning. Judge Moore, focusing on the Supreme Court’s guidance in Diamond v. Chakrabarty, 447 U.S. 303 (1980), feels that the correct approach is to determine whether the isolated DNA sequences “have markedly different characteristics with the potential for significant utility … as compared to nature.” Slip op. at 7 (Moore, J. concurring-in-part). By that standard, short isolated sequences are patent-eligible because they can be used in a number of different ways, such as in diagnostic screening tests designed to detect gene mutations, while the original gene cannot do so.

Claims to longer sequences, including the gene itself, are a problem under Judge Moore’s standard. As she notes, they may not have any new uses. She wrote that, “Whether an isolated gene is patentable subject matter depends on how much weight is allocated to the different structure as compared to the similarity of the function to nature.” Slip op. at 18 (Moore, J. concurring-in-part). She concedes that under the “new utility” standard, an isolated DNA sequence that includes an entire gene (or most of a gene) would probably not be patentable. (Judge Moore concurred in the patent-eligibility of longer sequences based on her policy concerns discussed below.)

Judge Bryson disagreed that DNA sequences found in nature should be patentable. He views DNA as a vehicle to encode information. Because the sequence is the same whether a gene is isolated or in a human body, it is not patentable. He analogizes extracting a gene to “snapping a leaf from a tree.” “[N]ature has defined the genes as independent entities by virtue of their capacity for protein synthesis and, ultimately, trait inheritance.” Slip op. at 11 (Bryson, J. concurring-in-part and dissenting-in-part). Judge Bryson believes that the chemical differences are irrelevant, because the gene is still the gene.

In light of the serious split, this issue seems like a strong candidate for review by either the Federal Circuit sitting en banc or the Supreme Court.

Myriad’s Patents

All three members of the panel agreed on a few issues. First, they agreed that a single plaintiff, Dr. Ostrer, had standing to bring this case. Dr. Ostrer stated “unequivocally” that he would begin research using the BRCA gene if Myriad’s patents were invalidated. The other plaintiffs were non-committal, expressing only an interest in BRCA-based research. Those plaintiffs did not have standing to sue Myriad.

There was a little controversy on standing that boiled up just before the Federal Circuit’s opinion issued. Dr. Ostrer is apparently leaving his post at NYU at the end of August and moving to a job with the Albert Einstein College of Medicine and Montefiore Medical Center. On July 27, just two days before the opinion issued, Myriad’s counsel sent a letter to the court, informing it of the job change. The letter asserted that the Albert Einstein College of Medicine lacks the ability to offer clinical genetic testing, and therefore Dr. Ostrer now lacks standing—he would be unable to perform clinical testing with the BRCA gene. The ACLU responded on behalf of Dr. Ostrer, writing that the Montefiore Medical Center has the same capability to do BRCA sequencing as NYU, and that Dr. Ostrer still “continues to wish to engage in the sequencing.” Given that Dr. Ostrer is the only plaintiff found to have standing, this issue will probably come up again.

The entire Federal Circuit panel also agreed that cDNA, which is a much shorter chain of nucleotides that removes extraneous information (called introns) from the gene, is patentable. cDNA must be created in a laboratory, and it has other uses, so it meets any test of patent-eligibility. So cDNA claims are safe.

Lastly, the entire panel agreed on the patent-eligibility of Myriad’s method claims. The court applied the machine-or-transformation test from In re Bilski, 545 F.3d 943 (Fed. Cir. 2008). Myriad’s method claims that involve comparing one BRCA sequence to another were not patentable, because they claimed only abstract mental processes of “comparing” and “analyzing.” In contrast, Myriad’s method claim that includes steps of growing modified host cells before comparing growth rates was patent eligible. The modification of the cells is a transformation, as the diagnostic methods in Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347 (Fed. Cir. 2010) are patentable. (Cert has been granted in Prometheus, and opening briefs are due on September 2.)

Moving the Legal Standard for An Entire Industry

Judge Moore is quite concerned about the fact that an entire industry has been built on the expectation that DNA sequences are patentable. She notes that thousands of patents have been issued on DNA sequences, and the PTO has been issuing them for decades. As a policy matter, in her view, Congress should be the institution to change the status quo and determine that DNA sequences are unpatentable.

In a twist, the Solicitor General actually argued that DNA sequences found in nature should not be patentable, even though that is not the current policy of the PTO. But despite this position, Judge Moore is still unwilling to carve out such an exception. “The patents in this case might well deserve to be excluded from the patent system, but that is a debate for Congress to resolve.” Slip op. at 31 (Moore, J. concurring-in-part).

Judge Bryson, however, feels that the PTO’s position isn’t entitled to deference, because it doesn’t have substantive rule-making authority. As he noted, the Supreme Court has previously held that long-standing practices of the PTO were incorrect.

These three opinions clock in at around 100 pages, so Myriad is a hefty read. But all three opinions express very different and reasonable approaches to a difficult question. If you have a little time, they’re worth reading.

 

 

 

 

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