United States: Are Human Genes Patentable?

The Supreme Court has long held that laws of nature, natural phenomenon, and abstract ideas are not patent eligible under 35 U.S.C. § 101. See, e.g., Diamond v. Diehr, 450 U.S. 175 (1981); Diamond v. Chakrabarty, 447 U.S. 303 (1980). Since 2010, the Supreme Court has twice more considered this issue, both times reversing the Federal Circuit. Mayo Collaborative Serv. v. Prometheus, Inc. 132 S. Ct. 1289 (2012) (a method of optimizing the efficacy of a drug is an unpatentable law of nature); Bilski v. Kappos 130 S. Ct. 3218 (2010) (a method of hedging risk in trading commodities constitutes an unpatentable abstract idea). On April 15th, the Supreme Court will hear yet another case concerning patent eligible subject matter, this time on an issue of great importance to the biotechnology industry; namely, the patentability of human genes. Ass'n for Molecular Pathology v. Myriad Genetics, Inc., U.S. No 12-398, (Nov. 30, 2012).

The claims at issue involve two genes known as BRCA1 and BRCA2. The Myriad inventors discovered that mutations in these genes are associated with a predisposition to breast and ovarian cancers. Women having BRCA mutations are said to have a cumulative risk of fifty (50%) to eighty (80%) percent of developing breast cancer and a cumulative risk of twenty (20%) to fifty (50%) percent of developing ovarian cancer. The discovery of these gene mutations and methods of diagnosing them are of paramount importance to millions of women.

The gene claims in the disputed patents are of two types: claims directed to "isolated" DNA encompassing full-length or genomic DNA sequences that are identical to the naturally-occurring BRCA1 and BRCA2 genes, and claims to shorter "isolated" DNA sequences including cDNA sequences as well as DNA fragments as small as fifteen (15) nucleotides.

In the District Court, Judge Sweet ruled that the "isolated" DNA sequences were unpatentable "products of nature." Ass'n for Molecular Pathology v. U.S.P.T.O., 702 F. Supp. 2d 181 (S.D.N.Y. 2010). Myriad appealed to the Federal Circuit, arguing, inter alia, that DNA isolated from the human body "differs markedly" from naturally-occurring DNA and that, unlike native DNA, the isolated BRCA DNA can be used for other purposes such as probes for diagnosing cancer. Ass'n for Molecular Pathology v. U.S.P.T.O. 653 F. 3d 1329 (Fed. Cir. 2011) (Myriad I).

Writing for the majority, Judge Lourie held that "isolated" BRCA1 and BRCA2 DNAs differ in chemical nature from BRCA DNA as it exists in the human body. Judge Lourie pointed out that in the natural state, the BRCA genes exist on chromosomes surrounded by other proteins such as histones. According to Judge Lourie, in order to isolate DNA from its native environment, covalent bonds between the DNA and the proteins which surround it, and the covalent bonds within the chromosomal backbone itself, must be broken. In his opinion, the cleavage of these covalent bonds constitute a chemical manipulation that require human intervention and result in a new, chemically distinct composition. Using this analysis, he found that both the full-length DNA sequences and the shorter 15 nucleotide fragments were not products of nature and thus patentable under §101.

With respect to the claims to cDNA sequences, Judge Lourie found that these were directed to non-naturally occurring man-made DNAs lacking the non-coding sequences (introns) present in the native BRCA genes. Accordingly, he concluded that they, too, were patent eligible.

Judge Lourie also noted that the USPTO has issued patents directed to human genes for over thirty (30) years. He argued that it was up to Congress, not the courts, to change the status quo by passing legislation to exempt DNA inventions as statutory subject matter under § 101.

Judge Lourie's fellow panel member, Judge Moore, concurred, but for different reasons.

Judge Bryson dissented, arguing that "breaking covalent bonds or isolating a gene from its natural setting does not turn DNA into a human-made invention any more than plucking a leaf from a tree would convert it [the leaf] into a man-made composition."

The ACLU filed a petition for certiorari which the Supreme Court granted. Rather than hearing the case, the Court vacated the Federal Circuit's decision and remanded for further consideration in light their concurrent decision in Mayo Collaborative Serv. v. Prometheus Laboratories, Inc. On remand, the Federal Circuit maintained its earlier position.

The Supreme Court has now twice granted certiorari for Myriad, and presumably is eager to weigh in on this issue. There is no end to the speculation on how it might rule. It is indisputable that the claims directed to full-length BRCA nucleotide sequences, and smaller fragments thereof, are identical to naturally-occurring DNA sequences. The question is whether the Court will agree with the Federal Circuit that DNA in its natural state differs chemically from "isolated" DNA.

Without doubt, a finding by the Court that human genes are products of nature and, therefore, not patent eligible, would have a devastating impact on the biotech community. The biotech industry was spawned with the advent of recombinant DNA technology in the early 1980s. As a result, treatments, diagnostic assays, and gene therapies have been developed for countless diseases and disorders. Absent patent protection, innovation in scientific fields that rely on the discovery and use of DNA would arguably come to a halt because there would be less incentive to invest in these areas.

Consequently, it may be that Court will punt and, like Judge Lourie, find that the USPTO has issued patents on human genes for so long that, absent Congressional action, this practice should not be disturbed by the courts.

However, should the Court decide that human genes are not patent eligible, patent prosecutors should not despair. Methods of using a known product in a novel manner would still be patentable, as are methods that incorporate a law of nature; provided the method does not preempt all uses of the law itself. While many commentators have argued that diagnostic methods are no longer patentable in view of Prometheus, this is not necessarily the case. In Prometheus, the Court specifically reiterated its position that "a process is not unpatentable simply because it contains a law of nature or a mathematical algorithm." (Citing Diamond v. Diehr, 450 U.S. at 187.)

It is important to note that the Myriad patents include claims directed to methods of using the isolated DNA sequences to screen for potential therapeutic agents that the Federal Circuit held were patent eligible. The Supreme Court denied cert. on this issue. This would seem to send a strong signal that, if properly written, methods of using novel human DNA sequences will continue to be patent eligible even if the Court holds that sequences themselves are not.

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