Naturally Occurring Genes Are Not Patentable Even When Isolated from Surrounding Genetic Material

Authored by D. Brian Kacedon, John C. Paul, and Kevin D. Rodkey

The scientific community uses DNA for research, testing, and product development. Discovering genes or genetic mutations that contribute to diseases, such as cancer, can enable pharmaceuticals and test methods. In Association for Molecular Pathology v. Myriad Genetics, Inc.,¹ the Supreme Court held that isolated, naturally occurring DNA sequences are not eligible for patent protection under 35 U.S.C. § 101 simply by virtue of their isolation from the surrounding genetic material. The Court also held, however, that synthetically created molecules known as complementary DNA (cDNA) may be eligible for patent protection as modified, non-naturally occurring DNA, provided they differ in sequence from naturally occurring DNA. This decision may have far-reaching implications for patents claiming isolated DNA molecules and research in the scientific community.

Background

Myriad owns the three patents at issue, each directed to "isolated DNA molecules" relating to the BRCA1 and BRCA2 genes; mutations in those genes can greatly increase a woman's risk of developing breast or ovarian cancer. Myriad's patent included claims directed to the isolated, naturally occurring DNA molecules and claims directed to cDNA, both defined by their sequences.

Eligibility of Isolated, Naturally Occurring DNA Sequences

The Court first considered that natural phenomena are excluded from patentable subject matter and held that naturally occurring DNA molecules are not rendered eligible for patent protection when isolated from surrounding portions of DNA. In particular, the Court stated that "Myriad did not create or alter any of the genetic information encoded in the . . . genes" and did not create or alter the structure of the DNA itself. Slip op. at 11-12. Rather, Myriad discovered the precise location of the genes at issue and isolated those particular portions of the DNA. The Court framed the issue as whether this act of isolation renders the isolated gene eligible for patent protection.

Distinguishing Myriad's claims to the genetically modified bacterium of Diamond v. Chakrabarty,² the Court stated that "Myriad did not create anything," but instead merely separated the gene from its surrounding material. Slip op. at 12. Although the Court characterized Myriad's discovery as "important and useful," it concluded that isolating the gene from the surrounding genetic material "is not an act of invention." Id.

Discovery alone, the Court noted, does not necessarily satisfy the § 101 eligibility inquiry. The Court compared Myriad's discovery to the composition of naturally occurring bacterial strains in Funk Brothers Seed Co. v. Kalo Inoculant Co.³ There, the patentee claimed a combination of bacterial strains but did not alter the bacteria in any way. Therefore, the claims were not eligible for patent protection. The Court determined that Myriad's claims to isolated, naturally occurring DNA resembled the Funk Brothers claims. Although Myriad discovered the location of the claimed BRCA1 and BRCA2 genes, the discovery itself did not make the genes patent-eligible under § 101. The Court also highlighted the fact that Myriad's specification described an extensive, iterative process to determine the location of the claimed genes. But it concluded that extensive effort alone does not satisfy § 101.

The Court then rejected Myriad's argument that isolating the DNA creates a new composition of matter by severing the chemical bonds of the natural genome to create a synthesized molecule. Here, it reasoned, Myriad's claims did not rely on chemical changes resulting from the isolation step and instead focused on the information in the specific genetic sequences.

The Court also rejected Myriad's argument for deference to the USPTO's practice of awarding patents for isolated DNA sequences. The Court stated that Congress had not endorsed the USPTO's views regarding patent eligibility of isolated DNA. Unlike plant patents, where Congress specifically enacted amendments regarding the patentability of plants, here Congress remained silent. The Court concluded that the USPTO's practice was not a sufficient reason to hold that isolated, naturally occurring DNA is patent-eligible under § 101. Lastly, the Court rejected Myriad's argument that it should avoid disturbing the reliance interests of patent holders, because "insofar as they are relevant," such concerns "are better directed to Congress."

Eligibility of Isolated cDNA Sequences

In contrast to isolated portions of naturally occurring DNA, the Court held that cDNA can be eligible for patent protection under § 101 because the creation of cDNA results in a molecule that does not naturally occur. Specifically, the Court noted, cDNA differs from naturally occurring DNA because certain noncoding regions are removed when creating the cDNA. Therefore, the "lab technician unquestionably creates something new when cDNA is made." Slip op. at 17. Although cDNA contains naturally occurring genetic sequences, it differs from the DNA used to derive it. The Court concluded that this distinction renders cDNA eligible for patent protection under § 101.

Regarding cDNA, the Court did make special mention of short-strand cDNA, which may not differ from the corresponding sequence of naturally occurring DNA, notwithstanding that the cDNA is a synthesized molecule. The Court reinforced that the key is whether the patent claim seeks to protect a naturally occurring sequence.

Situations Not Implicated by the Myriad Decision

The Court identified some situations not implicated by its decision. First, it did not decide the patent eligibility of any method claim. Second, the case did not involve new applications of knowledge about the genes at issue, and Myriad's claims relating to applications of the genes were not at issue in this case. Last, the Court did not consider the patent eligibility of DNA where the naturally occurring nucleotide sequences have been altered.

Summarizing its holding, the Court stated, "[G]enes and the information they encode are not patent-eligible under § 101 simply because they have been isolated from the surrounding genetic material." Id. at 18.

Strategy and Conclusion

The Myriad decision is significant because it prevents patenting isolated, naturally occurring DNA sequences, while indicating that some isolated and modified forms of DNA—such as cDNA—may be eligible for patent protection, thus providing encouragement for biotech companies. Although the effect of Myriad decision on scientific research and innovation remains to be seen, it may prompt patent owners to review claims relating to isolated DNA and other related inventions, and consider whether to modify pending or issued claims in light of the Court's decision.

Endnotes

¹ The Myriad opinion can be found at http://www.finnegan.com/files/upload/Association%20For%20Molecular%20Pathology%20v%20Myriad%20Genetics.pdf.

² The Diamond v. Chakrabarty opinion can be found at http://scholar.google.com/scholar_case?case=3095713882675765791.

³ The Funk Brothers opinion can be found at http://scholar.google.com/scholar_case?case=15445131955420619562.

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