US Supreme Court rules isolated DNA is not patent-eligible

In Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (US June 13, 2013), the Supreme Court rejected more than a decade-long practice of issuing patents directed to “isolated” DNA molecules by narrowly holding that such molecules were products of nature that are not patent-eligible. However, the Court also affirmed that some cDNA molecules were patent-eligible. The Supreme Court explicitly did not address patent claims directed to methods, potentially limiting the reach of the decision. Read the CAFC Slip Op. (June 13, 2013).

Background

The case was initiated by a number of plaintiffs—including the Association for Molecular Pathology, medical organizations, and researchers affected by breast cancer testing—that brought suit against Myriad seeking a declaratory judgment that 15 claims from seven patents [1] relating to Breast Cancer Susceptibility Genes 1 and 2 (“BRCA 1/2”) were invalid. The district court ruled against Myriad, holding that all the challenged claims were drawn to patentable-ineligible subject matter under 35 USC. § 101 (“Section 101”). Ass’n for Molecular Pathology v. United States Patent & Trademark Office, 702 F. Supp. 2d 181, 232 (S.D.N.Y. 2010). Myriad appealed and the Federal Circuit overturned the district court decision, ruling that patent claims directed to “isolated DNA,” cDNA, and methods of screening potential cancer therapeutics were all patent-eligible, but upheld the district court’s judgment that certain of Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences were invalid as not patent-eligible. Ass’n for Molecular Pathology v. United States Patent & Trademark Office, 653 F.3d 1329, 1334 (Fed. Cir. 2011). The Supreme Court then granted certiorari and vacated and remanded the Federal Circuit’s decision for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012).

On remand, the Federal Circuit again upheld patent claims directed to “isolated DNA,” cDNA, and methods of screening potential cancer therapeutics, and the Federal Circuit reiterated that certain methods of “comparing” or “analyzing” DNA sequences were invalid as patent-ineligible. Ass’n for Molecular Pathology v. United States Patent & Trademark Office, 689 F.3d 1303, 1309 (Fed. Cir. 2012) (“CAFC Op.”). The Supreme Court granted a writ of certiorari on the question: “Are human genes patentable?” The case involved nine claims from three [2] of the original seven patents.

The Supreme Court decision

The only issue before the Supreme Court was whether claims to isolated genes and cDNA qualified as patent-eligible subject matter under Section 101. The Federal Circuit had held that both were because they possessed “markedly different” structure and function compared to native DNA. CAFC Op. at 1324-33.

The Supreme Court rejected both the Federal Circuit’s analysis regarding isolated DNA as well as the US Patent and Trademark Office’s (USPTO) longstanding policy of recognizing the patent-eligibility of isolated DNA. However, the Court’s holding was narrow: “We merely hold that the genes and the information they encode are not patent-eligible under §101 simply because they have been isolated from the surrounding genetic material.” Ass’n for Molecular Pathology, No. 12-398, slip op. at 18. In reaching its decision, the Supreme Court applied the analytic framework it had provided in Chakrabarty [3] and Funk Brothers [4].

The Court stated that the distinction between a product of nature, which is patent-ineligible, and a human-made invention for purposes of Section 101 turns on whether the invention is “new ‘with markedly different characteristics from any found in nature.’” Id. at 12. The Court also explained that “extensive effort alone is insufficient to satisfy the demands of §101.” Id. at 14. It applied these principles to hold that isolated natural DNA is not patentable because nothing is created: “separating that gene from its surrounding genetic material is not an act of invention.” Id. at 12. The Court’s rejection of the argument that isolated DNA is patent-eligible because it does not exist in nature may lead to some uncertainty about the patent-eligibility standard for non-natural products:

Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. Id. at 14.

The Court then also affirmed the Federal Circuit’s decision that Myriad’s composition claims direct to a cDNA that is “distinct from the DNA from which it was derived” are patent-eligible. Id. at 17. It reasoned that cDNA is not a “product of nature” because cDNA lacks the non-coding regions (introns) found in natural DNA. Id. at 16-17. However, the Court stated that there may be issues with short cDNA that “may be indistinguishable from natural DNA.” Id. at 17.

Significantly, the Supreme Court explicitly noted that no method claims were before the Court. Id. at 17. It further explained that the case did not involve “patents on new applications of knowledge” about genes, and quoted Federal Circuit Judge Bryson’s statement: “As the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge.” Id. at 17.

Justice Scalia’s concurrence in part and concurrence in judgment

In a very short concurring opinion, Justice Scalia agreed with the majority’s judgment but did not join in the Court’s opinion regarding the “fine details of molecular biology.” Ass’n for Molecular Pathology, No. 12-398, slip op. at 1 (Scalia, J. concurring). Justice Scalia explained that his trepidation in fully joining the opinion was due to his inability to, “affirm those details on my own knowledge or even my own belief.” Id. at 1.

Looking forward

The Supreme Court’s holding will be met with mixed feelings by different sectors of the biotechnology industry. Some will welcome the Court’s affirmance that cDNA is patent-eligible, but also disheartened by the narrow ruling that isolated natural DNA is not patent-eligible. Critics of the industry will be disappointed that the Court did not address Myriad’s diagnostic method claims, citing the significant financial burdens on patients and medical laboratories seeking to take advantage of patented genetic tests that are covered by patented methods.

In addition, certain challenges for the biotechnology sector arise from the Court’s reasoning in distinguishing what is patent-eligible from what is not. In particular, it is unclear if the Court’s reasoning that the information (i.e., sequence)—as opposed to the chemical structure—will affect claims to non-DNA molecules (e.g., polypeptides or antibodies). Another question left unanswered is how to distinguish a natural product from a man-made product in light of the Court’s holding that breaking two chemical bonds was insufficient to confer patent-eligibility while breaking multiple bonds across introns was sufficient. Moreover, some may be concerned about the decision’s effects on future innovation in light of the Court’s statement that “extensive effort alone is insufficient to satisfy the demands of §101.” Id. at 13.

Moreover, the Court’s decision did not explicitly indicate which of the specific claims under review were invalid under Section 101. While it seems clear that 1) DNA claims directed to a genomic sequence without any modification are invalid and 2) cDNA claims crossing at least one intron are valid, the challenged Myriad patents contained many other types of composition claims, including single primers, sets of primers, and kits that include primers and instructions. The patent-eligibility of these claims likely depends on whether they are directed to cDNA or genomic DNA, but the Court’s decision may nonetheless be subject to interpretation.

Finally, the impact of this decision will be more significant on previously issued US patents than on future patents, because while there still are novel genes, most human genes are no longer novel. Furthermore, the impact will also depend on whether such patents contained claims that are patent-eligible, such as those directed to cDNAs.

This legal update was prepared by Gina Shishima (gina.shishima@nortonrosefulbright.com / +1 512 536 3081), Mark Thomas Garrett (mark.garrett@nortonrosefulbright.com / +1 512 536 3031) and Sheila Kadura (sheila.kadura@nortonrosefulbright.com / +1 512 536 3027) of Norton Rose Fulbright’s Intellectual Property Practice.

[1] The seven patents at issue in that case were: United States Patent Nos. 5,747,282 (claims 1, 2, 5, 6, 7, and 20); 5,837,492 (claims 1, 6, and 7); 5,693,473 (claim 1); 5,710,001 (claim 1); 5,753,441 (claim 1); and 6,033,857 (claims 1 and 2).
[2] The three patents at issue in this case are: United States Patent Nos. 5,747,282 (claims 1,2, 5, 6, and 7); 5,837,492 (claims 1, 6, and 7); and 5,693,473 (claim 1).
[3] Diamond v. Chakrabarty, 447 U.S. 303 (1980).
[4] Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).