In Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (US June 13, 2013), the U.S. 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 U.S. Supreme Court also affirmed that some cDNA molecules were patent-eligible. The U.S. Supreme Court explicitly did not address patent claims directed to methods, potentially limiting the reach of the decision.
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 patents1 relating to Breast Cancer Susceptibility Genes 1 and 2 (“BRCA 1/2”) were invalid. The U.S. 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 U.S. 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 U.S. 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 U. S. 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 U.S. Federal Circuit again upheld patent claims directed to “isolated DNA,” cDNA, and methods of screening potential cancer therapeutics, and the U.S. 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 U.S. Supreme Court granted a writ of certiorari on the question: “Are human genes patentable?” The case involved nine claims from three2 of the original seven patents.
The Supreme Court decision
The only issue before the U.S. Supreme Court was whether claims to isolated genes and cDNA qualified as patent-eligible subject matter under Section 101.
The U.S. Supreme Court rejected both the U.S. 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.
The U.S. Supreme 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.
The Court then also affirmed the U.S. 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 U.S. 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.
Certain challenges for the biotechnology sector arise from the U.S. Supreme Court’s reasoning in distinguishing what is patent-eligible from what is not. In particular, it is unclear if the U.S. Supreme Court’s focus on the information (i.e., sequence)—as opposed to the chemical structure—of a DNA molecule 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, 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 U.S. Supreme Court’s decision may nonetheless be subject to interpretation.
Situation in Europe and Canada
In 1998, the European Union adopted directive 98/44/EC (the Directive on the legal protection of biotechnological inventions) which harmonized legislation in regards to biological patents. It allows for the patenting of natural biological products, including polypeptides, nucleic acid sequences in as much a credible function of these is disclosed in the patent. In Canada, claims to isolated molecules such as isolated DNA are allowed by the Canadian Intellectual Property Office.
There is no jurisprudence in Canada pertaining to the patentability of genetic materials, only guidelines implemented by the Patent Office. It will be very interesting to see if the patentability of genes and isolated DNA will be contested in a Canadian Court in the future following the U.S. Court’s findings in Myriad given the similarity of the definition of “invention” in section 2 of the Canadian Patent Act to the relevant provisions of the U.S. statute.