The Supreme Court has issued a long-awaited opinion on the patentability of isolated DNA molecules, unanimously holding that genomic DNA molecules are not patent eligible, while also affirming that patent protection may be available for modified DNA molecules, including complementary DNA generated by reverse transcription of RNA templates (cDNA). While the ruling continues a recent trend narrowing the scope of patentable subject matter, and disallows patenting of naturally-occurring sequences, it brings additional certainty to industry and affirms that methods of making and using isolated DNA remain patent eligible.
The Court’s decision involved three patents held by Myriad Genetics covering DNA sequences encoding the BRCA1 and BRCA2 genes. Mutations in these genes are associated with an increased risk of breast and ovarian cancers. The disputed patent claims cover “isolated DNA” coding for BRCA1 or BRCA2 polypeptides, and specify in some instances that the isolated DNA comprises certain sequences corresponding to genomic DNA. Other disputed claims cover synthetic cDNA, which includes only portions complementary to genomic sequences encoding mature mRNA sequences (exons), and excludes those sequences that do not (introns). Myriad’s patent specifications detail the process of genetic and physical mapping of the BRCA1 and BRCA2 loci and the subsequent cloning of the genomic DNA and the cDNA. In its opinion, the Court noted that, if valid, Myriad’s patents would give it exclusive rights over the isolation of an individual’s BRCA1 and BRCA2 genes as necessary for genetic testing, as well as the exclusive right to create synthetic cDNA.
Section 101 of Title 35 of the United States Code permits patents on new or improved processes, machines, articles of manufacture, or compositions. Courts, however, have long held that patent protection cannot be obtained for so-called products of nature. Thus the key issue in Myriad was whether isolated genomic DNA or cDNA molecules are somehow distinct from naturally occurring DNA.
The petitioners initially sought and won a declaratory judgment invalidating Myriad’s patents as directed to products of nature. On appeal, the U.S. Court of Appeals for the Federal Circuit reversed, finding the claimed subject matter patentable. The Supreme Court granted certiorari and remanded to the Federal Circuit for reconsideration in view of its 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In Mayo, the Supreme Court held that, in order to be patent-eligible, a method claim involving the application of a natural law must include an “‘inventive concept’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.” On remand in Myriad, a divided Federal Circuit panel once again held that both isolated genomic DNA and cDNA were patent eligible, with Judge Bryson dissenting as to the patentability of isolated genomic DNA.
In upholding the patentability of Myriad’s DNA claims, the Federal Circuit majority had reasoned that isolated DNA molecules differ from naturally occurring genomic DNA because DNA isolation relies on cleavage of covalent bonds at the ends of the isolated DNA molecule. However, Justice Thomas, writing for a unanimous Supreme Court, found this distinction unpersuasive, noting that the claims were directed to specific sequences rather than chemical compositions, that some of the claimed molecules had sequences identical to genomic DNA, and that “[t]he location and order of the nucleotides existed in nature before Myriad found them.” “[S]eparating [a] gene from its surrounding genetic material is not an act of invention,” Justice Thomas concluded. “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”
The Court drew an important distinction between genomic DNA and cDNA for purposes of patent eligibility. It reasoned that cDNA comprising sequences from multiple exons “is distinct from the DNA from which it was derived,” and therefore not a product of nature. cDNA therefore “is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.”
The Court was also careful to clarify that its decision did not address the patentability of methods involving genomic DNA, modified DNA, or “applications of knowledge about the BRCA1 and BRCA2 genes.” Additionally, while noting that claims directed to the chemical composition of isolated DNA rather than the genetic information encoded therein might be acceptable, the Court acknowledged the ease with which such claims could be designed around.
In reaching its conclusion, the Court emphasized the importance of balancing between “creating incentives that lead to creation, invention, and discovery,” and “impeding the flow of information that might permit, indeed spur, innovation.” In this case, the Court reasoned, patents on isolated DNA sequences would “tie up” the use of such tools and “thereby inhibit future innovation premised upon them.”
Myriad resolves a long-standing question over the patent-eligibility of DNA. While the Court found isolated genomic DNA not to be patent eligible, it placed the patent eligibility of cDNA on a firm legal footing, subject to an important exception: short DNA molecules comprising sequences from a single exon, or which are otherwise identical to naturally occurring DNA sequences are products of nature that are ineligible for patent protection. In narrowing the availability of patent protection for certain DNA molecules, the Court has again underscored the principle that discoveries arising from research into basic mechanisms of disease and the genes associated therewith are not necessarily patentable.
Going forward, claim coverage may be harder to obtain for some nucleic acid compositions, particularly primers, probes and other polynucleotides which have high degrees of homology to naturally-occurring sequences. Innovative companies may wish to re-calibrate their claiming strategies to target patent-eligible modifications and applications of such sequences. At the same time, many issued patent claims reading on naturally-occurring DNA sequences may now be subject to invalidity arguments, and companies may wish to re-evaluate their own portfolios as well as those of competitors.
This article was originally published by Bingham McCutchen LLP.