The U.S. Supreme Court dealt a blow to biotechnology companies with its ruling today in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. The question before the Court was whether isolation of naturally-occurring human DNA confers patent eligibility. Myriad Genetics owns patents that claim isolated nucleic acids having the sequence of BRCA1 and BRCA2, genes that are associated with an increased risk of breast cancer. A coalition including the ACLU, pathologists, and breast cancer patients sued Myriad Genetics, asserting that its claims to these nucleic acids were not eligible for patent protection as products of nature. The Federal Circuit upheld Myriad’s claims, relying, in part, on the fact that selecting and removing an otherwise naturally-occurring piece of DNA from its normal context of the human genome necessarily creates a new molecule that does not occur in nature. The Court also relied on the U.S. Patent and Trademark Office’s (USPTO) near three decade-long practice of granting patents to isolated nucleic acids.
The Supreme Court disagreed. In a near unanimous decision, the Court did not regard separation from the native context to be significant because, according to the Court, 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.” The Court faulted Myriad’s claims for not being directed to a “unique molecule,” but instead “focus[ed] on the genetic information encoded in the BRCA1 and BRCA2 genes.” With respect to the issue of deference to the USPTO’s longstanding practice of granting such claims, the Court pointed to the fact that, unlike prior cases where such deference was given, here, Congress had not endorsed the USPTO’s practice through any legislative measures and, to the contrary, the United States appeared before the Court to oppose Myriad’s claims.
The Court took a slightly different view of copied DNA molecules, called cDNAs, holding that under limited circumstances, they may be patentable. The Court noted that some genes are edited – fragments of the naturally-occurring sequence are removed – when these genes are activated in a cell and transcribed into mRNA. The resulting mRNA can be copied back into DNA to form a cDNA that is smaller than the original sequence because of the pieces that have been removed. According to the Court, there is no naturally-occurring counterpart to these cDNA molecules and, as such, these molecules are patent eligible. Since the BRCA1 and BRCA2 genes are edited when expressed, the Court upheld Myriad’s claims to BRCA1 and BRCA2 cDNAs as patent eligible. However, not all genes undergo this editing process. For those that do not, the corresponding cDNA would be, in the Court's view, indistinguishable from a naturally-occurring sequence. Consequently, cDNA molecules derived from such unedited genes would not be patent eligible.
Claims to isolated nucleic acid sequences have long been the gold standard for patents in the genetic arts. Thus, the sweeping language of the Court's decision will impact many of the claims in core patents of big and small biotechnology companies alike. A well-rounded procurement strategy pursued by most industry participants will mean that companies will have fallback positions including expression cassettes, expression vectors, and modified, non-native sequences. The inability to protect the central piece of most genetic inventions, however, constitutes a significant loss in the ability to protect genetic technology. In any event, nucleic acid patent holders will need to review and confirm that their existing patents include claims to more than just isolated naturally-occurring sequences. To the extent such claims are not found, it may be necessary to consider filing a reissue to add such claims. Similarly, pending applications may need to be amended to ensure that the claims do not run afoul of today’s decision.
The availability of corresponding patents to isolated versions of naturally-occurring sequences in other jurisdictions, of course, remain undisturbed by the Court's decision today. Going forward, it remains to be seen whether the availability of patent protection outside of the United States and these fallback claims in the United States will continue to motivate companies to disclose their sequence information or whether some will choose to maintain their discoveries as trade secrets.