In June, the US Supreme Court issued its opinion in the Myriad case (Association for Molecular Pathology v. Myriad Genetics Inc.). The Supreme Court had been asked a seemingly simple question: “Are human genes patentable?”, and concluded that naturally occurring gene sequences are no longer patentable in the US. In Europe, isolated gene sequences are still patentable, under certain conditions. However, the differences between the two legal regimes are not as stark as might initially appear, and the practical effect for the diagnostics industry is complex.
The patents at issue were three patents owned by Myriad on the BRCA1 and BRCA2 genes. Mutations of these genes are associated with significantly increased risk of breast and/or ovarian cancer, as was been highlighted recently by Angelina Jolie’s decision to have a double mastectomy as a precautionary measure.
The US Supreme Court found that naturally occurring DNA segments are “products of nature”, and therefore are not patentable in the US, regardless of the amount of effort involved in discovering such sequences, and even though these sequences had been isolated from the human body. This runs contrary to the long-standing US Patent Office practice of recognising the patent eligibility of genes. Shortly after the Myriad decision, the US Patent Office issued new guidance for its examiners, instructing them to “reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not”.
Despite the adverse decision on isolated DNA, Myriad’s share price rose when the Supreme Court’s ruling was released. The Supreme Court also found that cDNA claims can be valid. cDNA is synthetically created exon-only strands of nucleotides sequences, which the Supreme Court decided are not a “product of nature”, and so can be patentable.
While in Europe there is no absolute bar on patenting genes which have been isolated from the human body, even if identical in sequence to natural elements, obtaining patents that claim only isolated gene sequences is not plain sailing. Just like any other invention, gene patents have to satisfy the normal patent requirements of novelty, inventive step and industrial applicability. This can pose a significant challenge, as nowadays there are standard techniques for sequencing and isolating DNA, and vast quantities of human genomic sequences are already in the public domain.
The trend therefore for a number of years now on both sides of the Atlantic has been to move away from drafting the claims which have just been outlawed in the US, or at least not to rely exclusively on such claims, in favour of more complex patent claims involving non-native genetic constructs, and incorporating sequence changes to make the sequences appear less “natural”. Some niche areas, such as, for example, genomic biomarkers, may present more of a challenge than others in terms of claim drafting in light of this trend. Generally however, the ramifications of the Myriad decision for recently filed patents are unlikely to be fatal to many US patents, if they have been well drafted.
Importantly for the diagnostic industry, the Supreme Court did not make any rulings in relation to broader patent eligibility issues such as claims for methods of interpreting genetic testing results, testing drug efficacy or manipulating genes. The key case remains last year’s US Supreme Court decision in Mayo v. Prometheus, which divided opinion on the extent to which diagnostic methods could – and should – be patentable in the United States.
It is possible that the next chapter in the saga of Myriad litigation may yet shed light on these further issues. Myriad has a number of patents relating to the BRCA1 and BRCA2 genes, containing patent claims in different formats. Immediately after the Supreme Court decision in Myriad, a number of new testing products were launched relating to these genes. Predictably, Myriad filed law suits against the companies selling these hereditary cancer tests, relying on patent claims to synthetic DNA and methods of use relating to the BRCA1 and BRCA2 genes. The Supreme Court in Myriad did not consider the claims for methods of screening for potential cancer drugs, or methods of comparing patients’ genes with normal sequences to identify cancer-predisposing mutations, but Myriad is confident that the logic underpinning the Supreme Court’s ruling underscores “the importance and applicability of method-of-use patents for gene-based diagnostic tests”.
– Morag Peberdy, Of Counsel, Covington & Burling LLP