In a decision that has confused the biotech industry, the US Supreme Court decided last week that naturally occurring human gene sequences are no longer patentable.
In doing so, the court has put patent law in the US out on a limb – at
In a decision that has confused the biotech industry, the US Supreme Court decided last week that naturally occurring human gene sequences are no longer patentable.
In doing so, the court has put patent law in the US out on a limb – at odds with laws that apply in many other parts of the world. More worrying still, the decision seems to indicate an intrinsic misunderstanding of how patents are used by the biotech industry and the value they bring to society through the creation of potentially life-saving drugs and diagnostic tools.
In passing down judgement in Association for Molecular Pathology v Myriad Genetics, Justice Clarence Thomas stated that "laws of nature, natural phenomena and abstract ideas" should not be patentable. On this basis, he found that Myriad's patents for two naturally occurring human gene sequences, which had been isolated for use in diagnostic tests for breast and ovarian cancer – BRCA1 and BRCA2 – were invalid.
Why has the US Supreme Court singled out human gene sequences in this way when other naturally occurring chemical compounds remain patentable? Other chemical compounds found in nature, for example in plants or fungi, have in the past been isolated and used as drugs and would not appear to fall under this exclusion. Aspirin and penicillin are prime examples. But any biotech company that invests in research activity in order to isolate a human gene sequence and then use this knowledge to develop new products will be unable to claim protection for this vital first step in the innovation process, despite their significant upfront investment.
This is the second US Supreme Court ruling in as many years to target innovation in the biotech industry. Last year's shock decision in Mayo v Prometheus rendered some diagnostic tests unpatentable.
In reality, the disappointment caused by these recent decisions will not stop research work in the sector. Most patent applications for biotech innovations include a variety of different claims and are very unlikely to rely on a claim directed to just the naturally occurring gene sequence. While the isolated human gene sequence would normally be referenced in all patent applications for technologies that subsequently make use of it, a number of other claims are typically included too. These might relate to uses of the gene sequence, the vectors comprising the gene sequence or the derived complementary DNA sequence itself, for example. Crucially, these aspects of the invention are still patentable.
As the dust settles on this decision, biotech companies will be wondering what to do with the many thousands of patents that have been granted by the USPTO for naturally-occurring human gene sequences since 1982. In the vast majority of cases, little action will be needed, but it would be wise to review existing patents in the light of this decision. For the global biotech industry as a whole, it may also be time to review where to locate its research and development activity in the future.
Adrian Tombling is a partner and patent attorney at Withers & Rogers