By now you will be aware of the recent US Supreme Court decision concerning Myriad's gene patent.
The decision is of interest, more perhaps because of the profile of the debate among the pro and anti gene patent camps from which it arises.
Over the next few days and weeks we expect to see some hand waving regarding the decision. What is most important now is that the commercial implications are understood for what they are - without overcooking or under seasoning them.
This is what we see:
- A limited class of genes are now not patentable: naturally occurring genes, including genes isolated from nature, are now no longer patentable in the US.
- However, the decision is not a ban on gene patents: a gene patent application that covers a nucleic acid that is chemically distinct from a naturally occuring gene is still allowable, and a patent on such an application is still valid and enforceable. A cDNA ('complementary DNA') is one example of a chemically distinct class. Others might include derivatives of naturally occurring genes such as fusions, fragments, mutations or constructs that do not occur in nature.
- Genetic testing and diagnostic patents are not now necessarily invalid: patents which only cover a naturally occurring gene will be invalid. But most gene testing patents and patent applications also cover claims to diagnostic methods, and products of those methods, including cDNA versions of naturally occurring genes, all of which remain as patentable subject matter in light of the decision.
- Therapeutic patents based on gene technology are unaffected: most of the relevant patents and patent applications contain claims directed to genes that encode substances not found in nature. So these patents and patent applications are unaffected by this decision.
- Patents to transgenic or transformed organisms are unaffected: patents and patent applications having claims to living organisms, tissues and cells that include a gene - even a naturally occurring gene - remain allowable and enforceable.
- The decision is limited to those with business interests in the US: Yes, the US is clearly the most significant market for biotech companies no matter where located. But it is important to recognise that the decision does not apply in other major markets such as Europe, and emerging markets in Asia.
Some concluding remarks - while the decision is significant for changing the long understood position that isolated nucleic acids are patentable no matter whether naturally occurring, from the commercial perspective it more importantly points to a continuing need for patent applicants to diversify claim strategy.
Do not focus patent claims solely on nucleic acids. Make sure you cover the other patentable aspects of gene inventions that are unaffected by the decision, including those products and processes mentioned herein.
With this approach, we see the decision as having limited impact on most life science and biotech businesses. Indeed Myriad will not disappear merely because of this decision, and nor will other gene testing companies.