Myriad US supreme court decision
19.06.13
Last week the US Supreme Court ruled on the Myriad BRCA patent case that naturally occurring, isolated DNA i.e. “genomic DNA” does not constitute patentable subject matter in the USA. The ruling effectively ended the belief that the process of identifying, functionally characterising and physically isolating a gene sequence from its location buried in the human genome should distance it in patent terms from native DNA. However the Court has held in effect that this is a discovery rather than an invention and is hence not patentable.
US patent law requires general principles to be applied to the specifics of biotechnology, while the EU benefits from having laws that explicitly address the patentability of genomic DNA. For example the Biotechnology Directive states that genomic DNA can be subject to a product claim even though it is identical to natural DNA. However the scope of protection afforded under such product claims has since been qualified by the CJEU’s decision as limited to the technical function of the gene described in the patent.
It is, of course, disappointing for the research-based community that the Myriad ruling has reduced the scope of patent eligible subject matter. This is all the more frustrating when it occurs in an area that has for over twenty years attracted such intensive scientific endeavour and yielded inventions that are revolutionising the field of human therapy. Huge investments have been made in sequencing and understanding the function of the human genome and this has been done with the expectation that appropriate patent rights would be available to protect the fruits of such endeavours.
The Court did helpfully comment that methods of using genomic DNA and any non-naturally occurring DNA (such as cDNA) should continue to constitute patentable subject matter. While the Court’s comments on this are to be welcomed, they fail to clarify ambiguities arising from the principle established by the core of the decision. The concept of what is naturally occurring and what is artificial is not so easy to apply in practice, since the essence of biotechnology is to use materials and processes similar or identical to those that exist in nature to produce innovative new products. The decision raises more questions than it answers for example will a claim to a fragment of cDNA be valid when it can have the same sequence as that of a genomic DNA exon and does this decision have any effect on the patentability of RNA or proteins ? It is interesting to note that the US patent office has already issued a note to Examiners which goes some way beyond the specific facts of the Myriad decision: “ Examiners should reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not ”.
The effective invalidation of many existing US patents claiming DNA-based inventions and the creation of ambiguities as to the validity and future availability of patent protection to many biotechnology inventions will only negatively impact the levels of innovation in this area. Clearly both diagnostics and personalised medicines businesses will be impacted by this decision and those developing RNA-based therapeutics will be carefully considering whether any of their product patents might be said to relate to naturally occurring sequences. It is not yet possible to predict how significant the impact of this decision will be as it will depend on whether the decision is applied narrowly- only to genomic DNA product claims- and whether the use of genomic DNA or other “naturally occurring” compounds will allow third parties to “engineer round” the various categories of patent rights protecting relevant diagnostic or therapeutic products.
