In 2010 two landmark court rulings regarding DNA sequence patents were given in the US. In the first one, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al. US Federal District Court Judge Robert Sweet ruled that isolated DNA is not patentable in the United States. Therefore he concluded also that method claims relevant to testing for BRCA1 and BRCA2 genes are invalid. These patents are licensed exclusively to Myriad Genetics’ in Salt Lake City, a company that is highly criticized for their restrictive business model and aggressive use of their IP. In short the court ruled that isolated DNA is not significantly different from the DNA occurring in a cell (of the human body) and therefore is not an invention (as it would be a discovery – and cannot be patented). Now this was more or less to be expected but the court decisions go further than that! A diagnostic test based on that discovery is not considered patentable either as it involves only a simple mental correlation between facts.
The other case is Intervet Inc. Vs. Merial Ltd. In this case, one of the judges (Judge Timothy B. Dyke concluded that a product of nature could only be patentable if it is qualitatively different from the product occurring in nature. Interestingly judge Dyke is one of the judges ruling in the appeal of Myriad against the loss of their IP.
These are just two recent cases in the US but the implication on DNA sequence patents may be far reaching. Back in 2000, when the new economy was still alive, there was a lot of focus on DNA sequence patents. A lot of companies were very cautious and a lot of genetic test developments were stalled because of patent issues. When asking an expert you could get philosophical answers: either you licence or you ignore or you litigate. Now in 2000 there were still patents from the early days of DNA sequencing around. Some of these patents might have been inventive as the inventive step was a lot easier to achieve. The ones I was confronted with were not (in my opinion). Therefore I developed the view that the best thing to do in these cases was to ignore these patents and wait if the right holder tries to sue. I was sure that most of the start-ups and medium biotech companies would not risk loosing their IP in a revocation action. Especially as a lawsuit in this area may have put the public in even stronger opposition to DNA patents then it already was. In most of Europe the public is not in favour of such patents at all. Amongst several other reasons a lot of people see DNA patents a misuse of patent law. The public does not get a fair value (an invention) disclosed by the patentee but rather only a discovery (which should be public domain). When society does not get their part of deal (the disclosing of an invention) why should the society grant exclusivity? But legal decisions are made by courts and they rule according to laws. If the courts decide that DNA sequences are discoveries then suddenly all the expensive DNA sequence patents could easily fall prey to a competitor requesting revocation. Even just the threat of such an action should be enough to pull the teeth of most DNA sequence patents and make them useless for offensive patent action. Now this will only be true for isolated sequence patents and derived claims. Special arrangements of DNA sequences (PCR primer and probe sets, DNA microarray arrangements etc) most likely still keep their value (depending on their inventiveness). But keeping in mind the great progress in biotechnology the technical hurdles for something being inventive nowadays are much higher then they were 10 years ago. And since a lot of genomes are sequenced and published there is a lot of state of the art against new DNA sequence patents. That does not necessarily exclude improved or enhanced sequences differing in sequence and function from their natural counterparts. But the wild west days of DNA sequence patents seem to be over.
Holger Klapproth, IPEG Consultant