By guest blogger Doug Calhoun
Patent attorneys operate in a netherworld between science and law. We find it challenging to try to explain the law to scientists and the science to lawyers; and even more challenging to try to explain either to the uninitiated. But I’ll give it a go.
What it did decide was “that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”
When you get down to the detail of how the decision applies to the patents that were being litigated things get a bit more complicated. A patent gives the owner the right to exclude unauthorised exploitation of a patented invention for a limited period of time – 20 years. The exclusive right is defined by the claims at the end of each patent document. In the Myriad case, a few claims of each of seven Myriad US patents were challenged. (The seven patents are due to expire in 2015.) Courtney Brinckerhoff (a US Patent attorney) has analysed each of these and explains what patent protection remains for Myriad here.
The patent blogsphere is saturated with posts on what will be the spillover effect of the decision. Readers can explore these for themselves on such blogs as: Patentdocs, Patently-O, IP Kat, Patentology and IP Watchdog. There are far too many to try to do a synopsis.
Looking backward, the general consensus is that patents in all areas of biotechnology claiming isolated DNA molecules that are identical to the way they are found in nature are now vulnerable. Yes, that does include Monsanto’s patents covering inventions derived from the discovery of the gene that gives rise to glyphosate resistance. But it is also evident that many such patents are nearing the end of their 20-year life and the expense of challenging them has to be weighed up against the lost opportunity cost of waiting until they expire.
Looking forward, Eric Guttag (another American patent attorney) points out that the decision, “… addresses only that 2% of the human genome that follows the pre-ENCODE approach to genetics … [and] … is really inapplicable … to 98% of the human genome that doesn’t …”
The ENCODE website is here:
Patents are territorial in their coverage. There is no such thing as a worldwide patent. What is eligible for patent protection is governed by national laws and their interpretation by national courts. (In Europe there is a European Patent Convention, as well as national patent laws.) Therefore, US Supreme Court decisions are not the law in any other country. Paul Cole (a British patent attorney) explains:
He begins: “How does the Supreme Court decision of 13 June 2013 match international opinion on the patentability of biological material? From a European and indeed from an Australian standpoint it can be said with some confidence: not so well.”
Myriad Genetics has become for diagnostic service companies what Monsanto became for the seed industry – a convenient punching bag. How this happened is explained in this lengthy Nature article.
The authors concluded:
“The media, government reports, academic literature, and even Michael Crichton’s book Next, all portray Myriad as a greedy, self-absorbed, unconcerned, and inflexible company. … The facts as set out in this report suggest, however, that this view may be unfair. Myriad is certainly guilty of many mistakes: it failed to fully understand and perhaps even respect the nature of public health care; it allowed hostile attitudes to persist in the scientific community without seriously attempting to correct the public record; and it too quickly attributed hostile motivations to those working in government. However, Myriad was caught up in a debate inspired and sustained by much broader concerns than those relating to it alone including, general hostility to human gene patents, concern about the sustainability of public health systems, and anxiety at the apparent demise of ‘open science.’ Myriad became a lightening rod for these debates: a necessary foil for an already assembled opposition.”
In New Zealand, the GM Royal Commission Report did not recommend any change in the New Zealand interpretation. Our patent law does not exclude (otherwise patentable) isolated DNA sequences from protection.
A later Cabinet Paper called (in paragraph 42) for a committee of officials to
“report to Cabinet on the issues relating to the patenting of human gene sequences and their biological functions.”
The subsequent report advised that examination of patent applications for inventive step would
“reduce the likelihood that patents will be granted over generic material.”
(See page 51 of Cleary dissertation below.)
In October 2011, Thomas Cleary authored an honours dissertation asking if New Zealand should
“Let the gene genie out of the patent bottle.”
Cleary analysed both the 1953 Patents Act and the Patents Bill and found that neither would exclude isolated and purified DNA. In his opinion, they should. But he concluded (on Page 51) that this is unlikely to happen because:
- The issues have already been discussed by officials and the Patents Bill does not exclude them
- There has been a dramatic decrease in the filing of gene patents (see figure below)
- The introduction of examination for inventive step would reduce the likelihood of patents being granted.
In a refreshing contrast to most arguments for and against gene patents, Cleary offers in the Appendix empirical evidence in support of his observation that there has been a dramatic decrease in the filing of new gene patents in New Zealand.
For this jaded veteran participant in and observer of the gene patent debate over the last 15 years I can only now wonder what the fuss was all about.