Wellington
By guest blogger Doug Calhoun
Patent attorneys operate in a netherworld between science and law. We find it challenging to tryto explain the law to scientists and the science to lawyers; and even more challenging to try toexplain either to the uninitiated. But I’ll give it a go.
This US Supreme Court Myriad
What it did decide was “that a naturally occurring DNA segment is a product of nature and notpatent eligible merely because it has been isolated, but that cDNA is patent eligible because it isnot naturally occurring.”
When you get down to the detail of how the decision applies to the patents that were beinglitigated things get a bit more complicated. A patent gives the owner the right to excludeunauthorised exploitation of a patented invention for a limited period of time – 20 years. Theexclusive right is defined by the claims at the end of each patent document. In the Myriad case, afew claims of each of seven Myriad US patents were challenged. (The seven patents are due to expirein 2015.) Courtney Brinckerhoff (a US Patent attorney) has analysed each of these and explains whatpatent protection remains for Myriad
The patent blogsphere is saturated with posts on what will be the spillover effect of thedecision. 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 claimingisolated 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 thegene that gives rise to glyphosate resistance. But it is also evident that many such patents arenearing the end of their 20-year life and the expense of challenging them has to be weighed upagainst the lost opportunity cost of waiting until they expire.
Looking forward, Eric Guttag (another American patent attorney)
The ENCODE website is here :
Patents are territorial in their coverage. There is no such thing as a worldwide patent. What iseligible for patent protection is governed by national laws and their interpretation by nationalcourts. (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 Britishpatent attorney)
He begins: “How does the Supreme Court decision of 13 June 2013 match international opinion onthe patentability of biological material? From a European and indeed from an Australian standpointit can be said with some confidence: not so well.”
Myriad Genetics has become for diagnostic service companies what Monsanto became for the seedindustry – a convenient punching bag. How this happened is explained in this lengthy Nature
The authors concluded:
“The media,government reports, academic literature, and even Michael Crichton's book Next, all portray Myriadas a greedy, self-absorbed, unconcerned, and inflexible company. … The facts as set out in thisreport 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 allowedhostile attitudes to persist in the scientific community without seriously attempting to correct thepublic 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 thoserelating to it alone including, general hostility to human gene patents, concern about thesustainability 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 assembledopposition.”
A later Cabinet
“report to Cabinet on theissues relating to the patenting of human gene sequences and their biologicalfunctions.”
The subsequent report advised that examination of patentapplications for inventive step would
“reduce the likelihood that patents will begranted over generic material.”
(See page 51 of Cleary dissertation below.)
In October 2011, Thomas Cleary authored an honours
“Let the gene genie out of the patent bottle.”
Cleary analysed both the 1953 Patents Act and the Patents Bill andfound that neither would exclude isolated and purified DNA. In his opinion, they should. But heconcluded (on Page 51) that this is unlikely to happen because:
In a refreshing contrast to most arguments for andagainst gene patents, Cleary offers in the Appendix empirical evidence in support of his observationthat 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 15years I can only now wonder what the fuss was all about.
