A contributor commenting on the ‘Patents’ article (see below), has questioned whether new law protects researchers from being sued by Big Pharma over patents. No, says CLA Director Tim Vines, the new law has so far only created more uncertainty. But, of course, one thing is for sure: you and I no longer own all our own genes.
A contributor, commenting online on Tim Vines’ article about patents, wrote:
“which includes the freedom for researchers to research”.
Don’t understand Section 119C of the Patents Act 1990 eh?
Thanks Dave for your comment. I assume you are an expert in Patent Law, which is why you kept your comment so short.
For everyone else, Dave is referring to the new ‘experimental purposes exemption’ introduced into the Patents Act 1990 by the recently passed Intellectual Property Laws Amendment (Raising the Bar) Act 2012.
This new exemption states that:
(1) A person may, without infringing a patent for an invention, do an act that would infringe the patent apart from this subsection, if the act is done for experimental purposes relating to the subject matter of the invention.
(2) For the purposes of this section, experimental purposes relating to the subject matter of the invention include, but are not limited to, the following:
(a) determining the properties of the invention;
(b) determining the scope of a claim relating to the invention;
(c) improving or modifying the invention;
(d) determining the validity of the patent or of a claim relating to the invention;
(e) determining whether the patent for the invention would be, or has been, infringed by the doing of an act.
So what Dave is saying (we think) is that everything is OK now: researchers are free to researcher genetic material and we should all go home. Or at very least, that our claim that researcher’s speech has been chilled by gene patents is wrong.
But this experimental use exemption isn’t good enough. And it’s not just us saying it. Professor Ian Olver, from the Cancer Council of Australia, has expressed his concern with the new exemption: http://www.abc.net.au/lateline/content/2012/s3502732.htm
His concern (and ours) is that the exemption may only cover ‘blue-sky’ or basic research. It might not cover applied research, especially where that research has a commercial goal. So, for example:
A researcher is developing a new diagnostic tool, which she hopes to commercialise. To test the effectiveness of her tool, she runs a test on the gene ‘owned’ by Myriad with her new device (which tests lots of genes, including BRCA1/2). Because her intention is to commercialise, her research might not be ‘experimental’ enough.
A researcher, working at University A, sends genetic samples to a fellow researcher at University B, because University B has a better and more efficient set up for sequencing lots of genes. Both researchers may be experimenting but is University B experimenting or is it offering a ‘service’ – i.e. large scale, but not for profit, genetic testing? If so, it would be infringing the patent.
Suppose you or your family member enrolled in a clinical trial that was researching a new way to screen for genetic mutations. Some of those genetic mutations had patents over them. The researcher takes your DNA, sequences it, and analyses their results. So far, no infringement. But what if they discover, in the course of their research, that you had a genetic mutation that put you at risk of developing cancer. Under Australia’s guidelines for ethical research they should offer you the choice to be told about the results; but now are they researching, or offering a screening service?
A university runs a Masters program in molecular biochemistry. As part of that course, students have an assignment to test for genetic mutations present in a tumour held by a Biobank. There is a patent over the particular gene being tested for. Is the University engaged in research? No, it’s teaching – which is its business. So is it infringing the patent? The defence in section 119C wouldn’t cover this kind of activity. And… come to think of it, would the Biobank be liable for authorising the infringement, just like Napster was liable for authorising copyright infringement?
Think this is far fetched? Wrong. In the US….
- a survey of laboratory directors in the United States conducted by Dr. Mildred Cho found that 53% decided not to develop a new clinical test because of a gene patent or license, and 67% believed that gene patents decreased their ability to conduct research.
- American Society of Human Genetics… [reported] that 46% of respondents felt that patents had delayed or limited their research.
- a purportedly valid scientific survey of labs in the United States found a 26% drop in the number of labs performing testing for hemochromatosis as a result of gene patents.
- Cho’s study also found that nine labs had ceased performing BRCA1/2 genetic testing as a result of Myriad’s patents; and
- Myriad has prohibited researchers telling patients involved in research the results of their BRCA1/2 testing.
This in a country that had a Common Law experimental use defence to patent since 1831, 181 years before Australia’s Raising the Bar reforms!
Of course, there are other problems with the exemption, for example, the cost of defending your actions against an expensive IP lawsuit. The Pharma industry allegedly budgets $3-5 million for a patent dispute case. Even if the law is on your side, you will need money to run the case and time to turn up in court or work with lawyers.
Many small research institutions cannot afford this and will simply fold in the face of a ‘cease-and-desist’ letter. Moreover, these organisations depend on gifts, bequest and donations. We want these organisations to spend their money (our money!) on research, not lawyers’ fees.
Secondly, the exemption only applies to acts done after 13 April 2012. So Myriad, or GTL could sue a person for research down as far back as July 2006, even if that research, today, would be protected.
But finally, the most important reason why the exemption isn’t good enough is that we shouldn’t need the Government to throw us the scraps of our own DNA via infringement exemptions. We believe gene patents are not good to begin with. No company invented your DNA and no company should claim a monopoly over it.
Far from ‘not understanding’ section 119C Dave, we know its limitations all too well.
- Tim Vines, Director and National Media Spokesperson, CLA