KEY ISSUES IN LIFE SCIENCES IP


Myriad’s tests Essex: Anna, you have written about Myriad for our monthly newsletter. What do you think?


Duch: At the beginning, they were aggressively protecting their tests. The ability of others to test for BRCA mutations was limited, and for a while that stopped any new research being done, even in academic institutions. Later, they allowed testing for research purposes but they did not allow the test results to be disclosed to the patients, arguing that if they were given the results for free (or for their participation in research) there would be no incentive for them to pay to get tested, so there would be no benefit to Myriad. Their approach was very controversial.


Martin Essex


England: There is also a big economic upside


for the pharmaceutical with personalised medicine. companies If you take the


investment in your average blockbuster drug as £1.2 billion, you clearly want to make the most of every candidate drug.


So if you’ve got something that goes to clinical trial stage three and then fails in a sub-population, then the prospect that you can return to that drug for a sub-population and find that it works, as AstraZeneca discovered with gefitinib, that is a huge bonus because your money was not wasted after all.


The reason it appeared to fail the first time was because it was a proposed lung cancer treatment tried on a very large population of people. Some of them were affected badly by it, while some benefited hugely. Those who benefited were lost among those who didn’t benefit, which skews your results. It was only when they found a mutation of one particular gene in a sub-population of people who have lung cancer, did it turn out that gefitinib was extremely helpful for those people with just that one mutation.


The drug was resurrected and all the investment that went into it was effectively recouped. So it has a huge benefit for certain business models.


Wainwright: That one went on to be approved by the UK National Institute for Health and Care Excellence (NICE) as well. You wouldn’t normally expect NICE to be approving drugs that had previously failed, so it shows how beneficial it can be when you target the right sub-population.


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“It is interesting that Myriad, at the time, tried to keep things secret and that caused problems.”


Paul Chapman


Essex: More generally, you would expect to do some sort of cost-benefit analysis. The general public does not tend to understand cost-benefit analysis. People say things like ‘it’s worth spending every penny we have to save the life of a child’ and we say ‘hang on a minute, it would save more lives if we spent the money in another way’. Isn’t that what we are talking about here: that this money would be better spent in some other area?


Paranavitane: This is very interesting. Having done some research into Myriad,


they have


genetic data from 300,000 breast cancer patients and they have this whole data bank of all the possible clinical treatments of each patient. Their business model is that they would sell a licence for various tests done and the results of them, and they have retained that. This is exactly the sort of area where personalised medicine can be valuable.


I doubt very much that the results of this huge patient population and the results of


specific


treatments are in the public domain, or being used directly to serve society at large.


Life Sciences Intellectual Property Review Roundtable


Chapman: It was a business decision they made and maybe they did not handle it particularly well. If you think back to Monsanto and how they managed the press when they were genetically modifying organisms, they didn’t manage that particularly well either. On the converse, PPL recognised very early that there could be PR issues with Dolly the Sheep.


PPL knew Dolly the Sheep was coming and knew this was going to be a very controversial area so they got a PR company on board to look at the issue and were very open about it. I don’t remember a lot of negativity about Dolly, and yet it could have been very negative. It shows that they wanted to be very open, certainly when they filed the patents, and the business model was to explain it to people, rather than keep everything secret.


England: They probably learned from Monsanto.


Chapman: I agree. It is interesting that Myriad, at the time, tried to keep things secret and that caused problems.


Duch: And caused controversy. Yet one could say bad PR is good, because it is stronger, so it depends on what they were looking for. They would not be as well-known, or the case would not be as well-known, if they had approached it differently. I doubt they were looking for this type of PR, especially being a company in the healthcare sector, but I am not sure it affected them negatively that much.


Essex: What do we think about Myriad? Good guys or bad guys?


Duch: Business guys!


Wainwright: They are a company and they have a business model and they have followed that business model. They have actually followed it relatively successfully. They have had a lot of bad PR, but they have also licensed their tests and


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