KEY ISSUES IN LIFE SCIENCES IP


earned a lot of money from people using their tests and they still plan to enforce their patents.


They have patents that are still probably valid. They are just a business like any other biotech or pharma company.


Stothers: Throughout pharmaceuticals there is this additional problem where, if your product is successful, and lots of people stand to benefit from it, you will come in for criticism when you try to price it in a way that gets you a return to reflect the success of your product.


You do not have the same in sectors like mobile phones. Some people might dislike the product because it becomes ubiquitous, but they don’t take it personally or ethically. We always have this with pharmaceuticals, particularly in controversial areas such as life or death treatment. When you add the genetic stuff in it adds to that sense of outrage, but it is not something new in the life sciences sector.


Wainwright: Every time NICE refuses a drug, for whatever reason, there is a huge amount of media coverage of it, but they do not cover every drug that is approved.


Conlon: It is how the media work, unfortunately.


Wainwright: But you do not get that when a new iPhone is released—you don’t get a huge uproar that it’s £600 if you buy it yourself.


Blockbusters Conlon: Somebody said to me recently that they think the rise of personalised medicine means there will be fewer blockbuster drugs; what do you think?


England: It is inherent in the fact that the traditional blockbuster drugs are typically those small-molecule drugs that an entire population can take to treat the symptoms of a disease. But, as we have been saying, with personalised medicine you’re looking for a biomarker in a particular set of patients and you’re looking to treat the cause of a disease, rather than the effect it will have on people physiologically. Because it is a smaller population, the sales will be lower and you won’t be breaking the billion dollar mark generally associated with blockbusters.


There is also another element to it, which goes back to what I was saying about diversification. A lot of companies have reported that they have been struggling to fill their pipelines with small-molecule drugs so there has been a lot of diversification into medical devices, into therapeutic foods and things like that as a base to their businesses.


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“Formulation is an area that is really going to play out with biologics, even more so than with small molecules.”


Paul Chapman


They have been moving away from blockbusters so, in a sense, there has been a move away from blockbusters generally as part of the change in pharmaceutical business models.


Blockbusters are risky as well. You invest so much money in a blockbuster that you need a huge return to offset it, and that is incredibly risky. It tends to be all or nothing.


Blockbusters, remember, are protected by a fairly small portfolio of patents—again this is unlike electronics, which typically have a huge portfolio of patents for every product. There is an argument, and only time will tell, that the life sciences sector is moving away from the old blockbuster model.


Essex: On the pricing of blockbuster drugs I don’t think there is a simple answer. GlaxoSmithKline, say, argues it has invested seven years of hard work and has come up with this major drug. India says ‘well let us have it for a penny a person, because we really need it’. That is an ethical question that there is no answer to, because both are right.


Paul Chapman


Take Ebola and the drug ZMapp. At least one patent is owned by the US government and it seems a whole group of other drugs have their patents owned by government organisations, because they are somehow seen as strategic. Why would the US government own a patent for a drug to treat Ebola?


Wainwright: It has to be an issue of security, in case somebody would weaponise it.


Chapman: The US government does invest a lot in research and even in the case of anti- malaria vaccines you have to ask why they have done that—perhaps for the greater good. Primarily, it’s because they know their soldiers are going to other countries in the world where there is malaria and it would be advantageous to vaccinate them. You have to hope that it would be for the greater good, ultimately, and that may be the original raison d’être. But if the drug is good enough, hopefully it’ll be given out to the population at large.


Essex: Yet ZMapp wasn’t even developed by American companies. How did it get to the US government?


Wainwright: They stumped up the cash. It happens a lot. The US government gives out a lot of cash for things that are particularly important to them and to make sure they have ownership of them. If it is less important to them, and they are doing it for research purposes, the money comes through the National Institutes of Health (NIH), for example. They don’t usually get named as an owner, but they will make sure they are acknowledged as having contributed to it.


Life Sciences Intellectual Property Review Roundtable 9


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