KEY ISSUES IN LIFE SCIENCES IP


very small quantity at the research lab where it was still at a very early stage. They have been asked to produce as much as possible as quickly as possible, but when you have a new molecule, a new biologic, then you don’t necessarily have the scale.


Duch: And with a biologic you have a problem with storage.


Essex: So even when it appears to be working, you cannot produce it in large enough quantities to be useful?


Duch: Manufacturing capacity is one issue and another issue is storage, because if an epidemic happens you know you will need a lot. But to be prepared for it costs a lot of money. You need to invest a lot ofmoney in order to produce the drug; then you have to store the drug and even if it is not used before it goes out of date, it still costs money.


Anna Duch


Conlon: Does the UK government invest much in innovation and research?


Wainwright: A reasonable amount. Certainly in relation to chemical or biological warfare, they have their own facilities to do research, file patents and take things from that. Through various funding bodies they fund other institutions to do research, although not on the scale of the US.


Stothers: Sometimes patents will be owned by the government but often they won’t be. In some of the patents that are worth fighting a battle over, fighting over the technology, quite often there is some government involvement in the back story. They may not be the named owner of the patent, but there will be some government investment somewhere in the research; sometimes through universities, but often directly through government departments.


Essex: If you’ve got people dying, does it matter who holds the patent; whether it’s the US government or a big drug company?


Wainwright: As long as they are willing to make the drug and help somebody use it, it doesn’t really matter. It comes down to whoever owns it and what they want to do with it. If the US government is quite happy to license it for other people to manage for free then they’ll do that. If not, they won’t. The US government is no different from any other business. They have reasons for doing everything.


Stothers: It also depends where the patent is because patents are country by country, so very often there isn’t a patent covering the product in many countries around the world. The issue is


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“Different parts of the process may be covered by different patents with different owners. That is a complicated situation.”


Anna Duch


whether there are countries that have the facilities to make it readily available.


There may be plenty of drugs without patent protection, but there may be plenty of other barriers to stop people making a copy, particularly in biologics. It is not just the patent that stops people copying; there are other issues in the short term. Over the long term, people work things out, but in the short term it can be a problem.


Duch: It can also be complicated when you look at the drug manufacturing process; different parts of the process may be covered by different patents with different owners. That is a complicated situation. The issue is often more complex than it seems.


Essex: Going back to ZMapp, is the lack of availability due to the fact that the government owns the patent or simply because it was a test drug that nobody had produced in large quantities because it hadn’t been approved by anyone?


Wainwright: What I read is that they only had a Life Sciences Intellectual Property Review Roundtable


Wainwright: Swine flu was a good example a few years back. Once swine flu got into the country it started spreading quite rapidly and there was a lag before the anti-virals that could potentially be useful to the people who needed them could be produced because


there wasn’t enough manufacturing


capacity. There were limitations to what people could be given while they stocked the system.


Duch: In most cases it is about timing. If the timing is right, then we do not hear about it. They stop it early and stop it spreading.


Biosimilars Essex: What is a biosimilar? I believe there are some debates about the definition.


England: My understanding of a biosimilar is that it is as near as you can get to a copy of the biological. There are other expressions such as ‘biobetter’, which refer to things that are not exact copies but are biologicals that have a similar function. So a biosimilar is essentially a generic version of a biological, but they are not called generics because generics is a term used for copies of small-molecule drugs. Instead of generics they are called biosimilars. But


they are essentially


generic versions of a biologic drug. Wainwright: There is a debate on what is similar.


Stothers: With a small-molecule generic, it is exactly the same; there is not really any discussion about it. Occasionally, there might be something about salt forms, but by and large there is no difference whereas, with a biosimilar, the whole point is that it is not the same.


It is different, and how different it can be and still be similar is a classic question where you know you’re going to have a lot of views, you know


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