KEY ISSUES IN LIFE SCIENCES IP


which side everyone is going to come down on and what they will be arguing. It is very difficult to settle on something that is going to work and it’s complicated.


You’re not just saying that it’s a different size or a different colour so it’s not similar. Each biological is complicated to begin with, and trying to set rules that apply fairly raises patent questions and also regulatory questions. There are health and safety questions.


Wainwright: Most of it is regulatory. Just because it is very similar doesn’t mean it is going to have the same effect or be as safe and that is where the question of similarity come in.


Paranavitane: Each batch of the same or a


modified protein will possibly be a little bit different in the way that it works in the human body. Slightly different doses may be necessary to produce a biological effect, so there is a difficulty in being able to rely on the reference of a biologic for safety and toxicity.


Chapman: For conventional small-molecule generics, you can rely on some of the data that have been submitted so you don’t have to go through the whole regulatory bit again. But as Jane said, if you can’t define what a biosimilar is, or you don’t know how similar it is, then should you be allowed to rely on the previously submitted data on when it is safe to do so and when is it not safe to do so? It is not a patent issue; it really is a regulatory issue.


Essex: So if the US Food and Drug Administration comes up with one definition and we come up with something different, how would we resolve that?


England: The answer is that the proof of the pudding is in the eating. Case by case, if a company produces a biosimilar of a biological that is already on the market, then in Europe it has to pass the European Medicines Agency (EMA) guidelines first. They have to submit the correct data and show that it is not a health risk, but is essentially the same drug.


So you don’t really know it is a biosimilar until all of that has been passed and been approved; then we can call it a biosimilar. But even then that’s effectively a linguistic issue; it’s jargon as far as I am aware, not a defining term.


Essex: I thought it was a term that had different definitions, and that was part of the problem.


Wainwright: It is subjective. Different people will think of a different set of data as being similar or less similar depending on their point of view. I don’t think there is an easy definition.


www.lifesciencesipreview.com


Ed Conlon


“It is a relatively recent thing to be able to copy a biologic or make a very similar biologic in any lab without too much difficulty.”


Jane Wainwright Essex: Is there a cost issue as well?


England: The interesting thing about biologics, and another reason why industry is trying to move towards biologics to some extent, is that the difficulties in producing a biosimilar and then getting approval, and the cost of doing so when you may actually have to perform your own clinical trials, means that if you’re an originator company that has come up with its own biologic you know it is more difficult for someone else to come to the market later, regardless of your patent protection.


It is more difficult for them to come on the market because of


those cost hurdles, so it is


more difficult to compete against a biologic than a small-molecule drug. And that for businesses is attractive.


Duch: And they also present new challenges for delivery.


Essex: The delivery system can be separate from the actual product; is that right?


Duch: Then we are moving into the field of medical devices. Delivery of biologics, for example, such as therapeutic antibodies, presents


new challenges. Diseases treated


with therapeutic antibodies require long-term treatment; a simple administration method, possibly self-administration via a subcutaneous injection, is preferred. High doses are often required to achieve the therapeutic effect. A low volume limit for subcutaneous injection on one hand and a concentration-dependent increase in the viscosity of antibody solutions on the other present a major challenge for the delivery of therapeutic antibodies. At the moment therapeutic antibodies are delivered in a clinical setting and that takes a long time, is expensive and inconvenient for the patient. There is a need for, and a lot of effort is being put into developing, a system for delivery of highly viscous drug formulations that would be portable and could be used by patients in a home setting.


At the moment there are antibodies that are


delivered in a clinical setting and that is expensive. It is not convenient for the patient, it takes a long time and so there is a need for, and a lot of effort is being put into developing, a system for high- viscosity drugs to be portable and used by patients in home settings.


Paranavitane: And presumably those methods will be patentable.


Essex: We’ve been hearing a lot about a patent cliff in biologics and how more biosimilars are therefore about to enter the market. Have there been any biologic v biosimilars actions?


Life Sciences Intellectual Property Review Roundtable 11


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