Biosimilars: litigation outlook

28.10.2016

This article was first published in European Pharmaceutical Review, October 2016
In the Foreword article contributed by Consultant David P. Elder in Issue 3, 2016 of European Pharmaceutical Review, entitled ‘Biosimilars: future prospects’, Dr Elder concluded that it is likely that biosimilars will become increasingly established in both Europe and the United States and that in addition to proteins and peptides, biosimilar monoclonal antibodies (mABs) will form a greater part of the future global biological market. He also cautioned that biosimilar development is more complex than for small-molecule generics, which leads to higher costs and a likelihood of premium pricing in the market, which could in turn increase the burden on health services. Against the context of Dr Elder’s commercial outlook, in this article we will consider the litigation outlook for biosimilars from the perspective of patent exclusivity.
Commercial and patent litigation considerations are usually closely intertwined: where there is money, there is litigation. The market for originator biologic products is huge; as Dr Elder noted, $50 billion globally for the mAB segment alone. Therefore, as biosimilar competition grows, can we expect to see an increase in the volume of biosimilar patent litigation? The short answer is: yes. From a slow start, we are now beginning to see a gradual rise in the number of cases issued, both in Europe and the US. This article will focus on the cases filed in the courts of the United Kingdom, which is one of the few jurisdictions outside the US where court decisions are freely available and third parties can access written arguments.
A slow start
Until recently, almost all UK patent litigation cases on biologics concerned disputes between originator companies over competing original biologic products. There have been one or two cases concerning patented platform technology — such as Medimmune’s phage display technique for antibody production1 or, more recently, Regeneron’s patent for transgenic mice2 — but by and large patent litigation has concerned battles between originators over patents blocking a specific product market, often a mAB product. Being the highest value biologic products, and also some of the most challenging to develop and bring to market, mABs can be viewed as the bellwether for biologics litigation, as reflected by the subject matter of the first biosimilar cases described below.
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Dominic Adair

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