What are the notable concerns of releasing biosimilars over the original biologics in terms of existing patents?
The most notable issue for the originator and for the biosimilar competitor relates to the scope of a patent claim that protects the original product. Such claims are usually broad enough to cover biosimilar products, and they are frequently supplemented by claims covering necessary platform technologies (eg, monoclonal antibodies) and manufacturing processes. Such comprehensive patent protection can make it extremely difficult to develop and launch biosimilars, and these difficulties are increased by uncertainties over applicability of the Bolar exemption to activities required for development of biosimilar products.
Is it safe to say that with the expiration of notable biologic patents from now until 2020, we will see an increase of biosimilars in the UK?
It is likely that we will see an increase in biosimilar approvals across the EU, but not that we will see a corresponding trend in the UK. Biosimilar products are not automatically substitutable for their corresponding originator reference products, and therefore they suffer a significant competitive disadvantage in the market. This disadvantage is compounded by an elevated risk of patent infringement in the UK where the existing Bolar exemption from patent infringement doesn’t apply to activities carried out to obtain approval of biosimilar products.
What biosimilar regulation is in the pipeline in Europe, and what is it expected to look like?
The European Medicines Agency (EMA) has released draft revised guidelines concerning approval of biosimilars for consultation in 2013. The new guidelines provide guidance on design of non-clinical studies, demonstration of clinical comparability, design of clinical studies, design of immunogenicity studies and extrapolation from one therapeutic indication to another. The final version of the guidelines has not been released following the consultation.
The first monoclonal antibody biosimilars were approved by the EMA in 2013, both containing infliximab, a chimeric anti-TNFα antibody, and this represented a landmark decision. The authorisations were based on trials showing equivalent therapeutic efficacy compared to the originator compound in two of the previously authorised indications, but extended to other indications for which the originator compound was authorised, which surprised some commentators.
Biosmiliars are not the same as the original, unlike generic drugs. How can this present difficulties when seeking a supplementary protection certificate?
Since biosimilars are not the same as their reference products it is possible that they may not infringe patent claims covering the reference products. It is important when drafting patents to draft the claims broadly enough to cover putative biosimilars.
More significant difficulties will arise regarding the scope of supplementary protection certificates (SPCs), since these will be limited to the authorised product. The timing of conducting the necessary trials and applying for market approval for biosimilar products becomes critical. The patentee may perhaps try to frame its SPC on the originator medicine broadly if it is aware when the SPC is being prosecuted of clinical trials by a biosimilar developer.
It is long established that a patentee can obtain a SPC for a product based on a market approval granted to another party. For a biosimilar developer, there is a risk that a patentee might obtain a SPC covering its biosimilar if market approval is obtained while the patent remains in force. The question of whether a patentee that was not involved in obtaining market approval can obtain such a SPC is before the English courts and will likely end up before the Court of Justice of the EU (CJEU) in due course, and until it is answered it remains critical that biosimilar developers delay obtaining approval until originator patents expire.
Why is the UK so behind other European countries in the biosimilar market? Is this expected to change?
One significant obstacle to approval of biosimilar products in the UK is the narrow implementation of the EU Bolar exemption that is currently in place here and that is restricted to activities required for approval of generic medicinal products. This compares very unfavourably with the more generous regimes in countries such as Germany that encompass activities required for approval of biosimilars.
Following a public consultation on the Bolar exemption in 2012, the UK Intellectual Property Office proposed introduction of legislation that will broaden the exemption in the UK so that it mirrors that of German law. Initially, it was expected that the legislation would take effect in April, but this has been postponed to 1 October and the language of the proposed legislation has not yet been made public.
One study in 2013 suggested that the UK market is favourable to biosimilars; there are economic analyses of the cost-effectiveness of prescribing biosimilars by NICE. However patentees will utilise the available protections of SPCs and extensions, and the courts tend to be inclined to favour the important pharma and biotech innovator business sectors in the UK by enforcing intellectual property rights.