Between the Scheldt and the Meuse: Navigating Biologics-Related Patents
When navigating the already-choppy river of patent prosecution, it is always disconcerting to see white water ahead. For researchers developing new classes of drugs there are, unfortunately, a number of regions which seem to contain more than their fair share of rapids. One of these is the massive entity known as the European Union.
Biologics (derived from the term ‘biological drugs’) are a relatively new class of medical compounds and treatments manufactured from, or by, living systems. Common examples of biologics include antibody-based vaccines or medicaments, fusion proteins, protein drugs, and gene therapies. Biologics include existing blockbuster drugs such as Humira, Remicade, Rituxan, Enbrel and Lantus. The biologics market, although already huge by any standards, is estimated to grow to over $400 billion by the 2020s.
The EU, as a massive single market with 500 million potential customers in it, is one of the most important jurisdictions in which to patent drugs of any sort. However; there are a number of sometimes-conflicting issues affecting the patentability of both biotechnological products and drugs which intersect here. Where drugs themselves are concerned, the EPO has taken a relatively liberal stance on what can be considered patentable. This may include, for instance, new dosage regimens as well as second medical uses. This stance is, of course, mitigated by the fact that the normal standards of novelty and inventiveness (as well as the prohibition on patents related to methods of treatment) are to apply to such cases.
The stance regarding biotechnological inventions, however, is markedly different. Here the Boards of Appeal at the European Patent Office (the organisation which oversees EU patent examination) have held that an invention would be considered obvious where a person skilled in the art would be expected to try a given approach with a reasonable chance of success. This need not even extend to an absolute certainty of success, and may be applied where a ‘try and see’ attitude is likely.
This state of affairs is obviously very far removed from the stance currently taken towards conventional drugs. It has also lead to numerous inventions derived from known gene sequences or proteins foundering on the rocks of obviousness, wherever structurally similar analogues may be brought up to provide a hint as to their likely behaviour. This is all the more perplexing because isolated, naturally-occurring gene sequences are presently patentable in the EU (a state of affairs which does not pertain to the US after the Myriad case).
These two conflicting streams of case law meet head-on where biologics are concerned. Inventions making use of antibodies (a core component of most currently-successful biologics) are especially hard-hit, as the wealth of information afforded by the “omics” revolution (the explosion of biotechnological disciplines such as genomics, proteomics and metabolomics) has afforded Examiners a rich prior art to comb through when constructing obviousness arguments. In general, where an antibody or its associated target is known and relatively well-characterised, the chances for obtaining broad protection are slim. However; antibodies are also understood well enough for the case law related to second medical use and dosage to be applied as well.
Inventors looking for broad protection in this field are accordingly advised to seek out the rapidly-diminishing space of new binding targets, or new (and surprising) medical uses for known targets. In cases where the target is known, or its medical utility already established to some degree, the protection of a promising biologic must usually be undertaken using a series of narrow patents which make use of the more liberal approach afforded to conventional drugs. Here, exquisite coordination between researchers, managers and patent professionals is required in order to prevent an earlier patent from becoming a novelty-destroying document to a later one.
For a city located between two large, relatively straight rivers, Brussels seems adept at providing a complex series of rapids for would-be inventors to navigate when moving from idea to patent.