Biotech IP in 2018 – Never a Dull Moment?
What will define biotech in 2018? Andy Bentham of J A Kemp’s Cambridge office picks a few technologies from an Intellectual Property perspective.
There is no shortage of technologies to watch at the moment: epigenetics, the microbiome, immunotherapy, regenerative medicine, next-generation sequencing, microfluidics, digital health, and more. All have their own IP considerations but three areas stand out.
Gene editing. In the CRISPR wars, the saga continues. 2017 saw the US Patent Office find for Harvard/MIT’s Broad Institute, but 2018 begins with a Broad patent revoked in Europe.
All subject to appeal and with further patents and applications in examination and/or dispute so we will likely not know this year who if anyone really has control. Meantime, other editing approaches that may not be subject to key CRISPR patents are coming through, and many applications are being filed on downstream developments so expect sub-plots to develop this year in areas such agriculture.
Antibodies and friends. This is a maturing technology whose patent space is filling up with ever more detailed claims to treatment regimes, formulations and so on as well as antibodies defined by individual sequences and epitopes.
Examination is getting tougher and claims narrower. On the FTO side, the oldest patents are now expiring and biosimilars are coming over the horizon. Some originators of early monoclonals did not seek patents outside the main developed country markets, so things may move differently and faster in the developing world.
In parallel, new antibody-related molecule formats are being patented and starting to come on stream commercially. It is not yet clear which of these will win out but Cambridge has always led the way in this area and 2018 will likely see this continue.
Gene therapy. 2018 may be the year this powerful technology, which eventually promises one-shot cures for the world’s most debilitating genetic diseases, finally comes of age.
Practical complications have chilled the field but there is renewed optimism following a recent FDA approval. The big focus is currently on rare diseases but more common ones such as haemophilia may also be treatable before long.
There is a corresponding upswing in patent filings but examination is usually challenging as often much is known in principle about what to treat and how, so Patent Offices tend to argue obviousness.
Look for unexpected advantages but also consider orphan drug status in case patenting proves intractable.
Watch this space…