7 December 2017Europe

LSPN Europe 2017: Brexit, second medical use and more

Brexit and second medical use patent claims were two topics featured in the roundtable discussions at Life Sciences Patent Network (LSPN) Europe, a conference held in London.

The event included eight roundtables in total, with licensing, solving in-house counsel challenges, the UK doctrine of equivalents, and IP considerations in mergers and acquisitions some of the other topics.

On the Brexit roundtable, participants discussed how Amsterdam may have been picked over Milan for the new headquarters of the European Medicines Agency (EMA) because Milan has shown an interest in hosting a central division seat of the Unified Patent Court, should that seat be taken away from London in light of Brexit.

In November, the EMA announced that it will relocate from London in March 2019. It was reported that Amsterdam and Milan were tied at 13 votes each in the last round.

Some on the roundtable raised concerns that the UK may lose expertise in clinical trials after Brexit, but there were hopes that the British IP system could become more flexible and reach quicker solutions once the UK separates from the EU.

Even though there are potentially some positives and opportunities, such as the supplementary protection certificate regulation being ripe for review, the participants feared that the UK could become mired in transposing legislation before any advantages are realised.

In the meantime, the consensus is that it’s ‘business as usual’, while patenting strategies have been largely unaffected.

Attendees at the second medical use roundtable discussed a range of topics, including the threshold for showing plausibility in a patent application. One agreement was that having no data can be better than having some data which is incorrect, however the participants struggled to find a solution to the problem, in what is clearly a challenging area.

Other questions which went unanswered concerned who should judge plausibility and how much skill they should have.

The discussion turned to second medical use as applied to devices, with the question being whether a second indication can be shown for these products. While there is no conceptual problem with doing this, there is a practical challenge, especially as there is no ‘skinny labelling’ in this area (and having it would require new regulation).

There would also be difficulties in deciding whether method or second medical use claims would be most relevant, however most participants agreed that overall, the issue of devices was not significant.

Attendees at the open clinic roundtable tackled some of the challenges facing in-house counsel, including budget concerns.

Hourly rates charged by private practice lawyers were highlighted, with some participants noting that they can be a barrier to engagement with smaller firms.

The question of how to restructure fees to allow engagement was raised. No clear answers were provided, although it was suggested that the concept of the hourly rate could be dead in 15 years.

The idea of getting rid of the patent system completely was mulled—so that drugs would instead just have a fixed period of exclusivity.

State intervention would be necessary, noted participants, adding that the exclusivity period could be commensurate with the investment made in developing the drug.

On the IP portfolio management roundtable, participants began by exploring the relationship between in-house counsel and private practice.

Participants agreed that IP portfolios should be diversified (like any other type of portfolio), while patents should always be an asset and have commercial value, not just commercial relevance.

One of the most difficult decisions to be made comes in the form of dropping patents. Who has the authority to drop the patents and when should this be done were two questions raised.

LSPN Europe was hosted by Life Sciences IP Review.

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