Last week, life sciences patent professionals from around the world gathered at London’s Hallam Conference Centre for IAM’s second annual Pharma and Biotech IP Summit – the first ever IAM event to be held on UK home turf. Delegates – and there were twice as many in attendance than were at our first summit in Munich in 2016 – were treated to insightful presentations and discussions by seasoned in-house and private practice professionals on a range of key legal, strategic and policy-related topics.
For those of you who were not able to make it this time, here are a few of the key talking points to come up at the summit put together by myself and IAM's life sciences reporter Adam Houldsworth:
Third-party involvement in patent litigation – One, admittedly unexpected, hot topic at the conference was the prospect of increased third-party involvement in pharma patent disputes, and what this could mean for litigation strategy.
Against the background of the Commonwealth of Australia’s ongoing dispute with Sanofi-Aventis, there was debate about whether governments, public-funded health bodies, insurers and patient groups might increasingly take legal action against pharma patent holders. The Australian state is seeking compensation for the additional money the country’s Public Benefits Scheme had to spend as the result of Sanofi’s interlocutory injunction keeping generic versions of its Plavix drug off the market prior to the innovator’s patents ultimately being found invalid.
If such suits become more frequent, in Australia or elsewhere, it was suggested, patent holders might have to be more cautious in their enforcement strategies. And not only because of the possibility of damages: one delegate suggested that disputes between innovator pharma companies and –for example – the UK National Health Service would pose reputational risks for the patentee, and intensify political controversies surrounding market exclusivity in the life sciences.
US patent eligibility as a break on innovation – Not so unexpected was the debate that arose on the subject of patent eligibility, particularly in the United States. The restrictions on patenting diagnostic methods under US law were delineated by panellists, one of whom described them as a threat to the United States’ status as the world hub of innovation in the life sciences.
The ITC as a venue for biosimilar litigation – Issues surrounding biosimilar litigation were a major talking point, too. The options available to US patent holders in light of last year’s Supreme Court decision that the so-called patent dance could not be enforced by injunction at federal level were discussed at length, with one speaker suggesting that the International Trade Commission (ITC) could become a major venue for biosimilars disputes. ITC Section 337 investigations, it was said, could provide efficient means of achieving injunctive relief against IP-infringing drug imports for biologics patent holders.
Brexit and the UPC - Of course, no patent-related event in Europe these days is going to escape discussion of either Brexit or the potential impact of the Unified Patent Court – should it ever get up and running.
On the former, there was wide agreement that as things stand, no-one has much idea what is going to happen. Patents and patent owners are not directly affected by Brexit because there is no unitary patent system in Europe, but it was noted that over recent years there has been a trend for European patent judges to spend more time talking to each other, with courts in one country now prepared to give much more weight to judgments handed down in others when hearing similar cases. As England and Wales is perhaps Europe’s most important life sciences venue, there is no doubt that decisions reached by judges in the jurisdiction are currently looked at very closely by their peers elsewhere. Whether this will continue post-Brexit remains to be seen.
As for the UPC, there was widespread scepticism about it seeing the light of day pre-Brexit and around the UK’s participation in the system at any time. However, some at least are continuing to make preparations on the off chance that the UK does ratify the UPC Agreement and the case currently before the German constitutional court on the legality of Germany’s ratification goes nowhere quickly. One interesting point raised was whether the opting in and opting out regime might give rise to generic companies making accusations of patent owners gaming the system, with all the consequences that might have as they seek to enforce their rights. Like the UPC itself, it was an issue left hanging in the air. Perhaps one day, though, we might find out whether it has some legs.
Patent quality waning? – Questions were raised about the quality of patent drafting, with one questioner – whose point seemed to resonate with other delegates – suggesting that there had been a decline in the standard of filings in recent years. Another contributor argued that a number of weak patents had been granted by the EPO, many of which seemed to survive opposition proceedings, but not litigation.
Patent credibility in danger? – A recurring theme across a number of discussions was the gaming – or perceived gaming – of the patent system, and the consequences this might have for the IP system. While noting that most secondary patents protect significant innovations, more than one panellist suggested that there was a problem in some cases with patents representing only minor modifications being used to extend exclusivity significantly beyond the expiration of the core patent. One said that the future credibility of the IP system would depend on market exclusivity only being enforced to protect significant inventions.
Plausibility and data requirements - With the UK Supreme Court’s pregabalin hearing around the corner, there was much talk of ‘plausibility’ and ‘sufficiency’ in connection with patentability. There was consensus that plausibility, rather than absolute proof, is the proper standard for patent applications, but there was a vigorous debate about what that should mean in practice.
The requirement and ability to include data in patent applications in different jurisdictions became a particular focus of discussion, with talk of China’s restrictions on post-filing data capturing the audience’s attention.
Big thanks - As noted, the Pharma and Biotech Summit was the first time we had ever put on an event in the UK, which given that IAM has been around since 2003 is a bit of an oversight! Everyone at IAM would liek to thank all delegates, speakers and sponsors for making the conference such a success. Stay tuned for news of more IAM life sciences events in the very near future.
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