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Pharma and biotech legal developments - C5 conference report

I spent two fascinating days at the C5 Pharma and biotech conference last week. Some of the more interesting takeaways:

  • in determining the appropriate boundaries for the patentability of biotechnology, EU law is currently triumphing over the EPC with the CJEU supporting a relatively pro-biotech industry interpretation, permitting the patenting of inventions involving parthenotes (cells derived from a human ovum that cannot develop into a full term human embryo) - a case where DLA Piper acted for the winning party. However, Rob Aerts (Tigenix) highlighted that the absence of an official cross-referral mechanism between the two regimes risks an unhelpful lack of consistency.
  • whilst the result is not surprising, Luca Falciola's (DROIA Oncology Ventures) analysis of EPO statistics confirms that pharma and biotech patents are opposed more often than the average and generally older when amended, suggesting a systemic delay somewhere in the system (examination and/or opposition/appeal).
  • the importance of incentivizing research for new uses of existing drugs by providing fairly balanced patent protection to support new therapies coming to market, given the high costs of developing such therapies. Juergen Dressel, Novartis Pharma, advocated a pragmatic and realistic approach when deciding the standards for infringement and plausibility in this area, and the need to provide legal certainty for all players.
  • The greater effort that market entrants put into clearing the way early and the major role of process patents were highlighted in the discussion on Biologics and Biosimilars, with companies seeking to enter the market being more risk adverse given, e.g., the difficulties of relocating manufacturing facilities and expertise. There was a lively dispute between Lorenz Kallenbach (Merck) and Corinna Sundermann (Fresenius Kabi) around whether a EU SPC manufacturing waiver was appropriate.
  • Whilst there are significant differences between the search and seizure regimes of France, Belgium and Italy, orders are easy to obtain (with over 50% of patent cases being started by way of a saisie-contrefacon). Differences include the ability to protect confidential information and what information can be accessed (with Dutch courts ordering access be provided to foreign and cloud based servers). The current trend in France is to seek seizure orders based on both patents and trade secrets.
  • Finally Francesco Maccetta (Bracco), valiantly tried to crystal ball-gaze on the fate of the UPC, with an encouragingly optimistic assessment of the ability for the UK to continue to participate in the system post Brexit.


upc, pharmaceuticals, patents, biotechnology, second medical use, epo

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