Highlights from our pharmaceuticals conference

Compulsory licensing in Europe 

Key takeaways:

• The patent compulsory licensing regimes differ from country to country in Europe, but the requirements are generally difficult to satisfy.
• In patent litigation, proportionality defences may also be available, but again only in very exceptional circumstances.
• The European Commission is seeking to build a more efficient and co-ordinated compulsory licensing scheme in the EU.

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Rare diseases: exclusivity protection and its limits for therapeutic products in this area

Key takeaways:

• Research into rare diseases is booming, with technological advances enabling targeted cures and lucrative returns.
• Therapeutic products for rare diseases are however pushing the limits of traditional exclusivity protection under intellectual property rights.
• While patents still have a role to play, the most powerful right - if it can be obtained - is a 10 year orphan drug exclusivity right.

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Forum shopping – what's your UPC strategy?

Key takeaways:

• The new system will provide opportunities for patent litigation strategies in addition to those in the existing national systems.
• Using Unitary Patents and the Unified Patent Court (UPC) involves in particular the balancing of cost benefits, enforcement risk and revocation risk. 
• The UPC has mixed civil law and common law features, meaning that broad skill sets will be required from lawyers to develop fresh UPC approaches to law, preliminary injunctions and other procedural aspects of the court.
  
   

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Preparing your company for an exit

Key takeaways:

• When preparing for an M&A, IPO and/or funding round exit, it's key to understand what the buyer is looking for, and to pre-empt their likely due diligence so as not to be caught off guard.
• Establishing good corporate housekeeping is essential to tie up any loose ends ahead of the sale, including deal structure considerations for a share sale or asset sale; solving litigation such as supplier disputes; and maintaining an organised data room to be handed over to the buyer on completion.
• Aligning your IP strategy to your exit strategy is important. As well as shaping the filing strategy, IP counsel can help to identify new assets to maximise the value of your IP portfolio, and in turn increase the value of the company.

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Collaborating with an AI company to identify molecules or targets

Key takeaways:

• There are a large variety of ways that AI is featuring in the market, including activity around the design and optimisation of molecules in silico for pharmaceutical applications, identifying trends in literature and risks of patients developing disease.
• Although deals are structured in familiar ways, very high upfront fees are being seen which seem to reflect the multiple disease areas being covered and royalties are tiered and slightly higher than traditional discovery stage deals.
• There is typically sensitivity about the transfer of algorithms and data between AI providers and their pharmaceutical partners, which can require extensive negotiation to ensure the protection of respective rights.
  
   

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Latest from the EU and UK on data privacy regulations

Key takeaways:

• Following publication of the European Commission's ambitious digital strategy vision in February 2020, a significant number of new (and revisions of existing) laws have been drafted, with an emphasis on digital platforms, regulation of data and AI. 
• The EU is establishing an ambitious new data sharing and access framework under laws that encourage public sector data sharing, data intermediaries, data altruism and general data sharing. Additionally, there is a proposal for a European Health Data Space (the first of the proposed data spaces) which will give individuals more control of their health data and will set out a new environment for sharing health data for secondary use purposes. The proposed EU AI Act attempts to regulate AI systems (distinguishing between prohibited and high risk AI systems) and sets out where further safeguards are required.
• The UK Government does not currently intend to bring in legislation for AI systems but has proposed a new Data Protection and Digital Information Bill to replace the UK GDPR (although at the time of writing, this proposal is currently paused). 
  
   

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Vital disease education/information through the use of digital marketing tools such as social media and other specific apps

Key takeaways:

• In Europe, advertising prescription-only products is not permitted, while disease education is permitted, leading to a clash of requirements.
• Lawyers from across Europe discuss ways and means for manufacturers and distributors to compliantly engage in disease education programmes.
  
   

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Early access schemes  

Key takeaways:

• A number of European countries provide routes to medicine use in limited circumstances before they are authorised, including compassionate use and/or early access schemes.
• Although there are many similarities between these schemes, there are also a number of differences and so local advice is required.
• A particular marketing challenge in most jurisdictions is that it is not permitted to promote a product before it is authorised.
  
   

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