The CMA marks a structural shift in EU life science policy, introducing new definitions, supply obligations, disclosure requirements and procurement mechanisms that will directly impact pricing, manufacturing strategy and governance frameworks. It signals a move from crisis-driven coordination towards a permanent resilience regime, embedding supply security and transparency as enforceable regulatory objectives.

This session will dissect this important new legislative framework, addressing its key aims, uncertainties and implications for your company.

- What will constitute a critical medicine?
- How will the Act work in practice?
- How will the responsibility for its implementation be divided between the Commission and Member States?
- What incentives or other support will companies receive for diversifying their supply chains towards Europe and participating in Strategic Partnerships?
- How will the new public and collaborative procurement initiative influence pricing dynamics?
- How will supply continuity obligations for critical medicines be enforced? Where is the litigation risk, and what is the scope for force majeure?
- What supply chain information will need to be disclosed/reported? What steps will be taken to protect commercially sensitive information?
- How will the Act interplay with the EU HTA Regulations and other legislative frameworks?

The life sciences sector has seen a marked increase in strategic acquisitions in recent years, as companies seek to replenish innovation pipelines and safeguard future growth against looming patent cliffs and loss of exclusivity. In this context, merger control is becoming a central strategic constraint, with competition authorities responding to heightened deal activity by intensifying their focus on pipeline overlaps, future competition and integration across R&D and manufacturing value chains.

This session will explore recent trends in the life science M&A landscape, before drawing on case studies to examine the latest developments in how competition authorities are scrutinising transactions.

- What are the key trends shaping life science M&A activity today? What are the predominant transaction types, and where is the most significant deal activity occurring globally?
- How are competition authorities currently assessing life science M&As? What types of deals are attracting the most scrutiny?
- What conclusions can be drawn from Illumina/Grail, Novo Holdings/Catalent and other recent cases in terms of how authorities are approaching innovation risk, vertical integration and control over critical capabilities?
- How should companies evaluate antitrust risk when acquiring early-stage or pre-market pipeline assets?
- When does horizontal or vertical integration create meaningful competition risk?
- At what stage in the M&A process should antitrust considerations influence the deal structure, valuation and conditionality, and how are companies adapting in practice?

Further medical use patents are directed to a new therapeutic use of a known active pharmaceutical ingredient. Clinical trials are often conducted to confirm therapeutic efficacy of the claimed medical use. A sponsor of a clinical trial is obliged to publish information on the trial. Already the protocol of the trial, i.e., the fact that patients with a specified disease are recruited for a clinical trial, wherein these patients are treated by administering a specified amount of a specified drug according to a specified dosage regimen, is regularly published before the first results are available.

Applicants for further medical use patents are therefore often caught in a dilemma. If the patent application is filed before the results of the clinical trials are available, there is a risk that the claimed teaching may be considered to have been insufficiently disclosed. If the patent application is based on the results of the clinical trial, the prior publication of the protocol will be considered in the assessment of inventive step.

In two recent decisions the German Federal Court of Justice (FCJ) confirmed patentability of further medical use patents in view of prior publications disclosing a trial protocol (X ZR 165/23 and X ZR 72/24, which both relate to the use of Fampridine for treating multiple sclerosis). Key considerations of the FCJ provided in these decisions will be explained and placed into the context of respective decisions of Boards of Appeal of the EPO confirming or denying patentability of further medical use patents in view of clinical trial protocols. On this basis, strategies for navigating the minefield will be outlined.

In the modern era of AI-driven in silico approaches for target selection and lead compound identification, companies must navigate nuanced and unresolved patentability issues, centred on inventorship, disclosure, novelty and non-obviousness. In parallel, regulatory agencies are scrutinising AI algorithms, data provenance and transparency within MA dossiers. To combat this, companies must tightly align their IP and regulatory strategies to secure defensible IP and exclusivity positions for their AI-assisted inventions.

This session will address the key unanswered questions surrounding AI patentability and examine the strategies available to you for securing comprehensive patent protection and straightforward regulatory approval for your latest AI-assisted inventions.

- Should you disclose the use of AI in generating a lead compound on a patent application?
- What are the potential consequences of not disclosing AI use for downstream litigation?
- How are patent offices evaluating key issues around inventorship, disclosure, novelty and non-obviousness for AI-assisted inventions?
- How are regulatory authorities handling AI use during drug discovery processes?
- How should patent drafting strategies for AI-assisted invention be shaped to align with downstream regulatory requirements?
- To what extent should human decision-making be documented during the AI-assisted drug discovery process?
- How and to what extent should IP and Regulatory leads brief R&D teams on their use of AI?

Evolving clinical trial transparency obligations are materially affecting life science patent strategies, both in Europe and internationally, with growing tensions around public disclosures, post-filing amendments and the requirement for more data to demonstrate a plausible clinical effect. Now more than ever, the ability to successfully patent a clinical invention depends on crucial decisions at the interface between IP and regulatory strategy.

This session will discuss the need for coordination between IP and regulatory teams on the publication of clinical data, strategies for safely redacting confidential clinical information relevant to your future patent filings and approaches for aligning your patent filing strategies with timelines around clinical trial disclosures.

- How do different jurisdictions define a novelty destroying act in the context of a clinical trial?
- Where are the boundaries drawn between prior art and novel material in Europe post G1/23?
- How are the EPO approaching plausibility and post published clinical data following G2/21?
- What are you required to disclose in clinical trial publications? What can you safely redact?
- Can retaining confidential information relevant to future patent filings be used as an argument to justify redactions from clinical publications?
- How might transparency and data-sharing reforms under the EU Pharma Package and Biotech Act impact disclosure risk and optimal filing strategy?