As life science companies expand across multiple jurisdictions, decisions about where and how to structure your company’s operations can carry significant implications for IP strategy, regulatory oversight, corporate exposure and competition risk. 

This session will examine the core legal and strategic considerations underpinning entry into new international life science markets, with a focus on the key IP, regulatory and commercial risks across major jurisdictions and how companies can align their operations across borders.

-Which IP, regulatory and commercial legal risks should drive jurisdiction selection when expanding life science operations internationally?
- How should companies structure corporate entities, IP ownership and licensing agreements when entering regulated pharmaceutical markets?
- How should companies manage competition law, pricing and market access risk when expanding internationally?
- What governance frameworks are needed to manage legal exposure on a global scale and ensure coordination between corporate, regulatory and IP teams?

Second medical use patents remain one of the most commercially sensitive tools in the originator playbook. Yet they are among the most volatile of protection mechanisms when it comes to validity challenge and “skinny labelling” carve-out strategies.

This session will explore the latest case law updates and patentability challenges in the European, U.S., and Brazilian second medical use and skinny labelling spaces, covering new strategies for building and attacking these patents.

- What are the key implications of recent second medical use case law, including the landmark UPC Local Division ruling on Amgen v Sanofi (2024)?
- What is the current EPO stance on reasonable expectations of success for second medical use?
- How should companies approach plausibility and data requirements in Europe post G2-21?
- How has the UPC shaped strategy around second medical use claims?
- What does the U.S. Supreme Court decision in Hikma v Amarin reveal about the future of skinny labelling practice?
- How is the approach to second medical use patents evolving in Brazil, and what do INPI’s new examination guidelines mean for patentability and enforcement strategies?
- How do second medical use claims and skinny labelling practice interact with competition law?

Communications about third-party therapies play a critical role in life science competition, particularly where companies seek to influence clinical practice and decisions surrounding pricing and reimbursement. However, statements relating to the safety, efficacy or regulatory status of rival products may raise competition concerns where they risk distorting market perceptions.

This session will examine the competition risks associated with product communications in the life science sector, and explore how you can manage the boundaries between legitimate scientific debate and unlawful disparagement when discussing third-party medicines.

- Where do competition authorities draw the line between legitimate scientific debate and unlawful disparagement?
-How might Sanofi's proposed commitments in response to the European Commission's antitrust investigation into Efluelda reshape the competition law boundaries for communications about third-party therapies, and how do they compare with the earlier Vifor commitments?
- What types of product communications are most likely to attract competition scrutiny?
- How should companies manage the legal risk of product comparisons across departments?
- How might product communications about third-party therapies become evidence in competition investigations?
- How does disparagement fit within the broader category of exclusionary conduct in life science competition law?

Legal teams handle relentless volumes of routine contracts and repetitive requests from the business. A significant proportion follows playbooks, yet the work still goes through senior lawyers. 

Every team is being told to adopt AI. A few have figured out how to actually create more capacity for the legal team and improve the service to the business with it. This session shares what those teams do differently and offers a practical framework: mapping the line between the routine, high-volume work AI agents can reliably handle and the judgement-heavy work that needs to stay with lawyers. Charlotte Kufus, co-founder at Flank, looks at how those teams keep control of quality and risk, and where the line is likely to move next.

Supplementary Protection Certificates remain at the heart of pharmaceutical and biotechnology patent lifecycle strategies. Recent CJEU referrals, together with divergent decisions emerging from national courts, have raised crucial questions about key provisions of the SPC Regulation and how they are interpreted across European jurisdictions. The outcomes of these important cases hold significant strategic implications for the future pursuit, enforcement and opposition of SPC protection across the life science industry.

This session will review the past year’s most significant SPC-related decisions from the CJEU and national courts, bringing together private practitioners, senior in-house counsel and representatives from European patent offices to explore their implications for future SPC practice. In addition, the discussion will consider how ongoing SPC-related policy developments, including draft measures under the EU Biotech Act and the proposed introduction of a unitary SPC system, may further reshape the strategic use of SPC protection within the broader European exclusivity framework.

- CJEU Referral C-456/24 (Halozyme) and Advocate General Emiliou's Opinion: what qualifies as an “active ingredient” under Article 1(b)?
- CJEU referral C-15/26 (Boehringer Ingelheim v GPTO) concerning ciclesonide: can a later veterinary MA qualify as “the first authorisation to place a product on the market as a medicinal product” where an earlier human MA already exists for the same active ingredient? How strict is Article 3 (d) on this point?
- Conflicting European national case law concerning lisdexamfetamine and the recent CJEU referral C-794/25 (Stada v Takeda): what constitutes the “product” in a pro-drug scenario?
- Pending CJEU referrals and national court decisions on the SPC manufacturing waiver, including C-371/26 (Janssen v Samsung Bioepis).
- How might proposed incentives relating to 12-month SPC extensions for innovative biotech medicines and ATMPs under the EU Biotech Act play out in practice?
- What are the latest developments on the proposed unitary SPC system? What are the likely timings? Who will have jurisdiction? How will appeals be handled?

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?

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?