AI is rapidly transforming life sciences and healthcare, powering applications in drug development, diagnostics and clinical decision support. With many technologies now likely to fall within the EU AI Act’s high-risk category, companies must implement robust governance and oversight mechanisms while navigating complex interactions with medical device frameworks and emerging product liability rules.

This session will examine how the EU AI Act’s high risk framework is shaping AI deployment across the industry, and explore the implications of the landmark legislation for your legal governance structures, technology validation and liability risk.

-Which life science technologies are most likely to fall within the EU AI Act’s high-risk classification?
- What governance, transparency and human oversight obligations will companies need to implement when deploying high-risk AI systems?
- How will the AI Act interact with existing MDR and IVDR frameworks, particularly for AI-enabled diagnostics and medical device software?
- Could overlapping requirements between the AI Act, MDR/IVDR and product liability frameworks create new litigation risks and challenges for technology validation?
- What practical steps should legal teams take to ensure their high-risk AI governance frameworks are fit for purpose?

From recent updates to patent term extensions and the patent linkage system to fundamental reforms to judicial enforcement and regulatory exclusivities, the Chinese life science legal landscape has undergone change on a seismic scale in recent years.

This compare-and-contrast session will examine how China’s evolving patent linkage system, PTE regime, regulatory exclusivities and enforcement landscape compare with similar frameworks in Europe, and what this means for your international strategy.

- Patent Term Extensions - How well is the system working? What are the core issues? How does it compare to SPC protection?
- Patent Linkage System – How well is it working? Where are the difficulties for companies? Does it provide a different level of certainty around the time of exclusivity loss and generic entry compared to the EU?
- Data Exclusivity & RDP – How are protections changing in China? Are the new regulatory frameworks converging with those in the EU?
- How similar is the patent litigation and antitrust enforcement landscape between China and the EU?

High-value life science acquisitions seldom occur without scrutiny. As governments increasingly treat advanced biotechnology, pharmaceutical manufacturing capabilities and proprietary research platforms as strategically sensitive assets, cross-border transactions in the sector are more likely than ever to trigger foreign investment screening and national security review. At the same time, the core patent portfolios, platform technologies and regulatory data packages driving these deals often attract immediate attention from competitors seeking to challenge the strength and scope of acquired IP before commercial launch.

This session will examine how legal teams safeguard the value of life science acquisitions by navigating foreign investment clearance processes while proactively managing the IP risks associated with newly acquired technologies. Bringing together corporate and IP perspectives, the discussion will explore how your company can structure transactions and prepare for potential IP challenges that may arise once high-profile acquisitions become public.

- When do life science acquisitions trigger foreign investment screening, and how can companies manage the resulting deal approval risk?
- How do regulators assess transactions involving strategically important life science technologies and IP portfolios?
- How can legal teams identify vulnerabilities in acquired patent portfolios and assess FTO risks before completing a transaction?
- What early IP and legal measures need to be put in place to protect newly acquired products?
- How should legal teams coordinate post acquisition to safeguard exclusivity and maximise the long-term value of acquired assets?

Differences between European and U.S. patent doctrines in areas such as inventive step/non obviousness, sufficiency/enablement and the treatment of plausibility/written description create significant strategic complexity for companies seeking to secure or challenge patent protection globally. For IP teams, the challenge lies not only in understanding how different jurisdictions approach core aspects of patentability in isolation, but also in assessing how contrasting approaches shape the coordination of prosecution and litigation strategy across international markets.

This multi-jurisdictional compare-and-contrast session will analyse diverging European and USPTO approaches to patentability, and examine how legal teams can adapt patent drafting and broader portfolio management strategies in response.

- What are the most consequential points of divergence between European and USPTO approaches to inventive step/non-obviousness and sufficiency/enablement?
- Is plausibility in Europe becoming a higher hurdle than U.S. written description and enablement, or are the two systems beginning to converge in these respects?
- How do contrasting approaches to patentability shape how originator and generic companies approach opposition and litigation strategies in each jurisdiction?
- What do doctrinal differences mean for how legal teams coordinate patent drafting, prosecution and post-grant strategy, including the use of PTAB proceedings, across the U.S. and Europe?

As life science companies expand across multiple jurisdictions, decisions about where and how to structure your company’s operations can carry significant implications for tax exposure, regulatory oversight, IP protection 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 risks across major jurisdictions and strategies for aligning operations internationally.

-Which legal, IP and regulatory risks should drive jurisdiction selection when expanding life science operations internationally?
- How should companies structure corporate entities 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?

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 vs 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?
- How do second medical use claims and skinny labelling practice interact with competition law?

Communications about competing 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 competing medicines.

- Where do competition authorities draw the line between legitimate scientific debate and unlawful disparagement?
- 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 competing therapies become evidence in competition investigations?
- How does disparagement fit within the broader category of exclusionary conduct in life science competition law?

As competition authorities intensify scrutiny of patent settlements in the life sciences sector, so called “pay-for-delay” agreements remain firmly in the enforcement spotlight. For litigators and legal teams navigating complex disputes, the challenge is no longer simply whether to settle, but how to structure agreements that balance commercial objectives against evolving antitrust expectations.

This focused industry briefing will provide a practical overview of how pay-for-delay risk is shaping settlement strategy in the life sciences sector, drawing on recent enforcement trends and real-world considerations across the U.S. and Europe. Attendees will gain clear, actionable insight into how to identify risk and structure defensible agreements that withstand scrutiny while preserving commercial outcomes.

- How are competition authorities in the U.S. and Europe currently assessing pay-for-delay agreements? Where are the key divergences?
- What value transfers are most likely to attract antitrust scrutiny in settlement agreements?
- How are evolving antitrust enforcement trends influencing whether, when and on what terms companies choose to settle life science disputes?
- What practical steps can legal teams take to structure settlements that withstand competition scrutiny while achieving commercial objectives?
- How should companies assess whether a proposed settlement could be perceived as restricting competition or delaying market entry?

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): 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.
- 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?