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 competitor therapies become evidence in competition investigations?
- How does disparagement fit within the broader category of exclusionary conduct in life science competition law?