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08:50
09:00
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The EU Pharma Package and the proposed EU Biotech Act together represent the most significant legislative intervention in the European life science sector in over two decades. Taken together, these in …
09:50
10:30
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The EU Pharma Package’s controversial expansion of the Bolar exemption has the potential to recalibrate launch timing, litigation leverage and competitive dynamics across the originator-generic divide …
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The EU Pharma Package is poised to reshape the commercial landscape for life science companies operating in Europe, with far-reaching implications for pricing, reimbursement negotiations and market ac …
11:10
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This quick-fire presentation will examine how influence is built and exercised within life science legal functions, and how it shapes decision-making authority, career trajectory and team performance.
11:20
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Regulatory exclusivity frameworks are evolving at pace, with profound implications for how life sciences companies approach legal strategy across jurisdictions. In Europe, the EU Pharma Package is rep …
11:25
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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 A …
12:15
13:15
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Armed conflict, pricing interventions, the weaponisation of tariffs and intensifying policy competition between major jurisdictions are rapidly reshaping the global operating environment for life scie …Speakers
14:15
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Evolving clinical trial transparency obligations are materially affecting life science patent strategies, both in Europe and internationally, with growing tensions around public disclosures, post-fili …
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Once viewed as a defensive, compliance-driven function, regulatory engagement is increasingly being integrated into broader corporate strategies for long-term product protection. In the context of MFN …
15:00
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This interactive discussion explores how knowing what evidence and arguments have already succeeded or failed in litigation/oppositions around the world provides a head start and advantage in preparin …
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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, manuf …
15:20
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As scrutiny of inventive step and sufficiency intensifies in Europe under evolving EPO and UPC practice, originators face growing pressure to substantiate broad antibody claims with a credible technic …
15:40
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This session will bring together senior in-house counsel for a candid discussion on career progression, leadership development and building influence within life science organisations. Participants wi …
16:25
16:55
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This roundtable will examine the legal and strategic implications of the EU SPC manufacturing waiver, focusing on its “safe harbour” role in enabling export and day-one EU market entry while reshaping …
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As the U.S. Patent Trial and Appeal Board (PTAB) recalibrates its approach to discretionary denials under Director Squires' leadership, PTAB strategy is becoming harder to predict and more important t …
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The recent, high-profile Munich Regional Court decision on aflibercept has brought renewed focus to the application of the Doctrine of Equivalents in pharmaceutical patent disputes. The court’s reason …
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Managing IP ownership transfers following cross-border M&A transactions remains an underestimated challenge for many organisations, with ownership errors creating significant hidden risk across global …Speakers
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Trade secret protection is becoming an increasingly critical component of life sciences IP strategy, as companies reassess the boundaries between patent protection, regulatory disclosure and confident …
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This session will examine evolving Environmental, Social and Governance (ESG) obligations affecting the life sciences sector, including the revised Urban Waste Water Treatment Directive and its potent …
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This session examines the legal and governance challenges and solutions for life science companies engaging in collaboration and information sharing, including joint advocacy through trade association …
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When setting up a collaboration that is designed to last for 20+ years and enable development, manufacturing and worldwide commercialisation of critical medicines, the deal structure, governance and c …
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This session examines the legal and structural complexities facing small-to-medium-sized life science companies when pursuing licensing, collaboration, joint venture and M&A agreements with larger, mo …
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This discussion will examine the deployment of AI-driven legal tools across IP, regulatory, competition and transactional workflows within life science organisations. The session will explore the stre …
08:00
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Now firmly established as a key pillar of the European patent litigation framework, the UPC is forcing the life science industry to reassess how EPO prosecution strategy translates into downstream lit …
09:00
09:10
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Competition law is an industry hot topic and a central strategic risk for life science companies. This exclusive opening keynote interview will provide you with direct insight into the current perspec …
09:25
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Competition law is no longer a standalone legal discipline within the life science sector. As antitrust scrutiny expands across patent practices, litigation settlements, pricing and deal-making, compe …Speakers
10:20
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This closed-door workshop will bring together General Counsel, Chief Legal Officers and senior life science legal leaders for a peer-led briefing on the most consequential legal strategy challenges shaping the industry in 2026. Discussions will explore issues ranging from the legal implications of AI and legislative uncertainty to increasing antitrust scrutiny and expanding geopolitical pressures affecting the life science sector. Designed to encourage candid, off-the-record exchange, the session provides a confidential forum for senior leaders to share perspectives, compare strategic approaches and sharpen board-level legal judgement.
11:00
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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 un …
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The EU Pharma Package has instigated a landmark shift from market-access discretion to increasingly mandated market participation, with new launch and supply obligations raising fundamental questions …
11:30
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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 medica …
11:50
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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...
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Due to be implemented across Member States by December 2026, the new EU Product Liability Directive (PLD) introduces a fundamental shift in life sciences legal risk, marked by potential reversals of the burden of proof onto defendants, expanded disclosure obligations and new limitation periods of up to 25 years...
12:35
13:35
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Supplementary Protection Certificates remain at the heart of pharmaceutical and biotechnology patent lifecycle strategies. Recent CJEU referrals, together with divergent decisions emerging from nation …Speakers
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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 reim …
14:25
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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 …Speakers
14:35
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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 chall …Speakers
14:45
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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 over …
15:35
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High-value life science acquisitions seldom occur without scrutiny. As governments increasingly treat advanced biotechnology, pharmaceutical manufacturing capabilities and proprietary research platfor …
16:05
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Divisional filing strategies have become a crucial and often contentious issue at the intersection between life science IP and antitrust law. As patent offices face growing pressure to alter their sta …
16:25
16:55
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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 …
