• Managing dual-covered members across all lines of business—commercial groups, ACA, individual plans, Medicare Advantage, and Medicaid
• The latest industry tools designed to automate COB identification and processing and how you simplify your workflows, reduce errors, and ultimately save both members and plans money
• Scenario planning to share and learn actionable strategies that can be implemented when you return to your office

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.

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?