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The Evolving SPC Framework: CJEU Case Law, National Divergence and Patent Office Perspectives
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?
