In a landmark decision concerning SPC for Durvalumab, the District Court of The Hague upheld the Dutch Intellectual Property Office’s (IPO) refusal to grant a Supplementary Protection Certificate (SPC) for AstraZeneca’s cancer immunotherapy drug Durvalumab, marketed as Imfinzi®. Durvalumab is an anti-PD-L1 antibody used in treating various cancers, and the refusal of SPC status has sparked significant discussion in the pharmaceutical intellectual property landscape. This ruling highlights the strict application of SPC regulations in the Netherlands and sheds light on how inventive steps beyond broad patent claims are increasingly recognized and protected.

SPC for Durvalumab Dispute – Basic Details:

  • Case Number: SGR 22/1516 OCT95
  • Court Name: The District Court of The Hague
  • Decision Issued Date: Oct 15, 2025
  • Patent Number: EP1210428B1
  • Associated SPC Number: 300972
  • Applicant: Dana-Farber Cancer Institute, Inc.

SPC for Durvalumab Dispute – Basic Details of SPC:

An SPC is an intellectual property right that extends the protection of patented active ingredients in pharmaceutical and plant protection products beyond the standard 20-year patent term. This extension compensates for regulatory delays that companies often face before market authorization of their products. To qualify for an SPC under EU Regulation (EC) No 469/2009, the product must be “protected by a basic patent,” requiring a direct, clear, and explicit link between the product and the patent’s claims

SPC for Durvalumab Dispute: Dutch Court’s Position

AstraZeneca applied for an SPC based on Dana Farber Cancer Institute’s (DFCI) broad patent EP1210428B1, which covers PD-L1 antibodies in general. Although SPCs for durvalumab were granted in several European countries, the Dutch IPO rejected the application, and the denial was later upheld by the District Court of The Hague (case number SGR 22/1516 OCT95).

The court applied the two-stage test for SPC eligibility derived from key Court of Justice of the European Union (CJEU) rulings in

  • Teva UK Ltd v Gilead Sciences Inc (C-121/17),
  • Royalty Pharma (C-650/17), and
  • Teva v Clonmel.

This test requires that the product must

  • be specifically identifiable from the patent and
  • be protected directly and explicitly by the claims.

SPC for Durvalumab Dispute – The Court’s Finding:

  • The court ruled that durvalumab was not sufficiently “protected” by the DFCI patent despite the drug falling within the patent’s broad claim category.
  • This was because the DFCI patent did not mention durvalumab explicitly or specifically, nor was it directly derivable from the patent’s claims.
  • The court emphasized the “independent inventive step” involved in developing durvalumab, an advancement that went beyond the contributions claimed in the earlier patent.

SPC for Durvalumab Dispute – Key Insights from the Decision:

  • Strict Interpretation of SPC Requirements: The Dutch court’s decision underscores a stringent and literal interpretation of Article 3(a) of the SPC Regulation. The product must be clearly and explicitly protected by the patent, not merely fall within its scope broadly.
  • Inventive Step Matters: The court recognized that even if a product fits under a broad patent claim, significant additional invention can exclude it from SPC eligibility. This acknowledgment protects innovation that builds on earlier inventions but involves distinct, non-obvious contributions.
  • European Inconsistency: This ruling contrasts with decisions in countries such as Germany, the UK, and Ireland, where SPCs for durvalumab were granted. Such divergence illustrates ongoing legal uncertainty and uneven application of SPC law across the European Union.

SPC for Durvalumab Dispute – Next Step:

Applicant able to appeal against the decisions to the Dutch Council of State.

SPC for Durvalumab Dispute – Implications for Pharmaceutical Innovation and Patent Strategy:

This Dutch ruling serves as a cautionary tale and a beacon for innovators. Patent claims must be precisely crafted to define the invention clearly and comprehensively if one aims to secure SPC protection. Companies cannot rely solely on broad foundational patents to safeguard incremental innovations via SPCs.

The decision may encourage pharmaceutical companies to draft more specific patents tailored to new drug variants or molecules to ensure eligibility for SPC protection. Additionally, it highlights the ongoing challenge of navigating an inconsistent SPC framework in Europe, where national courts interpret regulations independently, leading to varying outcomes for the same products.

SPC for Durvalumab Dispute – Potential Regulatory Reforms Ahead:

To address these disparities and enhance legal certainty, the European Commission is considering reforms to the SPC Regulation. The proposed draft revision aims to harmonize SPC grant criteria across member states and prevent SPCs based on third-party marketing authorizations without explicit consent from the marketing authorization holder.

While these reforms could streamline SPC processes and foster innovation incentives, their implementation timeline remains uncertain. Until then, pharmaceutical companies must carefully strategize patenting and SPC applications across different jurisdictions.

SPC for Durvalumab Dispute – Important References:

  • Dutch District Court of The Hague, case number SGR 22/1516 OCT95, upheld the Dutch IPO’s refusal of the durvalumab SPC.
  • CJEU rulings:
    • Teva UK Ltd v Gilead Sciences Inc, Case C-121/17 (April 2019)
    • Royalty Pharma Investments v Comptroller General of Patents, Case C-650/17 (October 2019)
    • Teva Pharmaceuticals Europe Ltd v Clonmel Healthcare Ltd, Case C-443/19 (July 2021)
  • European Commission draft proposal for SPC Regulation revision (2023) [pending implementation]

SPC for Durvalumab Dispute – Conclusion:

The Dutch court’s refusal of the Durvalumab SPC for AstraZeneca marks a significant stance towards protecting genuine innovation in pharmaceuticals. It demonstrates that an inventive leap beyond broad patent claims can preclude SPC eligibility, encouraging clearer patent drafting and robust inventive efforts. Until EU-wide SPC harmonization takes effect, pharmaceutical companies must navigate a patchwork of national interpretations, balancing protection strategies with evolving regulatory landscapes.

This decision ultimately supports a fairer reward system for breakthrough innovations while reminding the industry of the complexities in SPC law making it a decisive moment for patent practitioners and pharmaceutical R&D strategists alike.