In industries like pharmaceuticals, biotechnology, and plant protection, the standard 20-year patent term is often not enough. Lengthy regulatory approval processes can consume much of a patent’s lifespan, leaving companies with limited time to commercialize their innovations.
Supplementary Protection Certificates (SPCs) were introduced in Europe to solve this problem. By extending patent protection for up to five additional years, SPCs help companies safeguard innovation and recoup R&D investment.
This updated guide explains what SPCs are, who they apply to, the latest 2025 developments, and why they remain a critical part of IP strategy.
What Is a Supplementary Protection Certificate (SPC)?
An SPC is an intellectual property right available in the European Union and certain associated countries. It extends the protection of a patented product that has undergone regulatory approval before market entry.
SPCs are most relevant for:
- Medicinal products (including pharmaceuticals and biotech therapies)
- Plant protection products (such as pesticides and herbicides)
The SPC takes effect once the basic patent expires and can last for up to five additional years. In some cases—such as pediatric medicines—an extra six-month extension is also possible.
Why SPCs Exist
Developing new medicines or agrochemicals is expensive and time-intensive. It often takes 10–15 years from patent filing to receiving marketing authorization. By then, a large portion of the 20-year patent term is already used up.
Without SPCs, companies might only enjoy a few years of exclusivity before generic competition enters the market. SPCs are designed to restore balance by ensuring innovators have a fair chance to benefit commercially from their discoveries.
Conditions for Obtaining an SPC
To qualify for an SPC, several conditions must be met:
- A valid patent must cover the active ingredient.
- The product must have obtained a marketing authorization in the EU (or relevant jurisdiction).
- The SPC application must be filed within six months of either:
- The marketing authorization date, or
- The patent grant date (whichever is later).
- Generally, only one SPC per product per patent is allowed.
SPCs vs. U.S. Patent Term Extensions
While SPCs are unique to Europe, the United States has a similar mechanism: the Patent Term Extension (PTE) under the Hatch-Waxman Act.
Both aim to compensate for regulatory delays, but the rules differ:
- SPCs (EU): Maximum of five years (+ six months for pediatric use).
- PTE (U.S.): Maximum of five years, but the total patent life cannot exceed 14 years after FDA approval.
Other countries, including Japan and South Korea, also have patent term extensions. Companies with global portfolios must understand how these systems differ in order to maximize exclusivity.
Recent Trends in SPCs (2025 Update)
The SPC framework continues to evolve. In recent years:
- Unitary SPC Proposal: The European Commission has advanced plans for a unitary SPC linked to the Unitary Patent, allowing centralized filing across EU states instead of separate national filings.
- Manufacturing Waiver: Since 2019, generic and biosimilar manufacturers have been allowed to produce medicines for export outside the EU during the SPC term. This “manufacturing waiver” remains a hot topic in balancing innovation and access.
- Case Law Developments: The Court of Justice of the EU (CJEU) continues to refine rules on eligibility—especially around combination therapies and defining what qualifies as a “product protected by a patent.”
- Policy Debate: The EU is considering reforms to harmonize SPC rules further, aiming to reduce complexity for innovators and corporates filing across multiple jurisdictions.
How to Track SPCs in Practice
Professionals monitoring SPC activity often use data from the European Patent Office (EPO) and national patent offices. Useful tools include:
- Espacenet legal events for SPC status
- INPADOC patent family data for tracking filings globally
- Federated Register for consolidated SPC and patent information
For example, SPCs extended exclusivity for high-profile products like Lipitor (pharmaceuticals) and Spinosad (plant protection), highlighting their commercial impact.
Strategic Importance of SPCs for Corporates
For pharma and biotech companies, every additional year of exclusivity can represent billions in revenue.
SPCs are not just a legal extension—they are a strategic safeguard against early generic entry. In-house IP teams must coordinate carefully on:
- Filing timelines
- Regulatory approvals
- Global patent portfolio management
At a policy level, SPCs also play a critical role in encouraging R&D investment in Europe. Industry groups like EFPIA argue that SPCs ensure a fair return on innovation while maintaining balance with timely generic entry once exclusivity ends.
Conclusion
Supplementary Protection Certificates remain one of the most important tools for extending patent protection in Europe. They ensure innovators in pharmaceuticals, biotech, and plant protection can recover the enormous investments required to bring products to market.
But SPCs are complex. Each jurisdiction has unique requirements, deadlines are strict, and case law continues to evolve. At Azami, we help law firms and corporates navigate these IP challenges—ensuring valuable protections are secured wherever possible.
Frequently Asked Questions About SPCs
1. What products are eligible for an SPC?
Primarily medicinal and plant protection products that require regulatory approval.
2. How long can an SPC extend a patent?
Up to five years, with an additional six months for pediatric medicines.
3. Do SPCs apply worldwide?
No. SPCs are specific to Europe. Other countries have similar—but different—systems.
4. What’s the difference between an SPC and a patent term extension in the U.S.?
Both compensate for regulatory delays, but the rules and maximum terms differ.
5. How can SPCs be tracked?
Through the EPO’s Espacenet, INPADOC, and Federated Register tools, which record SPC status and expiry.
6. Why are SPCs important for businesses?
They can protect billions in revenue by extending exclusivity during the most commercially valuable years of a product’s life cycle.
