Patent Term Extensions and SPCs
For medicines and agrochemicals, years of a patent’s 20-year term can be lost waiting for the regulatory approval needed to bring a product to market. Supplementary Protection Certificates (SPCs) and patent term extensions exist to give that time back, extending protection for products whose commercial life has been shortened by the approval process.
Panoramix IP helps you secure and manage this valuable additional patent protection, with an in-house team that handles the eligibility analysis, the filing and the deadlines, so your product keeps its exclusivity for as long as the law allows.
SPCs can add up to five years of protection, potentially covering some of the most commercially valuable years of a product’s life, so getting the strategy and the timing right is critical. We guide innovators through the requirements in the UK and coordinate international IP protection across Europe and beyond.
• Eligibility and strategy analysis for SPCs and patent term extensions
• Filing and prosecution handled in-house, with deadlines tracked
• Coordinated UK and international extension strategy
SPC & Patent Term Extension Experts: Here To Help
Our patent professionals help you capture every additional day of protection your product is entitled to, assessing eligibility, filing on time, and managing the extended rights that follow, so nothing is left on the table.
Here’s what we help with:
• Assessing whether a product qualifies for an SPC, including medicinal and plant protection products
• Identifying the correct basic patent and marketing authorisation to rely on
• Filing and prosecuting SPC applications at the UK IPO
• Coordinating SPC filings across European and other jurisdictions
• Advising on and securing paediatric extensions of SPC term
• Managing SPC and extension deadlines, renewals and lapse risk
• Advising on equivalent patent term extensions in other territories, including the US
For businesses in the pharmaceutical industry, we can integrate SPC planning with the wider patent portfolio and product lifecycle strategy, helping ensure protection is considered from initial filing through to the end of a product’s commercial exclusivity.
Our SPC & Patent Extension Process
If you want to extend protection for a regulated product, here’s how it works with Panoramix IP:
• We have a quick call to understand the product, the basic patent and the regulatory approval position
• We assess eligibility and identify the strongest basis for an SPC or extension
• We calculate the likely term and advise on the commercial value of proceeding
• We prepare and file the SPC application within the strict deadline
• We handle prosecution and any objections through to grant
• We manage the ongoing deadlines, including any paediatric extension and renewals
We offer a free consultation to new customers who would like to discuss their patent protection and renewal requirements with us, so that we can guide on the next best steps for your business.
Brands we have Helped
Reclaiming Lost Patent Term
A patent lasts 20 years from filing, but for medicines and agrochemicals a large part of that term can be consumed by the clinical trials and regulatory review needed before a product can be sold. By the time a marketing authorisation is granted, much of the patent’s commercial life may already have passed.
An SPC compensates for that delay, extending protection for the approved product by a period linked to the time lost, up to a maximum of five years, with a possible further six months where the relevant requirements for a paediatric extension are met. Because these can be some of the most commercially important years in a product’s lifecycle, an SPC can become one of the most valuable rights in a patent portfolio.
We help you secure it correctly and on time, while considering how the extension fits into your wider patent strategy.
Timing, Eligibility and Getting It Right
SPCs are governed by detailed and often technical rules, and eligibility is not always straightforward. Questions frequently arise over which patent and which authorisation to rely on, what counts as the relevant product, and whether earlier authorisations affect the position. Mistakes or missed deadlines can mean losing the extension entirely, with no second chance.
The filing deadline is strict and tied to grant of the marketing authorisation and the patent, so early planning is essential. We assess eligibility carefully, identify the best basis for the application, and manage the deadlines so your extension is secured.
Where protection is needed across multiple countries, we coordinate filings as part of a wider international IP strategy, helping extend protection consistently across the markets that matter.
A Coordinated International Approach
Supplementary protection is territorial. In the UK an SPC is obtained through the UK IPO, and separate certificates are needed in relevant European countries where extended protection is sought. Other regions operate their own mechanisms, including patent term extension in the United States, which follow different requirements and timelines.
For products sold internationally, a joined-up strategy helps ensure valuable additional protection is secured where it counts, without deadlines slipping in any one territory.
Through our in-house team and trusted associate network, we coordinate international patent protection, SPCs and patent term extension strategy across jurisdictions, giving you a coherent plan to maximise the protected life of your product.
Speak to our team on 01522 712 433 or email info@panoramixip.co.uk to get started.
FAQs
What is a Supplementary Protection Certificate (SPC)?
An SPC is a right that extends protection for a patented medicinal or plant protection product beyond the expiry of the basic patent, to compensate for some of the time lost obtaining regulatory approval.
It comes into effect after the patent expires and can provide up to five years of additional protection, making it a potentially valuable part of the wider patent protection available to pharmaceutical and agrochemical innovators.
What is the difference between an SPC and a patent term extension?
They are closely related concepts serving a similar purpose, restoring patent protection lost to regulatory delay, but they are separate legal mechanisms in different regions.
SPCs are the system used in the UK and across Europe, while other jurisdictions, such as the United States, have their own patent term extension mechanisms. The eligibility rules, term calculations and deadlines differ, so an international product needs a coordinated approach. Our international IP team can help coordinate protection across territories.
How much extra protection can an SPC provide?
An SPC can extend protection for a maximum of five years. The exact term is calculated by reference to the period between filing the basic patent and obtaining the relevant first marketing authorisation, subject to the applicable statutory calculation and five-year cap.
A further six-month paediatric extension may also be available where the relevant requirements have been satisfied. We calculate the likely term as part of assessing whether an SPC should form part of your wider patent strategy.
What products are eligible for an SPC?
SPCs are available for qualifying medicinal products for human or veterinary use and plant protection products that are protected by a patent and require the relevant authorisation before they can be placed on the market.
Eligibility depends on several detailed conditions, including the relationship between the product, the basic patent and the relevant authorisation. For businesses operating in the pharmaceutical industry, we can assess SPC eligibility alongside the wider patent portfolio and commercial lifecycle of the product.
When do I need to apply for an SPC?
The deadline is strict and is tied to the grant of the relevant marketing authorisation and the basic patent. Generally, an application must be made within six months of the relevant authorisation being granted, or within six months of the patent being granted if that occurs later.
Missing the deadline can mean losing the opportunity entirely, so early planning is essential. We track these dates and coordinate them with the wider management of your patent portfolio.
Do I need separate SPCs in different countries?
Yes. Supplementary protection is territorial. In the UK an SPC is obtained through the UK IPO, and separate certificates generally need to be applied for in the European countries where extended protection is required.
For products sold internationally, we can coordinate SPCs and other forms of international patent protection so that filing decisions and deadlines are managed across the markets that matter to your business.
How much does it cost to obtain an SPC?
Costs depend on the number of territories involved, the complexity of the eligibility questions, any objections raised during prosecution and the official fees applicable in each jurisdiction.
Given the potential commercial value of additional exclusivity, the cost of obtaining an SPC should be considered as part of the product’s overall patent strategy. We will scope the work and provide a clear estimate before proceeding.
Client Testimonials
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Our Case Studies
Case Study: British American Tobacco
Case Study: Cambridge Mechatronics
Case Study: The Chartered Institute of Patent Attorneys
Case Study: Wow Hydrate
Case Study: The Earthshot Prize
Case Study: Escape Fitness
