Tag Archives: spc

If you work with pharmaceutical patents, you’ve probably come across the term
SPC—Supplementary Protection Certificate. It’s one of those acronyms that pops up
regularly in discussions about extending patent life for drugs, especially in Europe. But how
do different jurisdictions approach patent term extensions, and more importantly, does
Turkey have something similar? Let’s break it down.

Why Is Patent Extension Needed in Pharma?
Patents typically last 20 years from the filing date. However, in the pharmaceutical industry,
a good chunk of that time is eaten up by regulatory approval processes. Between clinical
trials and market authorization, it can take 10–15 years for a drug to actually reach patients.
That leaves very little time for innovators to enjoy the benefits of market exclusivity before
generics step in.
This is where systems like SPCs come into play. They help restore part of the lost time by
offering a limited extension of protection for approved medicinal (or plant protection)
products.

How Different Jurisdictions Solve This Problem
European Union:
The EU introduced SPCs in 1992 (Regulation (EEC) No 1768/92, now replaced by Regulation
(EC) No 469/2009). An SPC can extend the protection of a patented active ingredient by up
to five years, with the possibility of a six-month extension for pediatric studies. SPCs are not
automatic—you need to apply for them within a strict timeframe after the first marketing
authorization in the EU or an EEA member state.
United States:
In the US, patent term extensions (PTEs) are governed by the Hatch-Waxman Act (1984).
Here, too, the idea is to compensate for regulatory delays. A PTE can add up to five years to
a patent, but the total effective patent life (including the extension) cannot exceed 14 years
from the product’s approval date.
Both systems aim to strike a balance between rewarding innovation and allowing earlier
access to generics.

Does Turkey Have SPCs?

Not exactly—but it has a workaround.
Turkey is not part of the EU, so EU SPCs don’t apply here. Also, Turkish patent law does not
currently provide a local equivalent of the SPC or a direct patent term extension mechanism.
Once a patent expires, protection ends—regardless of how long it took for the drug to
receive marketing authorization.
This can present challenges for pharmaceutical companies, especially when launching in
Turkey takes longer than in other jurisdictions due to pricing negotiations or regulatory
procedures.
The Turkish Alternative: Data Exclusivity
While Turkish law doesn’t offer SPCs, there is a specific provision in the Regulation on the
Licensing of Human Medicinal Products (last amended in 2022) that provides limited data
exclusivity:
 Data exclusivity in Turkey lasts for six years starting from the first marketing
authorization date in Turkey, or from the first authorization in the European Customs
Union (whichever is later), provided that the application is filed in Turkey within 12
months of that first authorization.
This is not the same as a patent term extension—but it does create a form of market
protection by preventing generic applicants from relying on the originator’s data during the
exclusivity period.
What does “relying on the originator’s data” mean?
When a pharmaceutical company develops a new drug, it submits a detailed dossier to
regulatory authorities that includes preclinical and clinical trial data to prove the drug’s
safety, efficacy, and quality. This data is costly and time-consuming to generate.
Generic companies, when they want to enter the market, typically don’t repeat these trials.
Instead, they file an abbreviated application that refers to the original drug’s
dossier—effectively relying on the originator’s data to gain approval.
Data exclusivity blocks this shortcut. For the duration of the exclusivity period (six years in
Turkey), regulators are not allowed to approve generics based on the originator’s data.
Generic manufacturers would need to generate their own full set of clinical data—a move
that is rarely feasible in practice.
So, while data exclusivity doesn’t extend the patent, it offers a different type of barrier to
generic entry by protecting the data that supports the original drug’s approval.

Final Thoughts

For companies operating globally, it’s important to remember that patent protection in
Turkey ends when the 20-year term ends—no extensions. However, data exclusivity may
offer limited commercial protection post-patent in some cases, especially for innovative
products with later Turkish launches.
If you’re filing in Turkey or advising clients who are, the key is to plan early. Consider
regulatory timelines, pricing strategy, and data exclusivity terms to make the most of the
available protection.