Protection beyond 20 years: data on SPCs and other term extensions for pharmaceutical patents

https://www.epo.org/en/node/protection-beyond-20-years-data-spcs

Protection beyond 20 years: data on SPCs and other term extensions for pharmaceutical patents

22.04.2024

Developing new drugs is a long and complex procedure. Before bringing a new medical product to market, pharmaceutical companies need to conduct all kinds of studies, trials and safety tests to obtain marketing approval from the relevant government authority. On average, this process takes around 12 years, which significantly shortens the effective period of patent protection for a new product.

To compensate patent holders for this "loss", various patent authorities around the world have introduced patent term extension systems for IP rights in pharmaceutical fields, including Supplementary Protection Certificates (SPCs) in the European Union.

This series of articles takes an in-depth look at SPCs. After introducing their basic features, we show you how you to access data on SPCs and other forms of term extensions using the EPO's search tools. Finally, we also explore SPCs for patents with unitary effect.

To set the scene, we begin by comparing SPCs with term extension systems in other major jurisdictions.

Part I: Basic concepts at a glance

Background

Patent term extensions for drug patents were first introduced in the U.S. in 1984, with South Korea following suit in 1987 and Japan in 1988. The EU subsequently introduced SPCs in 1993, primarily to ensure that European pharmaceutical companies did not suffer any competitive disadvantage compared to their counterparts in other major jurisdictions.

Unlike regulations in the U.S., South Korea or Japan, SPCs are not term extensions by strict definition, but rather separate IP rights that come into effect once the related patent expires. The table below compares the key features of SPCs with those of patent term extensions (PTE) in other major jurisdictions.

Requirements

	EU (SPCs)	U.S.	South Korea	Japan
Eligible technical fields	Pharmaceuticals, Plant protection products	Pharmaceuticals, Agrochemicals	Pharmaceuticals, Agrochemicals	Pharmaceuticals, Agrochemicals
Eligible categories of patents	Substance, process, use, composition	Substance, process, use, composition	Substance, process, use, composition	Substance, process, use, composition

EU (SPCs)

U.S.

South Korea

Japan

Eligible technical fields

Pharmaceuticals, Plant protection products

Pharmaceuticals,

Agrochemicals

Pharmaceuticals, Agrochemicals

Pharmaceuticals,

Agrochemicals

Eligible categories of patents

Substance, process, use, composition

Request

	EU (SPCs)	U.S.	South Korea	Japan
Authority to grant extension/SPC	For national patents: IP authority of member state in which the corres-ponding patent is in force For patents with unitary effect: EU Intellectual Property Office (EUIPO)*	U.S. Patent and Trademark Office (USPTO)	Korean Intellectual Property Office (KIPO)	Japan Patent Office (JPO)
Time period for filing request	Within 6 months of either marketing approval or grant of the patent, whichever is later	Within 60 days of marketing approval and prior to the expiry of the patent	Within 3 months of marketing approval, but not later than 6 months from the end of the patent term	Within 3 months of regulatory approval, but not later than 6 months from the end of the patent term
Person eligible to file request	Only patent owner (i.e. not licensee or other third parties)	Only patent owner (i.e. not licensee or other third parties)	Only patent owner (i.e. not licensee or other third parties)	Only patent owner (i.e. not licensee or other third parties)

EU (SPCs)

U.S.

South Korea

Japan

Authority to grant extension/SPC

For national patents: IP authority of member state in which the corres-ponding patent is in force
For patents with unitary effect: EU Intellectual Property Office (EUIPO)*

U.S. Patent and Trademark Office (USPTO)

Korean Intellectual Property Office (KIPO)

Japan Patent Office (JPO)

Time period for filing request

Within 6 months of either marketing approval or grant of the patent, whichever is later

Within 60 days of marketing approval and prior to the expiry of the patent

Within 3 months of marketing approval, but not later than 6 months from the end of the patent term

Within 3 months of regulatory approval, but not later than 6 months from the end of the patent term

Person eligible to file request

Only patent owner

(i.e. not licensee or other third parties)

Only patent owner (i.e. not licensee or other third parties)

Only patent owner

(i.e. not licensee or other third parties)

Only patent owner

(i.e. not licensee or other third parties)

Period of extension

	EU (SPCs)	U.S.	South Korea	Japan
Maximum number of extensions per patent	One	One	One	Several***
Calculation of period of extension	Period between filing date of patent and date of marketing approval, reduced by a period of 5 years	Period consisting of half of the testing phase of the product and entirety of the approval phase by the government authority responsible	Period between either patent grant or start of clinical tests (whichever is later) and marketing approval	Period between either patent grant or start of clinical tests (whichever is later) and marketing approval
Maximum period of extension	5 years	5 years	5 years	5 years
Paediatric extension permitted?	Yes (6 months)**	Yes (6 months)**	No	No
Maximum remaining term from product approval until end of extended term	15 years	14 years	No limitation	No limitation

* Subject to approval of the unitary SPC by EU legislative bodies.

** The paediatric extension can be granted as further compensation for research and development of medicines for children. The maximum extension period may therefore cover 5.5 years.

*** Multiple extensions possible, e.g. for several active ingredients included in the same product or for several applications or dosages of the product. However, these extensions are not aggregated but run in parallel, i.e. the maximum period of extension is still limited to five years.