Merck Sharp & Dohme v Deutsches Patent- und Markenamt (CJEU, C-125/10, 2011)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Bundespatentgericht (Federal Patent Court, Germany), the Court held that Article 13 of Regulation 1768/92, read with Article 36 of Regulation 1901/2006, allows a supplementary protection certificate (SPC) to be granted where less than five years have elapsed between the filing of the basic patent application and the first marketing authorisation (MA) in the European Union. The certificate then has a negative duration, which cannot be rounded up to zero: the six month paediatric extension runs from the date obtained by deducting from the patent expiry date the difference between five years and the period actually elapsed.

Facts and procedure

Merck Sharp & Dohme (Merck) held a European patent covering dipeptidylpeptidase inhibitors for the treatment or prevention of diabetes, applied for on 5 July 2002 (para 15). On 14 September 2007 it applied for an SPC for sitagliptin, giving 21 March 2007 as the date of the first MA in the Union (para 16). The German Patent and Trade Mark Office (DPMA) refused the application on 1 July 2008: only four years, eight months and sixteen days separated the patent filing from the first MA, giving the certificate a negative duration of three months and fourteen days (para 17). Merck appealed to the Bundespatentgericht; a paediatric investigation plan for sitagliptin had been approved by the competent authority on 27 March 2009, with the studies to be completed by 2017 (paras 18 and 19).

The applicable law

Since the application predated the entry into force of Regulation 469/2009, which codified Regulation 1768/92, the Court applied the earlier regulation (paras 23 to 25). Article 13(1) sets the SPC term at the period elapsed between the filing of the basic patent application and the first MA in the Community, reduced by five years; Article 13(3) provides for its extension by six months. Article 36(1) and (4) of Regulation 1901/2006 grant that extension to a holder whose MA application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan; under recital 27, the extension is available only where an SPC has been granted (paras 13, 14 and 36).

Question

May an SPC be granted where less than five years have elapsed between the filing of the basic patent application and the first MA in the Union and, if so, from what date does the paediatric extension run (paras 26 and 27)?

Decision

The Court observed that Article 13(1) does not expressly rule out an SPC of negative duration (para 28) and that a positive term is neither among the conditions in Article 3 nor among the procedural rules in Articles 7 to 9, Article 10 requiring grant where the conditions are met (para 30). It recalled the purpose of the SPC, which is to make up for the insufficient effective protection under the patent so as to encourage pharmaceutical research (paras 31 to 33), and that of Regulation 1901/2006, which rewards paediatric research (para 34). An SPC of zero or negative duration serves no purpose of itself, but it may be of use to a holder seeking the paediatric extension (para 35); refusing it would deprive the extension of its effectiveness (para 37). Taken together, the SPC and the extension give a maximum exclusivity of 15 years and six months from the first MA (para 38); the extension is therefore of value only where the first MA comes at least four and a half years after filing, since it is of use only if the negative term does not exceed six months (para 39). An SPC cannot therefore be refused solely because the term calculated under Article 13(1) is not positive (para 40). A negative term cannot be rounded up to zero: the extension runs from the date obtained by deducting from the patent expiry date the difference between five years and the period elapsed (paras 41 and 42). On the facts, the SPC and the extension give 2 months and 16 days of protection from the end of the lawful term of the basic patent (para 44).

Key points for practice

• A positive term is not a condition for grant: an SPC of zero or negative duration must be granted where the Article 3 conditions are met (paras 30 and 40).
• A negative term is not rounded up to zero; it is set off against the six months of the paediatric extension, which therefore starts to run before patent expiry (paras 41 and 42).
• Practical point: where the first MA comes less than five years after the basic patent application, an SPC application remains the necessary route to the paediatric extension, and the residual protection is calculated by deducting the negative term from the six months.

Provisions applied

Regulation (EEC) No 1768/92

Arts 3, 7, 8, 10 and 13

Regulation (EC) No 1901/2006

Art. 36 and recitals 26 and 27

Regulation (EC) No 469/2009

Art. 13 (codified version, not applicable to the dispute)

Case law cited

Hässle (C-127/00); AHP Manufacturing (C-482/07)

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.