The English High Court has referred questions to the European Court of Justice (ECJ) concerning the meaning of several provisions of the Supplementary Protection Certificate Regulation (1768/92). Synthon sought revocation of Merz's Supplementary Protection Certificate (SPC) in relation to its patent for a second medical use of the compound memantine, on the grounds that memantine was first marketed in the Community without any testing, let alone testing in compliance with 65/65.
It takes a great deal of time to conduct the safety and efficacy testing needed to obtain a marketing authorisation (MA) to place medicine on the market. The requirements for such testing are prescribed by EU Directive 65/65/EEC ("65/65") (now consolidated into Directive 2001/83/EC as amended). An SPC provides an extension to the term of a patent for a medicinal product or process to compensate the patentee for the lost period of monopoly caused by the need to obtain an MA.
1976 - Memantine was sold in Germany. At the time, the national laws required no testing for this product
1978 - Under the laws in Germany and Luxembourg, memantine was authorised to be sold without any further testing for an additional 12 years provided that a requisite notification was made. Memantine's authorisation was therefore extended to 1990 in Germany and Luxembourg.
1983 - Luxembourg implemented 65/65. Merz applied for an MA for memantine in Luxembourg. An MA was granted erroneously without 65/65 compliant testing, on the basis of the German authorisation.
1989 - Merz applied for the patent for a second medical use of memantine.
1990 - Authorisation in Germany expired.
1993 – Second use patent was granted.
2002 - Following requisite testing, Merz was granted a Community-wide MA ("2002 MA"). Merz then applied for an SPC.
2003 - Merz was granted the SPC in suit for memantine, based on the 2002 MA.
2009 - Patent expires.
The judge considered the arguments raised by Synthon under three headings as follows:
Issue 1: Is the Luxembourg authorisation in accordance with 65/65?
Article 3 must be satisfied for an SPC to be granted. Synthon argued that the SPC was invalid as in contravention of Article 3(d), because the Luxembourg authorisation was the first authorisation, not the 2002 MA on which the SPC was based.
Merz contended that the Luxembourg authorisation was not granted in compliance with 65/65 and so should be ignored for the purposes of applying Article 3.
Issue 2: Should the dates of Luxembourg or German authorisation be applied when considering whether the transitional provision under Art 19 applies or the term of the SPC under Art 13?
Synthon argued that if the regulation intended the "first authorisation" in Articles 13 and 19 to refer to only those granted in compliance with 65/65, it would have said so, as it did in Articles 2 and 3(b). Therefore, Synthon argued that the transitional provision under Article 19 should be interpreted to exclude all products from being eligible for protection under an SPC which were first authorised in compliance with 65/65 or any other law, before 1985 (as memantine was).
Further, Article 13 governs how the term of SPC protection is to be calculated. Synthon argued that the "first authorisation" in Article 13 refers to the German and Luxembourg authorisations and accordingly, the term of the SPC would be zero.
Merz contended that both Articles 13 and 19 intended "first authorisation" to mean those MAs granted in compliance with 65/65 only.
Issue 3: Is memantine outside the scope of SPC Regulation?
Synthon submitted that memantine is outside the scope of SPC Regulation altogether pursuant to Article 2 because it was already on the market by the time an authorisation under 65/65 was granted. It follows, said Synthon, that the SPC was invalid.
Merz contended that the effect of Article 2 was identical to Article 3(a) and 3(b) combined (see issue 1), and thus required that the product was subject to a 65/65 procedure in the Member State in which the application for the SPC was being made, i.e. the UK, where the 2002 MA was the first 65/65 compliant authorisation, under which memantine was allowed to be sold for the first time. Merz contended that Article 3 stipulated all the conditions which need to be satisfied for a grant of an SPC, and that Article 2 did not provide any additional ground.
The judge preferred Synthon's arguments that the SPC was invalid in relation to issues 1 and 3.
In relation to issue 2, the previous ECJ decision of Hässle v. Ratiopharm held that Article 19 referred to an MA granted under 65/65. However, the ECJ in this case was concerned to distinguish the grant of an MA from pricing and reimbursement approval, that is also necessary to put a medicine on the market i.e. an authorisation that is more than a 65/65 authorisations. The ECJ had not explicitly considered whether an authorisation that is less than a 65/65 authorisation could be within the scope of Article 19.
In conclusion, the judge decided that the clarification of the SPC Regulation needed to be sought from the ECJ. Such reference was appropriate despite the fact that the Synthon is likely to face considerable commercial harm resulting from the delay. Although the precise wording of the reference remains to be determined, the judge considered that the following points need to be clarified.
Question 1: For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92, is an authorisation a "first authorization to place ... on the market in the Community", if it is granted in pursuance of a national law which is compliant with Council Directive 65/65/EEC, or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority complied with the administrative procedure laid down in that Directive?"
Question 2: For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92, does the expression "first authorization to place ... on the market in the Community" include authorisations which are permitted by national law to co-exist with an authorisation regime which complies with Council Directive 65/65/EEC?
Question 3: Is a product which is authorised to be placed on the market for the first time in the European Economic Community (EEC) without going through the administrative procedure laid down in Council Directive 65/65/EEC within the scope of Council Regulation (EC) 1768/92 as defined by Article 2?
Question 4: If not, is an SPC granted in respect of such a product invalid?
As the judge indicated, Merz has an uphill struggle to win the case, as it will have to win on all three issues to retain its SPC. Synthon's case on two of the issues is strong.
 Relevant provisions from the SPC Regulation
Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorization procedure as laid down in Council Directive 65/65/EEC or 81/851/EEC may, under the terms and conditions of this Regulation be the subject of a certificate.
Conditions for obtaining a certificate
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
a. the product is protected by a basic patent in force;
b. a valid authorization to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate;
c. the product has not already been the subject of a certificate;
d. the authorization referred to in (b) is the first authorization to place the product on the market as a medicinal product.
Duration of the certificate
- The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community reduced by a period of five years.
- Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.
- Any product which on the date of accession is protected by a valid patent and for which the first authorization to place it on the market as a medicinal product in the Community or within the territories of Austria, Finland or Sweden, was obtained after 1 January 1985 may be granted a certificate.
- An application for a certificate as referred to in paragraph 1 shall be submitted within six months of the date on which this Regulation enters into force.