Granting SPCs for single compounds with differing uses
The European Union has two council regulations regarding supplementary protection certificates (SPCs): Council Regulation (EEC) No 469/2009, a codified version of the original Council Regulation (EEC) No 1768/92 of June 18, 1992, concerning the creation of an SPC for human and veterinary medicinal products; and Regulation (EC) No 1610/96 of the European Parliament and of the Council of July 23, 1996, concerning the creation of an SPC for plant protection products.
The two regulations do not comprise cross-references; they form two entirely separate protection systems. However, when considering the duration of an SPC, the notion of the first authorisation to place the product on the market in the Community (now the EU) plays a key role in both regulations.
The owner of a Hungarian patent filed an application for the grant of an SPC with regard to a compound which was granted Hungarian marketing authorisation as a plant protection product. The patentee referred to a Dutch marketing authorisation as the first authorisation to place the product on the market in the Community.
If the Hungarian Intellectual Property Office (HIPO) had accepted this Dutch marketing authorisation as the first authorisation, the duration of the SPC would have been five years—the longest duration possible under the regulations referred to above.
However, the HIPO did not accept this Dutch marketing authorisation as the first authorisation. Rather, the office took into account a British marketing authorisation which was granted in respect of the compound in question to commercialise it as a veterinary medical product, and therefore granted a much shorter term extension, of two-and-a-half years.
The standpoint of the HIPO was that in Article 13 of both regulations the relevant term is the first authorisation to place the product on the market in the Community, but there is no mention of whether the product is a medicinal or plant protection product.
“If the Hungarian Intellectual Property Office had accepted this Dutch marketing authorisation as the first authorisation, the duration of the SPC would have been five years.”
The patentee filed a request for reconsideration of this decision with the Metropolitan Court of Budapest.
Its main argument against the position of the HIPO was a reference to Article 3, paragraph (b) of each regulation under which, as one of the conditions for obtaining an SPC, a valid authorisation to place the product on the market as a medicinal product or as a plant protection product is required.
The patentee emphasised that the European legislator’s intention was certainly to have an identical definition regarding the authorisation to place the product on the market in Articles 3 and 13 of both regulations.
The court approved the request for reconsideration and granted a fiveyear term extension. The court underlined that the purpose of a patent term extension is actually to compensate for the time frame between the filing date of the patent application covering the product in question (the start date of patent protection), and the date of the grant of a marketing authorisation for that product.
A marketing authorisation granted for a veterinary medicinal product cannot play any role in the term extension granted in respect of a plant protection product.
Furthermore, the court established that the Court of Justice of the European Union’s (CJEU) decision in the Pharmacia Italia SpA case, which the HIPO referred to in the prosecution, was irrelevant in this case because the issue there was whether the marketing authorisation granted for a human medicinal product and a veterinary medicinal product respectively, differ in the above situation.
The CJEU established that the marketing authorisations for these products do not differ from each other as they must be considered equal under the terms of the Council Regulation (EEC) No 469/2009 on medicinal products.
