When is a product ”protected by a basic patent”? – a crucial question for supplementary protection certificates (SPCs) in Europe

If a product is to be eligible for supplementary protection in the member states of the European Economic Area,¹ one of the requirements is that the product is “protected by a basic patent in force.”²

The criteria for meeting Article 3a have already been decided on one occasion by the Court of Justice of the European Union,³ which stated that since patent law has not been harmonised on this issue, the extent of protection of a patent can only be determined by the provisions applying to a patent in question, i.e. either national law or the European Patent Convention, whichever applies.

On 24 June 2010, the UK Court of Appeal referred a question to the Court of Justice of the European Union for a preliminary ruling on what the criteria are for a product to be “protected by a basic patent in force”.

In the meantime, the lack of clarity on this issue has given rise to a non-harmonised practice by the national authorities. The practice is particularly divergent with regard to combination products, i.e. where the medicinal product authorised by the marketing authorisation (MA) is a combination of two active ingredients and the basic patent only expressly claims one of the active ingredients.

Consequently, the practice ranges from the infringement test used in Germany to the expressly claimed criteria applied in France.

Below is an overview that includes some of the most important European countries.

Given the uncertainty reflected by the table, the best advice to heed when drafting patent applications is to at least include in the specification of the patent that an active ingredient claimed is combined with another active ingredient. If possible at the time of drafting, a second category of all conceivable second or further active ingredient(s) should be specified and a list of all conceivable specific compounds mentioned should be included.

It is also advisable to include at least one claim directed at a composition comprising the express active ingredient as well as “another active ingredient”, possibly specifying the category(ies) of active ingredient(s).

For granted patents, the different requirements for expressly claimed subject matter may be met in most European countries, through the use of either administrative reexamination or limitation, which can be requested at any time. This will enable a limitation of the claims to a certain combination for which an SPC is desired and where express claiming is required. However, France, for example, does not offer the option of such proceedings.

Since the EPC2000 came into force, giving the patentee an opportunity to limit the patent claims at any time after grant, this option has been available for a granted European Patent. The drawback here is that the patent may be unnecessarily restricted for some countries and the limited patent must be revalidated in each relevant country.

Hopefully, the issue will be resolved with the recent referral, though there is a risk that the Court of Justice of the European Union will simply give the same answer as was given in Farmitalia or dismiss the referral on the grounds that the question has been answered once already.

Reported by Sidsel Hauge, European Patent Attorney, Copenhagen office

1 the EU member states as well as Iceland, Liechtenstein and Norway
2 Art 3a of Council Regulation 469/2009/EC. S See page 9 for full article
3 Farmitalia C-392-97, recitals 23 to 27
4 e.g. Medeva B.V. BL O/357/09 (decision appealed)
5 Imclone Systems Inc. Et al BL/O/066/10
6 Gilead sciences BL 0/006/08
7 New practice of the Danish PTO TO following AN2008 00047
8 Allowed according to the Danish PTOTO
9 AB Hässle RR 3248-96
10 Pantoprazole, 8 July 2008, FSC X ZB 1/08