Escilatopram - English translation of German decision available

Yesterday, we posted a piece on the German Federal Supreme Court decision on Escilatopram.

Non-German speakers will be delighted to know that the English translation of the decision can be obtained here. It was kindly provided to the Blog by Klemens Stratmann (Hoffmann-Eitle, Munich)

Escilatopram in Germany - the BGH decides

The German Federal Supreme Court (FSC) recently reversed the German Patent and Trademark Court decision on the validity of Escilatopram patent EP 0347 066 and its related SPC (SPC No. 103 99 030 to Escitalopram and non-toxic acid addition salts thereof) - Read the decision in original - here (unfortunately, no English language version available). The IPKat (Thanks!) provides a short summary of the facts of the case here.

On SPCs, the FSC held that a marketing authorisation for a racemic product does not prevent the grant of a supplementary protection certificate to an enantiomer form of the product based on a later marketing authorisation to the enantiomer of the product and a patent on that enantiomer.

You might recall that this case has also been heard and decided in the Netherlands (here in Dutch, and here for an English translation) and the UK (here).

Triptorelin - a salty case

The SPC Blog has come across another decision of the German Federal Patent Court relating to the granting (or refusal to grant) of an SPC on salts of active ingredients - in essence no SPC for a formulation of a salt of an active ingredient if a previous marketing authorisation already exists for a different salt of the active ingredient.

In the case in question, the patent owner applied for an SPC for the peptidic product Triptorelin (as the pamoate salt) based on basic German patent DE3822459 and the marketing authorisation for Triptolrelin Pamoat Dibioclinic 11,25 mg, granted on 16 March 2004. The German Patent and Trademark Office (GPTO) refused the application on the basis that the marketing authorisation cited was not the first marketing authorisation for the peptidic active ingredient. There existed a previous marketing authorisation to the Triptorelin, but for the acetate salt.

The applicant appealed this decision at the German Federal Patent Court (GFPC), arguing that since the different salts have different properties, especially in terms of their solubilities, the marketing authorisations were for different actives.

The GFPC considered that Triptorelin pamoate was not a new product in comparison with Triptorelin acetate, making the marketing authorisation for Triptorelin acetate the first marketing authorisation for the product. An SPC can therefore not be granted because the requirement of Art. 3(d) of Regulation 1768/92 are not satisfied. In a final note, the court mentioned that even if an SPC may be issued for a different salt of an active ingredient according to recital 14 of Regulation 1610/96 (applied to Regulation 1768/92 according to recital 17 of Regulation 1610/96), the requirements of Art. 3 of Regulation 1768/92 still need to be satsified in order for an SPC to be granted for that different salt.

Tour of Patent Offices - Germany

For the first posting in 2009, the SPC blog decided it was time to check out the scene in Germany.

Information about patent applications, patents, including status can be obtained from the register website of the German Patent Office (here, https://dpinfo.dpma.de/). Although there is an English language search mask, the results are posted in German. You can however click to a table containing a translation of the terms listed in the search results. The site may be rather slow during peak usage times and refuse to run your search.

The site does provide information on whether an SPC application was filed, but unfortunately, no information on the status of the SPCs can be obtained.

For those interested in reading up on German SPC case law, the website of the German Patent and Trade Mark Court is your place to look (that is, if you want it for free). You can search cases from 2003 onwards by date, case number and term. But a word of warning, you'll have to brush up your German because there isn't an English language site. If the case has gone up to the Federal Supreme Court, you can check out the pages of the Bundesgerichtshof for cases back to 2000. Here again, the site's in German.

Hopefully, short summaries of future cases will be published here in English, for those that don't have a grasp of the lovely language of Goethe.