Valsartan: now it's the turn of Düsseldorf

The SPC Blog thanks Frank-Erich Hufnagel and Cordula Tellmann (Freshfields, Bruckhaus Deringer LLP, Düsseldorf) for drawing our attention to two decisions by the Düsseldorf District Court.  Both were issued on 8 March 2011 in preliminary proceedings which had been initiated by Novartis AG against Actavis Deutschland GmbH and Actavis Ltd, Malta. Frank-Erich and Cordula (who acted for Novartis in these proceedings) explain as follows:

"On 8 March 2011, in preliminary proceedings initiated by Novartis AG against Actavis Deutschland GmbH and Actavis Ltd, Malta, the Düsseldorf District Court held that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCTZ) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036).  However, in view of the pre-trial correspondence between the parties, there was no imminent threat as to an infringement of the underlying basic patent EP 0 443 983 B1. These decisions may be appealed.

The key legal question before the court was whether a combination product containing two active ingredients (in this case valsartan and HCTZ) would fall under the scope of a SPC for just one of those active ingredients, valsartan. The Court explained: 

"In view of the not very precisely phrased and thus not easy to understand wording of article 4 of the SPC Regulation, the legislative purpose of the limitation of the protection only to "the product covered by the marketing authorisation" is of key importance for the interpretation of this article."  

The Court then refers to Recitals 3, 6 and 7, 8 and 9 of the SPC Regulation and summarized them thus:

"The cited Recitals show that the Regulation aims at a de facto extension of the patent protection in order to achieve a compensation of the loss of effective patent protection ...

In view of this ratio of the SPC Regulation, the content of Articles 4 and 5 SPC Regulation and its relationship between each other must be understood as follows: Article 5 SPC Regulation concerns -- as is confirmed by its official title -- the effects of a certificate and stipulates that they are identical to the effects of the underlying basic patent. On the other hand the purpose of Article 4 SPC Regulation is to determine the object of these effects - i.e. the subject-matter. In this context, Article 4 uses three criteria: 

- First - and actually merely declaratory - it is clarified that the absolute limit is set by the scope of protection of the basic patent. 

- Then the product is identified in order to delimit it from other compounds which potentially are also encompassed by the basic patent. Here, Article 4 SPC Regulation does not - contrary to the view of the Defendant - aim for a limitation to the specific authorised medicinal product, as results from various passages of the SPC-Regulation which speak about the product identified by the marketing authorisation: Articles 8(1)(b) and (c), 9(3)(d), Article 11(1)(d), SPC Regulation. 

- Finally, Article 4 SPC Regulation stipulates a purpose-bound compound protection by limiting the subject-matter to the authorised uses (see Kraßer, § 26 A II, p. 586). This third criterion confirms that with regards to the understanding presented here Article 4 SPC Regulation is not redundant and cannot simply be replaced by a mere term extension for the basic patent. 

The limitation of the subject-matter of a certificate in Article 4 SPC Regulation as a whole has to be understood in a sense that it has the sole purpose to exclude an "over-extensive" protection: In case the basic patent protects further products or active ingredients which are not subject-matter of the certificate, it stipulates an exception from the principle of Article 5 SPC Regulation that the protection of basic patent and certificate are identical. When determining the subject-matter of the certificate the patent claims which possibly also protect further compounds fictitiously have to be regarded as if they only contained the active ingredient indicated in the certificate; Article 4 SPC Regulation thus leads to a hypothetical patent claim which is product and purpose related (see Benkard/Grabinski, PatG, 10th edition, § 16a, note 38). The compensation is not limited to an authorisation procedure for a specific medicinal product, but for the term since the filing of the basic patent during which a product according to the invention cannot be marketed (considering also a maximum term of 5 years since the certificate entered into effect, Article 13 SPC Regulation)." 

The Court also rejected Actavis' position that the purpose of an SPC was a reward for obtaining a marketing authorisation, pointing out that this approach would mean that "the compensation for loss of effective patent protection could be circumvented all too easily which would contradict the purpose of the SPC Regulation (see ECJ, GRUR Int. 2000, 69, 70 et seq. - Farmitalia)".

A copy of the German original of the decision against Actavis Deutschland GmbH can be accessed here. Frank-Erich and Cordula inform the blog that, possibly early this week, they might be able to provide us with a full English translation of the judgment.