Going Dutch: taking a view post-Medeva in interim proceedings

The SPC Blog is again grateful to its friends Tjibbe Douma, Gertjan Kuipers and Margot Kokke (De Brauw Blackstone Westbroek N.V., Amsterdam) for sharing news of an interesting recent decision from the Netherlands.  This time it's an interim ruling of the District Court The Hague in Sanofi v  Teva c.s., 14 September 2012.  As Tjibbe his colleagues explain:

Further to the  recent posts (here and here) regarding the decision of the Patents Court for England and Wales in  Actavis v Sanofi [2012] EWHC 2545 , the Dutch decision in the somewhat similar Sanofi v Teva case  rendered on 14 September 2012 (cited by the Patents Court in its own decision) gives a rather different perspective on the interpretation of the SPC Regulation post-Medeva.

Where the Patents Court for England and Wales felt (again) that questions should be referred to the Court of Justice before establishing the validity of the SPC, the Dutch Court considered that it was in a position to decide (provisionally) on this issue and actually prohibited Teva from launching a generic version of Sanofi's product. To this end the interim relief judge held in the Dutch case that:

(i)                  The one-SPC-per-patent rule should be interpreted to read "one-SPC-per-product-per-patent"; and

(ii)                 The Medeva test "specified in the wording of the claims of the basic patent relied on" should in practice boil down to determining whether the combination product is part of the subject matter of the patent.

This different approach (and outcome) can in some respects be explained by the difference of the facts and nature of these cases.

Sanofi's patent, SPCs and MAs 

Sanofi has two SPCs, one for irbesartan (the mono SPC) and another for irbesartan in combination with HCTZ (the combination SPC). The SPCs were based on separate Marketing Authorisations (MA) for the mono product and the combination product respectively. Both SPCs were based on (different claims of) the same patent. The mono SPC expired in August 2012, but the combination SPC is valid until October 2012. The combination SPC is based on claim 7 of the patent which claims irbesartan in combination with a diureticum. HCTZ is not mentioned explicitly as an example of a diureticum, neither in the claim nor in the description.

Differences Dutch case and the England and Wales case 

The case in England and Wales was brought forward by Actavis on 26 June 2012. Actavis apparently wanted to clear to road before entering the market and Patents Court to declare the SPC invalid; Sanofi was the defendant in that case. The Patents Court felt that there were reasons to refer questions to the Court of Justice --- and that the nature of the case allowed for that.

In the Dutch case, however, there was no time for referrals. This case was a response by Sanofi to Teva's actions. Teva was preparing a launch at risk on 1 September 2012 (i.e. before the expiry of the SPC for the combination product). To this end, Teva's combination product was listed in the Dutch "G-standard" on 21 August 2012. In the Netherlands, a product needs to be announced on this list about two weeks before it can be marketed.

Sanofi - as could be assumed - did not appreciate this move (enlisting on the G-standard is considered 'offering' and thus an infringing action in the Netherlands) and filed an action with the District Court of The Hague requesting preliminary relief with a writ of summons dated 23 August 2012. On 3 September 2012 the Court already granted Sanofi's initial preliminary relief claim: Teva was ordered to refrain from offering the generic version for the duration of the actual preliminary relief proceedings.

Subsequently, the case was continued and resulted in the decision dated 14 September 2012. Teva argued as a defence that the SPC should be held invalid. Besides incompliance with Article 3(c), Teva also argued that Sanofi's combination SPC was invalid because of incompliance with Article 3(a) SPC Regulation because the product is not protected by the basic patent.

One SPC per patent? 

In the Dutch decision the interim relief judge provisionally ruled that the one-SPC-per-patent rule should be interpreted to read "one-SPC-per-product-per-patent" Teva's reference to a consideration in the Medeva ruling that "only one certificate may be granted for that basic patent" should not be read as meaning that only one SPC per patent could be granted. If the Court of Justice had meant to deviate from its earlier case-law which was widely interpreted to mean one-SPC-per-product-per patent, it would have done so explicitly, according to the judge. The preliminary relief judge also stated that, given Teva's announced launch at risk, there was no time for a referral and that the administrative court of the Hague had proposed to refer questions regarding thereto to the Court of Justice, so this question will already be dealt with by that court.

Specified in the wording of the claims? 

In the same judgment, the judge applied Medeva and Georgetown, interpreting "specified in the wording of the claims of the basic patent relied on" in a broader way than was done before. 

The interim Judge considered that, on the basis of the Dutch Court of Appeal's decision in Lundbeck/generieken, it should be determined whether the combination product was part of the subject matter of the patent. To determine what the subject matter was, she interpreted the claims taking into account not only the description and the drawings, but the general knowledge of the man skilled in the art at the priority date. Sanofi submitted several publications proving that, at the time of the priority, the man skilled in the art would immediately think of HCTZ when reading "a diureticum". This reading was not contested by Teva. . The judge therefore provisionally considered the product specified/identified sufficiently in the wording of the claims of the patent, the requirement of 3(a) met and the SPC valid

Thus, even though one of the active ingredients of the combination product for which an MA was obtained was not mentioned in the patent at all, the preliminary relief judge held that the SPC for the combination product was valid. This is different from the Lundbeck case where the active ingredient of the combination product was in fact mentioned in the (description of the) patent.

Where the Patents Court referred to the Dutch Court of Appeal decision in Lundbeck/ generieken  to point out the difference with Sanofi , the Dutch preliminary relief judge actually used Lundbeck/ Generieken to support her interpretation of the Medeva test,

In  Lundbeck/generieken  (The Hague Court of Appeal 24 January 2012)  the product of the MA was not mentioned literally in the wording of the claim. Claimed were escitalopram and certain salts thereof. The specific salt covered by the MA, escitalopramoxalaat, was mentioned in the description only. The Court of Appeal considered that escitalopramoxalaat "was obviously part of the subject matter of the patent" and was sufficiently 'specified or identified in the wording of the claims" for the SPC to be valid.

The judge's 'new' interpretation of the Medeva test in Sanofi v Teva is interesting and it remains to be seen how this will proceed.