Basic patent and SPC – what do they actually cover?

COURT OF JUSTICE, DECISION OF 9 FEBRUARY 2012, NOVARTIS AG V. ACTAVIS DEUTSCHLAND GMBH & CO. KG, ACTAVIS LTD., CASE NO. C-574/11

Upon reference from German patent infringement proceedings dealing with an application for an injunction against a generic combination medicament, the Court of Justice (CJEU) decided on the scope of protection of supplementary protection certificates (SPCs) and clarified that it corresponds with the scope of protection of the basic patent.

Background and Decision

The decision of the Court of Justice results from patent infringement proceedings before the District Court of Dusseldorf.

Novartis AG had requested injunctive relief against Actavis Deutschland GmbH & Co. KG, enjoining them from distributing a generic combination medicament containing the active ingredients Valsartan and Hydrochlorothiazide (HCTZ¹) for the treatment of high blood pressure (hypertension) in Germany. The application was based on a supplementary protection certificate (SPC) for the (single) active ingredient ("product") Valsartan.² This active ingredient had previously been protected by a basic patent. Based on this patent and the regulatory approval for the medicament Diovan® which contains the single active ingredient Valsartan and which is used for the treatment of hypertension, Novartis obtained an SPC for this active ingredient. In addition to Diovan®, Novartis also markets a drug called Co-Diovan®. This drug contains Valsartan in combination with the active ingredient HCTZ. The combination of these active ingredients is not protected by an independent SPC.

The District Court of Dusseldorf had stopped the marketing of the generic combination by way of a preliminary injunction. The following proceedings on the merits got stayed as the court referred to the CJEU the question whether the scope of protection of an SPC granted for a single active ingredient also extended to an embodiment which contains a combination of active ingredients, including the protected one.

In its judgment, the Court of Justice confirmed that an SPC directed to a product conferred the same rights at the time of expiration of the basic patent (within its limits) as the rights conferred to the basic patent regarding this product.³ Thus, if the holder of the basic patent could prevent any use of the product or its use as a medicament consisting of the product or containing the product on the basis of his patent, an SPC for this product provided the same rights for each use of the product as a medicament approved prior to the expiration of the SPC.  

Further, the Court of Justice referred to the main proceedings, in which it was established that the distribution of a medicament for the treatment of hypertension, which contains Valsartan combined with HCTZ, infringed the basic patent for Valsartan. It was also established that the therapeutic indications, for which the objected medical drug had been approved, include hypertension.  

As it was thus clear in the main proceedings that Novartis would have been able to prohibit the distribution of the generic combination medicament on the basis of its basic patent, the Court of Justice concluded that the same prohibition could be based upon the corresponding SPC.  

Remarks

This decision takes an exceptional position in the line of recent decisions dealing with SPCs. It resulted from infringement proceedings and, as a consequence, was concerned with an SPC's scope of protection, rather than with the requirements for the grant of an SPC. The Court of Justice clarified that the scope of protection of an SPC corresponds exactly to the scope of protection of the basic patent, as far as the product in question is concerned. The decision whether a specific embodiment is covered by the scope of protection still lies with the competent national courts of the Member States and must be made on a case-by basebasis.  

However, it is now clear that manufacturers of generic medicaments cannot escape the scope of protection of an SPC, simply by adding other active ingredients to the protected single active ingredient. This corresponds with the ratio of SPCs, which are designed to provide for a de facto extension of the protection of the basic patent.