Second medical use claims in Germany: No manifest preparation necessary for infringement

Second medical use patent claims protect a specific therapeutic use of a known substance. Such claims are of particular relevance once substance protection for a medicament has expired. Since the judgment of the Regional Court Hamburg of 2 April 2015 – 327 O 67/15 – Mittelbare Patentverletzung durch Beitritt zu Rabattvertrag found an indirect patent infringement of a second medical use claim by the accession of a generic company to an unlimited discount agreement with a health insurance the prerequisites of an infringement of such second medical use claims have been widely discussed in Germany. In its decision of 5 May 2017 – I-2 W 6/17 – Östrogenblocker, the Higher Regional Court Düsseldorf now clarified that an active act of a manifest preparation of a product for the patent protected use is no indispensable requirement for a direct infringement of a second medical use claim.

The Court referred to the leading decision of the Federal Supreme Court of 14 June 2016 – X ZR 29/15 – Pemetrexed. In that the Federal Supreme Court had emphasized once more that the subject-matter of a patent claim directed to the use of a substance to treat a disease is the suitability of the substance for a certain medical use, and thus ultimately a property inherent in the substance. This is true regardless of whether the wording of the patent claim is directed to a purpose-limited product protection, to the use of the medicament or to its manufacture for a certain use or to the use of a substance to manufacture a medicament ("Swiss-type claim"). Consequence of this is that the scope of the patent is to be determined – within the limits of the purpose – according to the rules of a substance patent. Any third party is prohibited from offering or distributing the product for the protected purpose. The actually protected "use" is not the therapeutic use of the product but its conveyance to trading by offering or distributing the product for the protected purpose. The product is offered or distributed for the protected purpose if it has the property protected by the second medical use claim, namely if it is suitable for and directed to the protected therapeutic use.

The product can obtain this property either by the manifest preparation for the protected purpose, in particular the formulation, packing, dosing or secondary packaging for the protected therapeutic use or by enclosing directions of use to the product directing to the protected therapeutic use. This is standing case law since the judgment of the Federal Supreme Court of 20 September 1983 - X ZB 4/83 - Hydropyridin. Equally, any other circumstances that determine and make foreseeable the use of the product for the protected therapeutic use give the product the protected property and make the offer or distribution of such product a direct infringement of the second medical use claim. Although this is immanent to the character of substance protection, the Higher Regional Court Düsseldorf decision of 5 May 2017 – I-2 W 6/17 – Östrogenblocker was the first to explicitly confirm this. The Court explained that an active manifest preparation for the protected use is no necessary requirement for an infringement in case (i) the product is suitable for the protected purpose and (ii) the distributor makes use of circumstances that ensure comparable to a manifest preparation that the offered or distributed product is used for the protected therapeutic use. The latter requires that the product is amply (not only sporadically) used for the patented use and that the distributor knew this, respectively shut his eyes to this knowledge. Under such circumstances, the limitation of patent protection to cases of an active manifest preparation would be, as explained by the Court, "completely beside the point."

These clear words of the Higher Regional Düsseldorf are a welcome clarification in the current discussion and will help to reliably qualify cases like the much discussed cross-label use as clear cases of direct infringement of second medical use claims.