Tenofovir disoproxil fumarate & Emtricitabine - Switzerland

The Complementary Protection Certificate C00915894 / 01 is based on basic patent EP0915894 B1. The Swiss SPC covers product “tenofovir disoproxil fumarate + emtricitabine“. A first marketing authorization for the active substance combination Tenofovir Disoproxil fumarate together with Emtricitabin the defendant for the Product Truvada® at no. 57316 on March 21, 2006. Tenofovir disoproxil, a nucleoside reverse transcriptase inhibitor (NRTIs) as an active ingredient with antiviral action is undisputed because it has the structure that was claimed in claim 1 of EP’894 patent. The fumarate salt of tenofovir disoproxil will also be detected but salts of the active substance are expressly mentioned in claims 1 and 2. Further references to co-formulations can be found in the paragraphs [0061] but without specific reference to further therapeutic agents.

As stated above and not questioned by the parties, the base product protects the active substance tenofovir disoproxil as a fumarate salt. This is the subject of the right of protection in the protection area of the base. Claim 27 of the base patent protects a pharmaceutical composition, which contain such an active ingredient as tenofovir disoproxil as Fumarate salt, together with a pharmaceutically acceptable salt thereof Carrier and optionally with other active ingredients. This is also described in [0047] basic patent. Further this combination of tenofovir disoproxil as a fumarate salt in the claims of the basic patent expressly specified in combination with another active ingredient, if only as an option. The individual concrete further active substance emticitabine, appears neither in a claim in combination with tenofovir disoproxil as a fumarate salt, or else in the description mentioned.

Against this point of view, however, would be the ECJ decision Actavis / Sanofi, according to which tenofovir disoproxil the core contribution of the basic patent, but not the further active ingredient and certainly not the specific selection of the further Active substance as emticitabine (not the subject of the basic patent). Even if one were to try the ECJ jurisprudence Medeva for the present case, one would not get a clear one answer, whether the law of suitability is legal, because the Medeva criteria are not clear. However the injury test, as described by the Federal Court in the decision Fosinopril has been confirmed, is simple and comprehensible and leads great legal certainty. Therefore the application for annulment of SPC dismissed accordingly. The decision may be appealed against within 30 days of the opening of the Federal Supreme Court.

[Mepha Pharma AG, V Gilead Sciences Inc; Case No. O2017_001; Oct 03, 2017]