Noerr client TAD Pharma GmbH is permitted to sell generic HIV drugs in Germany

Represented by a patent law team from the law firm Noerr, the generic drug manufacturer TAD Pharma GmbH, a member of the KRKA d.d. group of pharmaceutical companies,  was successful in temporary injunction proceedings of enormous legal as well as economic significance against the U.S. group of pharmaceutical companies Gilead Sciences Inc. The Munich Regional Court I dismissed Gilead's petition for temporary injunctions against a total of seven manufacturers of generic drugs, including TAD Pharma. Gilead had claimed a violation of a supplementary protection certificate (SPC) regarding its pharmaceutical TRUVADA (case nos. 7 O 11152/17 to 7 O 11158/17). An appeal against the ruling is possible.

TRUVADA is a medically highly effective and economically very successful pharmaceutical product ("blockbuster") for the treatment of HIV that consists of a combination of the active ingredients tenofovir disoproxil and emtricitabine.

The background of the legal dispute was the expiry of the protection period of the basic patent EP 0 915 894 B1 on 25 July of this year. The basic patent protected at least tenofovir disoproxil, an active ingredient in TRUVADA. The issue was whether manufacturers of generic pharmaceuticals are permitted to sell generic versions of the HIV blockbuster TRUVADA because the basic patent has expired. This is because Gilead had also been granted an SPC for the time after the basic patent expired, which protects TRUVADA itself, i.e. the combination of the active ingredients tenofovir disoproxil and emtricitabine.

The generics manufacturers that wanted to sell TRUVADA argue that the SPC preventing them from doing so was not legally valid because the combination of active ingredients tenofovir disoproxil and emtricitabine was not protected by the basic patent in breach of Art. 3 (a) of Regulation (EC) No. 469/2009. Claim 27 of the basic patent is said not to refer in a specific manner, even in the patent description, to the second active ingredient, emtricitabine, as the European Court of Justice has required, e.g. in its “Eli Lilly” decision. 

In the context of the parallel pending nullity proceedings (case no. 4 Ni 12/17), the German Federal Patent Court agreed with the arguments of the generic pharmaceutical manufacturers and, in a conditional notice pursuant to section 83 (1) of the German Patent Act, presented its preliminary opinion that the SPC in question is not legally valid. In the temporary injunction proceedings that have now been ruled on, the Munich Regional Court I came to the conclusion that the opinion of the German Federal Patent Court is in any case not obviously incorrect, but rather probably correct. Consequently, the regional court dismissed Gilead’s petitions for temporary injunctions to stop breaches of the SPC. It is possible and highly likely that appeals will be filed.

“The parallel case, Gilead v. Gernerika in the U.K., has already been submitted to the ECJ for a preliminary decision by the English judge Arnold. The proceedings at hand will probably also be continued at national as well as European level,” says Dr Ralph Nack, a Noerr partner based in Munich.  “The decisive legal issue for the proceedings at hand, i.e. the interpretation of Article 3 (a) of Regulation (EC) No. 469/2009 as regards the protection of combinations of active ingredients, has always been hotly disputed and is of great legal and economic significance beyond individual cases,” explained Dr Thomas Gniadek, a patent law expert and a Noerr associated partner. The ECJ has issued numerous rulings on this, including the “Medeva”, “Actavis” and “Eli Lilly” decisions.

Advisors to TAD Pharma GmbH: Noerr LLP

Dr Ralph Nack, Dr Thomas Gniadek; Associate: Dr Armin Kühne (Intellectual Property and Media, Munich)