Tenofovir disoproxil fumarate & Emtricitabine – Denmark

Tenofovir disoproxil fumarate & Emtricitabine – Denmark

On Oct. 26, 2017, the Danish Maritime and Commercial High Court issued a decision rejecting Gilead’s motion for preliminary injunctionagainst Accord Healthcare & found Gilead’s Danish SPC for the combination of tenofovir disoproxil (as fumarate) and emtricitabine (Truvada┬«) invalid. Accord counterclaimed by arguing non-infringement and invalidity of the asserted SPC (CR 2005 00032) which was issued on the basis of the patent DK / EP 0915894.
Accord claimed that the disputed certificate protects emtricitabine and tenofovir disoproxil only where the latter is in the form of its fumarate acid salt (i.e., tenofovir disoproxil (like fumarate)). Accord stated that their product is not in the form of fumarate acid, but instead in a free base form. Gilead claimed that the contested certificate protects medicines, which includes a combination of emtricitabine and tenofovir disoproxil in all forms. But court sided with Gilead & held that Accord’s generic combination product was covered by the SPC as tenofovir is covered in all its forms if SPC held valid.
Turning to the validity of SPC, the contested 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. Gilead claimed that the disputed certificate has been issued in accordance with Article 3 (a) of the SPC Regulation and that the combination of tenofovir disoproxil and Emtricitabine is protected by requirement 27 of the basic patent. Gilead however agreed with Accord that the basic patent does not describe emtricitabine by name, chemically name or structure. But Gilead’s said that emtricitabine must be considered sufficient functionally specified in claim 27. Because the basic patent focuses on the treatment of HIV, a professional would therefore know that the combination of NRTIs would be preferable and would read requirements 27 in light of this.

Court however disagreed with Gilead. Court held that use of tenofovir disoproxil in combination with another therapeutic component does not constitute a “central aspect” of the claimed invention. The basic patent describes no trial in which tenofovir disoproxil is used in combination with another therapeutic ingredient. Furthermore, the basic patent does not contain any mention or just a hint, of a functional definition or indication indicating that emtricitabine could constitute any further therapeutic component. Emtricitabine was neither approved nor launched on the basic patent priority date. Emtricitabine was first approved in Europe in 2003, i.e. seven years after the priority date of the base patent in 1996. Overall, court finally held that Accord’s drug does not violate the contested certificate & the disputed SPC is invalid. 

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