Generics (UK) Ltd (trading as Mylan) v ViiV Healthcare Ltd
Mylan sought revocation of the claims of EP (UK) 0 817 637 contended by ViiV to support SPC/GB05/027 in order to clear the path for a generic product containing the anti-HIV drugs lamivudine and abacavir in combination.
The Patent is entitled “Synergistic Combinations of Zidovudine, 1592U89 and 3TC”. Those three drugs (also known as AZT, abacavir and lamivudine, respectively) were known in the art to have efficacy against HIV.
Mylan challenged the Patent’s entitlement to priority , together with its novelty, inventive step (on the basis of classical obviousness, collocation and lack of plausible technical effect) and sufficiency. It also challenged the validity of the SPC on the ground that the marketing authorisation for Trizivir (which contains all three drugs) was the first marketing authorisation for the abacavir and lamivudine combined product under Article 3(d) of the SPC Regulation. Mylan had declared the later marketing authorisation for Kivexa (which contains abacavir and lamivudine, but not AZT) as the first marketing authorisation for the SPC.
The case settled on the fourth day of trial during the cross examination of ViiV’s experts.
Piers Acland QC, Tom Alkin and Adam Gamsa, instructed by Taylor Wessing LLP, appeared for Mylan