On May 15, 2018, Federal Patent Court (FPC) of Germany revoked
SPC to Gilead’s product, Truvada® in
a validity proceeding challenged by generic filers.
As per the decision summary reported on ‘SPC blog’, the 4th
Nullity Senate of the German Federal Patent Court nullified Gilead’s German SPC.
Gilead’s holds German SPC DE 2005 000 0041.8, which had been granted for
tenofovir disoproxil in combination with emtricitabine. Gilead holds European
patent No EP 0 915 894 (‘the basic patent’). This patent was expired on 24 July
2017. It covers, in general terms, a series of molecules, which are helpful in
the therapeutic treatment of a number of viral infections in humans and
animals, in particular HIV. Claim 27, which is important here, reads as:
‘A pharmaceutical
composition comprising a compound according to any one of claims 1 to 25
together with a pharmaceutically acceptable carrier and optionally other
therapeutic ingredients’.
Generic filers specifically argued that emtricitabine is not
implicitly, but necessarily and
specifically mentioned in claim 27. The term ‘other therapeutic
ingredients’ is very general & covers wide compound classes with different
medicinal characteristics. The FPC decided that this term was insufficient to
specify the active ingredient emtricitabine according to the criteria set by
the Eli
Lilly decision. Consequently, the requirements of Article 3(a) SPC-Regulation
were not fulfilled for the product in dispute.
On similar line, on Apr. 25, 2018, Advocate General Wathelet
(UK) also found that the combination (Tenofovir & Emtricitabine) SPC was
not protected by same basic patent.
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