On Oct. 26, 2017, the Danish Maritime and Commercial High
Court issued a decision rejecting Gilead's motion for preliminary injunction
against 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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