Tenofovir and Emtricitabine - France

On Sep. 05, 2017 the High Court of Paris issued its decision on the validity of the Gilead SPC on Truvada® covering tenofovir and emtricitabine.

Gilead Sciences Inc, is the holder of the supplementary protection certificate (SPC) no 05 C 0032 that is effectively valid until 24 February 2020, granted on the basis of the European Patent no 0915894, that expired as of 25 July 2017.  SPC covers the following combination : "tenofovir disoproxil and the salts, hydrates, tautomers and solvates thereof in combination with other therapeutic compounds such as emtricitabine" based on marketing authorisation of TRUVADA® in France.

The European Patent no 0915894 is entitled "nucleotide analogues", and covers compositions that are useful in the therapeutic treatment of several viral infections in humans or animals, in particular HIV. The compositions covered by this patent contain in particular tenofovir disoproxil, an active ingredient developed by the Gilead group for the treatment of viruses such as the HIV, and which may be used alone or, as provided for in claim no 27, in a pharmaceutical composition in combination with other therapeutic ingredients.

The Gilead group currently markets eleven medicaments for the treatment of HIV. Five of these drugs contain tenofovir disoproxil in the form of a fumaric acid salt, tenofovir disoproxil fumarate used :  VIREAD ® ,  as the sole active ingredient in the medicament

TRUVADA®, that combines tenofovir disoproxil with emtricitabine ;

ATRIPLA ®, that combines tenofovir disoproxil, emtricitabine, and efavirenz ;  

EVIPLERA ®, that combines tenofovir disoproxil, emtricitabine, and rilpivirine ;

STRIBILD ®, that combines tenofovir disoproxil, emtricitabine, elvitegravir, and cobicistat.

                                                         

In Dec 2016, Mylan received marketing authorisation for "Tenofovir disoproxil MYLAN", and "Emtricitabine  /  Tenofovir Disoproxil MYLAN". In France, the company MYLAN served summons in an action brought to invalidate the Gilead French SPC.

Court after analysing the relevant CJEU’s decision said that the claim no 27 is drafted so broadly that it does not describe any specific active ingredient that should be combined with tenofovir disproxil . It thus does not protect a combination that is likely to result in entitlement to the grant of a patent. Moreover, the combination claimed as active ingredient "tenofovir disoproxyl + emtricibatine" is not implicitly but necessarily and specifically taught in the description, there is no indication whatsoever that would enable the person skilled in the art to choose emtricibatine and it quite evidently does not constitute the core of the invention.

As a consequence, it is possible to say that the SPC is in all likelihood invalid and no preliminary injunction could be granted and requests of the GILEAD companies shall be dismissed.