Efavirenz & Emtricitabine & Tenofovir - UK

On Mar 21, 2017, in Teva UK Ltd. v. Merck Sharp & Dohme Corp., [2017] EWHC 539 (Pat)(U.K. High Court 2017(Arnold, J.), claimants Teva et al. successfully challenged the validity of the Patentee-Defendant’s Supplementary Protection Certificate for the anti-retroviral medication “Atripla”.

In these proceedings the Claimants challenge the validity of the Defendant’s (“MSD’s”) supplementary protection certificate SPC/GB08/022 (“the SPC”) for a product described in the SPC as “A combination of efavirenz, emtricitabine or a pharmaceutically acceptable salt or ester thereof, and tenofovir or a pharmaceutically acceptable prodrug, salt or ester thereof, particularly tenofovir disoproxil, especially tenofovir disoproxil fumarate” (“the Product”). The SPC covers a product which is marketed by Bristol-Myers Squibb Co (“BMS”) and Gilead Sciences Inc under the trade mark Atripla. Atripla is an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV).

The Claimants contend that the SPC does not comply with Article 3(a) because the Product is not protected by European Patent (UK) No. 0 582 455 (“the Patent”), which is relied upon by MSD as the basic patent for the SPC. It may be noted that MSD obtained the SPC by amending the Patent to insert claim 17 and relying upon claim 17 as protecting the Product, but MSD did not rely upon claim 17 at trial. Instead, MSD relied solely upon claim 16.

The Claimants contend that the SPC does not comply with Article 3(c) because MSD had previously obtained an SPC for efavirenz based on the Patent, namely SPC/GB00/35 (“the 035 SPC”), which expired on 19 November 2013. It is common ground that the Patent discloses and claims both a class of compounds which includes efavirenz and efavirenz itself specifically. Accordingly, the Claimants say that the Product has already been the subject of a certificate within the meaning of Article 3(c), which compensated MSD for the delay in exploiting the invention in the Patent as a result of the need to obtain a marketing authorisation for efavirenz.

Court finally with respect to  Article 3(a) concluded that the scope of protection of claim 16 of the Patent extends to a combination of efavirenz and tenofovir or to a combination of efavirenz and emtricitabine, but not to a combination of all three. For the purposes of considering the Claimants’ case under Article 3(c), Court shall assume, contrary to the conclusion reached above, that claim 16 covers the combination of efavirenz with one or more nucleoside analogues active against reverse transcriptase, and hence covers the Product. Thus Court concluded that the SPC is invalid because it does not comply with either Article 3(a) or Article 3(c) of the SPC Regulation.