Charlotte May QC and Lindsay Lane represented the first claimant (“Teva”) in its successful challenge of the defendant’s (“Merck”) supplementary protection certificate (SPC) for an anti-viral drug marketed as Atripla.
The SPC covered a combination of the active ingredient efavirenz together with emtricitabine and tenofovir. The Court agreed with Teva’s case that the SPC failed to comply with Regulation 469/2009 (the “SPC Regulation”) because:
- The Patent did not disclose a combination of all three active ingredients, so the SPC was not protected by “a basic patent in force” for the purposes of Article 3(a) of the SPC Regulation.
- The active ingredient efavirenz had already been the subject of an SPC. Article 3(c) of the Regulation precluded the grant of an SPC in respect of a combination comprising efavirenz unless that combination was a distinct invention. Since the combination claimed was not independently valid over the use of efavirenz, it followed that the SPC protected an invention that was already the subject of an SPC, and therefore failed to comply with Article 3(c).