Teva UK Ltd & Ors v Merck Sharp & Dohme Corporation

Under the SPC Regulation, a second certificate is precluded where one active ingredient embodies the basic patent’s core inventive advance and has already received a certificate. A certificate may nevertheless be available for a combination representing a distinct invention protected by the patent. For Article 3(a), the product must fall within the extent of protection of at least one patent claim. A claim to a combination with “a nucleoside analog” ordinarily means one nucleoside analogue, not one or more. A nucleotide analogue may fall within “nucleoside analog” where it functions as a prodrug of the same active agent.

The claimants challenged the validity of MSD’s supplementary protection certificate SPC/GB08/022 for a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. They relied on Articles 3(a) and 3(c) of the SPC Regulation.

The Article 3(a) issue was whether claim 16 of European Patent (UK) No. 0 582 455 protected the three-component product. The Article 3(c) issue was whether MSD’s earlier certificate for efavirenz precluded a further certificate for the combination. The court also considered the construction of “nucleoside analog” and “a nucleoside analog”.

1. Article 3(a). Claim 16 covered a combination of efavirenz with tenofovir or emtricitabine, but not all three ingredients. The product therefore did not fall within the extent of protection of any claim of the basic patent. The SPC consequently failed Article 3(a).
2. “Nucleoside analog”. The expression bore its ordinary technical meaning: a structurally modified nucleoside. A nucleotide or nucleotide analogue could also fall within the expression. Tenofovir was a nucleoside analogue because it was converted in the body into the active agent and inhibited reverse transcriptase by the same chain-termination mechanism as other nucleoside reverse transcriptase inhibitors.
3. “A nucleoside analog”. In claim 16, “a” meant one and one only. The wording, read with the claims and specification, did not extend the claim to combinations containing more than one nucleoside analogue. The decision T 405/00 was distinguishable because it turned on the presence of “comprising”.
4. Article 3(c). Assuming that claim 16 covered the product, the earlier efavirenz certificate still precluded a further certificate unless the combination represented a distinct invention. The combination did not independently constitute such an invention. Ordinarily, that conclusion followed from the patent itself without expert evidence.
5. Alternatively, the evidence showed that combining efavirenz with a nucleoside reverse transcriptase inhibitor was an obvious thing to try, with a fair expectation of success in vitro. The skilled person had strong motivation to improve HIV treatment, knew of combination therapy and its advantages, and would have expected a reasonable likelihood of an additive or synergistic result. The combination was neither difficult nor labour-intensive to test.
6. Disposition. The SPC was invalid because it failed both Articles 3(a) and 3(c).

First-instance decision of the High Court (Patents Court). No prior appellate decision is stated in the judgment.