Compound Claim Insufficient to Support SPC for Combination Product

In "Can A + B = SPC?," Rob Burrows of Bristows notes that while a pharmaceutical patent containing broad claims may be desirable for the prevention of infringement by competing products, the patent might not contain the support necessary for a European Supplementary Protection Certificate (SPC) in respect of a particular combination product that falls within the claims and has proved to be successful commercially.

Supplementary protection certificates were introduced in European Union member countries to compensate for the long time needed to obtain regulatory approval of these products (i.e. authorization to put these products on the market). They come into force after the corresponding patent expires for a term of up to 5 years. However, the market exclusivity cannot however exceed 15 years. There is no unitary European supplementary protection certificate, but national ones only.

According to Burrows,

In [in Re Gilead Sciences, Inc.] an application was made for an SPC in respect of EP (UK) 0 915 894 and the combination of two antiretroviral compounds, namely tenofovir disoproxil and emtricitabine. Importantly, the second of these compounds was not mentioned anywhere in the '894 patent and the applicant therefore relied on claim 27, which covered "[tenofovir disoproxil] together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients" in support of its application. In deciding whether to grant the SPC, the question arose as to whether the combination product in question was "protected" by a basic patent in force, as is required by Article 3(a) of Council Regulation 1768/92.

Following the decision in Takeda Chemical Industries Ltd's SPC Applications (No.3) [2004] RPC 3, the Hearing Officer confirmed that what amounts to an infringement of the basic patent does not equate to what is protected by the basic patent. After all, although a claim to A will be infringed by a composition comprising the combination A + B, it would be a "sleight-of-hand" to say that the combination is protected by such a claim. What is protected is the A element of the combination. . . .

In this case the Hearing Officer held that the wording of claim 27 of the '894 patent, together with the priority date knowledge that antiretroviral compounds could be used in combination, was not enough to conclude that the '894 patent protected the combination of tenofovir disoproxil and emtricitabine. Accordingly, the SPC application was refused. The Hearing Officer went on to say that, in order for the combination product to be protected by a basic patent (and eligible for an SPC), the support for the product in the basic patent should "at least provide a clear pointer for the skilled reader in the right direction", although "it need not amount to the level of support that would be required to allow addition of a claim to the particular combination."

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