SPCs: Recent developments in the UK

Supplementary Protection Certificates (SPCs) provide an extended period of patent protection for medicinal products. The aim is to compensate the proprietor for the effective reduction in the normal patent term caused by the long regulatory approval process that must be undertaken before such products can be brought to market. SPCs are only available under certain circumstances, and the case law in this regard is constantly evolving; two new cases are discussed below.

Law relaxed on SPCs for combinations of active ingredients

The relevant statute explicitly confirms that SPCs are available for medicinal products containing more than one active ingredient. However, they will only be granted when such products are “protected” “as such” by a basic patent.

Previous case law has debated the meaning of these terms. A decision in 2003 (Takeda Chemical Industries Ltd’s SPC Applications) held that the combination of lansoprazole with two of three other antibiotics was not “protected as such” by the basic patent, which disclosed and claimed lansoprazole only. In spite of the fact that the combination product fell within the scope of the claim covering lansoprazole only, Takeda’s argument on this basis was considered “sleight of hand”; the specification contained no suggestion that lansoprazole could be used together with any other active ingredient, and it was considered that the patent did not protect the combination as such. The Swedish courts followed a similar reasoning in a different case, considering the point to be entirely clear and refusing to make a reference to the European Court of Justice.

However, in a recent UK decision (Gilead Sciences, Inc’s SPC Application), the basic patent contained a claim drawn to a pharmaceutical composition comprising the antiretroviral drug tenofovir (amongst other compounds) and optionally another active ingredient. No specific other active ingredients were mentioned in the claims or description, although it was common general knowledge that different antiretroviral drugs could be used in combination. Gilead obtained a marketing authorisation for a product containing tenofovir and emtricitabine (emtricitabine being another antiretroviral not related to the invention) and applied for an SPC. The UK patent office refused the application, citing the Takeda case and indicating that there was no clear pointer in the patent to the specific combination of active ingredients for which the marketing authorisation had been granted.

On appeal to the High Court, the judge overturned this decision. The case could be distinguished from that under consideration in Takeda and there was no need for the patent to specifically disclose emtricitabine. The judge also cast doubt upon the correctness of the Takeda decision; he made no conclusive finding on this point, but did go so far as to suggest that it would be helpful for the issue to be considered by a higher court or even the European Court of Justice.

The UK patent office have been granted leave to appeal, and it is not yet clear whether they will choose to do so, so this may not be the end of the story. It also remains to be seen whether other European courts will follow the decision in the Gilead case. However, for the time being at least, it does appear that the possibilities for obtaining SPCs in the UK for combinations of active ingredients have been extended somewhat.

SPC granted with negative term

The term of an SPC is determined by subtracting 5 years from the period elapsing between the filing date of the basic patent and the date of the first marketing authorisation in the EU for the drug concerned, but is subject to a maximum of 5 years. Last year, a new provision was enacted whereby an extra 6 months could be added to the SPC term, on provision of the results of paediatric studies of the drug (even if the drug is ultimately not shown to be effective in children).

In a recent decision (Merck & Co., Inc’s SPC Application), the UK patent office allowed the grant of an SPC with a term of around minus 3 months. Although at first sight unusual, the finding was that there was no explicit prohibition against this in the relevant statute, and it served a useful purpose in allowing for the possibility of a paediatric 6-month extension to the SPC, i.e. an overall extension of around 3 months to the normal patent term.

Clients should therefore consider the possibility of obtaining an SPC in the UK with a negative term (up to but not including minus 6 months), in situations where a paediatric extension might be available. For a blockbuster drug, such an extension could prove extremely valuable. Since an SPC only takes effect at the end of the normal patent term upon payment of fees, the proprietor should not be disadvantaged if the paediatric extension is never granted; they can simply fail to pay the fees at the end of the normal patent term and the SPC will never come into force.

31 Jul 2008

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