SPCs for Combination Products - Common Sense Prevails?
Hot on the heels of the Medeva and related decisions late in 2011, the CJEU has issued its latest order on SPCs for combination pharmaceutical products. The order was issued remarkably quickly, within eight months of its referral by the UK Patents Court, and will be welcomed by innovator pharmaceutical companies after the less favourable Medeva decision.
The ruling is the result of a long-running dispute between Novartis and generics manufacturers on combination drugs including the active agent valsartan. Valsartan is marketed by Novartis as Diovan® for treating high blood pressure; the company also markets a combination drug including valsartan and hydrochlorothiazide (HCTZ) as Co-Diovan® for the same indication.
Novartis formerly owned European patent no. 443983 covering valsartan: this patent was extended by an SPC, which expired on 12 November 2011. The company were also granted a European patent covering the valsartan / HCTZ combination: this basic patent expired before the valsartan SPC and was not itself extended by an SPC in the UK.
When Actavis announced its intention to market a generic version of the valsartan/HCTZ combination drug, Novartis sued it under the valsartan SPC. Novartis argued that, as the drug contained valsartan, it would have infringed the basic valsartan patent while it was in force, and would therefore infringe the SPC. Actavis counter-argued that the SPC only covered valsartan as a sole active ingredient, and the valsartan / HCTZ combination was a different ‘product’ for the purpose of the SPC Regulation and would therefore not infringe the SPC. The UK Patents Court referred the matter to the CJEU to clarify the law.
The CJEU has decided in favour of Novartis’ argument. According to the ruling, if an SPC is granted for a drug containing an active ingredient (A), the SPC holder can enforce it against a competitor marketing an authorised drug which is a combination of actives (A + B) after expiry of the basic patent for A, unless the claims of the basic patent specifically exclude the presence of another active. This ruling is in sharp contrast to the Court’s decision in Medeva, in which it decided that an SPC could not be granted for an authorised combination drug A + B if the wording of the basic patent only specifies A (or a combination of A with another, unspecified active), and specifically rejected the ‘infringement test’ as a basis for assessing whether a product is ‘protected by a basic patent’ for the purpose of SPC protection.
The legal basis of the order is somewhat uncertain, and it could be argued to run counter to the original intentions and purpose of the SPC Regulation. Moreover, it appears to enable Medeva to be bypassed by simply filing SPC applications for single actives. However, the ruling is good news for innovator pharmaceutical companies, as it would allow them to prevent generics from circumventing an SPC protecting A by marketing a combination of A with another active. After the confusion of Medeva, common sense may have prevailed at last.
Full text of decisions: