SPC decisions rain down from the ECJ

Between late November and mid-December 2011 there was a flurry of activity at the Court of Justice of the European Union (ECJ). Europe’s highest court handed down a number of decisions relevant to supplementary protection certificates (SPCs) – a unique form of IP right that provides an additional monopoly that comes into force after the expiry of a patent. These cases have been widely followed by the SPC community in Europe and elsewhere because they deal with the substantive requirements for obtaining SPCs under EU law, and have far-reaching implications for the pharmaceutical and plant protection industries.

The main clutch of these decisions related to combination medicines and the requirements which the patent must satisfy in order to qualify for an SPC for a combination medicine. The other decision (Merck Sharp & Dohme Corp, C-125/10) related to so-called “zero-term” or "negative-term" SPCs and ruled that these are indeed available to SPC applicants. All of these decisions have been broadly positive for the innovative pharmaceutical industry, although clearly the decisions will not suit everyone.

Decisions
The first decisions to issue were Medeva (C-322/10) and Georgetown (C-422/10), in which the ECJ explained how to obtain an SPC for a combination drug and confirmed that an SPC for a single active ingredient can be used to stop sales of a combination drug containing the same active ingredient.

The ECJ was faced with two difficult issues that have vexed the SPC system for years. The first issue (under Article 3(a) of the SPC regulations) was whether a patent with claims that describe only one active ingredient from a combination of active ingredients in an authorised drug can be used to obtain an SPC for that drug. This is a common scenario, particularly in the vaccine field, where patents are generally filed for single classes of active ingredients (antigens) many years before combination uses are identified. The court decided that an SPC could be granted for a combination of active ingredients only if those active ingredients were “specified in the wording of the claims”. In rejecting a direct infringement test, this approach would seem consistent with the approach previously applied by several national courts, although there may be future difficulties in deciding whether the active ingredients in a combination drug are adequately “specified in the wording of the claims” to satisfy the test.

The second issue (under Article 3(b)) was whether the authorisation of a drug that contains a combination of active ingredients can be used to obtain an SPC for only one active ingredient from that combination. This issue was decided generously for SPC applicants, allowing SPCs to be granted for single active ingredients that are authorised for use with other active ingredients. Crucially, however, an SPC for a single active ingredient (or combination of active ingredients) that is authorised for use with other active ingredients will be allowable only if the authorisation represents the first time that it has been authorised.

Lurking behind both issues was a third issue of broad importance to industry. This was whether an SPC for a single active ingredient could be infringed by sales of a drug that contained this active ingredient in combination with other active ingredients. This issue was again decided generously for SPC holders, suggesting that an SPC for a single active ingredient will be infringed by sales of a combination drug that contains the same active ingredient and other active ingredients.

Despite these positive aspects to the decisions, SPC applicants will be more concerned by the possible endorsement by the court of the “one SPC per patent” rule proposed in the advocate general’s earlier opinion in these referrals. Many commentators felt that the advocate general had misunderstood the ECJ’s earlier Biogen (C-181/95) decision in reaching this opinion, in particular by failing to consider whether more than one SPC could be granted for different active ingredients covered by a single patent. Worryingly, the ECJ did not seem to rule out the advocate general’s interpretation explicitly, so SPC applicants will have to rely on its reference to the Biogen decision to argue that the previous practice based on this decision remains correct.

Shortly following the Medeva/Georgetown decisions, the ECJ issued reasoned orders in the remaining pending cases in which similar questions had been asked of the court. These were Yeda Research and Development Company (C-518/10), Daiichi Sankyo Company (C-6/11) and University Of Queensland (C-630/10). Although there are some interesting insights in the detail of these decisions, it can broadly be stated in summary that the logic applied did not diverge from the Medeva/Georgetown cases described above.

Conclusion
There now remain three pending referrals at the ECJ on SPC matters. Two relate to the Novartis v Actavis proceedings in the United Kingdom and Germany, and ask whether the protection conferred by a certificate granted for a single active ingredient (in this case, valsartan) extends to an embodiment that contains this single active ingredient in combination with another active ingredient (in this case, valsartan plus hydrochlorothiazide). Given what the court has already said on this issue in Medeva/Georgetown, it may well be that reasoned orders can also be expected in these cases.

The third pending SPC case is Neurim (C-130/11), which pre-dated the Novartis referrals and is unrelated. If Neurim is successful in persuading the court of its position, this would significantly increase the number of patents to approved follow-on medical uses that would qualify for SPC protection.