An SPC trilogy: CJEU decides three in a day

The Georgetown University (C-484/12) and Actavis v Sanofi (C-443/12) cases were both concerned with the same question: if the same basic patent protects more than one authorised medicinal product, can this same basic patent be the basis of an SPC for each of these products? In other words, does the SPC Regulation specify “one SPC per patent” or “one SPC per product per patent”?

Both cases were also concerned with the specific question of if the basic patent protects a medicinal product (A), whether the same patent could also protect another authorised product (A+B) which is a combination of that product (A) and another medicinal product (B) not protected by the patent.

Although the general practice of most patent offices in the European Union (EU) has been to grant SPCs for each product in this situation, there has long been a slight uncertainty over the issue in view of a comment by the CJ in the earlier Biogen and Medeva decisions, which had potentially suggested only one SPC could be granted per basic patent.

In the Medeva decision (C-322/10) the CJ indicated that an active ingredient should be ‘specified’ in the claims of a basic patent in order for an SPC to be based on that basic patent. This caused controversy and confusion as it was unclear how the term ‘specified’ should be interpreted – in particular, how narrow the claim needed to be to adequately ’specify’ the product.

The Actavis v Sanofi reference was the final chapter in the Europe wide litigation between Sanofi and various generic manufacturers. Sanofi ’s basic patent contained both claims to irbesartan itself and to a combination of irbesartan and a diuretic. Based on this same patent, Sanofi had obtained, firstly an SPC to irbesartan as the sole active, and then a second SPC to a combination of irbesartan and the diruretic hydrochlorothiazide (HCTZ).

After the first SPC had expired, generic manufacturers had challenged the second SPC on the basis that the claim to irbesartan and a diuretic did not adequately ‘specify’ the product as required by the Medeva decision. National courts gave differing verdicts on this point: some upholding the second SPC, others revoking it. The UK High Court was unsure, and referred the matter to the CJ.

The CJ upheld Georgetown’s SPC, but invalidated the second Sanofi SPC. The court distinguished the two cases in that, in Georgetown, all the SPCs were filed on the same day (and therefore none could be granted before the others were filed), whereas in Actavis v Sanofi the first SPC had already been granted before the second was filed. This difference appears critical in the CJ’s reasoning in allowing the combination SPC in Georgetown but not in Actavis.

Both decisions appear to provide a qualified endorsement of the general principle of “one SPC per product per patent”, particularly in the situations wherein the first SPC has not been granted before the second was filed; and/or wherein the SPCs expire on the same day. However, in view of the restricted wording of both judgments, it is possible that national courts may follow it only in cases where one SPC relates to an active ingredient (A) and the other SPC relates to a combination (A+B).

The Eli Lilly v Human Genome Sciences case (C-493/12) was concerned with how strictly the Medeva ‘specified’ test should be applied. In this case, the court ruled that it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula to meet this test: in particular, it is acceptable that the active ingredient is covered by a functional formula. This is good news in that the potential restrictive effect of the ‘specified’ test in Medeva seems to have been partially relaxed, particularly for biological products which are often defined at least partially by function.

It should be noted that, in both the Eli Lilly and Actavis cases, the court declined to answer the more fundamental question of what Article 3(a) of the SPC Regulation means by a product “protected by a basic patent in force”. In the referring UK judgment, Arnold J suggested that, when deciding this question, consideration should be given to the ‘inventive advance’ embodied in the basic patent. The CJ appeared to concur with this view in Actavis, observing that the combinations were not “protected as such by the basic patent but simply referred to in the wording of the claims of the patent in general terms” and that the grant of such SPCs may be contrary to the objectives of the Regulation. However, it decided the case based on Article 3(c) of the SPC Regulation (ie, that the product had already been the subject of an SPC), rather than Article 3(a). Nevertheless, if a pharmaceutical company is developing in parallel a medicinal product (A) both as a sole active and in combination with another product (B), the CJ’s advice seems clear: if at all possible, file the SPCs on the same day.