Following two recent decisions of the English High Court, preliminary references have been made to the European Court of Justice (CJEU) seeking clarity on when a supplementary protection certificate (SPC) can be granted for pharmaceutical products comprising combinations of active ingredients (APIs).
SPCs aim to compensate innovators for the patent term which is "lost" because patented medicines cannot be marketed until a marketing authorisation (MA) has been granted. Without this compensation, there would not always be sufficient financial incentive for companies to invest in researching new and improved medicines.
"Specified/Identified in the Claims"
In judgments given in November 20111], the CJEU sought to clarify the proper interpretation of the SPC Regulation 469/2009 (the Regulation), in particular the requirements that for an SPC to be granted for a particular API or combination of APIs (a "Product"), the Product must be "protected by a basic patent." The CJEU found that for a Product to be "protected by a basic patent", all APIs that make up the Product must be "specified or identified in the wording of the claims" of the basic patent.
In three decisions earlier this year[3 , the English courts indicated that further guidance from the CJEU might be needed as to when in practice an API was "specified dentified" in the claims.
This need for further clarification has been reiterated by Mr Justice Warren in his 3 August 2012 decision in Lilly v. HGS, although the court refused to make a reference at that time because the facts of that case had not been adequately established.
On 20 September 2012, in Actavis v. Sanofi, Mr Justice Arnold found a suitable case in which to seek further clarification from the CJEU. Sanofi holds an SPC for a combination of Ibersartan and HCT, which Actavis sought to invalidate on the basis that the patent did not expressly mention a combination including HCT at all; it merely claimed a combination with a diuretic, and HCT was not necessary an obvious choice of diuretic. In response, Sanofi contended that references in the claim to a diuretic meant that HCT was "specified" in the claims of the patent because HCT was one of the most commonly used diuretics for the treatment of hypertension and the skilled reader of the patent would be prompted to choose HCT.
Mr Justice Arnold felt that he could not resolve this dispute without a clear test as to when an API was "specified / identified in the claims". Further, he noted that courts in France, Germany, and the Netherlands had given divergent rulings in parallel cases, showing that the test was not clear. Accordingly, the English court referred a slightly rephrased version of the first Medeva question to the CJEU, namely:"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the Regulation?". It will be interesting to see how the CJEU will answer this question second time around.
Two further issues were raised in the Lilly and Actavis cases:
Whose MA can be relied upon?
For an SPC to be granted, a marketing authorisation (MA) must first have been granted for the Product. In Lilly, the question arose as to whether HGS, as patent holder, was entitled to apply for an SPC based upon Lilly's MA when there was no connection between Lilly and HGS. The court concluded that the holder of a basic patent can make an application for an SPC in reliance on a third party's MA even where there is no connection between the parties. While the court thought this issue was sufficiently clear that it did not in itself justify a reference to the CJEU, the court suggested that if a reference were to be made later in the case on the meaning of "specified in the claims", then it would also be sensible to raise the MA issue to obtain a definitive answer.
How many SPCs per patent?
In Medeva, the CJEU stated that only one SPC may be granted for a basic patent. However it was unclear whether this statement was a limitation for each product protected by the patent, or whether the scope was narrower, limiting grant to one SPC per patent, even where a patent protects a number of different products. The UK Intellectual Property Office has adopted the former interpretation, while the Dutch Patent Office has adopted the latter, stricter approach. In Actavis, the English Court noted that the Dutch Courts have already referred a question to the CJEU seeking clarity on this issue. In light of the inconsistent approaches, Mr Justice Arnold chose to refer the same question as the Dutch Courts, namely, "does the Regulation, in the situation in which multiple products are protected by (the claims) of a basic patent, preclude the proprietor of the basic patent being issued an SPC for each of the products protected?".
It is disappointing that after the numerous references that have already been dealt with by the CJEU, there is still such a lack of clarify that further questions need to be asked (or repeated). The result is that a Regulation that was intended to harmonize European law is still leading to divergent judgments. However, we are hopefully edging towards a clearer and more precise system to support innovative R&D in the pharmaceutical industry.