SPCs for combination products - where are we now and what’s ahead in 2012?

There has been a multitude of references to the European Court of Justice (ECJ) to determine how and under what conditions, SPCs may be applied for and granted for medicinal products with multiple active ingredients where the combination of active ingredients in these medicinal products is only partially the subject-matter of a patent.

In our insight "SPCs for combination products: Clarification from the ECJ today?" and in our article "European Court of Justice set new test for the grant of SPCs for combination products" in InFocus January 2012 we discuss the recent decisions of the ECJ in Medeva (C-322/10) and Georgetown (C-422/10). We reviewed the AG's opinion previously. 

In the recent Medeva and Georgetown cases the ECJ has formulated a new test to determine whether a medicinal product is "protected by a basic patent in force" under Article 3(a) of the SPC Regulation: whether the product (a combination of active ingredients) is "specified by the claims of the patent".

Unfortunately, this new test is unlikely to provide any greater clarity.  This is not a test that has been considered by the UK courts (or any other courts) and the result will depend on whether one takes a narrow or a broad construction to the word "specified".  For instance, will a claim to A in combination with "other active ingredients" specify any combination of A that might be chosen; "other active ingredients" being taken to specify any other active ingredient?  If not, then what about a claim to A in combination with a specified class of compounds?  Or should "specify" be construed narrowly and require the specific compound to be named within the claim?  It will be open to a party to argue the interpretation that best suits its purposes.

The table below summarises the position as things stand.  The way that "specified by the claims of the patent" is interpreted will clearly affect what is protected by the basic patent, but this table does not attempt to answer this question.  Instead, the table addresses the situation where a patent is held to cover the product listed in the table (whatever the actual claim might say).  The table also assumes that the MA is the first one granted for the product in that Member State and that there have been no previous SPCs granted on the same product to the same patentee.

What next?

The ECJ decisions in Georgetown and Medeva have, unfortunately, probably failed to clarify the position on Article 3(a) completely.  There have been a number of other references to the ECJ and it is interesting to consider where these references now stand in light of these decisions.

The hearing in the Queensland University case (C-630/10) was due to be heard on 30 November 2011.  However, it appears that the ECJ did not wait for the hearing and made an order on the reference on 25 November 2011.  As was expected from a case whose facts are so similar to Medeva / Georgetown, the order follows those decisions.  There are, however, two points to note.

First, the test for Article 3(a) is formulated as whether or not the product is "identified" in the claims of the basic patent rather than whether it was "specified".  It is unhelpful that two different words have been used by the ECJ as it creates further uncertainty over the precise test to be applied.  However, we suggest that the test as set out in Medeva (i.e. whether the product is specified) is the correct test to be applied.

Second, the order confirms that SPCs are available for process claims but only if the product is "identified in the wording of the claims of [the] patent as the product deriving from the process in question."  Ignoring the use of the word "identified", this raises the same uncertainties as for product claims which are discussed above.

The reference in Yeda (C-518/10) assumes that the infringement test is the correct test and, in those circumstances, asks whether contributory infringement is enough to satisfy the test.  The ECJ appear to have rejected the infringement test (see paragraph 26 of the Medeva decision in which the ECJ says that A+B is not protected by a patent for A).  In these circumstances, it is not surprising that on 25 November 2011, the ECJ made an order that answered the question referred in Yeda in the negative: the single active cetuximab is not specified in the claims of the basic patent.  The argument that it was protected as a result of contributory infringement did not satisfy Article 3(a).

In another reasoned order dated 25 November 2011, the ECJ ruled on the reference in Daiichi (C-6/11). Again, the ECJ followed Medeva; except that like Queensland, the ECJ used the word "identified" rather than "specified". As discussed above, we suggest that the test set out in Medeva should be applied. This decision is disappointing because the court in Daiichi had asked a question that sought to draw a distinction between the facts of Gilead and Astellas which were considered by the UK courts in 2008 and 2009, respectively, and which produced different results. Gilead referred to "other therapeutic ingredients" in the claim and a combination SPC was allowed; Astellas referred to the particular active as "an" active ingredient – implying that there could be more than one – and a combination SPC was not allowed. An answer to this question may have provided greater clarity in how to apply the "specified by the claims of the patent" test. The ECJ has, however, not considered the specific question referred and has instead simply referred to the Medeva decision.  In doing so, the ECJ has failed to provide clarification as to how the new test should be applied. The application of the test will therefore be left to the national courts and it seems likely that future references to the ECJ will be needed.

It is also worth commenting on the recent reference that was made in Novartis v Actavis, which we discussed in the October issue of InFocus, about the scope of protection of an SPC and, in particular, whether selling a combination product (A+B) infringes an SPC to a single active (A).  Were the ECJ to decide that there was no infringement in this situation, it would mean that the SPC that Medeva and Georgetown are now entitled to would be worthless as the SPCs would not be infringed by the combination product being sold.  Indeed, comments in paragraph 39 of the Medeva decision suggest that the answer to the question referred in Novartis v Actavis has already been decided – the combination product would infringe.

Conclusion

It is now clear that an SPC can be granted if the product is authorised in combination with other products (article 3(b)) and there has, perhaps, been progress towards greater clarity in how to determine whether or not a product is "protected by a basic patent in force" (article 3(a)). However, it is unclear exactly how to apply the ECJ's new test of whether the product is "specified in the claim of the patent" so further references to the ECJ to clarify the situation are no doubt on the way.

Lawyers Matthew Royle