Patent extensions: continuing ambiguity on the application of the SPC Regulation
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Despite numerous referrals to the Court of Justice of the European Union (CJEU) in last few years, there is still ongoing uncertainty as to the interpretation of the SPC Regulation. Here we focus on just two live issues.
The product must be "protected by a basic patent in force"
There has been much controversy across Europe as to the condition in Article 3(a) of the SPC Regulation for obtaining an SPC that the product must be "protected by a basic patent in force". In November last year, the CJEU delivered its long awaited Medeva decision and related reasoned orders(1) when it held that an SPC application would only comply with Article 3(a) for active ingredients "specified [or identified] in the wording of the claims of the basic patent relied on in support of the SPC application". No guidance was provided on the meaning of the phrase though the CJEU did refer to its decision in Farmitalia that, in the absence of harmonised EU law, non-EU rules governing patents should be considered. This decision has led to much speculation amongst practitioners as to what the Court means by "specified" or "identified" in the wording of the claims.
In February this year, Mr Justice Arnold noted his disappointment that the CJEU had not answered all questions referred and that the guidance provided was not sufficiently clear to enable future disputes to be resolved in his judgment in Novartis v MedImmune. In his view it was inevitable that further references to the CJEU would be necessary for clarification of the test. Such a view was reinforced by LJ Jacob when the Medeva case went back to the Court of Appeal: "The ambit of "specified" may range from express naming, through description, necessary implication to reasonable interpretation. Where on that scale the dividing line is to be drawn will necessitate further references in due course in the light of the facts of the cases in which the issue arises."
Most recently Mr Justice Warren has agreed in Eli Lilly v Human Genome Sciences that the test laid down in Medeva and its progeny is unclear and that it is inevitable that there will have to be further references to the CJEU.
For straightforward cases, as in the cases of Novartis v MedImmune and Medeva, national courts will be able to apply the CJEU test without the need for a referral. Nevertheless, we predict that it will not be long before a further referral is made to the CJEU for clarification.
SPCs for second medical uses
In the recent Neurim decision delivered in July 2012, the CJEU has confirmed that it is possible to obtain an SPC for a new patented use of a known product where such product was previously covered by a marketing authorisation (MA) for a different use. This is a significant decision with potentially wide commercial ramifications especially as a number of patent offices across the European Union had up until now refused SPCs for second or further medical uses.
The CJEU has concluded that the mere existence of an earlier veterinary medicinal MA ("MA I") for REGULIN (consisting of melatonin, a natural hormone discovered in 1958) does not preclude the grant of an SPC under Article 3 for a different application of the same product for which an MA ("MA II") has also been granted (in this case, CIRCADIN to treat insomnia in humans), provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC. In interpreting what the first MA is for the purposes of establishing the length of an SPC under Article 13(1), it is again the MA within the limits of the protection conferred by the basic patent.
Unfortunately the CJEU has failed to provide its full reasoning for this decision and, in particular, whether it agrees with the earlier reasoning of the Advocate General. It is, however, unlikely that the Neurim decision will be limited to the specific facts of the case. Indeed, the decision considers scenarios where the earlier MA is for human use indicating that the principle would apply in relation to further human medical uses and applications. At least these are arguments that we expect the pharmaceutical industry to use in future SPC applications.
Melatonin was never protected by a product patent nor was an SPC grated relating to the first MA for melatonin. Nonetheless we expect the pharmaceutical industry to push for a broad interpretation of the Neurim decision, such that it should be possible to obtain an SPC for a formulation patent or a further use patent where the product that is the subject of the SPC has been claimed in a prior patent. Further, they are likely to argue that the fact that an SPC may have been granted in relation to the product claimed in the prior patent should not preclude the grant of an SPC on the basis of the latter patent as long as latter SPC application "is within the limits of the protection conferred by the basic patent relied upon". This is despite the condition in Article 3(c) that "the product has not already been the subject of a certificate".
Pharmaceutical companies will be actively reviewing their patent filing strategy with a view to eventual increased numbers of SPC applications based on further medical uses or applications. We will have to wait and see whether patent offices and national courts will apply the Neurim decision broadly but, if they do, the generics industry is unlikely to sit idly by. Yet again, this decision leads to unanswered questions likely to result in further references to the CJEU.