As many readers will be aware, Supplementary Protection Certificates (SPCs) provide a means of obtaining additional protection for pharmaceutical and plant protection products in Europe following patent expiry, to compensate for delays in placing products on the market due to the need to fulfil regulatory requirements. One of the key conditions for obtaining an SPC is that the product, i.e., the active ingredient or combination of active ingredients in the medicinal product, is protected by your patent – as required by Article 3(a) of the SPC Regulation. Sounds relatively simple, doesn't it? Such is the value of any extension of patent term however, that it is no surprise applicants continue to seek favourable interpretations on just what SPCs can be obtained for.
In our February 2014 newsletter, we reported on a flurry of decisions from the CJEU ( read here). In one of these cases, C443/12 (Actavis v Sanofi), the patent claimed the combination of irbesartan with "a diuretic", while an SPC was applied for directed to the specific combination of irbesartan with the diuretic hydrochlorothiazide (HCTZ). One of the questions the CJEU had been asked to address was, in the context of Article 3(a), whether HCTZ was "sufficiently specified or identified in the wording of the claims of the patent" by the term "diuretic". Unfortunately, the CJEU did not seek to clarify the criteria for deciding whether the provisions of Article 3(a) had been satisfied. Because Sanofi had already been granted an SPC for irbesartan on its own, the CJEU found that the additional term provided by a second SPC to the combination was not justified by the purpose of the SPC Regulation, and therefore felt no need to address the first question.
A second Actavis case (Avtavis v Boehringer, C577/13) involving similar issues was referred to the CJEU prior to the ruling in C443/12. Boehringer is the holder of European patent 0502314, on which it obtained a first SPC for its telmisartan product on the basis of an MA for telmisartan on its own. Later, Boehringer obtained a second MA for a combination product of telmisartan and HCTZ, and on the basis of the same patent, applied for a second SPC for the combination product. During prosecution of the SPC application, Boehringer successfully applied to amend the patent to insert a claim that explicitly defined the combination of telmisartan and HCTZ, to satisfy the requirements of Article 3(a) of the SPC Regulation.
To the extent that the facts of C577/13 mirror the Actavis ruling in C443/12, Boehringer's combination SPC would now appear to be invalid. However, it is hoped that the CJEU will still address the outstanding issue of whether or not a post-grant amendment can be used to ensure that the basic patent satisfies the requirements of Article 3(a).
Another recent referral to attempt to interpret Article 3(a) is C631/13 (Arne Forsgren). C631/13 concerns an SPC application for Protein D, which is present in the medicinal product Synflorix as a carrier protein that is covalently bound to serotypes of Streptococcus pneumoniae. The Austrian Patent Office initially rejected the SPC application on the basis that Protein D was only an auxiliary agent in Synflorix. On appeal the Patent Office accepted evidence that the Protein D component retained its inherent immunogenic effect, but confirmed the rejection of the SPC on the basis that Synflorix was not a combination of two active ingredients. Rather, Protein D was part of a molecular compound with other substances (the pneumococcal polysaccharides), and from a chemical point of view the medicinal product contained a substance that differed from that protected by the basic patent. The CJEU is thus asked whether an SPC can be granted for an active ingredient that is contained in the medicinal product as part of a molecular compound together with other substances (i.e. the active ingredient is a sub-unit covalently bound to other components). The CJEU's answer is awaited with interest.
As can be seen, the interpretations being sought from the CJEU on the SPC Regulation are becoming increasingly complex. It is hoped that future rulings of the CJEU will go some way to providing something closer to the simple, transparent system which can easily be applied by the parties concerned, as originally envisaged by the creation of the SPC Regulation.
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