|The AdvoKat: the wig looks great,|
but is still not friendly for protruding
As reported by the IPKat yesterday, on 19 July 2012 the Court of Justice of the EU (CJEU) has issued its judgment in C-130/11 Neurim Pharmaceuticals. The judgment is not what many predicted. Arnold J held that previous CJEU case law was fatal to Neurim’s contention that it was entitled to an SPC to protect Circadin, and he ruled that the interpretation of Article 3(d) was acte clair. The Court of Appeal recognised Neurim’s case as having merit and questions were referred to the CJEU in a characteristically robust judgment by Jacob LJ. Neurim has now prevailed before the CJEU.
The SPC system exists to compensate innovators of pharmaceutical products for the period, between innovation and commercial exploitation, which is lost due to the complexity of obtaining market authorisation. Neurim developed a formulation of melatonin for use in the treatment of sleep disorders and obtained a patent which was directed to that new use. Melatonin had, however, previously been authorised for the control of seasonal breeding in sheep. As a practical matter this earlier authorisation did not enable Neurim to take shortcuts in obtaining authorisation for Circadin and it took it 15 years to bring the product to market. (The average time to market of a pharmaceutical product is about 12 years.) It might be said therefore that the SPC system exists precisely to deal with type of circumstances Neurim found itself in.
Article 3(d) requires the marketing authorisation upon which the SPC is based to be “the first authorisation to place the product on the market”. Earlier CJEU rulings in Pharmacia, MIT, and Yissum had focused on the meaning of “product” within this provision. The “product” is the active ingredient as such, which in Arnold J’s judgment was an impediment to the obtaining of second medical use SPC protection.
Before the CJEU Neurim did not challenge this meaning of “product” but argued that the authorisation for the use of melatonin for the control of seasonal breeding was not relevant in identifying the “first authorisation” in Article 3(d) because it did not relate to the formulation and use which was the subject of the claims of the basic patent. It also contended that the period of protection (under Article 13(1)) is determined by reference only to those marketing authorisations which fall within the scope of the protection conferred by the basic patent.
The CJEU agreed with Neurim. The decision may be of interest for a number of reasons. First central to the CJEU’s reasoning was a recognition that a “fundamental objective” of the SPC Regulation was to ensure sufficient protection to encourage pharmaceutical research. The court appears therefore to recognise the value in encouraging research into new applications for known therapeutic agents and not precluding them from the benefits of SPC protection. Second it is a reminder that the CJEU is prepared to adopt a teleological approach to the interpretation of Regulations and not to get tied up in the type of black-letter analysis often favoured in the UK courts - indeed it is notable that it made no reference to the rulings in Pharmacia, MIT and Yissum. Third the decision may indicate that the effective barriers to SPC protection are to be increasingly found in the barriers to patent protection rather than elsewhere: in other words, if the product, use or process is patentable why should it not benefit from SPC protection? Fourth readers may find it interesting to consider the extent to which this decision opens the door to SPC protection in other areas, such as inventive formulations of known products for known uses.