Circadin, a patented formulation of melatonin for use in treating sleep disorders by oral administration to human patients over 55. To obtain its marketing authorisation, Circadin was treated as a new chemical entity by the regulatory authorities on account of the fact that melatonin had not previously been approved for use in humans and, therefore, a full stand-alone application for marketing approval consisting of pharmaceutical and pre-clinical testing results and clinical trial data was required in accordance with Article 8(3) of Directive 2001/83/EC. As a result, 15 years of the life of the basic patent for Circadin had passed before Circadin obtained marketing approval.
The basis of the refusal of the SPC application by the IPO was that, although Circadin was the subject of a basic patent in force, and hence satisfied Article 3(a), there was an earlier marketing authorisation in the hands of a third party for a different formulation of melatonin called Regulin for regulating the reproductive capacity of sheep by subcutaneous administration behind the ears of ewes to be mated.
Neurim argued that an authorisation should be considered relevant under Article 3(d) (and, by extension, Article 13) only if it were an authorisation in respect of subject-matter that would have infringed the SPC under Article 4. In other words, only if the earlier authorisation allowed its holder to work within the scope of the patent should the authorisation count under Articles 3(d) and 13. Neurim found legislative basis for this approach in Recital 14 of the plant protection product SPC Regulation, and argued that the approach is in line with the purpose and objectives of the regulation as well as some existing jurisprudence from national courts. Neurim argued that, for various reasons, it is wrong to extrapolate from Pharmacia, MIT and Yissum to its case. Neurim also based a further argument on the fact that the Circadin MA required a full stand-alone application in accordance with Article 8(3) of Directive 2001/83/EC.".Following Lord Justice Jacob's question as to whether the Directive is fit for purpose, the Court of Appeal is asking the following, somewhat more pertinent questions of Europe's highest court:
1. In interpreting Article 3 of Regulation EEC No. 1768/92 [now Regulation (EC) No. 469/2009] (“the SPC Regulation”), when a marketing authorisation (A) has been granted for a medicinal product comprising an active ingredient, is Article 3(d) to be construed as precluding the grant of an SPC based on a later marketing authorisation (B) which is for a different medicinal product comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier MA on the market within the meaning of Article 4?
2. If the grant of the SPC is not precluded, does it follow that in interpreting Article 13(1) of the SPC Regulation, “the first authorisation to place the product on the market in the Community” needs to be an authorisation to place a medicinal product on the market within the limits of the protection conferred by the basic patent within the meaning of Article 4?
3. Are the answers to the above questions different if the earlier marketing authorisation has been granted for a veterinary medicinal product for a particular indication and the later marketing authorisation has been granted for a medicinal product for human use for a different indication?
4. Are the answers to the above questions different if the later marketing authorisation required a full application for marketing approval in accordance with Article 8(3) of Directive 2001/83/EC (formerly a full application under Article 4 of Directive 65/65/EEC)?
5. Are the answers to the above questions different if the product covered by authorisation (A) to place the corresponding medicinal product on the market is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant?"We all keenly await the answers.