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How it began
At the end of 2009, a hearing officer at the UKIPO refused an SPC for its product Ciracadin (melatonin). Circadin is used to treat insomnia and the basic patent concerns the use of melatonin to correct a distortion or deficiency in the plasma melatonin profile of humans.
The Office said that melatonin had already been marketed since 2001 (by CEVA Animal Health under the name Regulin) and so Neurim’s product was not eligible for an SPC. In particular, the hearing officer said that the intended use of the medicinal product could not be taken into account when considering the relevance of an earlier marketing authorisation.
The patent owner took the case to the High Court. Mr Justice Arnold upheld the IPO’s decision that Neurim is not entitled to an SPC, writing: “I conclude that the hearing officer was correct to interpret Article 3(d) [Council Regulation 1768/92/EEC – now Regulation 469/2009/EC] as requiring the authorization referred to in Article 3(b) to be the first authorization to place the product on the market as any medicinal product.”
Neurim Pharmaceuticals appealed again and the Court of Appeal ruled in March last year. Lord Justice Jacob, who gave the decision for the Court, said it would refer questions to the Court of Justice of the EU.
|At a glance|
||EP (UK) 0 518 468|
||Melatonin to treat insomnia |
(branded as Circadin)
|Other party/ies involved
||Court of Appeal (Smith, Jacob, Patten)|
||Questions referred to CJ EU|
||Supplementary protection certificates; |
pharmaceuticals; second medical use
He added: “We consider that Neurim's arguments are not only tenable: in our view they are right. Many kinds of valuable pharmaceutical research will not get the encouragement or reward they deserve if they are not. Pharmaceutical research is not confined to looking for new active compounds. New formulations of old active substances are often sought. Most are unpatentable but from time to time a real invention is made and patented … It would be most unfortunate if second medical use patents could not get the benefit of an SPC. In short, if Neurim are wrong, then the Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose. Whether that is so or not is clearly a matter for the EU's highest court.”
What questions will the Court answer?
The Court of Appeal in London referred five questions to the CJEU.
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?
How is the Court likely to rule?
In May this year, Advocate General Trstenjak, the Court’s legal adviser on the case, backed Neurim. She recommended the Court rule that the fact that the same product has previously been authorised as a medicinal product for human use or a veterinary medicinal product in the member state for which the application is made does not preclude the grant of an SPC based on a later authorisation to place that product on the market as a new medicinal product (as long as the first-authorised medicinal product is not within the scope of protection conferred by the patent designated by the applicant as the basic patent).
The Court is not obliged to follow the advocate general’s opinion, but does so in most cases.
Who is advising the parties?
Neurim is represented by barrister Andrew Waugh QC and Carpmaels & Ransford. The Comptroller-General of Patents is represented by barrister Charlotte May and the Treasury Solicitor.