1. 7th EGA Legal Affairs Forum Dr. Howard Rosenberg, Scientific Advisor hrosenberg@flhlaw.com Tel.+44 (0)208 213 3069

2. EU enlarges…. but the SPC doesn’tGalantamine and Memantine:- Authorisations… real or imaginary? Veterinary Authorisation ‘counts’ …or does it?

3. EU enlarges…. but no SPC(Case C-66/09)Kirin Amgen Inc. v Lietuvos Respublikos valstybinis patentų biurasKirin Amgen held a European patent and a Community marketing authorisation for a medicinal product…applied for an SPC – but an authorisation to place that product on the market had already been obtained more than six months before accession. The granting of a Community marketing authorisation has effect, (by virtue of Article 2 of the 2003 Act of Accession), in the new Member State of the EU from the date of its accession, so that the Community marketing authorisation granted to Kirin Amgen on 8 June 2001 entered into force in Lithuania on 1 May 2004…

4. but … Under Article 19a(e) of Regulation No 1768/92, an SPC may be granted only in respect of a product for which a first authorisation to place it on the market as a medicinal product has been obtained in Lithuania. This provision does not lay down any derogation concerning products which have been the subject of a Community marketing authorisation. To do so would run counter to the outcome of the accession negotiations So Articles 7 and 19a(e) ….have to be interpreted as not allowing the holder of a valid basic patent in respect of a product to apply to Lithuanian authorities, within six months of the date upon which the Republic of Lithuania acceded to the European Union …as the medicinal product was obtained more than six months before accession even though, at the time of first authorisation, the product did not obtain a marketing authorisation in Lithuania.

5. When is a marketing authorisation not a marketing authorisation?

6. Galantamine and Memantine. Background. Both drugs were marketed for many years in one or more member states prior to the later filing of dossiers which included the full regulatory details and studies that are required by the European Economic Community Directive 65/65/EEC

7. Galantamine had been on sale in Europe as a medicine for more than 40 years. There was a marketing authorisation for it as a treatment for polio in the 1960's under the trade mark "Nivalin" in Austria and Nivalin went on to be authorised in West Germany in 1978. On 1st January 1994 Austria joined the EEA and Nivalin continued to be marketed there after Austria's accession.

8. Memantine was on the market in Germany before September 1976. Under the relevant domestic German law of 1961, no testing of medical products for safety or efficacy was required. Council Directive 65/65/EEC included testing for safety and efficacy. Member States were permitted to introduce the requirements of 65/65 progressively. In Germany products already on the market and which remained on the market on 1st January 1978 were automatically granted continuing authorisation. Provided notification occurred within 6 months of 1st January 1978, the deemed authorisation was to remain in force until January 1990. Memantine met these requirements and was treated as authorised without going through the procedures required by 65/65, either in Germany or Luxembourg.

9. Subsequently EU-wide authorizations for galantamine (Synaptec) and memantine (Merz) were completed in line with 65/65/EEC, and SPCs were then obtained based on these new 65/65/EEC authorizations. The case before the CJEU raises questions to clarify what constitutes an acceptable marketing authorization for ‘first authorisation’, (i.e., approval under a national law or only under 65/65?) and/or whether products marketed for the first time in the EEC without going through the administrative procedure Directive 65/65 actually fall within the scope of SPC law at all?

10. Veterinary Authorisation ‘counts’ …or does it?

11. Up until know all seemed pretty clear….Case C-31/03, Pharmacia Italia v Deutsches Patentamt [2005]Decision was that the grant of a certificate in a Member State of the Community on the basis of a medicinal product for human use authorised in that Member State is precluded by a marketing authorisation for that product as a veterinary medicinal product granted in another Member State of the Community before the date specified in Article 19(1) of the regulation.

12. Court of Appeal in Neurim Pharmaceuticals v The Comptroller-General of Patents [2011] EWCA Civ 228. The case concerned Neurim’s European Patent (EP 0518468) and was an appeal against the refusal for an SPC for the use of the natural hormone melatonin as a medicine (Circadin) to treat insomnia. 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.

13. Circadin, is a 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.

14. At first instance Mr Justice Arnold was of the opinion that the Regulation was acte clair, and upheld the IPO’s assessment of the relevancy of the sheep. However the Appeals court said..“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.Moreover there is much endeavour to find new uses for known active ingredients. The European Patent Convention 2000 has indeed made the patenting of inventions in this area clearer. Its effect is that a patent for a known substance or composition for use in a method of treatment is not to be regarded as old (and hence unpatentable) unless use for that method is known. It would be most unfortunate if second medical use patents could not get the benefit of an SPC.”

15. Following Lord Justice Jacob's question as to whether the Directive is fit for purpose, the Court of Appeal is asking the following questions of the ECJ.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?And…

16. 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?"

17. So …is the Appeal Court rocking the boat………to kill the sheep??!!

18. Thank You Any Questions?