The Court of Justice of the European Union (CJEU) has issued a preliminary ruling that overturns the decision of the UK lower courts and UK patent office, allowing Neurim’s treatment for insomnia Cercadin to obtain a supplementary protection certificate despite the active ingredient Melatonin being known and authorized for a veterinarian usage, i.e. to cause sheep to enter the breeding season a month earlier in a veterinary drug Regulin.
Background and History
The patent in question, European Patent (EP (UK) No. 0 518 468) relates to the use of the natural hormone melatonin as a medicine to treat insomnia. Neurim applied for the patent on 23 April 1992, but it took over 15 years before a marketing authorisation (MA) was granted, in June 2007. With less than 5 years of patent protection left, Neurim applied for the SPC, basing their application on their June 2007 marketing authorization.
The UK Patent Office (Intellectual Property Office) objected that the European Patent (EP (UK) No. 0 518 468) was not the correct marketing authorization to use for requesting the supplementary protection certificate (SPC) since this is not the first use of the drug, and an earlier marketing authorization had been granted to a different company, Hoechst, between January and March 2001 in relation to their 1987 patent for Regulin, which uses melatonin as a means of regulating the reproduction of sheep.
The IPO said that melatonin was “the product” and that, therefore, authorisation had been given when it was approved for use in sheep. Neurim argued that sheep were irrelevant since an SPC is intended to provide protection that supplements the protection of the basic patent. Accordingly, since each patent is entitled to have its own SPC, the relevant marketing authorization for that patent was a marketing authorization for a product falling within the scope of that patent. On appeal, Arnold J of the patents court upheld the IPO’s assessment of the relevancy of the sheep.
Appealing Arnold J’s decision, the Court of Appeal, under Justice Jacob disagreed. Lord Jacobs felt that the purpose of the legislation and justification for supplementary protection certificates (SPC) outweighed the literary and narrow interpretation of the lower courts and referred the case Neurim Pharmaceuticals v The Comptroller-General of Patents  EWCA Civ 228 to the CJEU back in March 2011 to the Court of Justice of the European Union (CJEU) for a preliminary ruling.
For more details, see here
Lord Jacobs referred the following questions for preliminary ruling:
- In interpreting Article 3 of Regulation 1768/92 [now Regulation 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?
- 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?
- 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?
- 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)?
- 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?
The CJEU gave its ruling as follows:
- Articles 3 and 4 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.
- Article 13(1) of Regulation (EC) No 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.
- The answers to the above questions would not be different if, in a situation such as that in the main proceedings where the same active ingredient is present in two medicinal products having obtained successive marketing authorisations, the second marketing authorisation required a full application in accordance with Article 8(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, or if the product covered by the first marketing authorisation of the corresponding medicinal product is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant.
For pevious write up, see here: https://blog.ipfactor.co.il/2011/03/09/counting-sheep-for-insomnia-do-sheep-count/
I am grateful to friend and Blogmeister Professor Jeremy Phillips of the IPKAT for bringing this development to my attention. His review is to be found here: http://ipkitten.blogspot.co.uk/2012/07/treating-insomnia-sheep-dont-count-in.html
The patent in question was written by my former partner, the Late Dr Stanley Davis. Whilst a partner of JMB Factor & Co. I did some work on Neurim’s patent portfolio.
I note that apart from Teva, Neurim is the only Israeli company to bring a patented drug to market.
This development paves the way for the Israel patent to obtain a patent term extension, since under Israel Law a patent may only be extended for the shortest time that a corresponding patent is extended by issued by a country providing patent term extensions.
People suffering from insomnia might try blogging. It doesn’t help one sleep, but it is fairly productive
Alternatively, one could read court decisions….