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Thursday, 19 July 2012

Treating insomnia: Sheep don't count in Court of Justice's eyes

An MA for sheep
In March 2011 the Court of Appeal, England and Wales, sent Neurim Pharmaceuticals v The Comptroller-General of Patents [2011] EWCA Civ 228 to the Court of Justice of the European Union (CJEU) for a preliminary ruling.  Readers may recall that this is the case in which Lord Justice Jacob, as he then was, trenchantly stated that
" ... 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".
To refresh readers' memories still further, this reference arose from Neurim's attempt to secure a supplementary protection certificate (SPC) in the United Kingdom for its European Patent (EP (UK) No. 0 518 468) on the use of the natural hormone melatonin as a medicine to treat insomnia. Neurim had applied for this patent on 23 April 1992, but it took over 15 years before a marketing authorisation (MA) was granted, in June 2007. So with less then 5 years to run on the patent, Neurim applied for the SPC, basing their application on their June 2007 MA, the Intellectual Property Office (IPO) objected that this was not the correct MA. An earlier MA had been granted to a different company, Hoechst, between January and March 2001 in relation to their 1987 patent for the use of melatonin as a means of regulating the reproduction of sheep - this product selling in the shops as "Regulin".


Had a valid MA been given for “the product” in question? 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: an SPC is intend to provide protection that supplements the protection of the basic patent. Accordingly, since each patent is entitled to have its own SPC, the relevant MA for that patent was an MA for a product falling within the scope of that patent. Before the Patents Court, Arnold J upheld the IPO’s assessment of the relevancy of the sheep; he saw no need to ask the CJEU what the SPC Regulation meant, since it was acte clair. The Court of Appeal disagreed and referred the following questions for  preliminary ruling:
  1. 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?
  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)?
  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?
This morning the CJEU gave its ruling as follows:
1.      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.
2.      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.
3.      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.
So good news for Neurim and for the development and investment of products for different uses and applications as long as the marketing authorization falls within the scope of the patent relied upon.   The IPKat and AmeriKat will say nothing further but  readers can expect further expert analysis on this decision by the new, although yet un-introduced, AdvoKat.

Sheep and insomnia: more connections here

2 comments:

Anonymous said...

Good news for Neurim, and it feels like justice was done.

However, in terms of legal certainty, this decision is not encouraging. The ECJ, following the advocate general, has gone against the express wording of the Regulation. To my common law eyes, this takes the prinicple of 'teleological construction' too far. The wording of the Regulation left no doubt here, but the court chose to ignore it.

As I say, however, the overall result seems fair to Neurim, but he reasoning is flawed. An amendment to the Regulation is required so as to restore some certainty to field of SPCs.

Tom Shillingford said...

I agree - surely the regulation needs to be amended now, seeing as we have travelled so far from the literal meaning of Article 3. Black now equals white - night has turned into day.

Also, I think that the esteemed court has made an error and should have referred to the second medicinal product at the start of paragraph 26, instead of referring to the first medicinal product.

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