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Supplementary Protection Certificates for new uses – ECJ clarifies “first authorization of the product”

melatonin

On July 19, 20120 the European Court of Justice (ECJ) rendered it decision in Case C-130/11 dealing with the availability of Supplementary Protection Certificates (SPCs) for new uses.  The matter involved Neurim Pharmaceuticals’ UK SPC application for its melatonin product (CIRCADIN) and European Patent Application  0 518 468.

Briefly, the objective of the SPC Regulation (469/2009) is to ensure sufficient protection to encourage pharmaceutical research.  SPCs are intended to compensate the patentee for the reduced effective patent protection for the period between the filing of a patent application and the authorization to place the product on the market (“MA”).  The maximum term of the SPC is limited to 5 years (extendable to 5.5 years if certain pediatric studies are conducted) and combined patent and SPC term cannot exceed 15 years (extendable to 15.5 years if certain pediatric studies are conducted).  The conditions for obtaining a SPC are set out in Article 3 of the SPC Regulation, which provides:

A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

(a) the product is protected by a basic patent in force;

(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or 2011/82/EC , as appropriate;

(c) the product has not already been the subject of a certificate;

(d) the authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal product

Background

In June 2007, Neurim received a MA for its melatonin product for human use for the short term treatment of primary insomnia characterized by poor quality sleep in patients 55 years old or older.  On the basis of the CIRCADIN MA, Neurim applied to the UK IPO for a SPC for the ‘468 Patent on the basis that the MA for CIRCADIN was the first authorization to place the product on the market as a medicinal product.  The UK IPO objected to the application on the basis that CIRCADIN was not the first authorisation to place the product on the market as a medicinal product –   REGULIN, a melatonin product regulating the seasonal activity of sheep was previously approved in 2001.

The UK IPO’s decision was initially upheld by Justice Arnold of the English High Court of Justice ([2010] EWHC 976 (Pat)), holding that article 3(d) requires the authorization in Article 3(b) to be the first authorization to place the product on the market as any medicinal product.  On appeal, the English Court of Appeal ([2011] EWCA Civ 228) stayed the proceedings in order refer the following  five question regarding the interpretation of Article 3 to the European Court of Justice.

1.      In interpreting Article 3 of [the SPC Regulation], when [an MA] (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 [MA] (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 [MA] 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 [MA] has been granted for a veterinary medicinal product for a particular indication and the later [MA] 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 [MA] 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 the 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?

ECJ Judgment

The ECJ grouped the five referred questions into three groups (Questions 1 and 3, Question 2, and Questions 4 and 5) and ruled:

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.

A copy of the ECJ’s Judgment may be found here.

 

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