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Expert Corner

Intellectual Property expert

Supplementary Patent protection (SPC): NEW OPPORTUNITIES

On 19 July 2012, the European Court of Justice issued a key decision on SPC in Neurim Pharmaceuticals (C-130/11), which will impact the life science industry.

Neurim Pharmaceuticals have developed melatonin for treating insomnia, obtaining a marketing authorisation (MA) for their product Circadia® which contains melatonin as the active ingredient. Neurim then applied for an SPC based on this MA and their European patent for their formulation, the claims of which were limited to its use in treating nocturnal melatonin deficiency or distortions in humans.

Article 3(d) of the SPC regulation (469/2009) states that an SPC may be granted if, among other things, a marketing authorisation has been granted and that authorisation is the first authorisation to place the product on the market as a medicinal product.

The UK Intellectual Property Office refused Neurim’s SPC application in view of an earlier granted MA (to a different company) for the use of melatonin as a veterinary product for regulating reproduction in sheep. The UK High Court confirmed this refusal.

The UK Court of Appeal referred questions to the Court of Justice of the European Union (CJEU) essentially for a ruling on the question of: which MA is to be considered as being a “first“ MA pursuant to Art 3 of the SPC regulation.

CJEU decided that the prior MA for use as a veterinary product did not preclude the grant of a later SPC for a different use provided that use fell within the limits of the basic patent on which the SPC was based.

CJEU considered the date of the later MA to be the relevant date for calculating the term of the SPC.  

Further, the decision appears not to be limited to situations where the earlier approval is veterinary and the new approval is for human use:

 “Therefore, if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of the product”

It follows, that an SPC may be granted despite the existence of an earlier marketing authorisation for the same active ingredient, provided that the previously authorised use does not fall within the scope of the protection of the basic patent on which the later SPC application is based.

Thus, in principle a new medical use for a known active ingredient can be eligible for a new SPC, even where an SPC has been granted previously for a drug containing the same active ingredient.

This may offer new opportunities to patent proprietors for obtaining an SPC in cases where the active ingredient has already been commercialized.

Whilst the Neurim decision appears to have relaxed the requirements for obtaining an SPC, it is still unclear how broadly this decision will be applied. For example it is still unclear whether new formulations, new routes of administration, dosage regimes or unit dosage forms fall within the meaning of the “new therapeutic application

 

August 2012

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