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Singulair - Sigma Pharmaceuticals Plc vs Merck Sharpe & Dohme

Specific Mechanism – Ambiguity, Confusion and Conflict

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Specific Mechanism – Ambiguity, Confusion and Unspoken Conflict

The Accession Treaty of 2003 sought to protect pharmaceutical IP rights in an expanding EU, but in so doing has created a legacy of confusion and unaddressed conflict in parallel trade.

The so-called “specific mechanism,” described in the treaty, permits the holder or beneficiary, of a patent or supplementary protection certificate for a pharmaceutical product filed in a member state at a time when such protection could not be obtained in one of the new member states for that product, to rely on the rights granted by that cover to prevent the import of that product in the member state or states where the product in question enjoys patent protection or supplementary protection.

However, the paucity of the treaty’s drafting has left it open to interpretation and ambiguity, which has not been helped by the absence of case law precedent, largely resulting from the general imbalance in resources between rights holders and prospective importers.

For example: The treaty does not specify whether the specific mechanism encompasses formula and process patents; While the passing of relevant patent laws in new member states are identifiable, the treaty does not state whether these must be compared with a patent’s filing or priority dates. It seems unlikely to be the latter, but nevertheless such an interpretation can be lodged.

Unfortunately, we are unlikely to see such matters resolved until the issue entirely disappears in the future. In the meantime, while this does create opportunity for vigilant importers, it also means industry players operate in an uncertain landscape that was surely not the intention of the original treaty.

Get in touch with MPA for further guidance on the specific mechanism and to access essential information including patent filing, expiry and SPC data.

 
   
 
 
 
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