Pharma patent appeals dismissed by Court of Appeal

The Court of Appeal (CoA) has dismissed appeals involving Irish pharmaceutical manufacturer Clonmel Healthcare and international giant Merck Sharp and Dohme (MSD) in a patent rights row over a cholesterol-reducing drug. 

 

In 2019, Clonmel succeeded in a High Court counterclaim against MSD in a dispute between the two over the rights to the drug. 

 

MSD had sued Clonmel claiming the defendant was breaching its 2005 supplementary protection certificate (SPC), governing MSD’s authorisation for its drug “Inegy”. 

 

Clonmel, which produces the Ezetimibe/Simvastin generic, counterclaimed, contending the SPC breached a 2009 EU SPC regulation. Clonmel said the combination of the two active ingredients of Ezetimibe and Simvastin, was not protected by the underlying patent. 

 

Clonmel also contended Ezetimibe was the only compound that is protected. The combination drug was previously authorised and therefore MSD’s 2005 SPC was invalid, it said. 

 

MSD disputed Clonmel’s claims. It said once the combination has been the subject of a specific claim in patent, this was a complete answer to Clonmel’s case. 

 

Invalid 

The High Court found with Clonmel that the SPC was invalid because the combination drug was not protected within Article 3 (a) of the 2009 SPC regulation. 

 

It also breached Article 3 (c) of the SPC because ezetimibe, which, according to CHL was the only compound protected by the patent, was already the subject matter of an earlier SPC granted in 2003. 

 

However, the High Court rejected a third claim by Clonmel that the SPC was invalid because the marketing authorisation for the combination was not the first marketing authorisation for such combination and SPC was granted contrary to the provisions of Article 3(d) of the regulation. 

 

MSD appealed the decision in relation to the first two findings (on 3a and 3c) in favour of Clonmel, while Clonmel appealed in relation to the third matter (3d). 

 

In a judgment on behalf of the three-judge CoA, Ms Justice Caroline Costello agreed with the High Court in relation to all of his findings. Therefore, she rejected both appeals. 

 

The Irish Times