A row between two pharma companies over patent rights covering a cholesterol reducing drug has been referred to the European Court of Justice (ECJ).
Clonmel Healthcare and international giant Merck Sharp and Dohme (MSD) have now been through the High Court, the Court of Appeal and the Supreme Court over the dispute.
It began when MSD sued Clonmel claiming the defendant was breaching its 2005 supplementary protection certificate (SPC), and extended patent protection, governing MSD’s authorisation for its drug Inegy.
Clonmel, which produces the ezetimibe/simvastin generic version of the drug, counterclaimed contending the SPC breached a 2009 EU 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 to be 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.
The High Court in 2019 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 a combination and the 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. Clonmel appealed in relation to the third matter (3d).
Last year, the Court of Appeal agreed with the High Court in relation to all its findings and rejected both appeals.
MSD then sought a reference from the Supreme Court to the ECJ on the core issue of the appropriate interpretation and application of articles 3(a) and 3(c)
The application was opposed by Clonmel, which contended that a reference was unnecessary because the law was already clear.
A judgment by Justice Peter Charleton, on behalf of the five-judge Supreme Court, referred four questions to the ECJ for ruling on the finding that the legal position concerning the supplementary protection certificate for medicinal products and its effect on supplementary protection of combination products was not currently capable of a definite interpretation, or was not clear enough.