The High Court has dismissed Novartis AG’s appeal against the refusal of a Supplementary Protection Certificate for Co-Diovan, a medicine combining valsartan and hydrochlorothiazide. Mr Justice McGovern found no serious or significant error in the Controller’s decision that the combination was not protected by the basic patent in force.
The appeal concerned an application made in February 1999 for a certificate covering “Valsartan or a pharmaceutically acceptable salt or ester thereof in combination with hydrochlorothiazide”. Novartis relied on Irish patent 71155, titled “Acyl Compounds”, and said valsartan was disclosed in Example 16 and specifically claimed in claim 26. The application also identified an Irish marketing authorisation for Co-Diovan issued in December 1998.
The Controller’s office raised concerns that the patent did not protect the two-ingredient combination, and noted that a certificate had already been granted for Diovan, which contains valsartan. Novartis argued that patent claims 35 and 36 covered a pharmaceutical preparation containing a claimed compound and did not exclude additional active ingredients. Its patent agent accepted that the valsartan and hydrochlorothiazide combination was not specifically disclosed in the patent, but argued it was not excluded by the wording of claim 35.
The hearing officer refused the certificate on the basis that the combination was not protected by a basic patent, as required by Article 3(a) of the EU regulation. On appeal, Novartis also pointed to certificates granted in other European jurisdictions. The Controller relied on decisions concerning combinations where the second active ingredient had not been disclosed in the basic patent.
The judge said the appeal was not a fresh assessment of what the court itself would have decided. Applying the standard for appeals from expert administrative decisions, Novartis had to establish that the decision was unreasonable or vitiated by a serious and significant error, taking account of the hearing officer’s specialist expertise.
Justice McGovern concluded that the hearing officer had considered the arguments, the patent claims, the regulation and material from other jurisdictions. He found nothing unreasonable in the refusal and no serious or significant error in the adjudicative process. The court dismissed the appeal and refused the relief sought. The judgment did not grant a certificate.