EU Court grants longer patent protection for combined drugs.Mal

Daniela Bartolo | Published on 10 Jan 2012

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Patent protection has been extended for drugs and vaccines that are effective against multiple diseases. The preliminary ruling delivered by the European Court of Justice (ECJ) followed questions referred from the Court of Appeal in London for the Medeva and Georgetown cases both of which have clarified the law on supplementary protection certificates (SPCs) for medicinal products comprising a combination of active substances.

The ECJ held that an SPC, or extended patent protection, can only be given once per patent and can only be given to the company that owns the patent. The Court confirmed that the certificate cannot be given for active ingredients which are not the direct result of the original patent.

In having been granted a patent, the holder has the right to prevent third parties from performing acts that incorporate the subject-matter of the patent. In Malta, these rights are granted by the Maltese Patent and Designs Act.  However, Malta is one of the few EU countries that fully embraces the nature of the Bolar provision according to which exemption, despite the patent protection, it is permissible to carry out research for regulatory approval, even before the end of the patent term.

Malta’s wide interpretation of the Bolar provision has led to the re-location and launch of numerous plants, branches and agencies of large and medium-sized pharmaceutical companies in Malta.


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