The Court of Justice of the European Union (ECJ) has issued two rulings interpreting EU law at the request of British courts addressing whether drug makers can obtain a supplementary protection certificate (SPC), which extends patent protection, for products with active ingredients additional to those specified in the original patent. Medveda BV v. Comptroller Gen. of Patens, Designs and Trade Marks, 2011 E.C.J. C-322/10 (decided November 24, 2011); Georgetown Univ. v. Comptroller Gen. of Patents, Designs and Trade Marks, 2011 E.C.J. C-422/10 (decided November 24, 2011).
The issues arose in cases involving patents for pertussis and papillomavirus vaccines that are effective against multiple diseases with the addition of other active ingredients.
According to ECJ, as long as all other requirements are met under Article 3(b) of Regulation No. 469/2009, the competent industrial property authority of a member state may grant “a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a special protection certificate contains not only that combination of the two active ingredients but also other active ingredients.” While pharmaceutical interests reportedly reacted favorably to the ruling, some reservations were expressed about that part of the court’s rulings limiting companies to one SPC per patent. See BNA Life Sciences Law & Industry Report, December 2, 2011.