5th December, 2011
The expiry of patent for Lipitor and subsequent steps by companies to market the generic version and the erstwhile patentee to safeguard its revenue stream has grabbed headlines. It is undisputed that research and development costs are substantial and patentees do seek wider time horizon of exclusivity to recoup or reap benefits of research. The SPC is one such device by which an entity can get an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains marketing authorisation.
In its recent ruling in the case of Medeva BV, the Court of Justice of the European Union (CJEU) has ruled that SPC for a medicinal product can be granted only for active ingredients which are part of the basic patent. The Court held that Article 3(b) of Regulation No 469/2009 does not preclude granting of SPC for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent where the medicinal product for which the marketing authorisation is submitted to obtain SPC contains not only such combination of the two active ingredients but also other active ingredients.
The Court noted the fact that multivalent vaccines composed of multiple active ingredients are being developed and refusal to grant SPC to a medicinal product which has other ingredients besides those contained in the basic patent would be a disincentive for research as well as public health policy.
This ruling has wide implications for the pharma sector and the prevelant practice in the EU of granting multiple SPCs out of the basic patent. The CJEU has also reiterated that when a patent protects a product, only one certificate may be granted per basic patent.
The expiry of patent for Lipitor and subsequent steps by companies to market the generic version and the erstwhile patentee to safeguard its revenue stream has grabbed headlines. It is undisputed that research and development costs are substantial and patentees do seek wider time horizon of exclusivity to recoup or reap benefits of research. The SPC is one such device by which an entity can get an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains marketing authorisation.
In its recent ruling in the case of Medeva BV, the Court of Justice of the European Union (CJEU) has ruled that SPC for a medicinal product can be granted only for active ingredients which are part of the basic patent. The Court held that Article 3(b) of Regulation No 469/2009 does not preclude granting of SPC for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent where the medicinal product for which the marketing authorisation is submitted to obtain SPC contains not only such combination of the two active ingredients but also other active ingredients.
The Court noted the fact that multivalent vaccines composed of multiple active ingredients are being developed and refusal to grant SPC to a medicinal product which has other ingredients besides those contained in the basic patent would be a disincentive for research as well as public health policy.
This ruling has wide implications for the pharma sector and the prevelant practice in the EU of granting multiple SPCs out of the basic patent. The CJEU has also reiterated that when a patent protects a product, only one certificate may be granted per basic patent.