ADVOCATE-GENERAL SUGGESTS SPCs TO A PART OF A MEDICINAL PRODUCT SHOULD BE ALLOWED
19 August 2011
SPCs and their availability
SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation.
Under Regulation (EC) No 469/2009 any "product" that is protected by a basic patent in force, and that is validly authorised for marketing as a medicinal product, is eligible for SPC protection provided that it is new to the market and has not previously been protected by an SPC. The term "product" is defined as: "the active ingredient or combination of active ingredients of a medicinal product".
Cases concerning authorised medicinal products that contain a combination of active ingredients (e.g. A+B) have now brought two issues into sharp focus:
- What determines whether a Product is ‘protected' by a basic patent in force? For example, for a Product defined as A+B, is it sufficient that the basic patent protects only A and that A+B infringes the patent, or must the patent somehow identify both A and B?
- What is a ‘valid authorisation' to place the Product on the market as a medicinal product? For example, is an authorisation of A+B a ‘valid authorisation' of a Product defined as A alone?
The issues relate, respectively, to the interpretation of Articles 3(a) and 3(b) of SPC Regulation (EC) No 469/2009.
Medeva and Georgetown et al references
The UK Courts have referred questions on these matters to the CJEU. The questions arose from appeals lodged by Medeva and Georgetown et al, and the cases were joined by the CJEU (cases C-322/10 and C-422/10).
Both Medeva's and Georgetown et al's SPC applications relate to vaccines containing multiple antigens authorised in combination. Their allowability hinges on whether it is possible to define the Product as one of the antigens, or a sub-combination of antigens, present in an authorised vaccine. The allowability of Medeva's applications further depends on whether a patent that discloses some, but not all, of the antigens in an authorised vaccine nevertheless protects the entire combination of antigens for the purpose of securing an SPC.
Although the facts of the cases relate to combination vaccines, these issues apply equally to other areas of human and veterinary medicine and also in agriculture. Indeed, an increasing trend to authorise medicines and plant protection products in combination suggests that the Court's decision may have far-reaching consequences.