1 December 2011

SPCs on Combination Products - CJEU Rules in C-322/10 Medeva and C-422/10 Georgetown University

Garreth Duncan

Two long-awaited decisions of the Court of Justice of the European Union (CJEU) in the Medeva and Georgetown University cases have finally clarified the law on Supplementary Protection Certificates (SPCs) for medicinal products comprising a combination of active ingredients. These decisions may require a change in drafting practice for patent applications directed to pharmaceutical and plant protection products, as well as review of existing patent applications and even granted patents, so that they claim specific combination products if SPC protection is desired for such combinations in the future.

The effect of the two decisions can be summarised as follows:

• An SPC cannot be granted for an authorised medicinal product which is a combination of two active ingredients (A + B) if the literal wording of the basic patent claims A in isolation. This applies even if the claims use "comprising" or similar language which does not exclude the presence of another active.
• An SPC cannot be granted for an authorised medicinal product which is a combination of A + B if the literal wording of the basic patent claims a combination of A with another unspecified active ingredient.
• An SPC may be granted for an authorised medicinal product which is a combination of A + B if the literal wording of the basic patent claims A in combination with the specified active ingredient B.
• An SPC may be granted for an active ingredient (A) if the wording of the claims of the basic patent relied on specifies A, even if the authorised medicinal product contains not only that active ingredient but also other active ingredients (A + B, A + C and so on).

A full commentary on these decisions will be available in our February 2012 patent newsletter.

Useful links

Full text of decisions:
C-322/10 Medeva
C-422/10 Georgetown University