skip to main content skip to accessibility policy

IP Cases & Commentary – Details

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

Bookmark and Share
News

Send to a Friend

We are glad that you have found this page of interest. Please use this form to send your friend an email link to this page.





The details you provide on this page will not be used to send unsolicited e-mail, and will not be sold to a 3rd party.

Follow us

Newsletter subscriptions

In support of our environmental policy we encourage email subscriptions to receive our patent and trade mark newsletters as soon as they are published.








For RSS users

Our RSS news feeds allow you to see when we have added new content to our website so you can get the latest site updates in one place, as soon as they are published.

Social media

Privacy Policy

We are committed to protecting and respecting your privacy. To understand our views and practices regarding your personal data and how we will treat it please see www.dyoung.com/privacypolicy