GSK adjuvants reference: still time to comment

The SPC Blog has received the following email from the United Kingdom's Intellectual Property Office this afternoon:

We have received notification of a new case reference to the ECJ.  ...  In GlaxoSmithKline v Comptroller General of Patents [2013] EWHC 619 (Pat) the following questions were referred:

1.            Is an adjuvant which has no therapeutic effect on its own, but which enhances the therapeutic effect of an antigen when combined with that antigen in a vaccine, an 'active ingredient' within the meaning of Article 1(b) of Regulation 469/2009/EC?
 2.            If the answer to question 1 is no, can the combination of such an adjuvant with an antigen nevertheless be regarded as a 'combination of active ingredients' within the meaning of Article 1(b) of Regulation 469/2009/EC?"

 Case summary:

The appellant applied for an SPC relating to the product "an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", an adjuvant known as AS03. An additional application was filed for a pandemic influenza vaccine containing the adjuvant AS03.

Question 1 concerns whether or not an adjuvant, such as that common to these applications, can be considered an active ingredient within the meaning of Article 1(b) of the Regulation. Question 2 seeks to determine if the combination of an antigen, such as the influenza vaccine component of the latter application, and the adjuvant may be considered an active ingredient if the adjuvant alone may not.

This case and the questions referred to the court can be viewed on our website at:

http://www.ipo.gov.uk/pro-policy/policy-information/ecj/ecj-2013.htm

If you would like to comment on this case please email policy@ipo.gov.uk by 14 June 2013.

If you'd like to makes comments that will guide the UK government as to whether it should make representations in this reference, you have until Friday to do so.