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Expert Corner

Intellectual Property expert

Update on SPCs Case Law

The following decisions, recently issued, represent the first effects of the recent changes of interpretation of key Articles of SPC Regulation as set forth in ECJ Medeva and Geogetown judgments.

1.     The scope of SPC

ECJ Case C-442/11 Novartis v Actavis

ECJ Case C-442/11 (March 2012), confirming ECJ Medeva and Geogetown decisions, held that the same rights conferred on the Proprietor by the basic patent must exist for the SPC. Consequently an SPC covering “X” can be enforced against a competitor marketing “X + Y”, as long as the claims of the basic patent do not explicitly exclude the presence of another active ingredient.

Art. 3 of SPC Regulation

  • MedImmune v Novartis February 2012

This decision relates to the validity of ranibizumab SPC and represents the firstUK Court consideration of Art 3(a) in view of ECJ Medeva and Geogetown decisions. 

Even though the Court have acknowledged that there is still a great deal of uncertainty about the appropriate test to use to assess compliance with Article 3(a) of the SPC Regulation and that further references will be required to clarify what is meant by “specified or identified in the wording of the claims “, the SPC for ranibizumab was declared invalid, as no adequate “specification” of the active ingredient in Lucentis (the ranibizumab monoclonal antibody) was considered to be present in either in the claims or in the specification.

As a matter of fact the Court stated:

57. […] In the present case, claim 1 merely identifies the product of the method as “a molecule with binding specificity for a particular target”. This covers millions of different molecules of various kinds. It is not even limited to antibodies. Although ranibizumab falls within this extremely broad class of products, there is nothing at all in the wording of the claim, or even the lengthy specification of the Patent, to identify ranibizumab as the product of the process in question.

  • Merck&Co  SPC for antiviral product (Aripla) February 2012  

The SPC for Aripla, which is a combination of three active ingredients namely efavirenz, emtrycitabine and tenofovir dizoproxil, was refused by the Polish Patent Office on the grounds that the combination of the three ingredients does not fall within the patent claims.Such a decision was upheld  by District Adimistrative Court in Warsaw (DAC)and by  the Polish Supreme Administrative Court (“SAC”). Specifically SAC  stated that an SPC could not be granted for a product which extends over the literal meaning of the patent claims.

3. Number of SPCs-Queensland v CSL and UK Intellectual Property Office, February 2012

It has been confirmed that in the UK, at least, Medeva does not change the law set down in Biogen (C-181/95) and that the rule remains as more than one SPC is allowable per patent provided that each SPC is directed towards a different active ingredient.

It will be interesting to see how the different national Courts inEuropewill rule on the above points .

Finally, I would like to draw your attention to the analysis and its outcomes made by genericsweb(see the link below) concerning  SPCs directed to combinations of active ingredients with an expiry date after 01.01. 12. Specifically one needs to check if the compounds subjected to SPCs are “specified or identified in the wording of the claims”.

http://www.genericsweb.com/download/Generics_Bulletin_April_2012_article.pdf

 

Anna Pezzoli 24 April 2012.

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