The New Interpretation of How to Get a Supplementary Protection Certificate

4047891428_2329dbcecd_oAuthors: Birute Dauderiene, a Patent attorney at METIDADr Jacekas Antulis, an Associate Partner,  Head of  Patent Division at METIDA

Regulation (EC) No. 469/2009 of the European Parliament  of the Council of 6 May 2009 “Concerning the supplementary protection certificate for medicinal products” governs the scope of protection of the Supplementary Protection Certificate (SPC). It’s 1(b) article defines that SPC product means an active ingredient or combination of active ingredients of a medical product. Due to the increasing number of recently emerging cases associated with SPC active substances, the Court of Justice of the European Union (ECJ) gave the interpretation of Regulation No. 469/2009 and narrowed down the definition of a product as well as provided three different descriptions which are used to determine whether the product is protected by a basic patent.

The narrowed definition of the product was given in the ECJ decision regarding “Glaxosmithkline Biologicals” SA (GSK) vs “Comptroller-General of Patents” case, according to which, the fillers and adjuvants alone or in combination with antigens cannot form the basis of an SPC, if they do not have a therapeutic effect on their own, even though they enhance the therapeutic effect of the active ingredient. Due to this decision, it became impossible to obtain an SPC for most broad-spectrum ingredients and mixed products. This also includes GSK, which based its two SPC applications on the marketing authorization for Prepandrix. To specify, the first patent provides protection for the adjuvant ASO3 and the second for a vaccine which includes an antigen and ASO3. Hence, the vaccine cannot form the basis of an SPC.

At the end of 2013, the ECJ made a few important decisions clarifying on which patents’ basis SPC can be issued. The first decision, otherwise called “Neurim” case, says that if the new patent protects a new medicine of a known active ingredient which already has obtained the SPC, but which has a new therapeutic effect, that new patent can be issued with the SPC, the scope of which, could cover only the new use of that product, but not the active ingredient.

The second decision, otherwise called “Medeva” case, states that only one SPC may be granted to the basic patent which protects the product that has not received a certificate. This does not apply to a patent that provides protection for multiple products, as this type of the patent can receive several SPCs.

The third decision relates to 3(a) article of the Regulation, where one of the conditions for obtaining an SPC states, that the product must be protected by a basic patent in force which accurately describes and identifies the product. The description “accurately defined and identified” does not necessarily mean the reference to a product’s structural formula. However, as the “Eli Lilly” case showed, the active ingredient in the definition must be described not with generally known words, but with the specific terms relevant only to the ingredient.

It seems that more secret weapons are appearing in the battle for SPC and they will not be as easily issued as they have been up to this time.

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