"Supplementary Protection Certificates: is a new era beckoning for combination drugs in the EU?" is the title of an article by Michael Pears and Mike Snodin (both of Potter Clarkson) which has recently been published in Scrip Regulatory Affairs. This article, which considers the effects of Advocate General Trstenjak's Opinion in Joined Cases C-422/10 Georgetown University and C-322/10 Medeva, concludes with the following observations.
"Although the Advocate General seems to be ruling out an infringement test to establish whether a product is protected by a basic patent under Article 3(a), the precise test to be used remains unclear. At least some form of disclosure of each active ingredient of a product appears to be necessary, but how specific this must be is not known.
What is clear from the opinion, however, is the proposal for SPCs to be obtained for a patented part of authorised products containing a combination of active ingredients. In reaching this conclusion, the advocate general has obviously recognised the importance of providing SPC protection for active ingredients which are first authorised in combination with other active ingredients.
If the CJEU follows the opinion, the narrow interpretation of what is “protected” by a basic patent may mean that some granted SPCs are invalid. On the other hand, the more permissive interpretation of what represents a valid authorisation could provide new opportunities for obtaining useful (and very broad) SPC protection.
Overall, the above-mentioned aspects of the A-G’s opinion provide what seems to be a workable approach for obtaining SPC protection for combination products.
While the facts of the Medeva and Georgetown et al cases relate to combination vaccines, the issues apply equally to other areas of human and veterinary medicine and also in agriculture. Indeed, an increasing trend to authorise medicines and plant protection products in combination suggests that the Court’s decision may have far-reaching consequences. The final judgement will therefore be eagerly anticipated".
You can read this article in full
here.
Medeva: a new angle?
ReplyDeleteWe share the confusion expressed in this blog in relation to the AG’s Opinion. Two points in the AG’s argumentation raise our attention. In our view, the AG’s method of construing the Regulation No. 469/2009 merits a closer analysis as well as the proposed “subject matter of the basic patent” approach. Also, the AG’s belief that according to the case law of the ECJ, only one SPC may be granted for each basic patent, appears questionable.
1)The AG starts the interpretation of the Regulation in particular with a discussion of the meaning and the reach of the “product” and the “basic patent” according to Art. 1b and 1c. One can appreciate that only one single active ingredient cannot constitute the “product” if the respective medicinal product actually consists of a larger combination of active ingredients. She subsequently concludes that, in such case, no SPC might be granted – as in that case there would be no “basic patent” if such patent merely protected only one single active ingredient. In fact, if one applies and considers the requirements of the Regulation in the right order, namely with an analysis of the requirements for granting an SPC pursuant to Art. 3 of the Regulation, and determines the meaning of the terms “medicinal product”, “product” and “basic patent” in light of the purpose of Art. 3, the result may be different:
Art. 3a demands that the product is protected by a basic patent in force. The product is defined in Art. 1b as the active ingredient or combination of a medicinal product. Thus, according to Art. 3a, the specific product (i.e. active ingredient or combination of ingredients) for which the SPC is sought must be protected by a “basic patent” (and of course have marketing authorization). Thus, prior to considering whether that specific product – a medicinal product having a multitude of active ingredients – is protected by a basic patent, one has to determine which patent may qualify as a basic patent under Art. 1c. Interestingly, the basic patent in Art. 1c does not refer to “the” product, but to “a” product “as such”. As the product is defined as the active ingredient or combination of active ingredients and the definition of the basic patent merely demands a product as such to be protected. Such basic patent accordingly has to cover “an active ingredient or a combination of active ingredients of a medicinal product as such” – but not the specific product that is required in Art. 3a. Therefore, a basic patent for a medicinal product having a multitude of active ingredients may even be a patent that merely claims just one of those active ingredients – provided that it actually protects that product as required by Art. 3a.
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ReplyDelete2)In order to determine whether that “protection” requirement is met, the AG proposes a “subject matter test”. Dorothea von Renesse has already commented on that approach and disapproved it. In this respect, we agree with her analysis. In fact, using a “subject matter test” instead of determining the protective effect and reach, respectively, has been suggested already by the German Federal Patent Court in 1995 in the “Idarubicin” case, where the court suggested relying on the strict language of the claims in order to determine the core of the invention. Upon appeal, the German Federal Supreme Court subsequently referred that question to the ECJ, which then concluded that the question whether a product shall be protected by a basic patent according to Art. 3a Reg. (EEC) 1768/92 had to be assessed following the provisions which determined the basic patent (Case C-392/97). On that basis, the Federal Supreme Court rejected the suggested approach of the Federal Patent Court.
3)Further, the AG assumes that the ECJ’s case law, in particular the “Biogen” case (C-181/95) would be an impediment against the granting of more than one SPC per basic patent. In fact, the underlying case of Biogen did not raise the question whether the proprietor of a basic patent would be entitled to multiple certificates. Rather, the ECJ had to determine whether the Regulation was inhibiting the issuance of an SPC to each of a number of patent owners when the specific drug was protected by these multiple basic patents. The ECJ negated this question. But the facts of Biogen do not give cause to reconsider whether one basic patent could serve as foundation for two different products and therefore two independent certificates.
It will thus be interesting to see what the ECJ has to say.
sorry, but point 28 of Biogen is clear: "Under Article 3(c) of the Regulation, however, only one certificate may be granted for each basic patent". The ECJ didn't refer to one certificate per patent holder.....so, maybe we were wrong on that...
ReplyDeleteAccording to ECJ -Calendar.
ReplyDeletehttp://curia.europa.eu/jcms/jcms/Jo2_17661/
Thursday 24/11/2011
09:30 Judgment
C-322/10
Approximation of laws
Medeva
Court of Justice - Fourth Chamber EN
Thursday 24/11/2011
Thursday 24/11/2011
09:30 Judgment
C-422/10
Approximation of laws
Georgetown University and Others
Court of Justice - Fourth Chamber EN