Explicit Basis Test Conquers Infringement and Subject Matter Tests – The end of combination products?

November 25, 2011

On 24 November 2011, the Court of Justice of the European Union (CJEU) gave judgment in long awaited cases C-322/101 and C-422/102, Medeva and Georgetown.

Since the judgment in the case C-392/973 Farmitalia in 1999, the interpretation of Article 3a of the medicinal Regulation 469/20094 has been a matter of national law. Now the CJEU has ruled that only subject-matter specified in the wording of the claims of the basic patent can be the subject of a supplementary protection certificate (SPC), while there need not be identity between the product approved as a medicinal product and the product of the SPC.

In short this means that a very strict interpretation of Article 3a) and the teleological interpretation of Article 3b) has been adopted.

Regarding Article 3 a) the CJEU base their conclusion on Article 5 of the Regulation and the explanatory memorandum, i.e. on the protection conferred. While it is correct that Article 5 provides that the SPC confers the same rights as the basic patent and is subject to the same limitations and the same obligations as the basic patent it seems to be on a weak basis to directly conclude from this that it means that a given combination must be specified in the wording of the claims.

Rather, the wording of Article 5 could mean that the boundaries of the claim, e.g. a formulation or medical indication, constitutes the limitation. This view also appears from the explanatory memorandum related to Article 5. As regards the limitations and obligations the exceptions to the right conferred by the basic patent are also mentioned, for example acts allowed under the research exemptions (and now also the Bolar), private actions, compulsory licenses etc. Apparently the CJEU did not find these aspects relevant and chose an even stricter approach than the Advocate General (AG)5 who pleaded a subject matter test.

So, what are the immediate consequences hereof? All patents that include long lists of possible combinations and where a combination SPC is issued or contemplated to be applied for, will likely be limited to include the combination in the wording of the claims using the central limitation procedure now provided under EPC20006. This would be in accordance with the CJEU opinion. The question is just how this makes the basic patent any different than before except that the EPO, the national offices and translation providers will earn extra money on limitation and revalidations. This will hardly support further research in medicines.

Newly drafted patents will likely to a larger extent contemplate all known active compounds used in or known to be potentially usable in medicine, thereby providing the possibility of including such combinations in a claim. Again, one can ask how this contributes to the research in new medicines. And again one can conclude that this will become a potential high source of turnover for the EPO and national authorities which charge official fees on each page exceeding 35 pages.

Caught in the middle are patentees that for one reason or another did not include long lists of possible ingredients in the specification and for that reason are not able to obtain SPC for their products by requesting limitation of the basic patent. In addition, already granted SPCs in those Member States that followed the infringement test were accepted when the combination was generically disclosed or only disclosed in the specification, and will likely be challenged on their validity.

So has this in essence changed the possibilities for obtaining SPCs on combinations in the long run? My guess is no, since the obstacles can be overcome by the skilled draftsman.

Then on the other hand the CJEU has adopted the teleological approach to Article 3b) advocated by the AG, namely that there need not be identity between the Marketing authorisation (MA) and the SPC product.

Thus, in a situation where the basic patent claims A and the MA is approved for A+B+C, an SPC could still be granted for A. Given the fact that a SPC is valid for all medicinal products covering “the product A”, the protection conferred by the SPC seems to be much broader than it would have been if being restricted to A+B+C, as this would allow products A+B, A+C and B+C to be free from the protection of such SPC.

This may however not be the case once the CJEU in a request for a preliminary ruling in C-442/11 answers the question referred by the High Court of Justice (UK):

Where a supplementary protection certificate has been granted for a product as defined by Regulation (EC) No 469/2009 for an active ingredient, are the rights conferred by that certificate pursuant to Article 5 of the Regulation in respect of the subject matter as defined in Article 4 of the Regulation infringed:

(i) by a medicinal product that contains that active ingredient (in this case valsartan) in combination with one or more other active ingredients (in this case hydrochlorothiazide); or
(ii) only by a medicinal product that contains that active ingredient (in this case valsartan) as the sole active ingredient?

Just on note, one could also suspect that because the answer to question 6 is answered: that provision (Article 3b) does not preclude the competent industrial property office of a Member State from granting a SPC could lead to a continued disharmonized practice among the Member States in that it actually allows a Member State to refuse an application where there is not identity between the MA and the SPC (and the basic patent, c.f. supra).

In the quest for minimizing an alleged extension of protection for combination products, the CJEU has now come up with an answer which is primarily economically beneficial to the authorities charging applicants official fees for long specifications, and in reality confers a broader protection than would have been possible if using the infringement test to define the product, which may not be in the public interest.

On a constructive approach to the new legal situation, the best advice looking forward is for patent drafters to develop standard lists of all known active ingredients (approved or in the pipeline) in order to keep all options open for including combinations in the patent claims either in divisional applications, when time allows for that, or by limiting the patent using the central limitation procedure at the EPO.

Sidsel Hauge
European Patent Attorney

1) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62010CJ0322:EN:HTML (C322/10)

2) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62010CJ0422:EN:HTML (C-422/10)

3) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:61997CJ0392:EN:HTML (C-392/97)

4) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:152:0001:0010:en:PDF (Regulation 469/2009)

5) http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=EN&Submit=Submit&numaff=C-322/10 (Advocate General Opinion C-322/10 + C-422/10)

6) http://www.epo.org/law-practice/legal-texts/html/epc/2010/e/ar105a.html
EPC2000 Article 105a

25 November 2011