Patent Linkage: Administrative Court of Lazio rules SPC extension does not apply to combinations of patented active ingredients with other molecules
- July 30, 18
With a decision pronounced on 5 July 2018, the Regional Administrative Court (TAR) of Lazio upheld an appeal filed by Doc Generici S.r.l., an Italian pharmaceutical company that specializes in the development, manufacturing and sale of generic drugs. In the case, the appellant impugned the Italian Medicines Agency’s (AIFA) classification of an ezetimibe/simvastatin-based drug combination used for the treatment of dyslipidemia as a C-class medication, which effectively excluded it from qualifying for National Health Service coverage.
Upon expiration of the relevant supplementary protection certificate (SPC), on 16 April 2018, Doc Generici was granted authorization to market a generic version of ezetimibe. Meanwhile, the patent holder obtained an additional SPC extension for the combination of ezetimibe with other active ingredients until 1 April 2019. In a consequential decision, the TAR ruled in favor of Doc Generici, claiming that the patent protection “cannot be extended to any possible combination of the active compound with other molecules”.
Ezetimibe is a cholesterol-lowering medication distributed under the trade names Ezetimibe, Ezetrol, Viemm and Zient. It hit the shelves for the first time in Germany in 2002. Ezetimibe’s basic European patent expired on 14 September 2014, after which the product was covered and SPC until 16 April 2018.
SPCs are patent extensions that provide additional intellectual property rights on biologically active compounds ranging from medicaments to veterinary drugs and insecticides. Supplementary protection certificates guarantee appropriate levels of patent assurance. They were introduced in order to offset the considerable costs of R&D activities and potential delays in the process for marketing authorization.
The patent holder later applied for and was granted a new SPC related to the association between ezetimibe and simvastatin, in consideration of the fact that claim 17 of the basic patent claimed the possible combination of ezetimibe with molecules belonging to the category of statins.
On account of the issuing of the second SPC, AIFA listed the ezetimibe/simvastatin-based drug manufactured by Doc Generici in class C, pursuant to art. 11, paragraph 1-bis, of Law Decree n. 158/2012, which states that: “with regard to the periodical updating of the National Pharmaceutical Handbook, generic drugs are not reimbursed by the National Health Service prior to the expiration date of the basic patent or SPC”
In light of these considerations, Doc Generici filed an appeal before the TAR to thwart AIFA’s decision and have the additional SPC annulled.
AIFA – one of the defendants – claimed it acted in its law enforcing capacity, and insisted that its hands were tied as to the recognition of the second SPC. Settling patent disputes, the Agency concluded, falls outside its purview.
The patent and SPC holder filed a detailed report to show that the ezetimibe/simvastatin combination drug, protected by the second SPC, differed from existing products in its therapeutic efficacy, and thus constituted a novel invention worthy of a patent.
EU stance on the issue
AIFA’s approval of the additional SPC is clearly at odds with Regulation n. 469/2009, given that the declared goal of SPCs is to enable a patent owner to benefit (only once) from a period of exclusivity on top of the basic patent protection, and to “compensate for the delay to the marketing of what constitutes the core inventive advance that is the subject of the basic patent.”
In this respect, as pointed out by the TAR, the Court of Justice of the European Union, in its decision dated 12 March 2015 rendered in case C-577/13 (Actavis v. Boehringer Ingelheim) stated that art. 3, letters a) and c) of Regulation n. 469/2009 “must be interpreted as meaning that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained an SPC, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second SPC for that combination”.
However, this approach has been very recently specified by the same Court of Justice, which by its decision dated 25 July 2018 in case C-121/17 (Teva v. Gilead), stated that “Article 3(a) of Regulation n. 469/2009 must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent: (i) the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and (ii) each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent”.
Confirming the Court of Justice’s position, the TAR of Lazio ruled that while the basic patent provided for the possibility of combining ezetimibe with molecules belonging to the statin family, by no means does it follow that the patent holder ought to be entitled to any further protection other than the one granted by the first SPC issued.
The TAR also observed that, according to the landmark decision of the Council of State n. 693/2014, the behavior of the patent holder aimed at artfully and unduly extending the patent protection of a product, through an undue and improper use of administrative proceedings, and which delays the entering into the market of generic pharmaceutical products, represent an abuse of dominant position, regardless of whether the holder’s patents are validly obtained according to the patent law.
Hence, the Court granted Doc Generici’s appeal on the grounds that the SPC “cannot be extended to any possible combination of the active compound with other molecules (whose patent protection has expired) for the sole reason that the combination is mentioned in a patent claim or may have a therapeutic efficacy which may be different or increased vis à vis the patented active ingredient”.
The latest decision of the Court of Justice of the European Union in the case C-121/17, summarized above, might lead the judgment of the TAR to be appealed before the Council of State, because in said decision the CJEU has widened the concept of “basic patent in force” under Article 3 of Regulation n. 469/2009, to the extent that a new SPC on the combination of an active ingredient, expressly protected by the basic patent, with another active ingredient, not expressly mentioned in said patent, is possible if said combination, in the light of the description and drawings of that patent, necessarily falls under the invention covered by that patent, and each of those active ingredients is specifically identifiable, in the light of all the information disclosed by that patent.