On 28 October 2002, Hoffman-La Roche applied with the Italian Patent Office for a SPC covering the medicinal product Bosentan, based on a marketing authorisation granted by the European Medicines Agency, as the first marketing authorisation in the EU. The SPC, considering also the 6 months of paediatric extension, was determined to extend until 15 November 2017.
Further to the EU Court of Justice’s decision in the case Novartis AG and Others. v. Comptroller-General of Patents, Designs and Trade Marks for the United Kingdom (joined Cases C-207/03 and C-252/03), the patent holder found that the duration of the Italian SPC had to be recalculated on account of an earlier Swiss marketing authorisation and therefore it submitted to the Italian Patent Office a request for the limitation of the duration of the Italian SPC to the date of 28 April 2017. The Italian Patent Office rejected the patent holder’s request on the ground that, once granted, any issue concerning the SPC was within the exclusive competence of civil courts.
The patent holder appealed the decision, observing that Italian law expressly acknowledges the right of the patent holder to limit the patent (pursuant to Article 79 of the Italian Intellectual Property Code, the national provision corresponding to Article 105a EPC) or to partially surrender its right, while there was a legitimate interest to seek the recalculation in order to avoid unnecessary patent disputes before civil courts and in the light of the prejudice to the public that would be caused by the unduly prolonged duration, given that the existence of the SPC would have prevented the Italian Medicines Agency to grant the pricing and reimbursement of generic version of the product.
The Italian Patent Office Board of Appeal set aside the appealed decision, stating that there are no reasons preventing the application to SPCs of Article 79 of the Italian Intellectual Property Code on the limitation of a patent. The partial surrender of a patent’s scope of protection (as it is a patent limitation) should, in view of the Board of Appeal, apply also to the duration of the SPC, which would amount to the subject matter of the exclusive right conferred by the SPC.
The Board of Appeal therefore held that:
“It comes from the above that, even in the absence of specific provisions ruling the matter, also at European level (the surrender pursuant to Article 14 of EU Regulation 469/2009 would cause the lapse of the SPC in its entirety), the recalculation to the purpose of a reduced duration of an SPC cannot be excluded on formal grounds, as this facilitates generic products entering the market with clear benefits in curbing the health care expenditure“.
The decision of the Board of Appeal is welcome, as it is not apparent why a limitation of the duration of the SPC, if requested by the patent holder, should be refused by the Italian Patent Office. There are no doubts that the patent holder may freely dispose of the right at stake. It is also doubtful that the legal basis for such limitation may be found in the provision of law on the limitation of the scope of protection of a patent, which is apparently concerned with a quite different aspect of the protection. It might be argued that the right to surrender an SPC should include a partial surrender.
That said, it must be noted that the decision of the Board of Appeal should not apply to other cases of recalculation, which are not based on a limitation of the right sought by the patent holder, as the reduction of the duration sought by a third party, or its extension requested by the patent holder, as well as to any other dispute concerning the validity and infringement of an SPC, which are still to be adjudicated by Italian civil courts.
Authored by Riccardo Fruscalzo