A Supplementary Protection Certificate (SPC) extends the term of a patent for a medicinal or plant protection product by a period of not more than five years. The aim of SPCs is to compensate the patent owner for ‘lost’ patent protection which was caused by the time it took to obtain marketing authorisation for the product in question. An SPC is a national right, available in member states of the European Union (EU) by application to the national patent office of the state for which a certificate is desired. The SPC is based on a patent and is granted in respect of an active ingredient in a medicinal or plant protection product.
The Court of Justice of the European Union ruled that Article 13 of the old SPC Regulation (EEC 1768/92, identical to article 13 of the “new” SPC Regulation (EC469/2009) in conjunction with Article 36 of the Pediatric Regulation (EC 1901/2006), allow for the grant of an SPC of negative duration. The additional term provided by…
Multiple rulings of the CJEU on the SPC Regulation fail to answer questions posed by the national courts, result in greater confusion and give rise to a need for yet more references. Introduction In Novartis Pharmaceuticals UK Ltd v Medimmune Ltd & Anor [2012] EWHC 181, Mr Justice Arnold was required to apply the recent…
An SPC can only be granted if the product falls within the scope of protection of the basic patent. If the basic patent claims a combination of two known components (i.e. a monoclonal antibody with a neoplastic agent), that combination is the patent’s contribution to the art. An individual component is not equivalent to the…
The recent judgment from the ECJ of 24 November 2011 in case C-322/10 (“Medeva”) has surprised the patent community, since the ECJ appears to have changed the view expressed in its judgment of 16 September of 1999 in case C-392/97 (“Farmitalia”), where the Court declared that it was not for the ECJ, but for national…
The Court of Justice clarified the requirements for grant of an SPC under Articles 3(a) and 3(b) of the SPC Regulation. According to the Court, on the basis of Article 3(a) an SPC cannot be granted for active ingredients not specified in the wording of the claims of the basic patent. With reference to Article…
On 24 November 2011 the CJEU passed judgment in the cases C-322/10 (Medeva) and C-422/10 (Georgetown). In the Medeva judgment, the Court answers six questions put to it by the UK Court of Appeal and the High Court respectively. The facts are deemed known by the reader – they can be conveniently reduced to: A…
As already explained in a previous post, the company governed by the laws of Switzerland, Novartis AG, is the holder of patent EP 0 443 983 entitled “Acyl compounds”, whose subject-matter is a group of antihypertensive compounds, including valsartan, pharmaceutical preparations containing them and processes for the preparation of these compounds. This patent, filed on 12 February 1991, was to…
The Supreme Administrative Court –overruled the Patent Office (PO) denying AstraZeneca’s application for a supplementary protection certificate (SPC), because the PO should have applied § 77(2) – instead of §79 – of the Transitional and Closing Provisions of the Act amending the Bulgarian Patents Act, which does not contains any requirements relating to the product’s…
On 11 November 2011 the IP Chamber of the Court of Rome granted the motion for preliminary injunction requested by Novartis AG and Novartis Farma S.p.A. against Mylan S.p.A. on the basis of Novartis’ Italian valsartan and hydrochlorothiazide SPC, the active ingredients in Novartis’ Co-Diovan medicinal product (which is marketed in Italy as Co-Tareg). The…
A supplementary protection certificate SPC granted for an enantiomer (escitalopram) cannot be declared void because a prior SPC was granted for the racemate (citalopram) when both the racemate and the enantiomer are protected by individual patents and thus are different products. This must be so because otherwise the enantiomer patent would be invalid for lack…
