Merck Sharp Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals Limited v. Teva Pharma B.V. and Teva UK limited On 15 March 2012, the High Court in England and Wales delivered some useful guidance on when a patentee can obtain an interim injunction in a pharmaceutical patent infringement action. The case was Merck Sharp Dohme Corp. and…

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…

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…