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…

The Federal Institute of Intellectual Property can also issue a supplementary protection certificate to an applicant if a certificate for the same active pharmaceutical ingredients (API) or combination thereof has already been granted to a third person. By interpreting the law in that way – only restricting the grant of a certificate for the same…

In this blog, we reported earlier about a new nullity action initiated in 2010 against the German supplementary protection certificate (SPC) for enantiomeric escitalopram and the judgment of the German Federal Patent Court (Bundespatentgericht – BPatG) in favor of the validity of the SPC. Meanwhile, the BPatG issued the written grounds for its decision.

If a supplementary protection certificate (SPC) should have been denied (or granted with limited scope), because the six month application period following the date of first marketing approval has lapsed, it is entirely or partially void. There is a lack of legal interest for a negative declaratory action directed at declaring the non-existence of claims…

Hungarian Supreme Court’s decision on conditions for granting supplementary protection certificates (SPC) under the transitional provisions of the Accession Treaty. The Supreme Court held that the first marketing authorization for the pharmaceutical product granted in any EU Member State (including the entire territory of the EU as enlarged due to the 2004 accessions, not restricted…

The Swiss Federal Supreme Court held in a recent decision that the Swiss company Teva Pharma AG had to bear the court costs and reimburse Novartis’s attorneys’ fees in preliminary injunction proceedings because of Teva’s contradictory conduct in this case. The decision was based on the following facts: On March 16, 2010, Teva was granted…

Combination products (containing two or more active ingredients) raise difficult questions with respect to supplementary protection certificates (SPCs). Can a SPC be based on the market authorisation (MA) of a combination product, if the patent only covers one active ingredient? On 13 July 2011, the Advocate General at the CJEU delivered her Opinion on the…

The Court, in infringement proceedings brought by Novartis against Actavis for marketing generic Valsartan, held that the assessment of infringement had to be made as of the time of infringement, not as of the priority date. This is the first decision in years in Norway taking a position on this issue. The judgement also deals…