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Results: 1-10 of 115

New regulatory requirements in the pharmaceutical sector
  • Bird & Bird
  • European Union
  • October 30 2008

Regulation (EC) No 19012006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (hereinafter, “the Paediatric Regulation”) is intended to tackle the problems resulting from the absence of suitably adapted medicinal products for the paediatric population (including inadequate dosage information, non-availability to the paediatric population of therapeutic advances, suitable formulations and routes of administration as well as use of magistral or officinal formulations to treat the paediatric population


Recent Dutch seizures of generic drugs add fire to the WTO dispute regarding seizure of goods in transit
  • Bird & Bird
  • Global, Netherlands
  • March 23 2009

The dispute regarding goods in transit has been highlighted in recent months due to several seizures of generic drugs in transit by the Dutch customs authorities


UK Patents Court judgment in Laboratorios Almirall SA v Boehringer Ingelheim International GmbH
  • Bird & Bird
  • United Kingdom
  • March 11 2009

This case concerned a tit-for-tat revocation of two patents claiming the combinations of a particular anticholinergic with -agonists for treating respiratory illnesses


UK Patents Court judgment in Dr Reddy’s Laboratories v Eli Lilly
  • Bird & Bird
  • United Kingdom
  • December 31 2008

In a judgment handed down in October of this year, the Patents Court (Mr Justice Floyd) upheld EP (UK) 0,454,436 (the “Patent”) which is owned by Eli Lilly and which protects the schizophrenia drug olanzapine


Protection of dosage regiment for medicaments under the new European Patent Convention 2000
  • Bird & Bird
  • European Union
  • July 16 2008

The discussion before the European Patent Office on patentability of second medical use claims has now entered another round


The future of the Belgian kiwi reimbursement model jeopardised by a decision of the Council of State?
  • Bird & Bird
  • Belgium
  • July 17 2009

In 2006, Belgium implemented a procedure for the reimbursement of medicinal products that was inspired by the system applicable in New Zealand, known also as the "kiwi model"


Patent settlements under the authorities’ magnifying glass
  • Bird & Bird
  • European Union
  • December 15 2009

Drug prices are currently a key area of discussion in many countries around the globe


ECJ decision in AHP Manufacturing BV v the Bureau voor de Industriele Eigendom (Case C-48207)
  • Bird & Bird
  • European Union
  • October 13 2009

The ECJ has accepted that the holder of a basic patent is entitled to one SPC regardless of whether other SPCs have already been granted to other holders of one or more other basic patents


Status of the insufficiencyobviousness squeeze - an appraisal of the House of Lords’ Generics et al v Lundbeck judgments
  • Bird & Bird
  • United Kingdom
  • May 1 2009

In February 2009 the House of Lords unanimously dismissed an appeal by a number of pharmaceutical companies against the Court of Appeal’s decision to not revoke Lundbeck’s escitalopram patent on grounds of insufficiency


Inclusion in the G-Standard of a generic medicine held not to be infringing
  • Bird & Bird
  • Netherlands
  • August 20 2007

In Glaxo Group Ltd v. Pharmachemie B.V., the District Court of The Hague was asked to consider the question whether the inclusion of the generic medicine Ondansetron in the so-called ‘G-Standard’ prior to the expiry of the patent protection (of a second medical use of) this medicine constituted patent infringement