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Results: 1-10 of 859

Federal Circuit reins in patent infringement safe harbour for drug research tools

  • Pillsbury Winthrop Shaw Pittman LLP
  • -
  • USA
  • -
  • October 1 2008

On August 5, 2008, the Federal Circuit issued an opinion attempting to create statutory symmetry between two Hatch-Waxman Act provisions that sought to eliminate two distortions caused by the Food Drug and Cosmetic Act (“FDCA”

Confidentiality and the court process

  • McMillan LLP
  • -
  • Canada
  • -
  • September 30 2008

Pursuant to Rule 151 of the Federal Court Rules, on motion, the Court may order that material to be filed shall be treated as confidential

Generic may bring declaratory judgment action despite covenant not to sue

  • Locke Lord LLP
  • -
  • USA
  • -
  • October 13 2008

The Federal Circuit recently held that a unilateral covenant not to sue a competitor did not prevent a generic drug applicant from bringing a declaratory judgment action challenging the brand company’s patent

The biosimilars debate

  • Locke Lord LLP
  • -
  • USA
  • -
  • October 13 2008

Biologics are highly complex polypeptide products that are derived from living organisms and are used in the prevention or treatment of disease

Federal Court decision in first Section 8 damages case under the PMNOC Regulations: Section 8 remedy found not to include innovator’s profits

  • McCarthy Tétrault LLP
  • -
  • Canada
  • -
  • October 24 2008

In the first trial decision in an action brought pursuant to Section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations), Justice Hughes of the Federal Court has determined that the Federal Court has jurisdiction to hear and determine actions instituted under Section 8 of the Regulations, that Section 8 is properly enabled, and that the federal Parliament has the constitutional authority to pass Section 8

UK Patents Court allows supplementary protection certificate for combination product: Gilead Sciences, Inc’s application

  • Bird & Bird
  • -
  • United Kingdom
  • -
  • October 30 2008

Gilead has succeeded in its appeal to the Patents Court (Mr Justice Kitchin) from the UK Intellectual Property Office, which refused the grant of an SPC in respect of a combination product comprising tenofovir and another antiretroviral, emtricitabine

Proposed reform of the generic substitution regime

  • Bird & Bird
  • -
  • Finland
  • -
  • October 16 2008

A recent governmental Bill has set out proposals for the introduction of a reference price system for medicinal products in Finland and for generic substitution to be extended to include pharmaceutical products that were excluded from the scope of generic substitution by amendment of the Medicines Act in 2006

Confidentiality in clinical trials

  • Bird & Bird
  • -
  • Netherlands
  • -
  • October 30 2008

Confidentiality covering clinical trials is important in the context of the obtaining patent protection for an invention that is the subject of a clinical trial

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

UK Patents Court judgment in Eli Lilly v Human Genome Sciences

  • Bird & Bird
  • -
  • United Kingdom
  • -
  • October 30 2008

The Patents Court (Mr Justice Kitchin) has, somewhat unusually, revoked a patent on the grounds of lack of industrial applicability