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Results: 1-10 of 16

Utility, sound prediction and promise of the patent

  • Gowling Lafleur Henderson LLP
  • -
  • Canada
  • -
  • April 22 2013

In recent years, attacks on the lack of sound prediction and failure to meet the promise of the patent have proven to be a crushing hammer in the

Federal court rejects PMPRB Copaxone decision on excessive prices again

  • Gowling Lafleur Henderson LLP
  • -
  • Canada
  • -
  • May 3 2013

By a decision of Justice Zinn dated April 30, 2013, the Federal Court quashed a Board's decision on excessive pricing of Copaxone - for the second

Gilead Sciences Canada, Inc. v. Canada (Minister of Health), 2012 FC 2, Complera (tenofovir, emtricitabine and rilpivirine), patent listing decision

  • Gowling Lafleur Henderson LLP
  • -
  • Canada
  • -
  • April 3 2012

In this case the Court accepted the Minister’s position that a patent with combination patent claims and formulation claims to a triple medicinal ingredient product was not eligible for listing

Court affirms utility of Gleevec patent

  • Gowling Lafleur Henderson LLP
  • -
  • Canada
  • -
  • February 20 2013

"Sound prediction's introduction into Canadian law was not, as I understand it, to give a crushing hammer to those who challenge patents." Snider J

TPD statistical report 2008 PMNOC Regulations released

  • Gowling Lafleur Henderson LLP
  • -
  • Canada
  • -
  • April 14 2010

On March 17, 2010, the Therapeutic Products Directorate released its annual report for the year 2008 on the Patented Medicines (Notice of Compliance) Regulations ("PMNOC Regulations"

Private members' bills seek amendments to Patent Act and Food and Drugs Act

  • Gowling Lafleur Henderson LLP
  • -
  • Canada
  • -
  • May 28 2009

A review of certain current private members' bills before Parliament reveal that important changes are being sought to both patent and food and drug legislation

Regulations for extraordinary use new drugs (EUNDs)

  • Gowling Lafleur Henderson LLP
  • -
  • Canada
  • -
  • May 21 2010

Regulations to Amend the Food and Drug Regulations have been published, which would permit a new type of drug submission for certain types of drugs where there is a requirement to provide substantial evidence of safety and efficacy of the drug and, while there are ethical andor logistical challenges in designing appropriate clinical trials for a small number of emergency use drugs, such as anthrax and pandemic influenza vaccines

Guidance document regarding generic veterinary drugs

  • Gowling Lafleur Henderson LLP
  • -
  • Canada
  • -
  • April 14 2010

Following from a draft guidance published last June and consultations and revisions made subsequently, on April 1, 2010, a new guidance document will be in force with respect to the preparation of the Abbreviated New Drug Submissions (ANDSs) for veterinarian products

Recent cases

  • Gowling Lafleur Henderson LLP
  • -
  • Canada
  • -
  • April 14 2010

In this case Hospira had sought regulatory approval by the filing of a new drug submission (NDS), but which did not include independent preclinical or clinical trial data

PMPRB releases latest newsletter

  • Gowling Lafleur Henderson LLP
  • -
  • Canada
  • -
  • August 26 2010

On July 30, 2010, the PMPRB released its latest newsletter