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

Gowling Lafleur Henderson LLP
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Canada
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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
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Canada
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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
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Canada
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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Following from a draft guidance published last June and consultations and revisions made subsequently, on April 1, 2010, a new guidance document will be in force with respect to the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
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Canada
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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
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Canada
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August 26 2010

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

Supreme Court denies leave to appeal in Section 8 damage case

Gowling Lafleur Henderson LLP
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Canada
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February 12 2010

Recently, the Supreme Court denied Apotex's leave application for leave to appeal to the Supreme Court of Canada in respect of Apotex's case seeking damages for alleged delays due to a proceeding brought by Merck under the Patented Medicines (Notice of Compliance Regulations) ("NOC Regulations"

Guidance document relating to non-clinical good laboratory practice

Gowling Lafleur Henderson LLP
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Canada
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May 21 2010

On April 30, 2010, Health Canada released a finalized guidance document relating to non-clinical laboratory study data reporting drug product applications and submissions: adherence to good laboratory practice

Health Canada forums this fall

Gowling Lafleur Henderson LLP
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Canada
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May 21 2010

Health Canada has sent out notices indicating that the Health Products & Food Branch (HPFB) will hold an international regulatory forum in September 2010 relating to medical device regulations in Canada and, in October, and a separate forum in October relating to a workshop on biologics and pharmaceutical regulations in Canada

Important recent trends in pharmaceutical patent litigation

Gowling Lafleur Henderson LLP
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Canada
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June 28 2011

From a patentee’s perspective, the patent litigation landscape in 2010 and continuing into 2011 appears to have shifted to a more hospitable environment for innovators

Apotex Inc. v. Merck & Co. Inc., 2011 FCA 364 lovastatin; appeal from s.8 case

Gowling Lafleur Henderson LLP
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Canada
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April 3 2012

In a decision is dated December 20, 2011 (but not released until recently), the Court of Appeal has overturned the Court’s finding that s. 8 of the 1993 NOC Regulations and found that the underlying NOC Regulation proceeding was “pending” at the time of the amendment of the NOC Regulations in 1998 as an appeal had been heard by the Supreme Court at that time and a decision was under reserve

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