Canada, Smart & Biggar/Fetherstonhaugh updates

Healthcare & Life Sciences

Contributed by Smart & Biggar/Fetherstonhaugh
PMPRB releases scoping paper concerning proposed amended regulations
  • Canada
  • January 17 2018

The Patented Medicine Prices Review Board recently released a high-level overview of the potential new framework proposed by the Regulations Amending the Patented Medicines Regulations. The overview aims to provide a non-binding outline of preliminary thoughts on how best to implement the proposed changes and should be read in conjunction with the proposed amendments and the regulatory impact analysis statement.

Decision striking out challenge to constitutionality of PMPRB regime upheld
  • Canada
  • January 17 2018

The Federal Court of Appeal recently upheld the decision striking out Alexion's pleadings challenging the constitutionality of the Patented Medicine Prices Review Board (PMPRB) regime. The Federal Court of Appeal upheld the decision on the basis of, among other things, the fact that Alexion had not been entitled to bring the constitutional issue before the Federal Court, as it had not raised the issue before the PMPRB.

Canada releases proposed amendments to patented medicines pricing regulations
  • Canada
  • January 10 2018

The governor in council recently published the proposed Regulations Amending the Patented Medicines Regulations. The proposed regulations represent a significant overhaul of the Patented Medicines Regulations and are estimated by Health Canada to result in savings of C$12.6 billion net present value over 10 years. While the regulations have yet to be adopted, companies should be factoring these potential changes into their business planning now.

Health Canada publishes final guidance documents on quality requirements for regulatory filings
  • Canada
  • January 03 2018

Health Canada recently published the final version of a number of guidance documents and templates which implement new requirements for new drug submissions and abbreviated new drug submissions. The changes will be implemented by way of a phased-in approach, with the general quality guidance requirements being implemented in January 2018 and the new stability requirements and requirements for commercial and pilot scale batches being implemented in October 2019.

PMPRB releases Annual Report 2016
  • Canada
  • December 20 2017

The federal minister of health recently submitted the Patented Medicine Prices Review Board Annual Report 2016 to the House of Commons and the Senate. The report indicates that in 2016 Canadian patented drug prices were the fourth-highest among the seven comparator countries against which the board reviewed prices and that sales of patented drug products totalled C$15.5 billion. Research and development spending remained unchanged from 2015.


Intellectual Property

Contributed by Smart & Biggar/Fetherstonhaugh
Canada releases proposed amendments to patented medicines pricing regulations
  • Canada
  • January 15 2018

The governor in council recently published the proposed Regulations Amending the Patented Medicines Regulations. The proposed regulations represent a significant overhaul of the Patented Medicines Regulations and are estimated by Health Canada to result in savings of C$12.6 billion net present value over 10 years. While the regulations have yet to be adopted, companies should be factoring these potential changes into their business planning now.

Streamlined trademark litigation – Federal Court of Appeal opens door to full compensation
  • Canada
  • January 15 2018

A recent Federal Court of Appeal decision has shed light on a streamlined litigation procedure that brand owners may find attractive. In its decision, the court suggested that trademark owners which commence infringement proceedings in the Federal Court, by way of the summary procedure known as 'application', may still be able to recover damage awards – even by way of a reference.

Federal Court declines to assess litigation funding arrangement in patent infringement case
  • Canada
  • January 08 2018

The plaintiff in a patent infringement action against Pfizer recently brought a motion seeking approval of a litigation funding agreement (LFA) with a third party, as required by the terms of the agreement. The prothonotary dismissed the motion on the basis that such approval is not required beyond class proceedings. Further, the Federal Court had no jurisdiction to determine the validity of the LFA.

PMPRB releases Annual Report 2016
  • Canada
  • January 08 2018

The federal minister of health recently submitted the Patented Medicine Prices Review Board Annual Report 2016 to the House of Commons and the Senate. The report indicates that in 2016 Canadian patented drug prices were the fourth-highest among the seven comparator countries against which the board reviewed prices and that sales of patented drug products totalled C$15.5 billion. Research and development spending remained unchanged from 2015.

Federal Court finds PMPRB unreasonable in determining that patent pertains to medicine
  • Canada
  • December 18 2017

The Federal Court recently found that the Patented Medicine Prices Review Board's assessment that a patent pertained to Galderma Canada's Differin was unreasonable, as it had failed to consider the entire patent. As a result, the court quashed the board's decision requiring Galderma to file pricing information for Differin.


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