Smart & Biggar/Fetherstonhaugh updates

PMPRB releases scoping paper concerning proposed amended regulations
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

Canada releases proposed amendments to patented medicines pricing regulations
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Federal Court declines to assess litigation funding arrangement in patent infringement case
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

Health Canada publishes final guidance documents on quality requirements for regulatory filings
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Recent developments in Alexion cases
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • December 20 2017

The Federal Court of Appeal recently heard Alexion's appeal of a decision striking out its constitutional challenge to the price regulation scheme and confiscatory powers found in the Patent Act. A decision is under reserve. Alexion also has a pending judicial review of the Patented Medicine Prices Review Board's decision that it sold Soliris (eculizumab) at excessive prices.

Federal Court finds PMPRB unreasonable in determining that patent pertains to medicine
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

Recent developments in Alexion cases
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • December 18 2017

The Federal Court of Appeal recently heard Alexion's appeal of a decision striking out its constitutional challenge to the price regulation scheme and confiscatory powers found in the Patent Act. A decision is under reserve. Alexion also has a pending judicial review of the Patented Medicine Prices Review Board's decision that it sold Soliris (eculizumab) at excessive prices.

Federal Court finds PMPRB unreasonable in determining that patent pertains to medicine
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • December 13 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.

New pharmaceutical patent linkage litigation scheme
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • December 13 2017

The recent amendments to the Patented Medicines (Notice of Compliance) Regulations introduced a new scheme for pharmaceutical patent linkage litigation in Canada regarding generic challenges. The scheme is now much closer to the US Hatch-Waxman scheme, but with a number of key differences.

Court rejects Apotex's application for judicial review of omeprazole magnesium tablet submission
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • November 29 2017

The Federal Court recently rejected Apotex's application for judicial review regarding Health Canada's review of its omeprazole magnesium tablet regulatory submission. Apotex had applied for reconsideration, which was cancelled due to disagreement on an eligible question to pose to the reconsideration panel. Apotex had focused the question solely on safety and efficacy, while the minister of health had required that the question consider bioequivalence.

Patented Medicine Prices Review Board update
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • November 27 2017

The Patented Medicine Prices Review Board recently announced the release of a hearing panel's decision regarding the pricing of a breakthrough drug and the publication of a report which compares lists of drugs covered by the public drug plans to determine the extent of overlap in drug coverage. Further, in response to an unopposed request filed by the board to do so, a hearing panel discontinued an excessive pricing proceeding relating to Apotex's Apo-Salvent CFC Free.

Court declares that administrative errors during application cannot void issued patent
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • November 27 2017

The Federal Court of Appeal recently ruled that Pfizer's failure to pay the correct issue fee did not render its patent void. In the context of a Section 8 case, Apotex had brought a partial summary judgment motion to have Pfizer's patent declared void for failure to comply with the Patent Act. The court cited the general principle that "pre-patent issuance defects in the administrative process for applying for a patent cannot be relied upon by an alleged infringer to render a patent void".

Patented Medicine Prices Review Board update
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • November 22 2017

The Patented Medicine Prices Review Board recently announced the release of a hearing panel's decision regarding the pricing of a breakthrough drug and the publication of a report which compares lists of drugs covered by the public drug plans to determine the extent of overlap in drug coverage. Further, in response to an unopposed request filed by the board to do so, a hearing panel discontinued an excessive pricing proceeding relating to Apotex's Apo-Salvent CFC Free.

Ontario bill proposes mandatory disclosure of financial relationships
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • November 22 2017

The Ontario legislature recently introduced Bill 160, which – if passed – will enact the Health Sector Payment Transparency Act 2017. The act will require the disclosure of financial relationships between healthcare professionals and pharmaceutical or medical device manufacturers and the reporting of various information. More details, such as the manner and frequency of reporting, will be prescribed by regulation.

Government issues statement of intended actions to implement CETA
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • November 15 2017

Global Affairs Canada recently published its statement of intended actions regarding the implementation of the Canada-EU Comprehensive Economic and Trade Agreement, which has been provisionally applied since September 21 2017. The document summarises the Canadian government's position on its obligations and how it intends to implement the treaty. A number of the document's chapters are relevant to the pharmaceutical industry.

Current search

Refine search

Work area