Patented Medicine Prices Review Board releases July 2017 newsletter
CADTH issues Common Drug Review Update Newsletter
2016/2017 Statistical Report for PMNOC Regulations and Data Protection
TPD and BGTD Annual Drug Submission Performance Reports released
Federal Court permits quia timet pleading to stand
Patented Medicine Prices Review Board releases July 2017 newsletter
The Patented Medicine Prices Review Board has released the July 2017 issue of its newsletter. Its highlights include:
- an update on the status of proposed amendments to the Patented Medicine Regulations in respect of changes to the regulations of patented drug prices;
- a reminder that under the regulations, patentees are required to properly complete Block 5 information by filing "publicly available ex-factory prices for each dosage form, strength and package size in which their product is sold to each class of customer in each country set out in the schedule"; and
- notice of recent and forthcoming publications, including:
- CompassRx, third edition, which reports on prescription drug expenditures by Canada's public drug plans;
- the first of three reports on Canadian public drug plan formularies to be released in Autumn 2017;
- Generics360, which focuses on generic drug pricing in Canada and internationally; and
- a report entitled Potential savings from biosimilars in Canada.
CADTH issues Common Drug Review Update Newsletter
The Canadian Agency for Drugs and Technologies in Health (CADTH) issued a Common Drug Review Update on August 1 2017, which includes the following highlights:
- From September 1 2017, CADTH will no longer seek individual permissions from patient groups and will be sharing all patient input submissions online (subject to patient groups requesting that personal identifying information be redacted in their initial submissions and summary of patient input);
- CADTH invited stakeholders to provide comments and feedback on its proposed revisions to the biosimilar review process;
- CADTH initiated stakeholder consultation on its proposed revisions to Common Drug Review and pan-Canadian Oncology Drug Review resubmission eligibility criteria; and
- CADTH extended its deadline for stakeholder comments and feedback on the consultation for Revising Common Drug Review Recommendations in the CADTH Therapeutic Review Process until September 15 2017 at 5:00 pm EDT.
2016/2017 Statistical Report for PMNOC Regulations and Data Protection
On July 14 2017 Health Canada released the Therapeutic Products Directorate Statistical Report 2016/2017, providing an overview of administration under the Patented Medicines (Notice of Compliance) Regulations and Data Protection. The report includes information regarding trends in listing on the Patent Register and Register of Innovative Drugs, as well as related court activity. The report shows an increase in new listings on the Patent Register (769 in 2016/17 compared to 644 in 2015/16) and a decline in new human drug listings on the Register of Innovative Drugs (31 in 2016/2017 compared to 40 in 2015/2016). The number of prohibition applications increased from 18 in 2015/2016 to 32 in 2016/2017 (as of March 31 2017).
TPD and BGTD Annual Drug Submission Performance Reports released
The Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) have released their Drug Submission Performance Annual Reports. The reports contain information relating to pharmaceutical, biologic and radiopharmaceutical drug submission review activity over five consecutive fiscal years (April 1 to March 31) from 2012-13 to 2016-17, including approval times.
Federal Court permits quia timet pleading to stand
Otsuka has sued Apotex for patent infringement,(1) claiming that Apotex infringes several patents relating to aripiprazole based on Apotex's ongoing manufacturing and export of aripiprazole tablets for consumption by patients outside of Canada and on the basis that Apotex intended to sell its aripiprazole tablets to patients in Canada. Apotex brought a motion to strike Otsuka's statement of claim, alleging that the claim ought to be struck as a quia timet claim and was not supported by sufficient material facts. However, the court dismissed Apotex's motion. The prothonotary held that:
- the action was quia timet and therefore required material facts relating to Apotex having a deliberate intention to engage in infringing acts;
- the infringing activity must be imminent and not speculative; and
- the damages suffered by Otsuka must be substantial, if not irreparable.
The court held that the claim was not speculative and that the facts pleaded were stronger than those in other cases in which quia timet claims have been struck. In particular, it was sufficient to plead that:
- a lengthy notice of allegation was served and Patented Medicines (Notice of Compliance) proceedings had commenced;
- damages in excess of C$50,000 would be suffered; and
- Apotex was continuing to manufacture aripiprazole tablets, although presently for use outside of Canada.
For further information on this topic please contact Andrew Mandlsohn or Kevin Siu at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or by email ([email protected] or [email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
Endnotes
(1) Otsuka Pharmaceutical Co, Ltd v Apotex Inc, Order of Prothonotary Aalto dated June 15 2017 (Court File T-200-17), appeal pending.