September 13 2017
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
The Patented Medicine Prices Review Board has released the July 2017 issue of its newsletter. Its highlights include:
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:
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).
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.
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 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:
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