Drug shortages are an important issue in the health care system that Health Canada and the industry have been actively trying to address. On August 27, 2018, the Minister of Health made an order permitting the immediate importation and sale of epinephrine auto-injectors for use in emergency treatment of life-threatening allergic reactions, to address the shortage of EpiPen products. The order was approved on September 4, 2018, and will remain in effect until the earliest of one year after the order was made, repealed, or any regulations that address the need come into effect.
The interim order permits the importation of FDA-approved AUVI-Q, manufactured by Kaléo Inc., which has not been approved in Canada. This is the first time an interim order under section 30.1(2)(a) of the Food and Drugs Act has been used to address the shortage of an approved product. Interim orders, which can be made if the Minister believes immediate action is required to deal with a significant risk to health, safety or the environment, are one of several mechanisms available to provide access to products that have not been approved in Canada. Other mechanisms include: the importation of a drug on the List of Drugs for an Urgent Public Health Need enacted under Part C, Division 10 of the Food and Drug Regulations (as previously reported), and the Special Access Programme.
EpiPen products are reimbursed under certain public drug programs, including Ontario’s recent OHIP+ program, which provides drugs for free to those in Ontario 24 years of age and under. AUVI-Q does not appear to be covered under the OHIP+ program so it is unclear the extent to which the Interim order will sufficiently address the shortage, even if AUVI-Q is available in Canada.
Prohibition denied for Ranbaxy's bupropion extended-release tablets
By Tierney GB Deluzio
On August 20, 2018, the Federal Court dismissed Valeant's PMNOC application regarding Ranbaxy's bupropion extended-release tablets (Valeant's WELLBUTRIN XL) and Patent No. 2,524,300. Justice McVeigh held that Ranbaxy's allegation of non-infringement was justified: Valeant Canada LP v Ranbaxy Pharmaceuticals Canada Inc., 2018 FC 847. Justice McVeigh found that "permeation enhancer" in the amount of "about 20% to about 40% of the moisture barrier dry weight" is an essential element, construed "permeation enhancer" to exclude polyethylene glycol and triethyl citrate, and construed "about" to mean a range of plus or minus 10%. Therefore, the amount of permeation enhancer in the Ranbaxy formulation was outside the scope of the range claimed and Ranbaxy's allegation of non-infringement was found justified.
New Court Proceedings
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PMNOC Proceedings
lenalidomide (REVLIMID): Celgene v Natco Pharma
apixaban (ELIQUIS): Bristol-Myers Squibb and Pfizer v Teva
daptomycin (CUBICIN): Cubist and Sunovion v Teva
Other Proceeding
Herpes Zoster vaccine (SHINGRIX): GlaxoSmithKline v The Minister of Health
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AstraZeneca v Apotex (NEXIUM)
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