1. Proposed PMPRB amendments under consideration, proposed guidance pending; litigation matters

 
 

Consultation on proposed Regulations Amending the Patented Medicines Regulations closed on February 15; consideration is ongoing. Potential changes to pricing criteria include expanding the list of comparator countries to twelve, but excluding the US and Switzerland, and taking into account pharmacoeconomic value. On December 11, the Patented Medicine Prices Review Board (PMPRB) released a scoping paper, and a steering committee will now consult on drafting new guidelines, expected to be released this fall (see June 25 Guidance Document). The proposed amendments contributed to Canada’s appearance on the Office of the US Trade Representative’s Priority Watch List.

Alexion’s application for leave to appeal a decision dismissing its challenge to the constitutionality of certain PMPRB provisions of the Patent Act was dismissed on June 28. Two other court cases are pending: (i) the PMPRB’s appeal in GALDERMA on the jurisdictional issue of whether an invention “pertains to” a medicine and (ii) Alexion’s judicial review application of the Board’s decision regarding SOLIRIS (eculizumab) on the use of the Board’s Guidelines (scheduled for September).

 
 

2. Eight certificates of supplementary protection (CSPs) have issued

 
 

Certificates of supplementary protection (CSPs) provide an additional patent-like protection term, and are intended to partly compensate the innovator for the time required for research and obtaining regulatory approval in Canada. Canada’s regime came into force on September 21, 2017. Earlier this year, we provided a chart comparing CSPs to European Supplementary Protection Certificates. Eight CSPs have issued to date.

 
 

3. Amended PMNOC Regulations: early procedural decisions, updated Health Canada guidance, 21 cases started

 
 

Substantial amendments to the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) came into force on September 21, 2017, followed by release of the Federal Court’s practice notice. In March, two procedural decisions issued, finding: confidentiality rules cannot be varied until an action is commenced, and a motion to dismiss may be brought prior to completion of examinations for discovery. On May 11, Health Canada issued updated Guidance, including Patent Register eligibility of CSPs. To date, approximately 21 actions (regarding 14 products) have been started and 11 trials have been scheduled.

 
 

4. Biosimilars Update: Consultation on naming approaches; CADTH updates review process; REMICADE patent valid and infringed by INFLECTRA

 
 

We provided an update on biosimilars in our June issue, including on new biosimilar approvals (there are now 11 in total), ongoing litigation matters, the Canadian Agency for Drugs and Technologies in Health (CADTH)’s Environmental Scan, and aligned reviews between Health Canada and health technology assessment organizations. Further, there was a consultation on naming and CADTH revised its biosimilar review process. Finally, our most-read article this year related to the March 7 decision of the Federal Court finding a patent for a use of infliximab (Janssen’s REMICADE) in combination with methotrexate for the treatment of rheumatoid arthritis was valid and infringed by Hospira’s biosimilar INFLECTRAHospira v Kennedy Trust and Janssen, 2018 FC 259. Hospira’s appeal is pending.

 
 

5. Cannabis Act passes in Canada

 
 

Bill C-45, the Cannabis Actreceived Royal Assent on June 21, and adult use cannabis will be legal in Canada as of October 17. Final regulations to the Cannabis Act are expected soon, and will likely be similar to the proposals set out in the Proposed Approach to the Regulation of Cannabis: Summary of Comments Received During the Public Consultation

 
 

6. Consultation on national pharmacare 

 
 

On February 27, the creation of an Advisory Council on the Implementation of National Pharmacare (Council) was announced and on April 19, the Standing Committee on Health released a report advocating a national pharmacare program – a single payer universal publicly funded prescription drug coverage program for all Canadians. On June 20, the Council was launched, together with release of a Discussion Paper and the opening of a public consultation.

 
 

7. No section 8 liability for valid and infringed patent in NEXIUM proceedings; Teva succeeds in olanzapine section 8 appeal

 
 

On February 15, AstraZeneca was found not liable to Apotex for any section 8 damages relating to its esomeprazole magnesium product (a generic version of AstraZeneca’s NEXIUM), as Apotex’s claim would be fully offset by its liability for patent infringement in the but-for world: Apotex v AstraZeneca, 2018 FC 181. The Court separately held that AstraZeneca was entitled to a declaration of infringement in AstraZeneca’s infringement action (following the Supreme Court of Canada decision striking down the promise doctrine), and in doing so, rejected Apotex’s attempts to raise new grounds of invalidity. 

On March 20, the Federal Court of Appeal dismissed Eli Lilly’s appeal of a decision awarding $70 million in section 8 damages to Teva, relating to its lost olanzapine sales (a generic version of Eli Lilly’s ZYPREXA), but granted Teva’s cross-appeal seeking lost pipefill sales and an adjustment for under-reporting of sales. Eli Lilly has sought leave to appeal.

Finally, on April 25, the Quebec Superior Court declined to dismiss Apotex’s claim under the Ontario Statute of Monopolies relating to amlodipine besylate (Pfizer’s NORVASC), finding it has jurisdiction: Apotex c Pfizer, 2018 QCCS 1765.

 
 

8. Damages, accounting references: Teva’s $19 million levofloxacin damages appeal dismissed; $61 million perindopril profits award against Apotex stands 

 
 

On February 8, the Federal Court of Appeal dismissed Teva’s appeal relating to Janssen’s damages ($19 million) for infringement of Janssen’s patent for levofloxacin (LEVAQUIN): Teva v Janssen, 2018 FCA 33, including affirming that Janssen US had standing to make a claim, i.e. it was not required to demonstrate that it had engaged in conduct in Canada that would otherwise amount to infringement. Teva has sought leave to appeal.

On March 28, Servier and ADIR were successful in the redetermination of the profits reference relating to perindopril (Servier’s COVERSYL): the Federal Court again dismissed Apotex’s non-infringing alternative defence, finding that Apotex would not have called on foreign third parties to manufacture perindopril to supply Apotex affiliates in the UK and Australia. The original $61 million profits award against Apotex was therefore re-affirmed: ADIR and Servier v Apotex, 2018 FC 346. Apotex has appealed.

Finally, the Federal Court of Appeal has confirmed that an infringer does not have the right to elect a patentee’s remedy: Apotex v Bayer, 2018 FCA 32.

 
 

9. Health Canada updates: Strengthening post-marketing oversight

 
 

The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), which was approved on November 6, 2014, amended the Food and Drugs Act and granted the Minister of Health new post-marketing oversight powers over therapeutic products. We prepared a summary chart of the developments to date including: consultation on draft guidance governing public release of clinical information contained in drug submissions and medical device applications; a Notice of Intent to propose post-market amendments to the Medical Devices Regulationsnew regulations governing powers to require assessments, tests and studies and notification of foreign incidents; new regulations governing post-market oversight over opioids; and proposed new regulations for hospital report of serious adverse drug reactions and medical device incidents. Other new guidance documents include: a consultation on potential changes to the Use of a Foreign-sourced Reference Product as a Canadian Reference Product Guidance; administrative processing of submissions; and reporting of adverse reactions.