IN THIS ISSUE:
No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding
FCA dismisses Lilly’s olanzapine section 8 damages appeal and grants cross-appeal allowing for recovery of pipefill sales and under-reporting of data
New Use Patent for Janssen’s REMICADE valid and infringed by Hospira’s biosimilar INFLECTRA
Federal Budget 2018 announces advisory council for national pharmacare program
Alexion files for leave to appeal to Supreme Court of Canada in case challenging constitutionality of PMPRB remedial powers
Patented Medicine Prices Review Board releases March 2018 NEWSletter
CADTH Common Drug Review to accept submissions up to six months prior to market approval
Consultation on proposed regulations under the Health Sector Payment Transparency Act, 2017
Federal Court declares invalid a patent for a medical device measuring osmolarity of tear film
Federal Court grants motion to strike plaintiff’s quia timet pleading in oxycodone infringement action
Costco pharmacy directors fined for professional misconduct for acceptance of over $1.2M in rebates
New court proceedings
No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding
By Kevin P. Siu
What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations against a generic entrant, but subsequently prevails in an infringement action on the same patent? Can it be liable for section 8 damages under the Regulations? The answer appears to be no.
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FCA dismisses Lilly’s olanzapine section 8 damages appeal and grants cross-appeal allowing for recovery of pipefill sales and under-reporting of data
By Andrew Mandlsohn
On March 20, 2018, the Federal Court of Appeal (FCA) issued public reasons for judgment dismissing Eli Lilly Canada Inc. (Lilly)’s appeal of a Federal Court decision awarding more than $70 million to Teva Canada Limited (Teva) under section 8 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations in respect of olanzapine (Lilly’s ZYPREXA). The FCA granted Teva’s cross-appeal seeking to add to its recovery lost pipefill sales and an adjustment to account for an under-reporting of sales in the data relied on by both parties’ experts: Eli Lilly Canada Inc v Teva Canada Limited, 2018 FCA 53. See our prior article on the Federal Court’s decision here. Generally, section 8 of the PMNOC Regulations permits recovery for a generic manufacturer’s losses, if the innovator’s prohibition application is discontinued, dismissed, or reversed on appeal.
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New Use Patent for Janssen’s REMICADE valid and infringed by Hospira’s biosimilar INFLECTRA
By Katie Lee and Urszula Wojtyra
On March 7, 2018, the Federal Court upheld the validity of Kennedy’s patent for a use of infliximab (Janssen’s REMICADE) (Patent No. 2,261,630 [the “630 patent”]), and granted Kennedy’s counterclaim that Hospira’s biosimilar INFLECTRA infringed the 630 patent: Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research, 2018 FC 259.
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Federal Budget 2018 announces advisory council for national pharmacare program
By Brandon R. Heard
On February 27, 2018, the federal budget was tabled in the House of Commons. It announced the creation of an Advisory Council on the Implementation of National Pharmacare, to be led by former Minister of Health of Ontario, Dr. Eric Hoskins, and which will make recommendations on potential approaches to national pharmacare.
Alexion files for leave to appeal to Supreme Court of Canada in case challenging constitutionality of PMPRB remedial powers
By Abigail Smith
On February 5, 2018, Alexion Pharmaceuticals filed an application for leave to appeal a decision of the Federal Court of Appeal (FCA) dismissing its challenge to the constitutionality of certain of the Patented Medicine Prices Review Board (PMPRB) provisions of the Patent Act: SCC Case No. 37949. The FCA decision, Alexion Pharmaceuticals Inc v Canada (Attorney General), 2017 FCA 241, was previously reported here.
Patented Medicine Prices Review Board releases March 2018 NEWSletter
By Andrew Mandlsohn
The Patented Medicine Prices Review Board (PMPRB) released its March 2018 NEWSletter (the first NEWSletter since July 2017). Highlights include:
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an update on the PMPRB guidelines to reflect the “future framework envisioned by the PMPRB [which] aspires towards bright line tests that yield ceiling prices that are reasonable and foreseeable to patentees” (see our prior articles on the proposed amended Patented Medicines Regulations and scoping paper here and here);
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the release of the PMPRB’s 2016 Annual Report (released October 2017), Alignment among Public Formularies in Canada – Part 1: General Overview (published October 2017), Generics 360: Generic Drugs in Canada, 2016 (published February 2018); and
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notice that the following publications are to be released in 2018: Meds Entry Watch, 2nd Edition; CompassRx, 4th Edition; and Potential Savings from Biosimilars in Canada
CADTH Common Drug Review to accept submissions up to six months prior to market approval
By Andrew Mandlsohn
The Canadian Agency for Drugs and Technologies in Health (CADTH) announced on March 8, 2018 that, effective April 2, 2018, its Common Drug Review (CDR) program will accept drug submissions up to six months prior to a drug manufacturer’s anticipated receipt of a Notice of Compliance (NOC) or NOC with Conditions (NOC/c) from Health Canada. This will be earlier than the present three-month deadline. Additional details regarding this operational change can be found in CDR Update – Issue 134.
Consultation on proposed regulations under the Health Sector Payment Transparency Act, 2017
By Brandon R. Heard
As previously reported, on December 12, 2017, the Ontario Legislature passed the Strengthening Quality and Accountability for Patients Act, 2017, which enacts or amends 10 statutes including the Health Sector Payment Transparency Act, 2017 (Transparency Act). When in force, the Transparency Act will require disclosure of financial relationships between pharmaceutical or medical device manufacturers (among other “payors”) and health care professionals (among other “recipients”). On February 21, 2018, the Ontario Ministry of Health and Long-Term Care published for consultation proposed regulations under the Transparency Act. The proposed regulations specify: what constitutes a “transfer of value” that must be reported; who qualifies as an “intermediary” or a “recipient” of a “transfer of value”; additional categories of “payors”; what thresholds and exemptions exist to the reporting requirements; the manner and frequency of reporting; and the process for correcting posted information. The consultation period ends April 6, 2018.
Federal Court declares invalid a patent for a medical device measuring osmolarity of tear film
By Brandon R. Heard
On February 12, 2018, Justice Manson of the Federal Court found certain claims of Canadian Patent No. 2,494,540 (“540 patent”) invalid on the basis of obviousness and anticipation: Regents of the University of California v I-MED Pharma Inc, 2018 FC 164. The 540 patent relates to a chip for measuring the osmolarity of a sample of bodily fluid, including tear film. The plaintiff Tearlab Corporation and the defendant I-Med Pharma market competing medical devices for measuring tear film osmolarity. The Court agreed with the claim construction urged by the plaintiffs, finding that the claims encompassed both in vivo and ex vivo applications of the invention. As a result, I-Med Pharma’s medical device—which measured osmolarity in vivo—fell within the scope of the claims. However, as a result of this construction, the Court also found that the claims were anticipated by prior art that disclosed in vivo devices for measuring osmolarity, including of tear film. Further, the Court found that it was obvious to combine prior art to “create a device that can be used both in vivo and ex vivo, and includes a separate or onboard processing unit, to measure osmolarity of tear fluid”. The Court dismissed the attacks of inutility and insufficiency. The plaintiffs have appealed.
Federal Court grants motion to strike plaintiff’s quia timet pleading in oxycodone infringement action
By Abigail Smith
On February 21, 2018, Justice O’Reilly granted Collegium’s motion to strike Purdue’s statement of claim for infringement of a patent relating to oxycodone salt (Purdue’s OXYNEO): Purdue Pharma v Collegium Pharmaceutical, 2018 FC 199. The Court overturned the Prothonotary’s dismissal of the motion, finding that the facts did not allege anything beyond the regulatory use exemption and that the imminence branch for the test for a quia timet action was not met: Purdue’s allegations merely suggested that Collegium was attempting to meet Canadian regulatory requirements, and did not contemplate when Collegium might obtain a Notice of Compliance (NOC). Purdue’s action was brought in parallel with an application under the pre-amended (PMNOC) Regulations. The amended PMNOC Regulations (previously reported) will now effectively allow for quia timet actions by permitting a patent owner who receives a notice of allegation (NOA) to bring an action for infringement of patents not covered by the NOA, but which could be infringed by the generic drug.
Costco pharmacy directors fined for professional misconduct for acceptance of over $1.2M in rebates
By Abigail Smith
On March 14, 2018, the Discipline Committee of the Ontario College of Pharmacists found that two directors of Costco pharmacies committed acts of professional misconduct by soliciting $1,266,000 in payments related to advertising which would reasonably be regarded as rebates for purchase of interchangeable drug products, contrary to provisions of the Drug Interchangeability and Dispensing Fee Act and the Ontario Drug Benefit Act. The pharmacists were each fined $20,000.
New Court Proceedings
For complete details about these pharmaceutical proceedings, click here.
PM(NOC) Proceedings
mesalamine (ASACOL 800): Allergan v Tillotts
Other Proceedings
trastuzumab (HERCEPTIN, TRAZIMERA); pertuzumab (PERJETA): Hoffmann-La Roche and Genentech v Pfizer
gatifloxacin (ZYMAR, Apo-Gatifloxacin): Apotex v Allergan
Selected Rankings
Canadian IP Impact Case of the Year
AstraZeneca v Apotex (NEXIUM)
LMG Life Sciences
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Canada’s Intellectual Property Litigation Firm of the Year
Benchmark Canada
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