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Ontario Court dismisses Eli Lilly’s motion to strike Apotex’s claim for damages under almost 400-year-old Statute of Monopolies
by Urszula Wojtyra »
On August 28, 2015, the Ontario Superior Court of Justice dismissed Eli Lilly’s motion to strike Apotex’s claim for treble damages and double costs pursuant to the almost 400-year old British Statute of Monopolies and its 118-year-old Ontario re-enactment (collectively, “the Monopolies Acts”): Apotex Inc v Eli Lilly and Company, 2015 ONSC 5396. Apotex claims damages under the Monopolies Acts alongside damages pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) following the dismissal of Eli Lilly’s application for an Order of prohibition for Apotex’s generic atomoxetine product (Eli Lilly’s STRATTERA). Eli Lilly’s prohibition application was dismissed as moot, as previously reported when Apotex was issued a notice of compliance (NOC) after the patent at issue had been declared invalid in a separate impeachment action brought by Novopharm.
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Court dismisses Eli Lilly’s prohibition application for Apotex’s generic versions of CIALIS and ADCIRCA, states disclosure in patent not required to demonstrate utility
by Paul Jorgensen »
On September 11, 2015, the Federal Court dismissed Eli Lilly’s application for a prohibition Order against Apotex’s generic versions of CIALIS and ADCIRCA: Eli Lilly Canada Inc v Apotex Inc, 2015 FC 1016. Eli Lilly asserted Canadian Patent No. 2,379,948, which claims certain formulations of tadalafil. Justice Gleason determined that “in the rather unique circumstances of this case,” the application was not an abuse of process, even though Justice de Montigny had ruled earlier this year that Mylan’s allegation that the 948 patent was invalid for obviousness was justified: Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC, 2015 FC 178 (as reported here). The Court found that Eli Lilly would be severely prejudiced if the application against Apotex was dismissed and Eli Lilly later proved successful in its appeal of Justice de Montigny’s decision (which was unlikely to be dismissed for mootness). The Court noted that Apotex could have avoided the cost and inconvenience of the application by agreeing to a stay pending the appeal.
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Health Canada lifts import ban against Apotex Inc. products from India
Health Canada announced that the import ban against products manufactured in Apotex Inc.’s Indian facilities put in place in September 2014, as previously reported would be lifted on September 1, 2015, subject to several conditions, including requirement for testing at approved Canadian facilities and enhanced reporting requirements to Health Canada.
Health Canada Information Update
Updates to the Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy to reflect Plain Language Labelling Regulations
As reported previously, on June 13, 2015, the Regulations Amending the Food and Drug (Labelling, Packaging and Brand Names of Drugs for Human Use) were registered (SOR/2014-158, Canada Gazette Part II). The amendments aim to improve the safe use of drugs by making labels and packaging easier to read and understand, and require the inclusion of a brand name assessment in all new drug submissions and Drug Identification Number applications where a new brand name is being proposed, or where a change to an existing brand name is being proposed. On August 26, 2015, Health Canada published consequential updates to its Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Guidance Document.
Notice - Updates to the Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy to reflect Plain Language Labelling Regulations
Patented Medicine Prices Review Board releases NEWSletter
The July 2015 NEWSletter has been released. It includes the schedule for the next Outreach sessions, staffing updates, and an explanation of updates on Compendium of Policies, Guidelines and Procedures.
Patented Medicine Prices Review Board July 2015 NEWSletter
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court rules that assertion of different claims for the same patent in subsequent PM(NOC) proceedings is abuse of process. Apotex brought a motion under s. 6(5)(b) of the PM(NOC) Regulations seeking to dismiss proceedings relating to Canadian Patent No. 2,298,059 for tenofovir disoproxil fumarate (Gilead’s VIREAD) as an abuse of process. The Court held that Gilead could not re-litigate the validity of the patent that was the subject of a previous PM(NOC) proceeding against Teva (2013 FC 1270 and 2013 FC 1272; as previously reported, in which Teva’s allegation of obviousness regarding claims 3 and 4 was successful. The Judge held that Gilead was bound by its decision to assert only claims 3 and 4 in the first proceeding, and its subsequent attempt to assert the validity of all of the claims was an abuse of process since it had “effectively conceded” those claims. The Court reiterated that a patentee must put its strongest case forward in the first instance, and that a patentee’s assertion of different claims against different generic challengers would amount to splitting its case.
Gilead Sciences, Inc v Canada (Health), 2015 FC 610
Takeda’s application for an Order of prohibition re: pantoprazole dismissed. On June 15, 2015, Justice Barnes dismissed Takeda’s prohibition application regarding Mylan’s pantoprazole magnesium dihydrate product (Takeda’s TECTA). Claim 1 of Canadian Patent No. 2,341,031, which was construed to claim dihydrate forms of pantoprazole magnesium, was at issue. Justice Barnes found that Takeda had failed to refute Mylan’s allegations of anticipation and non-infringement. In relation to anticipation, he found that Takeda had not shown that following Example 10 of a prior patent application did not inevitably produce pantoprazole magnesium dihydrate. In relation to non-infringement, Justice Barnes found that Takeda had not met its burden of establishing that the Mylan product infringes, considering Mylan’s evidence that its product was the hemipentahydrate rather than the dihydrate form of pantoprazole magnesium.
Takeda Canada Inc v Minister of Health and Mylan Pharmaceuticals ULC, 2015 FC 751
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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desvenlafaxine (PRISTIQ)
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Applicants:
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Pfizer Canada Inc and Wyeth LLC
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Respondents:
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Teva Canada Limited and Minister of Health
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Date Commenced:
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August 24, 2015
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Court File No.:
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T-1399-15
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,436,668. Teva alleges non-infringement and invalidity.
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Medicine:
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infliximab (REMICADE)
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Applicants:
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Janssen Inc
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Respondents:
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Celltrion Healthcare Co., Ltd and Minister of Health
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Respondent Patentee:
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The Kennedy Trust for Rheumatology Research
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Date Commenced:
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September 2, 2015
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Court File No.:
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T-1478-15
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,261,630. Celltrion alleges non-infringement.
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Medicine:
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pemetrexed disodium (ALIMTA)
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Plaintiff:
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Eli Lilly Canada Inc
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Respondent:
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Teva Canada Limited, Minister of Health and Attorney General of Canada
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Respondent Patentees:
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Eli Lilly and Company; Takeda Pharmaceutical Company Limited
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Date Commenced:
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September 4, 2015
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Court File No.:
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T-1502-15
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 1,340,794 and 2,400,155. Teva alleges invalidity of the 794 patent and invalidity and non-infringement of the 155 patent. Teva had served and later withdrew a March 11, 2011 NOA also alleging invalidity of the 794 patent and invalidity and non-infringement of the 155 patent; the Court determined Eli Lilly’s earlier prohibition application was therefore moot. Eli Lilly seeks further relief in the present application including a Declaration that the Minister cannot act upon the second NOA.
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Other proceedings
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Medicine:
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unidentified
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Plaintiffs:
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Apotex Inc
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Defendant:
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Minister of Health and Attorney General of Canada
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Date Commenced:
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September 8, 2015
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Court File No.:
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T-1511-15
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Comment:
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Application for judicial review of the Minister’s decision to release certain records relating to an Apotex ANDS in response to a request received by Health Canada pursuant to the Access to Information Act.
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Medicine:
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rogesterone (PROMETRIUM, Apo-Progesterone)
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Plaintiff:
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Apotex Inc
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Defendant:
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Minister of Health and Attorney General of Canada
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Date Commenced:
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September 8, 2015
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Court File No.:
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T-1516-15
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Comment:
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Application for judicial review of the Minister’s decision not to issue an NOC for Apotex’s Apo-Progesterone product. Health Canada rejected the submission as the proposed limit for an excipient, sodium lauryl sulfate, was not considered qualified.
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To check the status of Federal Court cases, please click here.
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