|
Novartis successful in defending patent for imatinib mesylate (GLEEVEC)
On February 19, 2013, Justice Snider dismissed Teva's and Apotex's actions to impeach Novartis's patent claiming imatinib mesylate (GLEEVEC).
Read more »
Supreme Court of Canada news
Apotex seeks leave to appeal decision denying NOC for Apo-Omeprazole. As reported in the January 2013 issue of Rx IP Update, the Federal Court of Appeal dismissed Apotex's appeal regarding the Federal Court's rejection of Apotex's challenge to decisions denying a notice of compliance (NOC) for Apo-Omeprazole tablets. The application was dismissed as being outside the 30-day limit, and the Federal Court refused to extend the time limit. The Court also dismissed Apotex's claims that it had a vested interest in an NOC. The Court determined that the Minister is fully entitled to revisit scientific issues at any point in the review process up to the actual issuance of an NOC. The Court of Appeal disagreed with Apotex's arguments that 1) its application was not subject to the 30-day filing requirement, 2) it did meet the test for an extension of time, and 3) it had a vested right to an NOC.
Apotex Inc v Canada (Health), February 5, 2013 (SCC Case No. 35209).
Federal Court of Appeal decision — 2012 FCA 322.
Federal Court decision — 2011 FC 1308.
Health Canada news
Consultation on "Draft Revised Guidance Document for the Review of Drug Names for Look-alike Sound-alike (LASA) Attributes." Health Canada has launched a consultation regarding a draft revised guidance document updating the 2006 guidance document "Guidance for Industry — Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names." The revised guidance document arose out of Health Canada's internal analysis of LASA-related submissions since the release of the 2006 guidance, which revealed significant variation in the amount, type, and quality of the evidence submitted by market authorization holders. The consultation on the draft revised guidance document is open from February 19 to April 19, 2013. Stakeholders are invited to provide input on the "Draft Revised Guidance Document for Industry — Review of Drug Names for Look-alike Sound-alike (LASA) Attributes" using Health Canada's comment template.
Notice. Draft revised guidance document.
Consultation on draft guidance document "Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs)." Health Canada has launched a 75-day consultation from February 12 to April 29, 2013, inclusive on the draft guidance document "Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs)." The document is intended to provide guidance regarding pre- and post-market information and regulatory requirements under the Food and Drugs Act and related regulations for the authorization of EUNDs.
Notice. Comment form. Draft guidance document. French versions.
Recent Court decisions
Federal Court of Appeal upholds Minister's decision denying data protection for THALOMID. As reported in the March 2012 edition of Rx IP Update, Celgene had brought a judicial review of the Minister of Health's decision that THALOMID (Celgene's brand of thalidomide) was not entitled to data protection in view of prior approvals of thalidomide products in 1960 (KEVADON) and 1961 (TALIMOL). Justice de Montigny granted Celgene's application and declared that THALOMID is entitled to data protection. The Minister appealed, and on February 15, 2013, the Federal Court of Appeal released a split decision allowing the appeal.
The parties differed on their interpretation of "approved." Celgene focused on thalidomide's status as a prohibited drug at the relevant time, whereas the Minister asserted that "approved" refers to approval in the past. Celgene also asserted that its interpretation of the Food and Drug Regulations accorded with the purpose and object of data protection: "to promote innovation and protect innovators against unfair use of their confidential data gathered at great cost." The majority preferred the Minister's interpretation, holding that the words of the Food and Drug Regulations "do not lend themselves easily to the construction proposed by Celgene" and that protection given to confidential data is limited to certain innovations only. The Court was also concerned that Celgene's interpretation of the Food and Drug Regulations could "open the door to all kinds of unintended scenarios."
The dissenting judge focused only on whether thalidomide could be considered to be "previously approved." Citing the legislative history of the treatment of thalidomide and case law on data protection, he held that the previous approval of thalidomide was nullified and thus that data protection should extend to THALOMID. Given the highly unusual fact situation, he also rejected the Minister's "slippery slope" argument that allowing data protection for THALOMID would open the floodgates for other drugs with inconsistent approval histories.
This is the second split decision this year from the Court of Appeal on data protection. The first was the Court's decision on dismissing Takeda's appeal and affirming the Minister of Health's refusal to list DEXILANT (dexlansoprazole) on the Register of Innovative Drugs (see the February 2013 edition of Rx IP Update).
Celgene Inc v The Minister of Health, February 15, 2013.
Federal Court of Appeal decision — 2013 FCA 43.
Federal Court decision — 2012 FC 154.
Federal Court of Appeal dismisses Apotex's appeals of Orders requiring it to provide samples. On February 19, 2013, the Federal Court of Appeal dismissed three appeals and affirmed the Orders below requiring Apotex to provide samples of its raloxifene hydrochloride, escitalopram and esomeprazole magnesium for the purpose of conducting tests for litigation. Sanofi, Lundbeck and AstraZeneca had separately brought motions under Rule 249 to obtain samples of Apotex's drug products (the samples sought differed between the three cases but included bulk material, intermediate materials, finished drug product, and excipients). The Court of Appeal noted that the use of the words "necessary or expedient" in Rule 249 was intended to give broad discretion to the Court and that Rule 249 requires the Court to "balance any number of factors relevant to the three main interests at play: those of the party requesting the inspection or samples, those of the party in possession of the property concerned and those of the trier of fact." The Court of Appeal further noted that "in complex pharmaceutical patent cases like the present ones, the usual mechanism of discovery may well not suffice and parties will often have to rely on Rule 249."
Apotex Inc v Eli Lilly Canada Inc, February 19, 2013.
Federal Court of Appeal decision — 2013 FCA 45.
Federal Court decision — 2012 FC 880.
Apotex Inc v H Lundbeck A/S, February 19, 2013.
Federal Court of Appeal decision — 2013 FCA 46.
Apotex Inc v AstraZeneca Canada Inc, February 19, 2013.
Federal Court of Appeal decision — 2013 FCA 47.
Federal Court decision — 2012 FC 991.
Ontario Superior Court declines to strike claims against Attorney General of Canada for conduct in dealing with new drug submissions. Apotex is suing the Attorney General of Canada seeking damages as a result of the defendant's conduct in dealing with regulatory submissions filed by Apotex with respect to 11 drug products. The Attorney General of Canada brought a motion seeking to strike portions of the statement of claim and seeking an order for particulars. Justice Frank struck the claim of unlawful discrimination on the basis that there is no reasonable prospect of success. However, references to bad faith, breach of statutory duty and discrimination were allowed to remain in the pleading as supporting the claim for misfeasance in public office. The Court held that it was not plain and obvious that the claims with respect to Apo-ASA, Apo-Lansoprazole, Apo-Pantoprazole and Apo-Omeprazole were barred by res judicata or were frivolous, vexatious or otherwise an abuse of process in light of (as argued by the Attorney General) the Federal Court of Appeal decision Apotex Inc v Canada (Health), 2011 FCA 86 (reported in the April 2011 edition of Rx IP Update). Justice Frank also declined to strike the claims for lost section 8 damages (the difference between the losses it recovered, if any, from the innovators and what it would have recovered from them but for the impugned acts of the defendant) due to actions of the defendant delaying the issuance of NOCs. Finally, the Court declined to order particulars.
Apotex Inc v Canada, February 11, 2013.
Ontario Superior Court decision — 2013 ONSC 986.
Eli Lilly granted leave to appeal Ontario Superior Court's dismissal of motion to strike claims for unjust enrichment. On February 22, 2013, the Ontario Divisional Court granted Eli Lilly's motion for leave to appeal a decision of the Ontario Superior Court declining to strike claims for, inter alia, damages or an accounting of profits pursuant to sections 7 and 53.2 of the Trademarks Act, disgorgement of revenues or profits from the sale of STRATTERA (atomoxetine), and damages or an accounting of profits as may be otherwise available in law, all based on an allegation of delay in marketing its generic version of atomoxetine by the steps that Eli Lilly took under the PMNOC Regulations. The Ontario Superior Court decision was reported in the August 2012 edition of Rx IP Update.
With respect to the Ontario Superior Court's dismissal of the motion to strike the claim for profits based on unjust enrichment, Justice Ducharme noted that the decision of Justice Quigley in Apotex v Takeda and Abbott, 2013 ONSC 356 (reported in the January 2013 edition of Rx IP Update), conflicts with the decision of the Motions Judge in the present case. Justice Ducharme also noted that the appeal raises issues of general importance as the decision affects all innovator and generic companies involved in the PMNOC Regulations and, to the extent that the decision differs from the jurisprudence of the Federal Court, it could lead to forum shopping. Accordingly, leave to appeal on this issue was granted.
With respect to the Ontario Superior Court's dismissal of the motion to strike the claim for damages under the Trademarks Act, Justice Ducharme declined to grant leave to appeal on the basis that there was no conflicting decision and no reason to doubt the correctness of the decision on this issue.
Apotex Inc v Eli Lilly, February 22, 2013.
Ontario Divisional Court leave to appeal decision — 2013 ONSC 1135.
Ontario Superior Court decision — 2012 ONSC 3808.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
|
Medicine:
|
tadalafil (CIALIS, ADCIRCA)
|
|
Applicant:
|
Eli Lilly Canada Inc
|
|
Respondents:
|
Apotex Inc and The Minister of Health
|
|
Respondent/Patentee:
|
ICOS Corporation
|
|
Date Commenced:
|
January 24, 2013
|
|
Court File No.:
|
T-169-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,371,684. Apotex alleges invalidity and non-infringement.
|
|
Medicine:
|
tadalafil (CIALIS, ADCIRCA)
|
|
Applicant:
|
Eli Lilly Canada Inc
|
|
Respondents:
|
Apotex Inc and The Minister of Health
|
|
Respondent/Patentee:
|
ICOS Corporation
|
|
Date Commenced:
|
January 24, 2013
|
|
Court File No.:
|
T-171-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,379,948. Apotex alleges invalidity and non-infringement.
|
|
Medicine:
|
tadalafil (CIALIS)
|
|
Applicant:
|
Eli Lilly Canada Inc
|
|
Respondents:
|
Apotex Inc and The Minister of Health
|
|
Respondent/Patentee:
|
ICOS Corporation
|
|
Date Commenced:
|
January 24, 2013
|
|
Court File No.:
|
T-172-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,226,784. Apotex alleges invalidity and non-infringement.
|
|
Medicine:
|
tadalafil (CIALIS, ADCIRCA)
|
|
Applicant:
|
Eli Lilly Canada Inc
|
|
Respondents:
|
Apotex Inc and The Minister of Health
|
|
Respondent/Patentee:
|
ICOS Corporation
|
|
Date Commenced:
|
January 24, 2013
|
|
Court File No.:
|
T-173-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,380,087. Apotex alleges invalidity and non-infringement.
|
|
Medicine:
|
travaprost (TRAVATAN Z)
|
|
Applicants:
|
Alcon Canada Inc and Alcon Research Ltd
|
|
Respondents:
|
Mylan Pharmaceuticals ULC and The Minister of Health
|
|
Date Commenced:
|
January 25, 2013
|
|
Court File No.:
|
T-176-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patents Nos. 2,129,287 and 2,606,370. Mylan alleges invalidity and non-infringement with respect to the ’287 patent, and ineligibility for listing and invalidity with respect to the ’370 patent.
|
|
Medicine:
|
pregabalin (LYRICA)
|
|
Applicants:
|
Pfizer Canada Inc and Warner-Lambert Company LLC
|
|
Respondents:
|
Pharmascience Inc and The Minister of Health
|
|
Date Commenced:
|
January 28, 2013
|
|
Court File No.:
|
T-185-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,255,652. Pharmascience alleges invalidity and non-infringement.
|
|
Medicine:
|
gliclazide MR (DIAMICRON MR)
|
|
Applicants:
|
Les Laboratoires Servier and Servier Canada Inc
|
|
Respondents:
|
The Minister of Health and Apotex Inc
|
|
Date Commenced:
|
January 31, 2013
|
|
Court File No.:
|
T-222-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,629,670. Apotex alleges invalidity and non-infringement.
|
|
Medicine:
|
rivastigmine (EXELON PATCH)
|
|
Applicant:
|
Novartis Pharmaceuticals Canada Inc
|
|
Respondents:
|
Cobalt Pharmaceuticals Company and the Minister of Health
|
|
Respondent/Patentee:
|
Novartis AG and LTS Lohmann Therapie-Systeme AG
|
|
Date Commenced:
|
February 4, 2013
|
|
Court File No.:
|
T-238-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,315,784. Cobalt alleges invalidity and non-infringement.
|
|
Medicine:
|
tadalafil (CIALIS)
|
|
Applicant:
|
Eli Lilly Canada Inc
|
|
Respondents:
|
Mylan Pharmaceuticals ULC and the Minister of Health
|
|
Respondent/Patentee:
|
ICOS Corporation
|
|
Date Commenced:
|
February 14, 2013
|
|
Court File No.:
|
T-294-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,181,377. Mylan alleges invalidity and non-infringement.
|
|
Medicine:
|
tadalafil (CIALIS)
|
|
Applicant:
|
Eli Lilly Canada Inc
|
|
Respondents:
|
Mylan Pharmaceuticals ULC and the Minister of Health
|
|
Respondent/Patentee:
|
ICOS Corporation
|
|
Date Commenced:
|
February 14, 2013
|
|
Court File No.:
|
T-295-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,380,087. Mylan alleges invalidity and non-infringement.
|
|
Medicine:
|
tadalafil (CIALIS)
|
|
Applicant:
|
Eli Lilly Canada Inc
|
|
Respondents:
|
Mylan Pharmaceuticals ULC and the Minister of Health
|
|
Respondent/Patentee:
|
ICOS Corporation
|
|
Date Commenced:
|
February 14, 2013
|
|
Court File No.:
|
T-296-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,226,784. Mylan alleges invalidity and non-infringement.
|
|
Medicine:
|
tadalafil (CIALIS)
|
|
Applicant:
|
Eli Lilly Canada Inc
|
|
Respondents:
|
Mylan Pharmaceuticals ULC and the Minister of Health
|
|
Respondent/Patentee:
|
ICOS Corporation
|
|
Date Commenced:
|
February 14, 2013
|
|
Court File No.:
|
T-298-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,371,684. Mylan alleges invalidity and non-infringement.
|
|
Medicine:
|
tadalafil (CIALIS)
|
|
Applicant:
|
Eli Lilly Canada Inc
|
|
Respondents:
|
Mylan Pharmaceuticals ULC and the Minister of Health
|
|
Respondent/Patentee:
|
ICOS Corporation
|
|
Date Commenced:
|
February 14, 2013
|
|
Court File No.:
|
T-299-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,379,948. Mylan alleges invalidity and non-infringement.
|
|
Medicine:
|
celecoxib (CELEBREX)
|
|
Applicants:
|
Pfizer Canada Inc and GD Searle & Co
|
|
Respondents:
|
Mylan Pharmaceuticals ULC and The Minister of Health
|
|
Date Commenced:
|
February 15, 2013
|
|
Court File No.:
|
T-308-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,177,576. Mylan alleges invalidity.
|
|
Medicine:
|
ciprofloxacin hydrochloride (CIPRO)
|
|
Applicants:
|
Bayer Inc and Bayer Intellectual Property GmbH
|
|
Respondents:
|
Mylan Pharmaceuticals ULC and The Minister of Health
|
|
Date Commenced:
|
February 15, 2013
|
|
Court File No.:
|
T-328-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,414,271. Mylan alleges invalidity and non-infringement.
|
Other proceedings
|
Medicine:
|
nicotine gum (Chu; Nicotine Gum; Nicotine Polacrilex Gum Usp; Preferred Pharmacy Nicotine Gum)
|
|
Plaintiffs:
|
Fertin Pharma A/S and Gumlink A/S
|
|
Defendant:
|
Revolymer PLC (aka Revolymer (UK) Limited and Revolymer Limited)
|
|
Date Commenced:
|
January 29, 2013
|
|
Court File No.:
|
T-190-13
|
|
Comment:
|
Infringement action regarding Patent No. 2,440,016.
|
|
Medicine:
|
pregabalin (LYRICA)
|
|
Plaintiff:
|
Apotex Inc
|
|
Defendants:
|
Pfizer Canada Inc, Warner-Lambert Company LLC, and Northwestern University
|
|
Date Commenced:
|
February 11, 2013
|
|
Court File No.:
|
T-275-13
|
|
Comment:
|
Action seeking a declaration of invalidity regarding Patents Nos. 2,134,674 and 2,255,652; a declaration of non-infringement regarding APO-Pregabalin; and a declaration that Apotex need not address the patents for the purposes of the PMNOC Regulations.
|
To check the status of Federal Court cases, please click here.
|
