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Federal Court permits quia timet infringement claim to proceed
by Abigail Smith »
The test for sustaining a patent infringement action based on quia timet patent infringement (i.e. a claim based on likely future infringement) requires that the claim allege a deliberate expressed intention to engage in activity the result of which would raise a strong possibility of infringement; the activity must be alleged to be imminent and the resulting damage to the plaintiff must be alleged to be very substantial if not irreparable; and the facts pleaded must be cogent, precise and material: Connaught Laboratories Ltd v Smithkline Beecham Pharma Inc, 158 FTR 194. To date, very few such patent infringement actions have survived a motion to strike. As a result, most infringement actions are commenced only after the alleged infringer has received its notice of compliance (NOC) and/or has launched.
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Supreme Court news
Supreme Court hearing in NEXIUM/utility case scheduled — As reported in our IP Update, the Supreme Court of Canada granted AstraZeneca leave to appeal a Federal Court of Appeal (FCA) decision, affirming a trial decision invalidating its patent relating to esomeprazole (NEXIUM) for lack of utility. The hearing is tentatively scheduled for November 8, 2016.
Supreme Court dismisses Pfizer’s application for leave to appeal in Teva-sildenafil section 8 action — On April 7, 2016, the Supreme Court denied Pfizer leave to appeal the decision in Pfizer Canada Inc v Teva Canada Limited, 2015 FCA 257 in relation to Teva-sildenafil. As we previously reported, the FCA had upheld the decision of the Federal Court dismissing Pfizer’s motion for summary judgment in which Pfizer argued that a settlement agreement between Pfizer and ratiopharm (subsequently acquired by Teva) for ratio-sildenafil precluded a section 8 action for Novo-sildenafil (now Teva-sildenafil). The FCA held that the settlement agreement did not show that the parties intended to encompass damages arising from lost sales of Novo-sildenafil, which was a different drug covered by an Abbreviated New Drug Submission filed by what was then a separate company.
Supreme Court news release, docket.
Federal Court of Appeal decision — 2015 FCA 257.
Federal Court decision — 2015 FC 760.
Competition Bureau releases updated Intellectual Property Enforcement Guidelines
As previously reported in an IP Update, the Competition Bureau released a final updated version of its Intellectual Property Enforcement Guidelines (IPEGs) on March 31, 2016. The IPEGs describe the Bureau’s approach to conducting investigations of alleged anti competitive activities that relate to intellectual property. This updated final version follows consultation which took place in 2015 on the draft IPEGs released in June 2015, reported here. Of particular interest to the pharmaceutical industry are the examples outlining product switching, and the section relating to settlements of proceedings under the PMNOC Regulations. Regarding product switching, the IPEGs distinguish between a “hard switch”, where the original product is withdrawn from the market, and a “soft switch”, where the original product remains on the market. While the latter is likely not an issue under the Competition Act, a “hard switch” is likely to be investigated for anti-competitive effects. The section of the IPEGs dealing with the settlement of PMNOC proceedings includes many of the same examples and considerations included in the draft version (see our article on the draft IPEGs here). These final IPEGs include an additional example of a settlement agreement in which the brand firm withdraws one of its products that compete with a generic product, but the product is not the subject of the PMNOC proceedings at hand. Absent a legitimate justification, the Bureau would investigate such an agreement as a possible contravention of market allocation provisions.
Health Canada News
Consultation on draft guidance document regarding disclosure of confidential business information. On March 10, 2016, Health Canada released a draft guidance document, “Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act,” and will receive comments until May 24, 2016. Paragraph 21.1(3)(c) of the Food and Drugs Act came into force on November 6, 2014 as part of the Vanessa’s Law amendments, formally known as Protecting Canadians from Unsafe Drugs Act (see our prior articles on this topic: here and here). This paragraph allows the Minister of Health to disclose, without notice, confidential business information (CBI) about a therapeutic product to a person who carries out functions relating to the protection or promotion of human health or the safety of the public if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public. The draft guidance document describes Health Canada’s implementation of the discretionary authority under paragraph 21.1(3)(c) by providing the broad principles, considerations and processes that Health Canada will use when deciding whether or not to disclose the CBI.
Notice. Draft Guidance Document.
Health Canada issues several notices regarding the required format of regulatory filings. On March 2, 2016, Health Canada issued three notices regarding the proper format and content of certain regulatory filings:
- Instructions for filing Drug Notification Forms (DNF) and Supporting Documents Provided in Electronic Format. Sponsors must submit a DNF to Health Canada within 30 days of commencing sale of a drug. The notice provides details as to which DNF submissions must also include labelling information. This notice further states that effective immediately, DNFs or supporting documents provided in paper format will not be accepted.
- Preparation of Division 8 Regulatory Activities in the “Non-eCTD Electronic-Only” Format. Health Canada will now accept Division 8 regulatory activities for human drugs in “non-eCTD electronic-only” format. Division 8 activities include submissions such as new drug submissions, supplemental new drug submissions, and abbreviated new drug submissions and related transactions including Form IVs (i.e. patent lists and updates thereto), filed in accordance with the PMNOC Regulations. Effective June 1, 2016, Health Canada will no longer accept paper copies of transactions for these regulatory activities.
- Preparation of Clinical Trial Regulatory Activities in the “Non-eCTD Electronic-Only” Format. Health Canada will now accept Clinical Trial Applications in “non-eCTD electronic-only” format. Effective June 1, 2016, Health Canada will no longer accept paper copies of transactions for these regulatory activities or their related transactions.
Notice: Instructions for filing Drug Notification Forms (DNF) and Supporting Documents Provided in Electronic Format.
Notice: Preparation of Division 8 Regulatory Activities in the "Non-eCTD Electronic-Only" Format.
Notice: Preparation of Clinical Trial Regulatory Activities in the "Non-eCTD Electronic-Only" Format.
PMPRB set to hear allegations of breach of reporting requirements for Baxalta’s ONCASPAR
The Patented Medicine Prices Review Board (PMPRB) will hold a public hearing with respect to allegations that Baxalta Canada Corp. failed to provide the PMPRB with pricing and sales information in relation to its leukemia drug ONCASPAR (pegaspargase). Those wishing to participate must apply for leave to intervene by May 2, 2016.
Notice of Hearing, PMPRB Press Release.
Federal Court holds issued patent valid despite erroneous issue fee payment
As reported in our IP Update, in a February 4, 2016 decision, Apotex Inc v Pfizer Canada Inc, 2016 FC 136, the Federal Court found that an erroneous underpayment of a “final fee” to issue a patent did not invalidate the issued patent relating to XALATAN, and therefore Pfizer’s counterclaim for infringement against Apotex could proceed. Apotex has appealed.
Federal Court upholds Prothonotary decision refusing to bifurcate liability and quantification of section 8 action and infringement counterclaim
In an appeal of a Prothonotary’s order refusing to grant a bifurcation order between liability and quantification issues for both a section 8 action and infringement counterclaim relating to bortezomib (Janssen’s VELCADE), Justice Diner held that the Prothonotary did not err in her analysis and dismissed the appeal. The Prothonotary properly considered all of the factors for bifurcation and the findings were reasonable. Although one could have arrived at the opposite conclusion, this was not sufficient to overturn as it would subvert the high degree of deference owed to a discretionary decision of the Prothonotary.
Teva Canada Limited v Janssen Inc, 2016 FC 318.
June 2015 amendments to PMNOC Regulations relating to combination drugs found not to apply to motion filed before May 2, 2015
By notice of motion dated March 6, 2015, Apotex sought an order under subsection 6(5)(a) of the PMNOC Regulations to dismiss Gilead’s prohibition application regarding TRUVADA (a combination drug of tenofovir disoproxil fumarate/emtricitabine) on the grounds that the asserted patent relating to tenofovir disoproxil and its salts was improperly listed on the Patent Register. As we previously reported, amendments were made to the PMNOC Regulations which came into force on June 19, 2015, changing the requirements for listing of patents in relation to combination drugs. Prior to the amendment, patents claiming only one of the active ingredients in a combination drug were not eligible for listing. The transitional provisions for the amendment stated that it applied to “ongoing motion[s] … initiated during the period that begins on May 2, 2015 and ends on the day on which this section comes into force”. The Court rejected Gilead’s argument that the amended provisions applied, and as a result, applying the rulings in Gilead Sciences Canada Inc v Canada (Minister of Health), 2012 FCA 254 and ViiV Healthcare ULC v Teva Canada Limited, 2015 FCA 93, held that Gilead’s patent for tenofovir disoproxil salts was ineligible for listing on the Patent Register in relation to TRUVADA. Gilead has appealed.
Gilead Sciences, Inc v Canada (Minister of Health), 2016 FC 231.
Federal Court dismisses Shire’s application against Apotex relating to ADDERALL XR
On April 7, 2016, the Federal Court dismissed Shire’s application for an order of prohibition relating to Apotex’s generic version of Shire’s Adderall XR (extended-release capsules of mixed amphetamine salts). The Court found that Apotex’s allegations of non-infringement in relation to Patent No. 2,348,090 were justified. The patent claims an oral pulsed drug delivery system for treating ADHD. The system delivers the drug by means of a first pulse followed by a delayed second pulse, and is intended to mimic the twice daily dosing known to be effective in treating ADHD. Apotex successfully asserted non-infringement, arguing generally that its product did not deliver drug using the same pulsed system. While Apotex argued that the evidence of its expert witnesses should be favoured over the evidence of Shire’s experts because Apotex “blinded” its experts as to prior art/its product when seeking their opinions on construction, whereas Shire did not, the Court did not find the blinding to be determinative.
Shire Canada Inc v Apotex Inc, 2016 FC 382.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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desvenlafaxine succinate (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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Apotex Inc and The Minister of Health
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Date Commenced:
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March 7, 2016
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Court File No.:
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T-402-16
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,436,668. Apotex alleges non-infringement and invalidity.
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Medicine:
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adapalene/benzoyl peroxide (TACTUPUMP)
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Applicant:
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Galderma Canada Inc
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Respondents:
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Taro Pharmaceuticals Inc, Taro Pharmaceuticals U.S.A., Inc and The Minister of Health
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Respondent/Patentee:
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Galderma Research & Development, FR
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Date Commenced:
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March 23, 2016
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Court File No.:
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T-488-16
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Comment:
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Application seeking an Order declaring that Taro Pharmaceuticals U.S.A. (“Taro U.S.A.”) is not a second person and that the letter sent by Taro U.S.A. is not a notice of allegation. Galderma submits that Taro U.S.A. was not the entity that filed the abbreviated new drug submission. Galderma seeks in the alternative an Order of prohibition regarding Patent No. 2,466,321. Taro alleges non-infringement and invalidity.
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