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Section 8 cases: Supreme Court dismisses sanofi-aventis' ramipril appeal; Ontario Court of Appeal dismisses Apotex's atomoxetine unjust enrichment appeal
by Andrew Mandlsohn »
Section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") in broad terms provides for damages to a generic manufacturer if the innovator is unsuccessful in a prohibition proceeding.
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Court of Appeal upholds Order prohibiting Cobalt NOC for generic of Bayer's YAZ, comments on standard of review for construction
by Urszula Wojtyra »
As reported previously, the Federal Court issued an Order of prohibition against Cobalt for its proposed generic version of Bayer's YAZ (drospirenone and ethinyl estradiol) until the expiry of one of two patents. Cobalt appealed the Order of prohibition, while Bayer appealed the Order dismissing Bayer's application in respect of the second patent. On May 4, 2015, the Federal Court of Appeal dismissed both appeals: Bayer Inc v Cobalt Pharmaceuticals, 2015 FCA 116, aff'g 2013 FC 1061.
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Supreme Court denies leave to appeal in celecoxib litigation
As we reported previously, the Federal Court of Appeal upheld prohibition Orders in the celecoxib litigation and rejected Mylan and Apotex's arguments relating to the "promise" of the patent. The Supreme Court has denied leave to appeal to both Mylan and Apotex.
Mylan Pharmaceutical ULC v Pfizer Canada Inc, et al, SCC Case No. 36228.
Apotex Inc v Pfizer Canada Inc, et al, SCC Case No. 36227.
Federal Court decisions — 2014 FC 38 (Mylan); 2014 FC 314 (Apotex).
Federal Court of Appeal — 2014 FCA 250.
Health Canada News
New online access to information on inspections of companies that manufacture and sell drug products. On April 13, 2015, the Health Minister announced the launch of the Drug and Health Product Inspections Database. This online resource provides information on inspections since 2012 of companies that manufacture and sell drug products for the Canadian market, whether the companies are located in Canada or abroad. Health Canada also maintains the Inspection Tracker: Drug Manufacturing Establishments, which publishes information regarding emerging issues identified by Health Canada's drug inspection program.
Announcement; Drug and Health Product Inspections Database.
Online Drug Product Database scope expanded. On April 24, 2015, Health Canada announced that the online Drug Product Database, found here, will be expanded to include all approved products, including human, veterinary, disinfectants and Schedule C drugs (for example, radiopharmaceutical products), at the time of authorization. Currently, approved but not marketed products are not available online.
This expansion in scope stems in part from implementation of the brand name assessment required in the Plain Language Labelling Regulations, reported previously, which come into force in June 2015. The new Regulations will require sponsors to conduct a brand name assessment against all products in respect of which a Drug Identification Number (DIN) has been assigned and all Schedule C drugs authorized for sale in Canada. Products will be listed as "Approved," "Marketed," "Cancelled Pre-Market," "Cancelled Post-Market" or "Pending change in brand name/manufacturer." The expanded Drug Product Database will assist in this assessment, and the changes are scheduled to be implemented in June 2015.
Notice: Posting information in the Drug Product Database Online.
Release of Final Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience). On May 1, 2015, Health Canada released the final version of the Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience). The Guidance Document applies to New Drug Submissions (NDSs) or Supplementary NDSs involving pharmaceuticals, certain biologics, and radiopharmaceuticals that substantially rely on literature and market experience to support the clinical safety/efficacy of the proposed products.
The Guidance Document lists conditions and requirements for such submissions including:
- a rationale must be provided to explain why a conventional drug submission was not assembled;
- evidence establishing that the product used in studies reported in the literature (i.e. reference product) is representative of the proposed commercial product;
- evidence of extensive current foreign market experience with the same medicinal ingredient (for a minimum of 10 years under the same conditions of use), or evidence that the same medicinal ingredient is currently or has previously been marketed in Canada (under the same conditions of use); and,
- a pre-submission meeting with Health Canada to discuss the safety and efficacy evidence required to support market authorization and the data requirements to bridge the proposed product to the reference product.
The Guidance Document emphasizes:
Clinical studies reported in the literature and included in the submission will not be considered sufficient to establish the clinical safety and efficacy required by the Regulations unless it is demonstrated that the proposed commercial product will have the same in vivo performance as the reference product used in the studies reported in the literature.
For solid oral dosage forms, demonstration of comparative bioavailability between the proposed and the reference products would be required.
The Guidance Document also indicates that if the submission contains direct or indirect comparisons with, or references to a Canadian product that is still marketed in Canada, the PM(NOC) Regulations and/or data protection provisions will be triggered. Further, reliance on foreign products cannot be used to circumvent intellectual property considerations.
While not referenced in the Guidance Document, at least one Submission Relying on Third-Party Data (SRTD) has been the subject of judicial consideration. As reported previously, in Hospira Healthcare Corporation v Attorney General of Canada (Minister of Health) 2010 FCA 345, the Federal Court of Appeal granted Hospira's judicial review, and required the Minister to reconsider her refusal of an NOC. The Court of Appeal held that the Minister has the discretion to permit, for example, reports of clinical trials conducted by others to meet the requirements of safety and efficacy in an NDS. Hospira's NDS continues to be the subject of judicial consideration as Hospira has sought judicial review of the Minister's subsequent refusal to issue an NOC on the basis of data protection (Federal Court File No. T-1963-13).
Notice; Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience).
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Teva's application for prohibition order against Apotex for rasagiline dismissed. On December 19, 2014, Justice Gleason dismissed Teva's application for a prohibition order for rasagiline (Teva's AZILECT). The patent disclosed that the stability of rasagiline formulations can be significantly improved by the addition of large amounts of pentahydric or hexahydric alcohols. The claims at issue were composition claims that included at least 60% by weight of a pentahydric or hexahydric alcohol. The sole issue was infringement, which turned on the construction of the terms "pentahydric and hexahydric alcohols." Justice Gleason preferred Apotex's experts' evidence on construction over that of Teva's including as Apotex's experts were not, unlike Teva's, provided with the identification of the alcohol used in Apotex's product before providing their construction opinions. Having regard to this construction, the allegation of non-infringement was justified.
Teva Canada Innovation et al v Apotex Inc et al, 2014 FC 1070.
Federal Court summarily dismisses portion of application relating to Bayer's AVELOX I.V. On March 26, 2015, Prothonotary Lafrenière granted Pharmaceutical Partners of Canada Inc. ("PPC")'s motion to strike portions of the application pursuant to paragraph 6(5)(b) of the PM(NOC) Regulations relating to moxifloxacin hydrochloride for injection (Bayer's AVELOX I.V.). PPC sought an order striking the application as it relates to one of three patents on the basis that it is scandalous, frivolous and vexatious or is otherwise an abuse of process. On the motion, PPC relied solely on the expert affidavit evidence served by Bayer in the application relating to the infringement or induced infringement of the patent. The facts on the motion were not in dispute as Bayer did not advance any further evidence on the motion and PPC did not seek to cross-examine Bayer's experts. Bayer conceded that there was no evidence of direct infringement by PPC but maintained that PPC's activities would induce or procure others to infringe the subject patent.
The Court held there is nothing in PPC's product monograph that is capable of establishing that PPC will infringe the patent by inducing infringement by others. The portion of the application sought to be struck would therefore "inevitably fail" and was therefore "vexatious" within the meaning of s. 6(5). Accordingly, the Court granted the motion to strike. The Federal Court has reserved its decision on Bayer's appeal, which was heard on May 5.
Bayer Inc v Pharmaceutical Partners of Canada Inc, 2015 FC 388.
Takeda's application regarding Apotex's ciclesonide dismissed. In a decision dated May 1, 2015, Justice O'Reilly of the Federal Court dismissed Takeda's prohibition application regarding Apotex's ciclesonide (Takeda's OMNARIS), finding that Takeda had not met its burden on obviousness regarding three patents (2,388,322; 2,388,325; and 2,538,419). Justice O'Reilly found, "All three patents in issue reflect the state of the art and the common general knowledge of the respective skilled persons at the relevant time. Even if there had been gaps between the prior art and the patents' inventive concepts, no inventive steps would have been required to bridge them."
Takeda Canada Inc v Apotex Inc, 2015 FC 570.
Other
Court enforces terms of settlement between Allergan and Apotex in patent infringement action. On March 24, 2015, Justice Hughes of the Federal Court granted Allergan's motion to enforce terms of settlement offered by Apotex in a patent infringement related to gatifloxacin (Allergan's ZYMAR). Justice Hughes held that Apotex had made an offer to settle, which had not been withdrawn when Allergan accepted it in February 2014. He therefore enforced the settlement agreement, granting an Order dismissing the infringement action, enjoining Apotex from manufacturing gatifloxacin for commercial sale, and limiting Apotex's use of gatifloxacin to regulatory and/or experimental use. Apotex has appealed.
Allergan, Inc v Apotex Inc, 2015 FC 367.
Trademark decisions
Trademark Opposition Board's refusal to register VIAGRA Tablet design upheld. On April 20, 2015, the Federal Court dismissed Pfizer's appeal of the Trademark Opposition Board decision refusing to register an application for a trademark of a blue diamond-shaped pill associated with "a pharmaceutical preparation for the treatment of sexual dysfunction" (1,244,118) on the basis of lack of distinctiveness. The Canadian Generic Pharmaceutical Association (CGPA) opposed the registration.
The Federal Court extensively reviewed prior decisions relating to trademarks for pharmaceutical products, concluding that trademark law applies to the pharmaceutical industry the same as it does to all other industries. As a result, Pfizer had to adduce sufficient evidence to establish that, on a balance of probabilities, consumers (including physicians, pharmacists, and patients) associate the mark with a single source of manufacture to a significant degree. There is no need to establish distinctiveness amongst patients, physicians and pharmacists.
The Court found that Pfizer's evidence failed to establish that patients, physicians or pharmacists associate the appearance of the pill in question with its source to any significant degree: "the limited use which physicians, pharmacists and patients may make of the appearance of the Viagra pill for identification purposes is not enough to establish the distinctiveness required for a valid trade-mark."
Pfizer Canada Inc v Canadian Generic Pharmaceutical Association, 2015 FC 493.
Interlocutory injunction against Jamieson Laboratories in trademark matter upheld on appeal. As we reported in an IP Update, the Federal Court had granted an interlocutory injunction against Jamieson Laboratories pending disposition of an action brought by Reckitt to enforce the latter's MEGARED trademark, used for omega-3 supplements. On April 23, 2015, the Federal Court of Appeal upheld the injunction against Jamieson, but modified the terms of the Order to allow for a 30 day period from the date of the order for Jamieson to comply.
Jamieson Laboratories Ltd v Reckitt Benckiser LLC, 2015 FCA 104, varying 2015 FC 215.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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cinacalcet hydrochloride (SENSIPAR)
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Applicants:
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Amgen Canada Inc and Amgen Inc
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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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April 16, 2015
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Court File No.:
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T-601-15
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,536,487. Apotex alleges patent ineligibility, non-infringement, and invalidity.
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Medicine:
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pemetrexed disodium (ALIMTA)
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Applicants:
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Eli Lilly Canada Inc
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Respondents:
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Apotex Inc and The Minister of Health
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Respondent/Patentee:
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Takeda Pharmaceutical Company Limited
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Date Commenced:
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April 10, 2015
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Court File No.:
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T-556-15
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Comment:
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Application for Order of prohibition until expiry of Patent No. 1,340,794. Apotex alleges non-infringement and invalidity.
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Other proceedings
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Medicine:
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marihuana
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Applicants:
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CEN Biotech Inc
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Respondent:
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The Minister of Health
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Date Commenced:
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April 10, 2015
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Court File No.:
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T-550-15
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Comment:
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Application seeking an Order directing the Minister of Health to issue to the applicant a licence to be a Licensed Producer under the Marihuana for Medical Purposes Regulations.
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Medicine:
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olopatadine (PATADAY)
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Plaintiffs:
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Alcon Canada Inc, Alcon Laboratories, Inc, Alcon Pharmaceuticals Ltd, and Alcon Research, Ltd
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Defendants:
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Apotex Inc
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Date Commenced:
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April 14, 2015
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Court File No.:
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T-574-15
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Comment:
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Infringement action regarding Patent No. 2,447,924.
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Medicine:
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olopatadine (PATADAY)
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Plaintiffs:
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Alcon Canada Inc, Alcon Laboratories, Inc, Alcon Pharmaceuticals Ltd, and Alcon Research, Ltd
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Defendants:
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Actavis Pharma Company
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Date Commenced:
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April 14, 2015
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Court File No.:
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T-574-15
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Comment:
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Infringement action regarding Patent No. 2,447,924.
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Medicine:
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Janssen Inc and Janssen Sciences Ireland UC
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Respondents:
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The Attorney General of Canada and The Commissioner of Patents
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Date Commenced:
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April 15, 2015
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Court File No.:
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T-590-15
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Comment:
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Application to vary all entries in the records of CIPO with respect to inventorship of Patent No. 2,485,834 by adding Piet Tom Bert Paul Wigerinck as co-inventor.
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